AstraZeneca PLC (LON:AZN)

Earnings Call: Q3 2026

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Oct 30, 2026

Summary

Nine-month revenue rose 7% and core EPS 14%, as oncology, rare disease and R&I growth offset CVRM erosion. FY guidance was reiterated, with more than 20 phase III readouts planned for 2027.

A warm welcome to AstraZeneca's nine-month and third quarter 2026 presentation conference call and webcast for investors and analysts. I'm Joris Silon, Head of Investor Relations, and before I hand over to Pascal and 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, please. 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, for 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, and 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, and Pascal, over to you. Thank you, Joris, and welcome, everybody. Next slide, please. I'm pleased to report that our strong growth momentum and pipeline delivery have continued through the first nine months of 2026. This reflects the progress we're making across our strategic priorities, and above all, the focus and the commitment of teams across our company. Total revenue grew 7% and core EPS increased 14%. Excluding Farxiga and Brilinta, total revenue grew 12%, demonstrating the underlying strength of our broad portfolio. Since our full-year results in February, we've announced positive results from 12 phase III programs, and we've achieved first approvals for four new medicines, including Adakama in the U.S. This brings our total number of approved new molecular entities to 14, as we progress towards our goal of delivering 20 new medicines by 2030. We've also presented positive phase III data for three new molecular entities, tozorakimab in COPD, efzimfotase alfa in HPP, and Sone-Ve, our first wholly owned ADC, including claudin 18.2-positive gastric cancer. With commercial momentum continuing and a deep late-stage pipeline advancing, we are increasingly confident in our ability to deliver our 2030 ambition, as well as sustainable long-term growth through the next decade. Next slide, please. Our strong performance is underpinned by the breadth of our therapy areas and our geographical footprint. In the first nine months, oncology, rare disease, and R&I all delivered double-digit growth. Together, they more than offset the expected headwinds we've seen from the loss of exclusivity of Farxiga and Brilinta in CVRM. We've also delivered robust growth across the U.S., Europe, and the emerging markets outside of China. In China, growth continued to be impacted by volume-based procurement. But excluding this impact, China grew 13%, with growth across all therapy areas. Next slide, please. Over the first 9 months of the year, we saw positive results from 12 important phase III programs. Let me say a couple of words about some of these. Tozorakimab has enormous potential, and we are now developing it beyond COPD. Volrustomig again is a blockbuster opportunity. I also want to come back on the Tagrisso franchise. A few years ago, we were told Tagrisso was going to be challenged by the launch of competitor regimens. Look at what we've done. The combination with Orpathys has the potential to drive both broader first-line use as well as longer Tagrisso-based treatment duration, keeping patients on Tagrisso rather than switching them off, and therefore protecting the franchise from newcomers. We have really made tremendous progress with Tagrisso. VOLGA is another example of building the Imfinzi franchise. Lastly, efzimfotase alfa and Sone-Ve could both become $3 billion-$5 billion products, depending on the type of label we get. You can see that we have added quite a number of substantial opportunities to our growth potential. Together, this positive readout represents more than $10 billion in non-risk-adjusted peak year sales potential, maintaining the scale of opportunity we outlined at the start of the year. Importantly, with the positive data in hand, much of the risk behind these opportunities has now been removed. This shows the strength and diversification of our pipeline and underpins our confidence in achieving our $80 billion ambition by 2030. As I will show you next, the platforms and technologies we are investing in today position us to keep growing well beyond that. Next slide, please. This quarter, we announced an equity investment in Summit Therapeutics, together with clinical collaborations to combine ivonescimab with Sone-Ve and Datroway, and plans to broaden our collaborations further. Under the terms of the agreement, each company will contribute their respective medicine for the planned combination trials and jointly contribute to trial costs. Ivo is the leading PD-1/VEGF bispecific, a class we expect to play a role in selected tumor types. It complements our own IO bispecifics, rilvegostomig and volrustomig, which we continue to progress at pace. This is an example of how we are maximizing the value of our rapidly growing ADC portfolio. We believe ADCs will become the backbone of treatment across tumor types, and this partnership gives flexibility to combine them with the optimal next-generation immuno-oncology partner for each setting. This collaboration strengthens the core pillar of our oncology vision, building novel combinations, and is of strategic benefit to the companies involved. We look forward to updating you as these programs progress. Next slide, please. Turning now to the longer term, our ambition is to keep growing well past 2030, and that is why we are investing today in the technologies we believe will change how a wide range of diseases are treated in the future. Across five platforms, the first 9 months of 2026 have brought significant progress. Starting with weight management and cardiovascular risk factors, we expect the first phase III data for laroprovstat in the first half of 2027. We now have phase III trials ongoing for elecoglipron, and we've initiated phase III trials for our respective, our selective, sorry, amylin receptor agonist, lenbelintide. In ADCs and radioconjugates, progress has been strong. Clarity-Gastric01 delivered an unprecedented overall survival benefit for sonesitatug vedotin second line and later gastric cancer. We expect the first phase III data for our second wholly owned ADC, puxitatug samrotecan, in the second half of 2027, and we initiated three phase III trials for torvutatug samrotecan this year. The Summit collaboration I described previously is another way we are maximizing the ADC opportunity. For our next generation immuno-oncology bispecifics, we now have 15 phase III trials across nine tumor types, six of which combine our bispecifics with our ADCs. We expect the first phase III readouts for rilvegostomig and volrustomig in the second half of 2027. Our cell therapy and T-cell engager portfolios are also advancing. We have three ongoing phase III trials of AZD0120 in multiple myeloma, and two phase III trials of surovatamig are progressing in B-cell lymphomas. Both platforms have been extended into autoimmune diseases, with early trials underway, underscoring their broader therapeutic potential. Beyond these lead programs, we have four further clinical stage cell therapies and four additional T-cell engagers in early development, which will help us reach more patients across more disease areas. Together, these programs form a deep late-stage pipeline of multi-blockbuster opportunities that will underpin our next wave of growth. You can expect a steady flow of news, with more than 20 key phase III readouts planned for 2027. I will say more about this when I close. With that, I will hand over to Aradhana to take you through our financials. Please move to the next slide. Thank you. Thank you, Pascal, and good morning, good afternoon, everyone. As usual, I will start with our reported P&L. Next slide, please. As Pascal highlighted, we delivered continued top-line momentum in the first nine months of the year. Total revenue increased by 7%, with product revenue up 6%. Alliance revenue increased by 32%, driven by higher profit sales from our partnered medicines in Enhertu, Datroway, and Tezspire in markets where our partners record product sales. Next slide, please. Turning to the core P&L. Core gross margin was 83% in the first nine months. As we indicated previously, we expect gross margin in the second half to be below the first half, reflecting the seasonal demand profile of lower-margin medicines such as FluMist and Beyfortus. We also expect to see the usual year-end impact of hospital budget capping and NRDL stock compensation in China in the fourth quarter. For the full year, we continue to expect core gross margins to be stable to slightly higher than in 2025. Core R&D expense increased by 5% year-to-date, reflecting continued investment in the pipeline. R&D represented 23% of total revenue in the first nine months, and we continue to expect it to be at the upper end of the low 20s percentage range for the full year. We are continuing to invest behind the opportunities that drive long-term growth, including bispecifics, cell therapies, and T-cell engagers, along with our ongoing investment in weight management and cardiovascular outcome trials. Core SG&A expense increased by 4% year-to-date. This reflects the investment behind the U.S. launch of Baxfendy, preparations for the anticipated launch of tozorakimab next year, and investment behind the launches of the 47 major market regulatory approvals received since the full year results in February. Overall, core operating expenses increased by 5% in the first nine months. As in prior years, we expect a sequential step-up in the fourth quarter versus third quarter in operating expenses. Other operating income was $618 million for the first nine months, including $277 million in the third quarter. This includes the sale of Zoryve royalties for $100 million. We expect the other operating income in the second half of the year to be slightly higher than the first half. The core tax rate was 19% year to date, consistent with our full year expected range of 18%-22%. Core EPS grew by 14% in the first nine months. Next slide, please. Turning to cash flow and the balance sheet. Cash flow from operating activities was $10.9 billion in the first nine months, lower than in the comparative period. There are two principal factors behind that. First, the prior year period benefited from the Lynparza milestone receipt in Q1 2025. Second, we have experienced working capital effects associated with the U.S. loss of exclusivity for Farxiga. As previously indicated, we expect these working capital effects to persist through the remainder of the year before normalizing. Capital expenditure was $2.3 billion in the period, and we now expect full-year CapEx to increase by low teens percentage compared to 2025. This is a change from prior indication, driven as a result of some project starts now moving into 2027. Deal-related payments totaled $4.3 billion in the first nine months. This includes the $600 million upfront payment for the Dizal collaboration, which closed during the third quarter, and other new deals during the year. Milestone payments relating to prior BD transactions amounted to around $2 billion in the first nine months, and we continue to expect this to be approximately $2.5 billion for the full year. This number does not include the $2 billion Summit equity investment, which closed this month. We expect finance expenses to be higher in the fourth quarter than in the third quarter, as this will include higher interest costs for the bonds issued in the third quarter, as well as lease expenses following the opening of our new Kendall Square R&D center, where we are today. Fourth-quarter finance expenses will also include a one-time expense relating to the premium paid for the Summit equity investment. Importantly, we remain comfortable with our current level of gross debt, and our current net debt-to-EBITDA ratio is at 1.2 times. Finally, we are reiterating our full-year guidance. We continue to expect total revenue to increase by a mid-to-high single-digit percentage and core EPS to increase by a low double-digit percentage. Today, we are also announcing the Reshaping for Sustainable Growth program, a three-year initiative to redeploy resources and strengthen capabilities across AstraZeneca's existing businesses and therapy areas. This program is expected to incur up to $2 billion in one-time restructuring costs and deliver $1.5 billion in annualized pre-tax run rate benefits. The savings from this program will continue to be reinvested back into the company, essentially in our pipeline. We expect activities to be completed by the end of 2029. To summarize, we have delivered another strong quarter with continued momentum across our portfolio and new launches. At the same time, we're investing in the pipeline, manufacturing capacity, and BD opportunities that we believe can support sustainable growth through the next decade while maintaining a strong balance sheet. With that, I'll hand over to Dave to take you through the performance of our oncology business. Next slide, please. Thank you, Aradhana. Next slide, please. Oncology total revenues grew 16% in the first nine months to $21.9 billion, with an impressive 17% growth in the business in the third quarter. During the first nine months, we saw double-digit growth across all major regions. The U.S., in particular, delivered strong year-over-year growth of 18%, demonstrating robust demand across our key brands, with Europe and emerging markets delivering mid-teens growth. Turning now to the quarterly performance of our key medicines. Tagrisso delivered revenues of $2.1 billion in the third quarter, surpassing the $2 billion mark for the first time, representing 12% growth on the prior year. Demand was broad-based across indications and regions, reinforcing Tagrisso's role as the backbone of care for EGFR-mutated lung cancer. We continue to see increasing adoption of combination regimens in the first line, with FLAURA2 maintaining its leadership position in all major markets. We anticipate continued growth across all indications through the remainder of the year. This was another exceptional quarter for our IO franchise, with Imfinzi and Imjudo delivering growth of 26% and 25%, respectively, with combined revenues exceeding $2 billion for the first time. As in previous quarters, growth was broad-based, with contributions from established indications and recent launches. VOLGA, which is currently under priority review in the U.S., will further expand the reach of Imfinzi in the increasingly competitive muscle-invasive bladder cancer setting, and continued demand across indications positions us well to sustain this growth through year-end. Calquence is now the leading BTK inhibitor in the first-line CLL across the top eight markets, with total revenues increasing by 16% to $1.1 billion in the third quarter. In the U.S., we're seeing an increasing adoption of the fixed-duration AMPLIFY regimen following its launch earlier this year, and uptake is rapidly expanding in major markets ex-U.S. With ongoing global readouts, we expect continued growth across key markets for the remainder of the year. Enhertu revenues grew 35% in the quarter to $969 million. While performance was broad-based across regions, growth in the U.S. was particularly notable at nearly 50%, driven by demand in the established breast cancer indications, as well as meaningful contributions from DESTINY-Breast09 in first-line HER2-positive disease, where nearly four in 10 patients are receiving Enhertu, and the two early breast indications, DESTINY-Breast05 and DESTINY-Breast11. In the high-risk post-neoadjuvant setting, Enhertu is already establishing a leadership position with DESTINY-Breast05. Strong growth of 40% in the emerging markets was driven by new launches and expanded access for existing indications. We expect continued growth for Enhertu through year-end. Truqap revenues grew 9% in the quarter to $210 million. As highlighted previously, the AKT PTEN biomarker altered population is fully penetrated in the U.S., with launches in developed and emerging markets driving growth for the brand overall. U.S. demand growth in the quarter was offset by unfavorable inventory movements resulting from the transition from bottles to blister packs. We are seeing early positive signals from the launch in prostate cancer and are working to establish PTEN IHC testing to bring Truqap to patients who may benefit. Datroway revenues reached $78 million in the third quarter. This reflects further uptake in late-line EGFR-mutated lung cancer, with Datroway maintaining a leadership position in the fragmented third-line plus setting. In breast cancer, we are seeing continued uptake in the hormone receptor-positive setting and a strong launch in the recently approved first-line triple-negative indication based on the compelling and differentiated results seen in TROPION-Breast02. We are also seeing encouraging early signals for Etcamah, following the U.S. launch for SERENA-6 in September. These include strong willingness among HCPs to test during the first-line treatment, alongside increasing test readiness and testing volumes. Finally, we were pleased to report our first revenues for Zegfrovy in the third quarter. Earlier this month, we launched this medicine in the United States for patients with previously treated non-small cell lung cancer with an EGFR exon 20 insertion mutation. This launch marks an important step as we bring this oral treatment to a patient population with substantial unmet need while further building on our leadership in EGFR lung cancer. With strong momentum demonstrated across our portfolio in the first nine months, we are well-positioned for continued growth through the year-end as we deliver innovative oncology medicines to more patients. With that, please advance to the next slide, and I will pass over to Susan to cover key R&D highlights from the quarter. Thank you, Dave. It has been an exceptional few months for our oncology pipeline. Across the World Conference on Lung Cancer last month and ESMO just a few days ago, we shared more than 140 abstracts, including 38 oral presentations, and five of our phase III readouts were presented in presidential symposia across these two congresses. These datasets mark significant progress against our strategy to redefine cancer care, intervening at earlier stages of the disease, transforming outcomes through powerful new combinations, and using novel ADCs to replace chemotherapy as the backbone of treatment. Starting in EGFR-mutated lung cancer, we presented two key phase III datasets. Firstly, SAFFRON, which addresses a significant unmet need for the one in three patients with MET amplification and/or overexpression following progression on Tagrisso. In these patients, adding Orpathys to Tagrisso reduced the risk of death by 32% versus platinum-based chemotherapy, extending median overall survival by nearly 5 months. SAFFRON is the first global phase III trial to show both a significant progression-free survival and overall survival benefit in this setting, and it does so with a biomarker-directed all-oral regimen. Importantly, it also demonstrates the benefit of continuing Tagrisso beyond progression in these selected patients, creating a treatment pathway across first and second line that further strengthens Tagrisso's leadership. Secondly, SANOVO, which brings Orpathys plus Tagrisso into the first-line setting for patients with MET overexpression at diagnosis, a selected and well-defined subgroup with poor prognosis. In this trial, the combination extended median progression-free survival to more than 2 years compared to just over 1 year with Tagrisso alone, which demonstrates the poor prognosis of this patient population. We also saw an encouraging 9.6-month improvement in median overall survival, highlighting the value of this combination upfront. Together, these trials reinforce Tagrisso as the backbone therapy in EGFR-mutated lung cancer, on top of which we can build combinations, both in biomarker-selected patients, as with Orpathys, and in broader populations, as previously demonstrated with FLAURA2. We are excited to build on this further with the TROPION-Lung14 and 15 trials, which look at combining Datroway with Tagrisso in the first and second-line settings. Also in lung cancer, DESTINY-Lung04 marks the first phase III trial to demonstrate improved progression-free survival versus the global first-line standard of care, pembrolizumab plus doublet chemotherapy in HER2-mutant non-small cell lung cancer. Enhertu delivered a median progression-free survival of 14.3 months and an objective response rate of 70%, underscoring the potential of moving Enhertu earlier to the time of metastatic diagnosis when treatment has the greatest opportunity to improve outcomes. Turning now to small cell lung cancer. DeLLphi-305 evaluated Imfinzi plus IMDELLTRA as first-line maintenance in extensive stage disease following Imfinzi-based induction. The combination reduced the risk of death by 58% versus Imfinzi alone, with a median overall survival of 21.1 months, the longest ever reported in a phase III trial in this setting. Imfinzi is the only immunotherapy to demonstrate a significant survival benefit in both limited and extensive stage small cell lung cancer, and DeLLphi-305 reinforces Imfinzi as the backbone IO across this disease. Next, in bladder cancer, VOLGA is the first trial of perioperative immunotherapy with enfortumab vedotin given only before surgery in patients with muscle-invasive bladder cancer who are not candidates for or have declined cisplatin. This regimen reduced the risk of recurrence, progression, or death by 49%, and the risk of death by 42%, with nearly 4 in 5 patients alive at 2 years. Limiting enfortumab vedotin to the neoadjuvant setting makes this an optimized, cytotoxic-sparing regimen. VOLGA is now under priority review in the U.S. Together with NIAGARA and POTOMAC, this trial reinforces Imfinzi as the immunotherapy backbone across bladder cancer. As a reminder, we see bladder cancer as an overall blockbuster opportunity for Imfinzi. Finally, in gastric cancer, CLARITY-Gastric01 evaluated Sone-Ve in patients with previously treated claudin 18.2-positive advanced gastric cancer, and is the first global phase III trial to show an overall survival benefit with a claudin 18.2-targeted ADC in this setting. In third-line and later-stage patients, Sone-Ve reduced the risk of death by 53%, doubling median overall survival from 5 to 10 months. Sone-Ve also reduced the risk of death by 42% in the broader second-line-plus population. Importantly, the benefit was consistent across claudin 18.2 expression levels down to 25%, a much lower threshold than other claudin 18.2-targeted therapies, meaning Sone-Ve could benefit approximately 60% of patients in this setting. We see significant further potential for Sone-Ve. We have already initiated CLARITY-Gastric02 in the first-line setting and are exploring the opportunity for Sone-Ve in biliary tract and pancreatic cancers. As Pascal mentioned earlier, we recently announced an exciting clinical collaboration with Summit Therapeutics to evaluate Sone-Ve in combination with ivonescimab, a first-in-class PD-1/VEGF bispecific in gastrointestinal cancers, with trials expected to begin imminently. Taken together, these datasets demonstrate the depth of our oncology pipeline, and with further readouts to come, we are confident that oncology will continue to drive AstraZeneca's growth through 2030 and well beyond. With that, please advance to the next slide, and I will pass over to Ruud to cover biopharmaceuticals performance. Thanks, Susan. Next slide, please. Our biopharmaceuticals business continues to navigate a period of transition, with strong growth from our respiratory and immunology portfolio offsetting much of the anticipated headwinds for Farxiga, Brilinta, and Roxadustat in CVRM. Overall, biopharmaceuticals total revenue declined by 6% in the quarter to $5.6 billion. R&I delivered another strong quarter, with total revenue increasing by 11% to $2.5 billion, driven by continued momentum across our key growth medicines. FASENRA grew 14% to $602 million, with particularly strong growth in emerging markets, driven by FASENRA's inclusion on the NRDL in China earlier this year. The clinical reach of FASENRA has continued to broaden, with the four major market approvals for hypereosinophilic syndrome in the second quarter. Tezspire maintained its impressive momentum, growing 51% to $429 million, with strong performance across all regions. Growth was driven by the expanded use of biologics in severe asthma and the launch of Tezspire in chronic rhinosinusitis with nasal polyps. The growing body of evidence supporting Tezspire's differentiated mechanism of action was further strengthened in the quarter by the positive readout from the CROSSING trial in eosinophilic esophagitis. BREZTRI increased 14% to $374 million, with a particularly strong performance in emerging markets as growth accelerated in China. The BREZTRI opportunity has broadened beyond COPD, with recent approvals in asthma, and that indication has seen rapid uptake in the U.S. since it launched in July. Saphnelo also continued its strong trajectory, increasing 32% to $235 million. Growth was supported by the recent launches of Saphnelo's subcutaneous formulation in the U.S., Europe, and Japan. In the next 12 months, we have readouts anticipated for three additional indications: lupus nephritis, systemic sclerosis, and cutaneous lupus erythematosus. The strong performances from key respiratory medicines more than offset an 11% decline for SYMBICORT, which generated $660 million in the quarter. This reflected a 25% decline in the U.S. following the entry of a second generic competitor, while China continued to deliver growth. Turning to CVRM, total revenue declined by 18% to $2.6 billion, reflected the anticipated loss of exclusivity headwinds. Farxiga declined 23% to $1.6 billion, reflecting loss of exclusivity in the U.S. and the impact of VBP in China. Demand remained strong in both Europe and established rest of the world, both of which grew double digits. The launch of Baxfendy is progressing to plan, with revenue of $9 million in the quarter. We are pleased with the uptake so far, with a good balance of prescriptions from primary and specialty care, and across resistant and uncontrolled patients. For the next few quarters, we expect the majority of Baxfendy's revenue to come from commercial customers as we continue to build access ahead of anticipated Medicare Part D reimbursement in 2028. We are also progressing our early launch preparations for tozorakimab. Currently anticipate U.S. launch in the first quarter of 2027, subject to regulatory approval. The initial focus will be on commercially insured and Medicare Part B patients, but as COPD tends to affect older patients, we hope to see the first Medicare Part D reimbursement during the course of 2028. We are encouraged by the sustained growth of our R&I portfolio and the opportunities ahead from new indications and launches. Finally, we are looking forward to an exciting year for the CVRM portfolio in 2027, with readouts anticipated for three NMEs, balci/dapa, zibo/dapa, and laroprovstat, and the first life cycle management opportunity for Baxfendy in primary aldosteronism. I will now hand over to Sharon to take us through the latest developments in the biopharmaceuticals R&D pipeline. Thank you, Ruud. Next slide, please. At the European Respiratory Society Congress in September, we presented results from the phase III OBERON and TITANIA studies for tozorakimab in COPD. These data reinforce our confidence in tozorakimab as a $5 billion plus asset. Tozorakimab was studied in the broadest COPD population evaluated for a biologic to date, spanning the full range of eosinophil levels and lung function severity, broader than the population studied for currently approved biologics. We saw clinically meaningful reductions in exacerbations across eosinophil levels. The reduction was 23% in patients with baseline eosinophil counts below 150 cells per microliter, 34% in those with counts of 150 or higher, and 43% in those with counts of 300 or higher. Importantly, the 23% reduction was observed in a population for which no biologic is currently approved. Overall, these results demonstrate highly clinically meaningful efficacy across a broad COPD population, with reductions in exacerbations of up to 34% in former smokers and up to 30% in the overall population. In addition to these data for tozorakimab, earlier this month at United European Gastroenterology Week, we presented phase III data from the CROSSING trial of Tezspire in eosinophilic esophagitis. The prevalence of EoE has increased nearly fivefold since 2009, and nearly half a million patients are affected in the U.S. alone. Despite available first-line therapies and dietary interventions, nearly 50% of patients continue to experience significant disease burden. This includes difficulty swallowing and a substantial impact on quality of life. CROSSING evaluated two doses of Tezspire, 210 milligrams and 420 milligrams every four weeks, in adults and adolescents with EoE. At week 24, both doses delivered statistically significant and clinically meaningful improvements on the co-primary endpoints of histologic remission and the frequency and severity of difficulty swallowing. Importantly, these improvements were sustained through week 52, marking the first time a biologic has demonstrated this durability in a placebo-controlled trial. In key secondary endpoints, Tezspire also demonstrated statistically significant improvements in endoscopic features of EoE, and approximately a third of patients achieved total endoscopic remission. These data contribute to our belief that Tezspire has multi-blockbuster potential across multiple indications. Beyond these two important readouts, I would like to highlight several additional advances across our biopharmaceuticals pipeline during the third quarter. In dyslipidemia, we expect initial phase III results for laroprovstat monotherapy in the first half of 2027. We also expect results in 2027 from the first two phase III trials of the laroprovstat rosuvastatin fixed-dose combination. These trials include both patients receiving background lipid-lowering therapy and treatment-naive patients. Within weight management, we have now dosed patients in 10 ongoing phase III trials with elecoglipron. We have also dosed the first patients in three phase III trials for lenbelintide, formerly known as AZD6234, which is our selective amylin receptor agonist. These trials are enrolling patients with obesity or overweight, with and without type 2 diabetes, including those receiving other incretin-based therapies. We look forward to sharing the phase II results for lenbelintide and AZD9550, our dual GLP-1 glucagon receptor agonist, both as monotherapies and in combination, at an upcoming medical conference. Beyond pipeline progress, earlier this month, we officially opened our newest strategic R&D center in Kendall Square, Massachusetts. This investment strengthens our presence in Greater Boston and places our scientists at the heart of one of the world's leading life sciences ecosystems. With that, please proceed to the next slide, and I'll pass over to Marc to cover rare disease. Thank you, Sharon. Rare disease total revenue grew by 11% in the first nine months to $7.5 billion, underpinned by double-digit growth across all key medicines. This is driven by increased patient demand and continued global expansion following launches. In the third quarter, ULTOMIRIS revenues were up 19%, driven by growth across indications, including continued momentum in neurology. SOLIRIS revenues continue to decline due to the successful conversion to ULTOMIRIS, as well as biosimilar pressure. STRENSIQ grew 34% year-on-year, reflecting strong patient demand, continued global launches, and improved access. KOSELUGO continues to deliver strong global momentum, supported by expansion in adult patients with NF1-PN and the uptake of the granule formulation in recently launched markets. I wanted to highlight the multiple launch opportunities across rare disease. ULTOMIRIS in IgAN recently received accelerated approval in the U.S., with filings underway in Japan. Klygefa, formerly gefurulimab, is now approved in Japan for generalized myasthenia gravis, has positive CHMP opinion in Europe, and filed in other major markets. Amlypave, formerly anselamimab, has also been approved in Japan. Finally, our second-generation enzyme replacement therapy, efzimfotase alfa, has been filed across major markets and received priority review in the U.S., with a PDUFA date expected in the first half of 2027. Please advance to the next slide, where I will talk more to some of these opportunities and others in the pipeline. First, for patients with IgA nephropathy, our phase III data for ULTOMIRIS demonstrated rapid, complete, and sustained terminal complement inhibition, with benefit consistent across patients. Our focus is on patients with higher risk of progression and inflammatory disease, which we estimate is approximately 20% of IgAN patients. IgAN is important in the continued expansion of our C5 franchise, building on ULTOMIRIS' established leadership across multiple complement-mediated diseases. We are confident this indication would reach blockbuster potential, given our established nephrology presence across AstraZeneca and Alexion. Separately, we have also announced the discontinuation of ULTOMIRIS development in delayed graft function following a lack of consistent efficacy. Moving to efzimfotase alfa, as highlighted at the ASBMR, we believe the totality of evidence from the phase III program supports the potential to expand the treatment opportunity in HPP. With less frequent, lower-volume dosing, improved tolerability, and evidence across a broader range of disease manifestation, we see the potential to reduce treatment burden and support better treatment continuity. Combined with enhanced manufacturing capabilities and continued global expansion, we believe these attributes can support broader patient reach versus STRENSIQ. We believe efzimfotase alfa has the potential to become the preferred treatment option for patients with HPP. We expect growth to be driven by both the transition of patients currently receiving STRENSIQ and the expansion of the treated HPP population. This underpins our peak year sales expectation of $3 billion-$5 billion for efzimfotase alfa. Cliramitug represents a significant opportunity to address the residual disease burden in ATTR cardiomyopathy. Despite currently available therapies, ATTR-CM remains progressive for many patients, with ongoing clinical events and functional decline. Cliramitug differentiated depleter mechanism is designed to remove existing amyloid deposits, with our phase I-B data showing positive cardiac remodeling. Importantly, around 90% of patients in that study were already receiving tafamidis, providing early evidence of activity on top of standard of care. The phase III DepleTTR-CM trial builds on this, evaluating cliramitug on top of background therapy with hard clinical outcomes across all-cause mortality and cardiovascular events. If successful, we see the potential for cliramitug to alter the course of disease and become an important complementary treatment in ATTR-CM, representing a $3 billion-$5 billion non-risk-adjusted peak year revenue opportunity. Taken together, we see an exciting next phase of growth for Alexion, combining continued expansion of our established franchises with multiple new launch opportunities and a pipeline with the potential to reach significantly more patients. With that, please advance to the next slide, and I will hand back to Pascal. Thank you, Marc. Next slide, please. Before we move to your questions, let me close with why we are so confident about the road ahead. Our pipeline continues to deliver, and the momentum builds further in 2027. It's going to be a very, very rich year. We expect more than 20 high-value trial readouts and pivotal data for nine potential new medicines. If you look at the whole list of readouts on this slide, of course, not everything is going to work, you have in non-risk-adjusted peak year revenue more than $20 billion. If you look at the right-hand side of this chart, it represents 40% of that peak year revenue. I'm drawing your attention to this because there is a whole series of small and mid-sized readouts that tend to fall below the radar, but it's important to look at those because the potential of our company and our pipeline should be assessed in aggregate. It takes time to go through all these products and all these indications, but that is the best way to get a good view of the potential growth we have, not only to 2030, but more importantly, through the next decade. A significant part of this more than $20 billion of peak year revenue should actually become reality over the next few years. Next slide, please. This slide shows what I see as the foundation of our growth into and through the next decade, our new molecular entities with pivotal data readouts before 2030. We have 12 programs with peak year revenue potential of more than $5 billion. We have already launched three of these medicines, Datroway, Amlypave, and Baxfendy, and we've seen positive phase III data for three more, efzimfotase alfa, tozorakimab, and Zegfrovy. In addition, we have four programs with peak year revenue potential of between $3 billion and $5 billion each, which will support our strengths beyond 2030. Again, not everything is going to work, but it's important to look at the aggregate progress of the pipeline across so many products and indications. We expect our pipeline to more than offset the upcoming loss of exclusivities and to drive sustainable growth through the next decade. Next slide, please. Let me bring this together. First, commercial momentum. Our medicines are in strong demand across therapy areas and geographies. That demand is driving growth across the company, and more importantly, it means more patients are benefiting from our medicines. We are firmly on track to deliver our 2030 ambition. Second, pipeline delivery. We have reported 12 positive phase III program readouts this year, with a collective potential peak year revenue well in excess of $10 billion, and we've had approval for four new medicines. We have a very rich upcoming series of readouts in 2027, with a potential non-risk adjusted peak year revenue of more than $20 billion. Third, we're investing for the future. By focusing on transformative technologies and by partnering with companies like Summit, we're building the platform that will fuel growth into the next decade and beyond. That pipeline is already delivering, with pivotal data expected for nine new medicines next year. Thank you for your time, and with that, we are ready for your questions. As a reminder, as Yuri mentioned at the start of the call, please try to limit the number of questions you ask to allow others a fair chance to participate. Please use the raise hand function on Zoom, and let's move to the first question. That first question is from Mattias Häggblom from Nordea. Over to you, Mathias. Mathias, can you hear us? We don't hear you. Yes, I can. Sorry for that. Yeah. Thanks so much. Mattias Häggblom, Nordea. Two questions, please. Firstly, with regards to the slide 24 and the more than $20 billion non-risk adjusted peak year revenue potential, and 60% of that value derived from the six key events to the left on that slide, is it fair to distribute the peak revenue broadly average across the six key readouts, or is it rather so that perhaps some of Ansar carry an unproportional component of those $12 billion peak year revenue? Secondly, regarding the comment on the ESMO call earlier this week that AstraZeneca would have appetite for personalized cancer vaccines, should we think of that as an area likely to include partnering, or may it be so, just like for ADCs, that AstraZeneca has built in-house know-how and capacity? Thanks so much. Thank you. Thank you very much for these two questions, Mathias. If I understand well, the first one, if your point was, is Datroway representing a disproportionate portion of the total sales? The answer is no. Datroway is an important product, but I am trying to go back to slide 24. Yes, to be sure I have got the right way. Datroway, as you can see it here, is represented as a $5 billion plus opportunity across a variety of indications, and AVANZAR, of course, is a very important one. But if you look at the rest, I mean, the laroprovstat is going to be big. We have also the fixed dose combinations, Adkarmai, Salopipe. Datroway is going to play an important role, but it is not the one that is going to be a make or break. We have a risk-adjusted approach in our forecast, and when we say that we can grow through 2030 and beyond, as I have said before, our risk adjustment across the totality of the portfolio, about 60%. So it is not very ambitious. We have done much better than that in the past. That is what also gives me confidence. Then the other thing I said, just to repeat, is on the right-hand side of this slide 24, 40% of the $20 billion are in these indications on the right-hand side. Again, you see Datroway there again in TROPION-Lung07, TROPION-Lung15. But there is many more indications. So, I guess that answers your question, and to say Datroway is an important product, but it is not the only one. The second question is cancer vaccines, we are, for now, looking at doing it internally. We have got an infectious disease group that has worked over the last few years, the last couple of years in particular, on a variety of technologies that we believe can give us a way forward, but in this cancer vaccine space. But, I will leave it at that for today, and you will hear more about it in the next few months or years. The next question is from Simon Baker from Rothschild. Over to you, Simon. Thank you, Pascal, for taking the question. Two quick ones, if I may, please. Firstly, one probably for Aradhana. I wonder if you could give us a little bit more color on the Reshaping for Sustainable Growth strategy. I would assume that this is a transfer of OPEX from SG&A to R&D, but any color you can give us there would be great. Also, is the $2 billion a cash cost, or is it a mix of cash and non-cash? Then a question for Susan on puxitatug samrotecan. The B7-H4 space is fairly crowded. I wonder if you could call out the points of differentiation that you would like to highlight on puxitatug samrotecan versus some of the other competitor molecules in the space. Thanks so much. Aradhana, you want to start? Sure. Thank you, Simon. I'll give you a few examples in terms of what this program actually involves. First of all, it's not targeted to one therapy area or one unit or one specific geography. It's really looking at, across our units, where all we have opportunity to align our investments and employees, et cetera, to make sure we're creating room for future opportunities and future growth. So, a good example would be, for example, clinical trial footprint. We run global clinical trials. As you know, where the opportunities are for clinical trials, what sites, new sites are emerging in places like the Middle East, et cetera, reimbursements changing in different geographies. So, we want to align our clinical trial footprint to where the future is. Similar, for example, cell therapy, which is an area we're investing in, and that requires different skills and different investments. We're making technology investments in improving our process development. So, those are the types of things that, again, there's not one major thing. There's many different smaller initiatives. The $2 billion is more a cash cost. The benefits are, again, it's a three-and-a-half-year program, so it's not a one-time thing. The cost will come over this longer-term period, as will the benefits. And the intention is, again, as I mentioned, to create room to continue to invest in new products and where the future growth will be. Susan? Yeah, sure. So, thanks for the question about puxitatug samrotecan. Just as a reminder, B7-H4 is a transmembrane protein that's expressed highly in a number of solid tumors, including endometrial, breast, and ovarian cancer. With puxitatug samrotecan, we have the first B7-H4 ADC to enter phase III registrational intent study, which is the BLUESTAR-Endometrial01. We have FDA breakthrough therapy designation, which was granted based on the results that we've already seen, and granted in the first half of this year. And we've seen efficacy, particularly in the prior IO patients, with a 60% response rate and really good durability of response, which represents the BLUESTAR-Endometrial01 patient population. And recognize that, coming off ESMO, there were a number of other ADCs also targeting endometrial cancer, but B7-H4 expression in endometrial is broader than, for example, folate receptor alpha. We are confident about the linker payload that we have got with puxitatug samrotecan. We have got something that has very stable linker performance, and that leads to a lower rate of bone marrow toxicity than some of the other drugs that you see out there. That is going to be really important in the combinations, which is what we are building behind. You will see the opportunity for multiple combinations coming through with different mechanisms of action that will help build the potential for added value for puxitatug samrotecan. Thanks for the question. Great. Thank you, both. The next question is from Sachin Jain at Bank of America. Over to you, Sachin. Thanks. Taking my questions, two please, one short-term and then one mid-term. The short-term question, I guess, for Aradhana. R&D growth year-to-date sort of 5%, which is also what consensus assumes for 2027. A lot of what we have heard today is a lot of new phase III starts. Very simply thinking, do we think about R&D growth accelerating next year and how that impacts the extent of margin expansion, which currently stands at about 100 basis points in consensus? The second one is to touch on Pascal's sort of mid-term post-2030 commitment to growth. When do you think you will be in a position or willing to quantify that? I guess my question is, can you achieve that growth post-2030 based on what you already know today? If the 2027 pipeline pays out as you hope for, what kind of growth could you envisage? Thank you very much. That's an interesting question, Sachin. Thank you so much. The first one, I think, Aradhana, maybe you want to answer. Just a clarification, what you've heard from us today is a lot of readouts in 2027. We will also start new phase III, but we have a lot of phase III readouts that carry a lot of potential peak year revenue. Over to you, Aradhana. Sure. Sachin, I think your question was R&D specific, and R&D always sort of ebbs and flows, because in one year there will be studies starting, and there will be readouts and so forth. But maybe if I can take this opportunity, and I'm sure others have this on their mind, sort of how we look at the year ahead. First of all, we still have one quarter remaining in this year, so still need to get through that. Also, as all of you know, this is the time in the year when we go through our planning process, et cetera, so we're right in the middle of that, so we can't really give guidance. As you know, we'll give that in early next year. But if I look forward to next year, there is the continued momentum that you've seen in the results today in all the growth brands. There were a number of LCMs that were Data was presented on that at ESMO. So, that momentum I expect to continue into next year. We also have a bunch of new launches. We're really looking forward to Tozo launching, Baxfendy's in the market, Etcamah across many markets, Dato, and all of those will require continued investment because they're early in their launch cycle. There are also some headwinds. Again, nothing surprising, things that you all are already aware of. Generic competition in some markets and Farxiga, SYMBICORT, Ruud covered, Calquence goes into IRA in 2027. Again, all the things that you're all very well aware of. We'll continue to invest in R&D, and focus remains on executing and building the pipeline, and we will share our guidance when we get to February of next year. Thank you, Aradhana. Sachin, your second question. The answer is really we haven't decided whether and when, if we did it, we would actually give a new number. Something we've sort of discussed, but we haven't really landed, and I think it's a little bit too early, to be honest. I'll explain why in a second. The reason why we are confident of growing past 2030 is the strength of the pipeline we have in our hands. In our long-range plan, what we do is we forecast each of these product and indications, at least those that we have a phase III plan for, and then we risk adjust. Of course, we include expected price pressures, including MFN, and we risk adjust all these projects. When we risk adjust this forecast, we use, as I said, roughly I mean, each project has a different probability of success, of course, but the sort of average across the pipeline is about 60%. You can see it's not incredibly optimistic. It's relatively conservative. Of course, we can be very unlucky and deliver less than 60%, but we could also deliver more than 60%, which is what we have done in the last few years. But based on this average probability and the forecast we have, we see ourselves grow through for the post-2030 period. Now, in terms of communicating more around this and quantifying it, I think we need a little bit more time and probably go through next year and the readouts, get more data on some of these critical technologies we're progressing, like AZD0120 and cell therapy, the TCE, and others. Then maybe at some point, we might be able to give a new sort of a target that we give ourselves. But no commitment here, and certainly from a timing viewpoint, I could not tell you when we would be able to do that if we were to do it. Thank you. Steve Scala at Cowen. Over to you, Steve. Thank you so much. Two questions. First, regarding Imfinzi subQ, competitors have been quite successful in shifting business to the subQ formulations. Does AstraZeneca now see similar opportunity? If so, is there time to execute the switch before the LOE of Imfinzi IV? The second question is on China. China recently laid out several ambitious goals for its domestic biopharma industry through 2030. Should they deliver on those goals, would that be a headwind, tailwind, or a neutral for AstraZeneca? Thank you. That's great. Dave, maybe you want to take the first one, and Iskra, you could take the second one, the China one. Thanks, Steve, for the question. We are progressing Imfinzi subcutaneous with good pace, and we do expect to launch a subcutaneous version prior to coming on, or prior to LOE for Imfinzi. As we move into more and more earlier settings, which you're seeing with the continued progress that we make, we think that that's going to be particularly valuable to have that subcutaneous version as an offering for HCPs and their patients. Thanks for the question on China. Let me frame it in two different parts. First, as you saw in our results, we have another strong quarter in China, and we see the strong underlying growth of our business in China. If you exclude for the impact of the VBP for Forxiga, Roxadustat, and Lynparza this year, the growth is at the level of the strong 15%. That definitely shows the strength of our current portfolio. Equally, we had a number of the positive regulatory news, and we expect new inclusions in NRDL next year, specifically for the few eligible drugs, new drugs like Datroway or Tezspire. We do believe that we have both portfolio and pipeline coming in China that will continue to fuel our growth in China. When it comes to the overall policies, we see many of the positives there, specifically when it comes to the better IP protection and strong regulatory data protection for the innovation, and overall, new 15th Five-Year Plan that recognize healthcare and innovation as a pillar industry and puts a lot of emphasis on the importance of the innovation in the biomedicines in China. Of course, that also comes with a strong competitive pressure, and as you know, we see more and more local Chinese companies that are strong competitors in some parts of our portfolio, specifically in oncology. I would argue that in our forecast and plans, we have both. I would be hopeful that the overall impact will be neutral and will actually prove that our plans and optimism for the China forecast is in the right space. Thank you, Iskra. From a global viewpoint, still, I would say it's both a tailwind and a headwind, of course, because these companies are very competitive. I think it's overall more of a tailwind than a headwind for the companies that will be able to collaborate with Chinese companies, but also learn to compete with them. That's why we believe our position in China helps us do both of those, both collaborate and compete, learn to compete with them in term of the speed at which they move, et cetera. We've learned a lot, and we have adjusted the way we operate, not only in China, but also globally, based on what we learned watching how they operate. I think overall, certainly both tailwind, headwind for industry, and certainly hope that for us, it's more tailwind because of our position in China and the way we are able to leverage our strengths there for China, but also globally in term of collaborations. Next question is Richard Vosser at JPMorgan. Over to you, Richard. Thanks. Sorry, excuse me. Thanks, Pascal. Maybe a question on Tagrisso development from here, please. Obviously, strong performance in the quarter, but just how we should think about the performance going forward, potential from the uplift from SAFFRON and SANOVO that was called out today in ESMO, and actually thinking further beyond that, just what could the combinations with Datroway, TL15 bring to that franchise as well? Then a second question, just on the read from Lynparza to saruparib. So, we saw you today maybe not to proceed forward in first-line ovarian with Lynparza, given the regulator issues between BRCA mutated and the HRD positive setting. So, just what are your thoughts on saruparib as we think about the readout next year in both the HRRm patients and the non-HRRm patients? Just thoughts on saruparib next year. Thanks. Maybe the first question, Dave, you could take, and then Susan, the second one. Absolutely. Thanks for the question. Tagrisso, with 8% sequential growth, I think is performing very well, and that strength is really coming on the back of a lot of good work that we are doing to establish FLAURA2 as the preferred regimen in frontline for patients with EGFR mutated disease. Now, what is really important on this, and gets to your point, what we saw, and I think is so key from SAFFRON, is in addition to opening up an opportunity for combinations in the second line for the 34% of patients who have MET-driven disease, we also now have the ability to be able to demonstrate and promote to starting with Tagrisso and staying with Tagrisso. This is something that really paves the way for what you asked about, TROPION-Lung15. We also have an opportunity with TROPION-Lung14 to be able to establish the Datroway combination in the frontline. As you begin to imagine kind of how the mindset becomes, we start with either FLAURA, FLAURA2, or TROPION-Lung14 in a frontline setting. There is an opportunity to then move to a Tagrisso-containing regimen post-progression on one of those, whether it is with SAFFRON or whether it is with TROPION-Lung15. All of this creates an opportunity for the Tagrisso franchise to continue growing in a meaningful way, well on its way towards the LOE time that it has. I would also like to note that the acquisition of Zegfrovy gives us an opportunity to expand not just within the EGFR portion, that is the exon 19, but also with the exon 20 insertions, and we think that this gives us an even stronger position within this important space. Okay. Thanks, Richard, for the question about saruparib. Just as a reminder, saruparib is a highly selective PARP1 only inhibitor, as opposed to Lynparza, which inhibits both PARP1 and PARP2. What that means is that you can get a much harder hit on PARP1 than you can achieve with Lynparza, and that is translated into an improvement in the efficacy that we have seen. We published some data at the ASCO GU Conference earlier this year in February. For example, in the castrate-sensitive patient population, we are seeing really good activity. We published data in the BRarna study as well in the castrate-resistant setting, where in both HRR and non-HRR, we see a PSA response rate in the 70% range for both groups of patients. If you just look at actual RECIST-based responses, we had 100% response rate in the HRR patient population and an 85% response rate in the non-HRR. We do see activity, as we did with olaparib, in both the HRR and non-HRR. Just as a reminder of the EvoPAR-Prostate01 study, this is now in an earlier line setting than PROPEL, so it is in the metastatic castrate-sensitive patient population, a setting where 50% of patients progress within five years and 40% die within five years. This is still a high unmet need. What we have done is we have taken the learnings from the PROPEL study. Although we only received a BRCA mutant label in the U.S. for PROPEL, we have got a broad label in Europe, and it was successful in the overall patient population. We did get a good hazard ratio for rPFS, including in the non-HRR population. Given the improved efficacy that we see with saruparib, including those data that I quoted from BRarna, and the design of the study, where we are taking in a powered element for both the HRR and non-HRR, as well as BRCA, which is one of the learnings that we took from the PROPEL study, I think we have got a good opportunity in this setting to really improve the standard of care in the castrate-sensitive patient population. Thank you, Susan. Next question is from Graham Parry at Citi. Over to you, Graham. Thanks. Taking questions. Pascal, on slide 7, you flagged the 12 positive phase III readouts year to date. I think the market's arguably focused more on two failures, Wainua and SERENA-4. On your internal estimates, if you were actually looking at the risk-adjusted NPV of those readouts that you were expecting as you went through the course of the year, is your projection now that internally you think the value of those has gone up rather than down on aggregate through the course of the year? Just sort of talking to your point on thinking about the aggregate numbers. Secondly, on Etcamah, pricing there looks in line with the approved oral SERDs. Obviously, both SERENA-6 and second line have a shorter PFS and smaller patient populations than in earlier lines. In the event that you were to see a positive readout on CAMBRIA-1 next year, is that level of pricing something you think would be sustainable for the large adjuvant population with treatment for five years plus? Thank you. Thanks, Graham. Maybe we start with the second question, Susan, so we have the time to load the slides so everybody can actually see it. Susan, do you want to call on For the pricing of Etcamah? Dave. Dave should cover it. Why don't I start first on the EpCAMR pricing question? Within that, I mean, first and foremost, what I'd like to just point out and use the opportunity, I think that the SERENA-6 enthusiasm is high across the globe. We've got over 30 markets with approvals. We are seeing good enthusiasm from clinicians. Just off the back of ESMO, we had an opportunity to meet with a number of clinicians across the globe who are already incorporating ESR1 mutation testing into their regular practice. There's work that we're going to have to do on education, of course, but the demand increase that we're seeing in interest in ordering new lab results for ESR1 is certainly going in the right way. That's really great. I would also say that we're seeing, on pricing in general, some really encouraging movement in terms of setting a good value for medicine price in countries like the Middle East, but also most importantly within Japan. I think that that sets a good benchmark against which to think about that value for innovation and what we're seeing. We will approach early breast cancer when we see those results from CAMBRIA-1, and obviously also within that context, in some regards, we'll see other agents establish the early breast cancer price with some of the upcoming approvals that are going to be coming in. We'll advise on that when we get to that point then. Thank you, Dave. We've got a slide that everybody can look at to answer Graham's question. There's no doubt, actually, Graham, that if we look at it in net NPV, if you want, we've gone up net-net of the two failed studies, Wainua and also SERENA-4. Let me tell you why. First of all, it's important to remember Wainua is a shared product, so we didn't own 100% of the profitability coming out of it. The second is, of course, SERENA-4 was a large opportunity. Some of that opportunity is replaced by SERENA-6. The last point I will make, and if you look at many of these products, tozorakimab, I can tell you now because product's positive, but our probability of success, I think, was 20% or 25% in our risk-adjusted forecast. Now it's, of course, 100%. It's a big product. If you look at efzimfotase, it's also a large product. Many of the others are blockbuster opportunities, like IgAN is, and a number of others, DeLLphi-305 is a big one. Clarity, of course, we've just shown you a number. If you look at all of this, and I have to be careful because they're not yet approved, of course, not all of those. I mean, many of those are in the approval process, but there's a good chance they get approved. The data for each of those is very strong. If you assume they are approved, definitely the net NPV has gone up, versus our risk-adjusted earlier forecast, even removing basically Wainua and SERENA-4, but adding all those readouts you see here on the slide. Thank you. The next question is from Rajan Sharma at Goldman Sachs. Hi. Thanks for taking my question. Just on some of the new or imminent launches that you talked about there, you obviously got Baxfendy and Etcamah this year, and tozorakimab potentially next year if it's approved. Could you just maybe talk about how meaningful they will be from a revenue perspective next year in terms of drivers of growth? For those are all indications or areas where you have existing commercial infrastructure. So how should we just think about the contribution to margins from those products, both next year and beyond? Thank you. Thank you. Thank you, Rajan. So maybe, Ruud, you can cover some of this. Just as a reminder, when we launch in the U.S., of course, you have to get access, but I'm sure Ruud is going to cover this in detail. So you have Baxfendy, you have maybe Tozo you want to talk about and other things. Yeah, absolutely. Let's give a little bit of flavor. We have just started the launch in the U.S. at the first full quarter. The way I would describe it's quite an encouraging start. We have already been able to deliver 12,000 new patient starts. As expected, most of those patient starts are in the commercial book of business, because we don't have any coverage yet in Part D, that will take some time. It's not unusual. We have submitted our bids for Part D to all the plans, hopefully we will see the coverage in 2028 coming through. We have bridging programs in place, what is very, let's say, pleasing to see is that both primary care physicians as well as specialists have started to prescribe Baxfendy. Likewise, there's a very healthy split between patients for resistant hypertension as well as for uncontrolled hypertension. So early days, for sure. We are hoping to see more commercial access as we go on in the course of 2028, then full coverage, if possible, in 2027 for commercial and 2028 for Part D. Likewise, for Tozo, the situation there is slightly different, because likewise, we need to have Part D access as well for Tozo, because the COPD patients are highly skewed to Part D. We will launch two formulations. One, the prefilled syringe, that will give us access in Part B in the U.S., as well as the auto-injector, that will give us access in Part D. So it's a bit more of a mixed one. Clearly, we are excited about the Tozo. Pascal already mentioned that. I think the data is very strong, there's a very clear unmet medical need. So we will put our best efforts behind that launch as well as we go. But let's first see whether the regulators are going to give us the approval in the first half of 2027. Thanks, Ruud. Dave, want Sorry? On camizestrant or not? Wendy, did you want to comment on camizestrant? I thought Marc, the question was more So I think maybe I'll take a step back and just add to this. I think that if we take a look at the growth drivers for next year, definitely camizestrant and SERENA-6 is something that globally we see, Rajan, as a blockbuster opportunity. And I think that becomes also something that has continued growth behind it with SERENA-4 not being part of something that would cannibalize SERENA-6. Remember, SERENA-6 is the only study in a frontline advanced population. And so, it's really an opportunity for us to differentiate there. I'd add to that Zegfrovy, DeLLphi-305, what we see with VOLGA together with the Imfinzi indications, back to what Pascal was speaking about earlier, each of those is blockbuster opportunities. So we've got several really exciting growth drivers from just the catalysts that have read out that give us opportunity for growth in the year ahead. Since we covered the whole pipeline, maybe we can also ask Marc, from an Alexion viewpoint, what are the major growth drivers for 2027? Yeah. We have the launch of Klygefa as a third-generation C5 inhibitor. This will be in myasthenia gravis. I think this is going to be a new option for patient in the most dynamic part of the segment, with an auto-injector on a weekly sub-cut, with a low volume. I think we are quite happy to have another option apart from our infusion injectable, SOLIRIS and ULTOMIRIS. You have heard that we have recently obtained the approval for ULTOMIRIS in IgAN. This is obviously a very interesting field where many new mechanisms are getting approved these days. We have good data on proteinuria reduction, and we do believe that the complement inhibition plays an important role in many patients of IgAN. I mentioned in my prepared remark, we have other products being prepared for launch, but we are also very excited by the progress we are making in the development. We do not know the results, obviously, for cliramitug, and we believe 2027 growth. 27 growth. This will not be for 27 years. Thank you, Pascal. So maybe just to add, I think your second question was around, how does it fit in terms of the cost and the launch cost, et cetera? I will not go into every product, but a few big picture themes to think about. First of all, we start investing in front of every launch, right? Depending on what that launch is, we may start somewhere between 18 to 24 months, in terms of whether it is market shaping activity, non-branded promotion, payer market research. So there is a whole bunch of activities that are going on before an actual launch. When we actually launch, when a product breaks even on an annual basis depends on a number of different things. It may depend on, in the biopharma space, that can take, for example, on average, four-plus years. First couple of years is really getting the access at the right place, and that is when your investment after that, in year three, four, starts breaking even. In oncology and rare diseases, it may be sooner, in a couple of years, but that is sort of the type of investment. There are obviously places where we have existing sales forces. For example, in Datroway, we are already in the breast cancer space. For Truqap, we are already in that space, but it does require building that even further. Then there are also new areas we are entering in, so eosinophilic esophagitis, we do not have a presence in that space, so that is where we need to build. Again, it is very dependent on those dynamics. We obviously try to leverage where we have the capabilities, but it does require investment, and it does require a few years before it breaks even. Thank you, Aradhana. The next question is coming from Thibault Boutherin at Morgan Stanley. Over to you, Thibault. Yes, thank you very much. Just a couple of pipeline questions. The first one is on the CAMBRIA-1 opportunity. As I understand it's in the setting for patients who already completed a cycle of adjuvant therapy on the CDK4/6 plus AI combo, or AI alone for the patient not eligible to CDK4/6. Just see if you could give us an idea of what's the biggest pool of patient, if it's coming from CDK4/6 combo plus AI, or if it's the AI mono in terms of funnel coming into CAMBRIA-1 opportunity. The reason I ask for this is because obviously a competitor is trying to address the AI mono, so how does that impact the funnel of patients going into CAMBRIA-1? I'll just stop there. Thank you. I'm going to start just first with making sure that we're clear on the design, and then we can go from there. Yeah. Thanks for the question. CAMBRIA-1 is looking at camizestrant in the extended adjuvant setting in patients with intermediate to high-risk hormone receptor-positive and HER2-negative breast cancer. It's a switch design, and it takes patients who've had already 2 to 5 years of adjuvant endocrine therapy with or without CDK4/6 inhibitor, who obviously then need to remain free of invasive disease, and are planning 5 further years of adjuvant endocrine therapy. Then it randomizes them one-to-one to continuing their current standard endocrine therapy and AI or tamoxifen, and versus camizestrant 75 milligrams. So that's the design of the study with the primary endpoint of invasive breast cancer-free survival. Then perhaps, Dave, do you want to talk about the size of the opportunity? Yeah, absolutely. I think the important point to note on this is that CAMBRIA-1 allows for us, first and foremost, to address the prevalent pool of patients. This is why it's such an important part of the strategy. CAMBRIA-2 is for the incident population pool, but I think that if we take a look then at CAMBRIA-1, it allows, if the study's positive and if we get it approved, to be able to come in and make an offer to patients, an option for patients they'll have today either being treated with an AI or an AI CDK4/6. On your question about what patients we expect to flow into this, I think in many respects, this study anticipates and is protected against multiple futures. Because it includes prior adjuvant CDK4/6 patients, if we see that grow, those are patients that would be eligible in the study, or if monotherapy without the CDK4/6 is what we see prior, that as well is something that would be eligible within CAMBRIA-1. Thank you, Dave. The next question is from Trung Huynh at RBC. Over to you. Frank, can you hear me? Yeah, sorry. I was just taking mute off. Thanks for taking my questions. Just on your oral CVRM combinations, in the presentation, you highlighted the PCSK9 Crestor combination with phase II data expected in the first half next year. Then we noticed in the appendix a GLP-1 dapagliflozin combination as well. Just thinking about how you're thinking about the differentiation of these assets and their subsequent positioning. And we also didn't see a GLP-1 PCSK9 combination listed. Is that still under consideration? Thank you. Thank you. Sharon, do you want to cover this? And maybe, Awad, if you want to jump in on that. Sure. I think you asked us three questions. The first was about the PCSK9 and the combinations. The second was about dapagliflozin combinations, and the third was about elecoglipron plus PCSK9. I will try to break those down. Your first question was about laroprovstat. That is our oral PCSK9, which we think is a very differentiated molecule. You have noted that we are moving forward with multiple studies for that molecule in phase III as monotherapy and also in combination. The combination makes a lot of sense there. In our monotherapy studies, we are allowing patients to add this on top of background statins because we know that is standard of care, but that is a really important mechanistic interaction, and the mechanistic interaction is a theme for our fixed-dose combinations. What PCSK9 does is let the LDL receptors keep recycling, and that effect is additive to statins. it is a clear rationale to be able to combine those two things together, and therefore, it makes sense to build a fixed-dose combination with rosuvastatin. Your second question was about combining dapagliflozin and- GLP-1 our oral GLP-1, elecoglipron. You can imagine why that makes sense. When we think about patients that were living with complex interrelated cardiovascular, renal, and metabolic disease, they are dealing with multiple disease drivers. By combining SGLT2, which is standard of care in diseases like heart failure, kidney failure, and type 2 diabetes, you are also dealing with patients who have interrelated disease that is driven by excess weight or obesity, which is effectively addressed by a GLP-1 receptor agonist. Only AstraZeneca has the portfolio that allows us to combine a small molecule GLP-1 receptor agonist together with an SGLT2 inhibitor. it is both logical for these patients to be able to address multiple disease drivers, and it is also a key feature in simplifying their patient care and making sure that they are not just maximizing the therapeutic window of each of these molecules, but deriving the at least additive benefit of these two put together. Your third question was about why would we not combine our PCSK9 together with elecoglipron? We have signaled that we are interested in that potential combination as one of the many combinations that we can partner with our oral GLP-1. As you know, dyslipidemia is frequently a comorbidity of patients who are living with excess weight or obesity, and so that is a logical next step for us as we explore how we maximize the potential for elecoglipron. We have already demonstrated the positive phase II data and moved into an expansive phase III program for elecoglipron as a monotherapy, and we are exploring fixed-dose combination opportunities for that molecule, as you mentioned. Thank you, Sharon. Awad, do you want to add anything? No. The only piece, Pascal, if I take it one step higher, is that our strategy is to address the comorbidities of the patients. Weight management, overweight is only one dimension of our strategy. I think, as Sharon said, we have a unique opportunity with our portfolio to combine and to address multiple morbidities at the same time. I think that is a unique feature of our strategy. Thank you. The next question is from James Gordon at Barclays. Over to you, James. Hello. James Gordon from Barclays. Thanks for taking the question. It is sort of two questions. One is, so new pipeline directions for AstraZeneca and the investment there. It sounds like quite a lot of exciting areas. So the in-house ADCs, IO bispecific, cell therapy, cancer vaccine, VEGF, obesity, lots of new areas. Which ones do you think would require the most incremental investment and the biggest growth potential when we are thinking about new ways to treat diseases? Connected to that, I know that there are new areas to invest in, but then there is also what sounds like quite a big cost reallocation program, and you have top-line growth. If we put it all together, is the message that the cost reallocation program and the top-line growth would be there to keep the margins above flat whilst you do all this investment? Can you do all this investment and also have margin expansion medium long term? Let me just start the first part, and Aradhana, you could take the second part, or maybe not. The first part, actually, James, is a good question, but some of these technologies are at different stages of development. If you look at cell therapy, we are more advanced, and we are spending more money in cell therapy right now, of course, because we are in full swing of our phase III programs and for AZD0120, but also looking at other CAR-T and investing in in vivo cell therapy. So, different technologies here are at different stages of progress. But we believe that we can actually balance the P&L. It is, of course, never easy when you have a pipeline of that magnitude. It is a great problem to have. We have many, many projects. We will continue investing in those and, of course, try to defend and protect our operating margin. Beyond this, I do not know, Aradhana, that we want to be more specific about these operating margins. We have given you our objective in the past, and I cannot say that anything has changed. Yeah, I'd just say, we look at what we've done over the last several years, right? We've continued to drive operating leverage, and at our investor day, we talked about this back in 2024, and we made a commitment to our 2026 margin. We did say at that time that going forward, it'll depend on a variety of scenarios. We're at a place now where our pipeline is very rich, and we'll remain disciplined, but we need to continue to invest in things as they unfold. We'll give our guidance for next year in February next year. Maybe also something that may be obvious, but it's maybe worth reminding everybody is that, you have a certain number of new projects, new technologies we're investing in, but there's also a number of products for which the life cycle and the investment plan is declining. If you look at Tagrisso, Imfinzi, or FASENRA, and some others, I guess, the investment is over the next couple of years, of course, going to start to decline as we invest in new products. So you got to really look at what is decreasing versus what is increasing, and that's how we manage it all. Of course, we constantly work on improving productivity, so that we can invest more in our pipeline. The next question is Peter Verdult at BNP. Peter? Hello, can you hear me? Yeah, go ahead. Can you hear me? Yeah, sorry. Yeah, go ahead, Peter. We can hear you. Good. Sorry. Peter Verdult, BNP Paribas. I wanted to continue a conversation we started at ESMO earlier this week. Just when we think about Europe, how are the European leaders reacting to one, the wave of innovation coming from China that was in clear evidence at ESMO, and your comments today build on what we are hearing elsewhere. R&D spend, clinical trial recruitment, manufacturing investments increasingly moving away from the region. So, when you interact with the leaders, do you have any optimism that innovation going forward is going to be better rewarded in Europe? Then just a much more simple question for Ruud. I heard all your comments during the Q&A and prepared remarks about Baxfendy, but can you just remind us, how have you approached ex-U.S. pricing in the U.K. and Mexico, where I think you have just recently launched, versus the U.S. given MFN considerations? Thank you. Well, thank you, Peter. Maybe let me just give a sort of overall view, and then Ruud could comment on Baxfendy, and maybe Dave, if you want to comment also on the Gamma, please feel free. But the overall view is that you have to look at not only Europe, but also Japan, because these are the countries that are in the reference basket of countries in MFN. I will say, again, historically, Europe and Japan were very big sources of innovation, and suddenly both of those have declined relative to the U.S. and more recently China, of course. So, I will say in Japan, there is a clear recognition by the government that the ecosystem needs to become more attractive. I must say that there is some very positive feedback in term of pricing level and access and reimbursement of new products. I think Japan is really quite encouraging, I must say. In Europe, there are green shoots of progress in some countries. It is still early days, so I think it is hard to be more definitive. I will say overall, my sense is, if you look at Japan and Europe, there are countries where we can be a little bit more hopeful than we were some time ago in term of adjusting, improving access, and improving pricing and reimbursement. As a reminder, by the way, MFN doesn't require Japan or Europe to reach U.S. prices. It requires that it reaches GDP-adjusted U.S. prices. Again, the logic of a MFN program is over time that U.S. prices would decline a little bit, and European prices would go up a little bit. That is really what we are trying to achieve with the various products. I must say I am a lot more optimistic, cautiously optimistic, they would say, today than I would have been a few months ago in term of our ability to improve the environment in Japan and some countries in Europe. Ruud? Yeah, not a lot to add, Pascal, for obvious reasons. Of course, we try to bring our new medicines, our new innovation to as many as possible, the patients around the world, including in Europe. The MFN dimension is one, of course, we are now considering. Let us go through the process. Let us get the regulatory approvals there. The positive element is that we have, beyond the United States, we have launched also now in the Middle East. The good news is that we are getting good prices for Baxfendy there as well. Hopefully that will also be a trigger moment for European governments to consider this important new medicine, helping patients with severe hypertension. Let us see how it is going to work out. The European teams are working day in, day out in order to get it in the hands of patients and physicians. Thank you, Ruud. In interest of time, we will move on because there is a couple of questions that are left. Seamus Fernandez at Guggenheim. Seamus, do you want to go? Yes. Thanks so much for the question. Aradhana, just hoping you could clarify and help us think about the impact that the restructuring program could have on margins going forward. Is this going to be fully recycled back into R&D? Then as we just think about the margin structure, are you comfortable with where the street is for the next couple of years as it relates to operating margins? Then just as a quick question for you, Pascal. One of the things that AstraZeneca has been extraordinarily good at is coming from behind in the areas where there's high competition. Can you just maybe help us think about the areas where you think Astra is uniquely underappreciated, but where areas like Farxiga would provide a good example for us to think about as Astra as a come-from-behind player? Thanks. A great question. Maybe, Hana, do you want to go on the first one? Yeah. The answer to, I think, your first question is yes, though we will look to reinvest. Again, it's also not just about reinvesting. It's also, like I said, creating the capacity to do more without expanding our cost base as much. Technology will play a role. Obviously, some of this reinvesting, recycling, reshaping, all of that will play a role. So that's the answer to your first question. Your second question, I won't go into, though I know everybody is very creative in asking the same question. We will not provide long-term margin guidance in spite of many ways and creativity in asking that question. Pascal will get into the third question. Thank you, Aradhana. First of all, I would say, Seamus, we are not always coming from behind. We sometimes are in the lead. We are in the lead in many places. I would say that if you go back in history, Tagrisso is in the lead, PACIFIC indication is in the lead. More recently, Tozo is in the lead. So we are not always coming from behind, as you say. But if I take your question about coming from behind, I think there's maybe two examples I could give, but there are more- Yeah quite frankly, because at the end of the day, if you look at the consensus forecast that is public knowledge, everybody looks at it, sees us decline post-2031 or 2032, something like that. It really shows that people do not necessarily appreciate the whole pipeline. Maybe two places. One is, I do not like this word, I think it is the wrong term, actually, weight management. The reason I think we can actually make it there is in part based on what Ruud and Sharon has explained before. We do not see this as simply a weight reduction approach. What we are trying to do is address the metabolic syndrome, the insulin resistance. There are a lot of people around the world, millions, hundreds of millions, who do not look obese. They may not even sometimes look overweight, but they have abdominal adiposity, the visceral fat. These people, they also often have complications like hypertension, cholesterol, pre-diabetes, diabetes, kidney disease, low-level inflammation in their body that leads to other complications. We are really aiming at addressing this complex multiform syndrome, if you want, by combining products that help people reduce the excess visceral fat they have, but also address their kidney disease or their pre-diabetes or their cholesterol. That is really what we are trying to do. I think if we do that well, I think we will do it well, because we have a really strong phase III programs of indications that I think will differentiate us, of course, combinations, which I think will also differentiate us. If we do that well, then we actually can craft a very nice position in this market and also help patients around the world. The second example I might give is cell therapy, where we know that we are newcomers to the field, but we are making rapid progress, and AZD0120 is looking pretty good, quite honestly. I think cell therapy is the other place. Today with CAR T, tomorrow with in vivo, where, because in vivo, we are also moving as fast as we can, in vivo cell therapy, that is. I think it is another place, but there are other examples, but also examples where we are in the lead. In interest of time, we will move to maybe the last question. Michael Leuchten. Michael, over to you. Oh, thank you, Pascal, for squeezing me in. Just a very quick one on RSG. Just interested in the timing of triggering that program now. Was there a gating item that triggered it? Why now? You have always been very busy with the pipeline. You could have triggered something like it earlier. Why now? I think the Again, there's no sort of ideal timing to pick for this. But when we looked across the company on the LOE of Farxiga, which happened in the U.S., some of the trial readouts that we've had and launching, looking at how we need to think about, we've had questions on pricing and launches, the clinical trial footprint, technology where about a year back, we had just started to embed and change many of our processes to enable AI being embedded. When I say process, it's not drug discovery research, but many of our other processes. It was just a confluence of factors that we decided to make this into a program and start now. Yeah, absolutely. And we didn't decide this in the last two weeks, right? We've been working on this, planning for this since the beginning of the year. But when you announce this, you need to be sure you have a good plan and you can implement it. It's not new. We've been working on this, and essentially because we believe we have to redeploy resources. We believe we have a pipeline we need to support, and then every dollar we can save, we reinvest in the pipeline, so we create future growth. And of course, today you have also AI that is helping in some areas to make us faster, smarter, and then we can, in some cases, grow without growing, is sort of the expression, which is you grow without adding as many people as you would have if you didn't have the use of AI. All these factors, as Aradhana said, have taken us to this place today, but we've been planning for this since the beginning of the year. With this, I'll maybe close the meeting. And again, thank you so much for your interest in the company, and I wish you all a good weekend.

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