Q1 2026 AstraZeneca PLC Earnings Call

Speaker #1: Civil Head of Investor Relations and before I hand over to Pascal and the members of our executive team, I would like to cover some housekeeping items.

Speaker #1: 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.

Speaker #1: 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.

Speaker #1: All numbers quoted are in millions of US 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.

Speaker #1: As usual, we will try to address as many questions as we can during the allocated time. Although, please limit the number of questions you ask to allow others a fair chance to participate in the Q&A.

Speaker #1: And with that, please advance to the next slide, and Pascal, over to you.

Speaker #2: Thank you, Joris, and welcome everyone. Next slide, please. We delivered a strong first quarter building on a momentum we generated in 2025. Total revenue grew 8% in the quarter, supported by a robust demand for innovative medicines.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: Additionally, we continue to see strong delivery from our pipeline. In the past weeks, we announced results from four positive phase three programs, including two NMEs, Tozorakimab and Epson Fortez Alpha.

Speaker #2: We continue to invest in our commercial capabilities both to support ongoing launches and multiple future launches such as Baxrostat, Camisestrant, and Tozorakimab. In R&D, we continue to invest in our pipeline including our transformative technologies.

Speaker #2: Please move to the next slide. The price of our business remains a competitive strength. With a solid growth outlook across CRP areas and key markets, oncology and rare disease saw strong double-digit growth, while high demand in RNI was offset by loss of exclusivity in CVRM.

Speaker #2: 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.

Speaker #2: With Europe and emerging markets growing at high single digits. Importantly, we continue to deliver impressive growth in the emerging markets, with exchange revenues up 9%, reflecting the benefit of our sustained presence in this market.

Speaker #2: Revenues in China increased by 2%, with VBP implementation impacting for Ciga, Limpaza, and Roxadostat growth. We are confident in our growth outlook in China, based on the positive 2026 NRDL outcomes.

Speaker #2: Next slide, please. In the first quarter, 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 are making towards our 2030 ambition and beyond.

Speaker #2: We look forward to discussing the significant potential of this readouts, during this call. And with that, I will hand over to Aradhana to take you through our financials.

Speaker #2: Please advance to the next slide.

Speaker #3: 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 first quarter, with total revenue increasing by 8%.

Speaker #3: 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 and HER2 and Tespire in regions where our partners book product sales.

Speaker #3: Next slide, please. This is our core P&L. The core gross margin in Q1 was 83%. For the full year, we continue to anticipate a stable to slightly higher core gross margin versus 2025.

Speaker #3: 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.

Speaker #3: 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 first quarter, for the full year, we continue to expect core R&D costs to be at the upper end of the low 20s percentage range.

Speaker #3: Core SGNA costs increased by 7% in the first quarter, this was partly driven by pre-launch investments behind Baxrostat which has a US PDUFA date in the second quarter of 2026.

Speaker #3: 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 SGNA investment to maximize their potential.

Speaker #3: In addition, we have several other upcoming launches for products with high-value potential including Baxrostat, Gamisestrant, and Tozorakimab, all of which will help drive growth through 2030 and beyond.

Speaker #3: 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.

Speaker #3: Core EPS grew by 5% to $2.58, with growth weight 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.

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: The recent CSPC deal closed in April, so will be booked in the second quarter. 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.

Speaker #3: 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.

Speaker #3: 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 digit percentage at constant exchange rates.

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: With that, I will hand over to Dave, who will take you through the business performance of our oncology business.

Speaker #2: Thank you, Aradhana. Next slide, please. Oncology total revenues grew 16% in the first quarter to $6.8 billion, with double-digit growth across all reported geographic segments.

Speaker #2: Performance in the US and Europe was particularly strong, with growth of 18% and 19% over the prior year respectively. Continuing the momentum demonstrated through 2025.

Speaker #2: 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 US and Europe, partially offset by higher than historic destocking in the US.

Speaker #2: In the frontline setting, Tagrisso remains the treatment of choice, with an increasing proportion of physicians opting for the FLORA2 combination. We anticipate continued growth over the balance of the year across all indications.

Speaker #2: Our foundational immuno-oncology assets Infinzi and Imjudo delivered growth of 28% in aggregate, Infinzi growth of 30% was, as in previous quarters, underpinned by robust demand growth across all regions.

Speaker #2: We are seeing an increasing contribution from more recent launches such as Matterhorn and Gastric, Niagara and Bladder, and Adriatic in lung cancer, alongside continued growth in more established indications such as Himalaya, and Topaz.

Speaker #2: With continued strong demand for Infinzi 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.

Speaker #2: Focusing in on the US, 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.

Speaker #2: While too early to comment on the trajectory in the US, excitement is building among prescribers, and we believe Amplify will be a key contributor to growth this year.

Speaker #2: Turning to Inhertu, 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.

Speaker #2: 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.

Speaker #2: We're also seeing encouraging early signs of adoption of Inhertu in first-line HER2 positive breast cancer in the US, following the DESTINI breast and nine approval in December last year.

Speaker #2: We look forward to broadening our reach further with additional launches into early HER2 positive breast cancer, later this year. TrueCap revenues of $198 million in the quarter represents 47% growth over the prior year.

Speaker #2: We expect some further growth to be delivered in ex-US markets, and we see US market share at peak. DATROI revenues of $43 million in the first quarter reflect ongoing demand in the US in later-line EGFR mutated lung cancer, with more than one in three third-line patients now treated with this medicine.

Speaker #2: Following its acceptance for priority review, we look forward to the US approval of Tropion Breast O2 later this quarter. This has the potential to drive significant further growth for DATROI, 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.

Speaker #2: After a robust first quarter 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.

Speaker #2: With that, please advance to the next slide, and I'll hand over to Susan to cover key R&D highlights from the quarter.

Speaker #3: Thank you, Dave. Earlier this month, we announced the positive results of the phase three Emerald III trial. Building on the success of Himalaya in advanced liver cancer, Emerald III now moves Infinzi in combination with Imjudo into the earlier local regional setting with the goal of transforming outcomes for more patients with hepatocellular carcinoma.

Operator: Good morning to those joining from the UK and the US. 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.

Speaker #3: Emerald III 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 Infinzi 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.

Speaker #3: 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.

Operator: 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.

Speaker #3: We await further follow-up and are excited by the potential Emerald III offers for the more than 200,000 patients with local regional HCC currently eligible for embolization.

Speaker #3: We look forward to presenting the data at ASCO. Emerald III marks the beginning of a series of high-value Infinzi readouts over the course of 2026.

Speaker #3: 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, then in the second half of this year, we have two data sets that present opportunities to further broaden use of Infinzi in lung cancer with Avanza, aiming to improve outcomes and significantly expand Infinzi's reach in the first-line metastatic setting, and Pacific Nine, which looks to consolidate and deepen our leadership in stage three unresectable disease.

Joris Silon: 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 US dollars unless stated otherwise. Next slide, please. This slide shows our agenda for today's call.

Speaker #3: Infinzi 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.

Speaker #3: 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.

Speaker #3: We look forward to sharing more data on Paxisam, our B7H4-directed ADC, in endometrial and ovarian cancers, and we're also excited to be moving forward with our plans to open two further phase three trials for our folate receptor alpha-targeted ADC, Torvusam, in ovarian cancer later this year.

Joris Silon: 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. Although, 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.

Speaker #3: We will also share further data for SunnyV, Inclodin 18.2 positive gastric cancer from a broad global population, which supports the ongoing phase three cavity gastric O1 trial, now expected to readout in the second half of this year.

Pascal Soriot: Thank you, Joris, and 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 4 positive Phase III programs, including two NMEs, tozorakimab and efzimfotase alfa.

Speaker #3: Also, at ASCO, additional evidence supports the use of our PD-1 digit bispecific rilvagostamic in combination with Inhertu in gastric cancer. Early phase data for rilvagostamic and head and neck cancer will also demonstrate safety and efficacy in this indication.

Speaker #3: And finally, I want to highlight that we will present impressive first-in-human data for our PRMT5 inhibitor, AZD3470, in a heavily pre-treated classical Hodgkin lymphoma population, strengthening our expanding hematology pipeline.

Speaker #3: ASCO 2026 looks set to be another significant congress for AstraZeneca. And with that, please advance to the next slide, and I'll pass over to Ruud to cover biopharmaceuticals performance.

Speaker #4: 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.

Speaker #4: Overall, biopharmaceuticals total revenue declined by 2% to 5.8 billion dollars. Our respiratory and immunology portfolio was up 7% to 2.3 billion dollars. This performance was driven by our key brands, which grew 18%.

Pascal Soriot: 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.

Speaker #4: Within the portfolio, Fasena delivered another strong quarter, growing 11% to reach 483 million dollars. This was supported by strong uptake in China following its NRDL listing, which revenues in emerging markets up 63%.

Speaker #4: Breasttree generated 353 million dollars in revenue, growing by 13%. Earlier this month, Breasttree achieved its first label expansion beyond COPD with US approval for asthma.

Speaker #4: Breasttree is now the first and only triple therapy in asthma approved for patients aged 12 and older. Regulatory reviews continue in other countries. The ASPIRE continues to perform well, and delivered 303 million dollars in revenue representing a growth rate of 34%.

Speaker #4: The ASPIRE is now approved for chronic Rhinosinusitis with nasal polyps in all major markets following approval in Japan and China this quarter. Savnello grew 24% to achieve 171 million dollars in revenue.

Pascal Soriot: Revenues in China increased by 2%, with VVP implementation impacting Farxiga, Lynparza, and Roxadustat growth. We are confident in our growth outlook in China based on the positive 2026 and NRDL outcomes. Next slide, please. In Q1, we saw a continuation of the successful clinical trial delivery seen in 2025. We announced 4 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.

Speaker #4: The new subcutaneous formulation is now approved in Europe, the United States, and Japan, which extends its reach to the large segment of patients who favor self-administration.

Speaker #4: 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.

Speaker #4: CVRM total revenue for the first quarter stood at 3.3 billion dollars. Representing a decline of 6%. Farxiga total revenue fell 3% to 2.2 billion dollars.

Speaker #4: Farxiga has a phased alloy profile, and in quarter one, that alloy effect was seen in established rest of the world and also with the implementation of VVP in China.

Aradhana Sarin: 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 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.

Speaker #4: As expected, generic manufacturers entered the US market in April. Our US markets continue to perform well. Fueled by Farxiga's market share leadership within the fast-growing SGLT2 inhibitor class.

Speaker #4: Lokelma achieved global market leadership in the potassium binder class and 199 million dollars in the quarter, reflecting growth of 26%. Our commercial teams are preparing for the launch of Bexvastat later this year, with the Perdufa date for FDA regulatory decision set for quarter two.

Speaker #4: If approved, Bexvastat 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.

Speaker #4: With the new approval for Breasttree and asthma, the anticipated Bexvastat launch, the recent success of Tosaraximab phase three COPD program, and the upcoming results from Wainua ATTR-CM trial, we have much to look forward to across biopharmaceuticals this year.

Aradhana Sarin: 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 Q1. For the full year, we continue to expect Core R&D costs to be at the upper end of the low twenties percentage range. Core SG&A costs increased by 7% in Q1. This was partly driven by pre-launch investments behind Baxdrostat, which has a US PDUFA date in Q2 2026.

Speaker #4: I will now hand over to Sharon to take us through the exciting Tosaraximab readouts in more detail.

Speaker #5: 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.

Speaker #5: We recently reported high-level results from our three pivotal phase three studies, and long-term extension study in our LUNA program studying Tosaraximab in COPD. Oberon, Titanium, Miranda, and Prospero.

Speaker #5: This represents the most comprehensive phase three program ever conducted for a COPD biologic, and the results reinforce our confidence in Tosaraximab's potential to be a first and best-in-class treatment option for patients living with this devastating disease.

Aradhana Sarin: As you've seen, we have had a great start to 2026 in terms of R&D, with success in 4 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 strong underlying performance. Core EPS grew by 5% to $2.58, with growth rate impacted by low tax rate in Q1 in 2025. Next slide, please.

Speaker #5: COPD remains a critical area of unmet medical need. It is the third leading cause of death globally, claiming over 3 million lives each year.

Speaker #5: 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.

Speaker #5: Importantly, only 50% of patients live more than three and a half years after their first severe COPD exacerbation. These statistics underscore why innovation in COPD is so urgently needed.

Aradhana Sarin: Cash flow from operating activities of $3.4 billion was a slight decline versus the same period last year due to large milestone received 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 licensing 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.

Speaker #5: What sets Tosaraximab 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.

Speaker #5: 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.

Speaker #5: These discoveries informed the development of Tosaraximab, a differentiated molecule which uniquely inhibits the signaling of both, reducing the inflammation and breaking the mucus dysfunction cycle, which drives disease worsening.

Aradhana Sarin: The recent CSPC deal closed in April, so will be booked in 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-digit 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.

Speaker #5: In Oberon and Titanium, Tosaraximab 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.

Speaker #5: 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.

Speaker #5: These results are further supported by Prospero, the long-term extension study of Oberon and Titanium. 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.

Aradhana Sarin: 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.

Speaker #5: Tosaraximab 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.

Dave: Thank you, Aradhana. Next slide, please. Oncology total revenues grew 16% in Q1 to $6.8 billion, with double-digit growth across all reported geographic segments. Performance in the US 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 US and Europe, partially offset by higher than historic destocking in the US. 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.

Speaker #5: With approximately six million biologic-eligible patients globally, Tosaraximab has the potential to address the broadest population of COPD patients. With that, please proceed to the next slide, and I'll pass over to Mark to cover rare disease.

Speaker #6: Thank you, Sharon. Can I get the next slide, please? Rare disease deliver total revenue of 2.4 billion dollars in quarter one, up 15% year over year.

Speaker #6: This is driven by growth in neurology, and metabolic diseases, increased patient demand, and continued global expansion. If you recall, first quarter 2025 performance included transitory headwinds, most notably tender market order timing for both Soliris and Stransic.

Speaker #6: In the quarter, Ultomeris grew 18%, driven by patient demand across indications, including the competitive myasthenia gravis and PNH markets. Soliris revenues continue to decline due to successful conversion to Ultomeris, as well as biosimilar pressure.

Dave: 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. 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 US, Calquence continues to maintain its share leadership position in the frontline CLL setting despite intense competition.

Speaker #6: This was partially offset by favorable order timing in certain tender markets. Stransic grew 43% year on year, reflecting strong underlying demand and a favorable comparison versus a prior year.

Speaker #6: We saw demand growth for Coselugo, including the newly launched adult indication, for NF1 PN patients. We continue to see great momentum across the rare disease portfolio.

Speaker #6: Please advance to the next slide. I'm delighted to announce a positive high-level result for phase three programs in rare metabolic and renal diseases. A synthetized alpha on X-generation enzyme replacement therapy demonstrated positive results from the global phase three clinical program for patients with HPP.

Dave: 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 US, 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.

Speaker #6: The Mulberry trial in treatment naive pediatric HPP patients made its primary endpoint, showing meaningful improvements in bone health, as well as other objective endpoints, including physical function and quality of life.

Speaker #6: In parallel, the chestnut phase three trial showed that a synthetized alpha was well tolerated in children switching from Stransic while maintaining benefit on bone health.

Speaker #6: In the ICORI phase three trial in adolescents and adults with HPP, a synthetized alpha demonstrated numerical improvements but did not achieve statistical significance in the primary endpoint of six-minute walk test in patients who have been who have not been previously treated with Stransic compared to placebo.

Dave: We're also seeing encouraging early signs of adoption of Enhertu in first-line HER2-positive breast cancer in the US 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 Q1 represents 47% growth over the prior year. We expect some further growth to be delivered in ex-US markets, and we see US market share at peak. Datroway revenues of $43 million in Q1 reflect ongoing demand in the US in later line EGFR-mutated lung cancer, with more than 1 in 3 third-line patients now treated with this medicine. Following its acceptance for priority review, we look forward to the US approval of TROPION-Breast02 later this Q1.

Speaker #6: 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 the six-minute walk test.

Speaker #6: The only approved adult endpoint. A synthetized alpha represents patient-centered innovation, improving upon Stransic profiles through a longer half-life, more patient-friendly dosing, and an improved manufacturing process.

Speaker #6: The phase three trials were designed to reflect the broad symptomatology of HPP, and synthetized alpha is well positioned for broader global adoption by removing key barriers to access.

Dave: 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 will hand over to Susan to cover key R&D highlights from the quarter.

Speaker #6: There are approximately 14,000 addressable HPP patients across the top eight countries, approximately 20% of these are pediatric cases, 60% adults with pediatric onset disease, and 20% adults with adult onset disease.

Speaker #6: We will share data across the program with regulators, and present autonomous coming medical meeting. We believe a synthetized alpha represents a peak yourselves opportunity of three to five billion dollars.

Susan Galbraith: 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.

Speaker #6: In addition, we recently announced positive high-level results from a pre-specified interim analysis of the ICANN phase three trial which showed that Ultomeris 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 ICANN who are at risk of disease progression.

Speaker #6: The primary endpoint of change from baseline in estimated glomerular filtration rate will be measured at week 106. Ultomeris demonstrated complete and sustained terminal complement inhibition with proteinuria reduction seen as early as week 10.

Susan Galbraith: 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 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.

Speaker #6: Benefits are consistent across patients including those at higher risk of progression and with more inflammatory disease. Importantly, updated 2025 CADIGO guidelines recommend using disease-modifying agents such as Ultomeris in combination with supportive medicine that manage a disease symptom such as RAS or SGLT inhibitors.

Speaker #6: Across the US, Japan, and the U5, there are over 560,000 patients diagnosed with ICANN and 60% of patients would be eligible for ICANN treatment based on proteinuria.

Susan Galbraith: In the H2 of this year, we have two data sets 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, PACIFIC-9 which looks to consolidate and deepen our leadership in stage 3 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 Puxtucim, our B7-H4-directed ADC in endometrial and ovarian cancers.

Speaker #6: 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.

Speaker #6: In addition, today we disclosed the discontinuation of Ultomeris in CSA AKI high-risk patients with kidney ischemia due to lack of consistent efficacy across CKD severities.

Speaker #6: And finally, I'm pleased to report that Calypso, our phase three trial investigating the safety and efficacy of inhibitor paratide in adults, with chronic hypoparathyroidism, will be presented at ECE in May, and CARES, our phase three program of Selamimab in Latvian amyloidosis patients, will be presented at ASCO in June.

Susan Galbraith: 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, Tograsum, in ovarian cancer later this year. We will also share further data for SunnyV, including 18.2 positive gastric cancer from a broad global population, which supports the ongoing Phase III CLARITY Gastric-01 trial, now expected to read out in H2 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's lymphoma population, strengthening our expanding hematology pipeline.

Speaker #6: This presentation marks important milestones in bringing new therapeutic options to people living with rare diseases, and with that, please advance to the next slide, and I will hand back to Pascal.

Speaker #1: Thank you, Mark. Next slide, please. We are off to a strong start with four meaningful programs readouts already delivered in 2026 and a rich catalyst path across the rest of the year.

Speaker #1: 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.

Speaker #1: 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.

Susan Galbraith: 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.

Speaker #1: 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 life cycle management indications.

Ruud Dobber: 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 US approval for asthma.

Speaker #1: 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.

Speaker #1: In closing, Q1 delivered strong commercial momentum and excellent pipeline execution. Reinforcing our growing confidence in achieving our 2030 ambition. With a broad portfolio and deep pipeline and meaningful advances, across multiple transformative technologies, we are well positioned to extend growth beyond 2030.

Speaker #1: And 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.

Ruud Dobber: 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 United States, 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.

Speaker #1: Please use the red hand function on Zoom, and now let's move to the first question. Which is from Richard Vosser, JPM. Over to you, Richard.

Speaker #2: Thanks, Pascal. Two questions, please. First question on Tozoracamab. Could you characterize how you see the product profile relative to Dupixent and Nicala? Do you think the breadth of activity sufficiently differentiates the product so physicians wouldn't need to test for eosinophils anymore?

Speaker #2: And then a second question just on the ramp of Enhertu. Could you just give us a bit of color around the DB09 rollout and how we should think about the pace of uptake for the adjuvant setting and neoadjuvant setting and DB11, DB05?

Speaker #2: Thanks very much.

Speaker #1: Thanks, Richard. So Joris didn't go very far, right? You failed on the first step. Who is going to take Tozoracamab? Sharon, do you want to take this?

Ruud Dobber: CVRM total revenue for 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 established the rest of the world and also with the implementation of VVP in China. As expected, gene-generic manufacturers entered the US market in April. Our US 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 decision set for Q2.

Speaker #1: And only if you have anything you want to add later.

Speaker #3: Sure. I'm happy to. So as you know, we announced the positive high-level results for Tozoracamab in Oberon and Titania and Miranda. And in these phase three 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.

Speaker #3: So 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.

Speaker #3: Now, we can't slice and dice those data until we present them at an upcoming medical meeting. But 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.

Speaker #1: Yeah. And the only thing, Richard, I would like to add regarding the potential is that the current biologics and COPD are primarily for high eosinophils.

Ruud Dobber: 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 and Asthma, the anticipated Baxdrostat launch, the recent success of Tozorakimab phase III COPD program, and the upcoming results from Wainua ADCRCN 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.

Speaker #1: There are studies that were done above 300. I think the uniqueness, as Sharon has shared, is that this is across the eosinophil counts of patients.

Speaker #1: So whether in the end of the day physicians want to test in COPD the eosinophil count is up to them. But we are hoping for a very broad label on the basis of the Oberon and Titania data.

Speaker #4: Yeah. And I think really of course it's left up to physicians, but we think we have a true whole commerce product from that viewpoint of EOS levels.

Speaker #4: Dave, do you want to take the Enhertu question?

Speaker #2: Yeah, absolutely. Thank you very much. So at the highest level, Enhertu with DB09 clearly is bringing transformative benefit with PFS now exceeding 40 months.

Sharon: 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.

Speaker #2: 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.

Speaker #2: We do, as you would expect, see academic HCPs are driving early adoption more so than you would see within the community within this first quarter post-launch.

Speaker #2: But we will look forward to continuing to see our efforts in the community. And I think importantly, we are seeing increased recognition of the importance of continuing Enhertu treatment for 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.

Speaker #2: In terms of the early breast cancer studies with 0.5 and 11, I think they build really nicely on the existing confidence that exists within the HER2 positive space with 0.3, 0.9, and now these studies.

Sharon: 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.

Speaker #2: 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.

Speaker #1: Thanks, Dave. So next question is from Jebs Gordon at Barclays. Over to you, James. You may be on mute, James. We can't hear you.

Speaker #5: Hello. Hopefully you can hear me now. James Gordon from Barclays. Thanks for taking the question. The question was on camisestrin for hormonal breast cancer.

Speaker #5: And the root to this being a $5 billion plus product. So I know you've got a couple of angles, but one is the Serena 4 readout in the second half.

Speaker #5: But on that one, to what extent does failure of Rush's Persevera first line metastatic ESR1 all-comers trial mean you're more cautious on that readout?

Speaker #5: Other 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?

Speaker #5: Or is this quite a long shot based on Persevera? And I know the other angle, probably the bigger angle, would be adjuvant hormonal breast cancer, which that could be a $20 billion plus category.

Sharon: 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 2-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 3 pivotal trials that enrolled broad populations. These results are further supported by PROSPERO, the long-term extension study of OBERON and TITANIA.

Speaker #5: But I think your Cambria 2-stop trial, which is like the analogous trial to Ladera that's already up for approval in Q4 for Rush, that's only going to have final data in 2013 still recruiting.

Speaker #5: So is there a way you can still be a big winner here, or is it looking tougher?

Speaker #1: Thanks, James. For that.

Speaker #3: Okay. Thanks for the question. So in terms of the first line metastatic hormone receptor positive patient population, obviously we'll have to wait and see the Persevera data at ASCO.

Speaker #3: But remember that we've said that we do have a differentiated asset in camisestrin. The effect size that we saw in the second line setting was robust in both the ESR mutant and wild type.

Speaker #3: And 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.

Sharon: 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 6 billion biologic-eligible patients globally, Tozorakimab has the potential to address the broadest population of COPD patients. With that, please proceed to the next slide, and I'll pass over to Marc to cover rare disease.

Speaker #3: So we sized for an effect size that will still be clinically meaningful in that population. So that's why I think we need to look out for both what the safety and the efficacy data are for Persevera at ASCO.

Speaker #3: Moving on to the adjuvant population, just as a reminder, we have two adjuvant studies: Cambria 1 and Cambria 2. So Cambria 1 study takes the patient population that's already had two to five years of CDK4/6 inhibition.

Speaker #3: So that's the, if you like, the prevalent patient population of positive. And then Cambria 2 is in a setting that's more similar to Ladera, but is differentiated from Ladera because it does allow for combination with CDK4/6 in the adjuvant setting.

Marc Dunoyer: 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. You recall, Q1 2025 performance include the 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.

Speaker #3: And 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.

Speaker #3: So if you think about the combination of Cambria 1 and 2 together, I think we have the opportunity to get the largest slow share of the adjuvant patient population given that and the success of Ladera, I think, does show that, first of all, there's positive proof of concept for the effect of these drugs in that setting.

Speaker #3: And given that we've got very good profile with camisestrin, I think that builds confidence on our likelihood of success in those settings.

Speaker #1: Thank you, Suzanne. Next question is from Sachin Jain at Bank of America. Over to you, Sachin.

Speaker #2: Yeah. Hi there. Thanks for my question. One topic we know in cardiotransformer question for both Sharon and Ruud. So for Sharon, as we head into the phase three, could you just remind us of a few factors?

Speaker #2: So could you remind us of TAF and SGLT usage at baseline? And where do you think that will complicate a cross-trial comparison versus the 30% benefit and future had in Helios B?

Speaker #2: And I know on the secondary TAF subgroup, are you powered to be statistically significant if you repeat the Amvutra benefits? And then just a quick one for Ruud.

Marc Dunoyer: 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. Asfotase alfa, our next-generation enzyme replacement therapy, demonstrated positive result from the global Phase III clinical program for patients with HPP. The Mulberry trial in treatment-naive pediatric HPP patients 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.

Speaker #2: If you could just talk to the commercial relevance of both of those points. Cross-trial benefit comparison and the secondary endpoint. Thank you.

Speaker #1: Thanks, Sachin. Sharon, do you want to start?

Speaker #3: Sure. So 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?

Speaker #2: It's a two-bit. So TAF, Tafamidis, and SGLT2 usage at baseline and whether that complicates cross-trial versus Amvutra 30% benefit. And then the secondary TAF subgroup powering.

Speaker #3: All right. So now we haven't disclosed the exact numbers there, but let me speak broadly about this. We always anticipated that the treatment landscape would evolve during the time that we're running the cardiotransformer study.

Speaker #3: And we designed a large study to account for that. The baseline standard of care treatments, and here you've included SGLT2 and Tafamidis. So stabilizer and SGLT2 are expected to have an impact on the event rate, but we previously extended our trial duration to account for that.

Speaker #3: If we look at the Helios B study, the treatment effect with fluticerine versus placebo looked very similar in trial participants who were on background Tafamidis versus those who were not.

Speaker #3: So 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.

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: Ruud, would you like to comment further?

Speaker #4: Yeah. Thank you so much. And regarding, let's say, the PTSS, Sachin, we have indicated in 2024 during the investor day that we see this asset as a $5 billion plus asset.

Speaker #4: I think, of course, as always, it's incredibly important to hit the primary endpoint and the primary endpoint is different from the endpoint of in the Allen Island trials with Amvutra.

Speaker #4: 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.

Speaker #4: So that in itself, I think, is a very important part of the differentiation of way NOAA versus the competition. Now, Eclease, as Sharon mentioned, every secondary, we can hit will further differentiate our product from the competition.

Speaker #4: So let's wait and see. But we remain highly excited about the prospects of this asset.

Speaker #1: Thank you, Ruud. Steve Scala, TD Coren, 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.

Speaker #1: Maybe we move to Graham Parry at Citi.

Speaker #5: Great. Thanks for taking my question. It's a one-on-to Zarakimab again. Just wondering if we you can confirm that we should interpret the way the headline press releases worded and your comments today to mean that the effect size across the different eosinophil groups is consistent across those groups?

Speaker #5: I think you talked just now about potentially having a broad label. So that would be the interpretation. And then 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 but missing on the endpoint on Prospero?

Speaker #5: Thank you.

Speaker #1: And so I hope Sharon, you got the second question because the line broke up a bit. And the first one I can quickly answer.

Speaker #1: We expect we hope and our expectation is we will get a broad label including all the OS level. But we can't today disclose the results in each group.

Speaker #1: You will see this when we present the data. And the second question, Prospero, Sharon, hopefully you got it in full.

Speaker #3: Yeah. I did hear the question. So 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.

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: And we look forward to submitting our data in totality to the regulators as quickly as possible.

Speaker #1: Thank you, Sharon. Next question is with Sarita Kapila, at Morgan Stanley. Sarita, over to you.

Speaker #6: Thanks for taking my questions. So you've had a number of successes for Thatchaway across lung and breast cancer, as you've outlined. So how should we now think about the totality of the commercial opportunity?

Speaker #6: And are you confident in reaching multibillion peak sales for Thatchaway excluding Avanza? And then just a quick one on Evo Alpha. How has the initial dialogue with the FDA been?

Speaker #6: And is there scope for approval in the subgroup of adolescents and adults with pediatric onset? And perhaps you could quantify what percentage or how large this population is?

Speaker #6: Thank you.

Speaker #1: Thank you. And I think maybe Dave, you can take the second one. The first one, second one is from you, Mark. But if you Sarita, if you go back to the script, I mean, maybe Mark can repeat it.

Speaker #1: Mark gave the split of the various groups. Pediatric, pediatric onset, adults and adult onset. But the first question, Dave, do you want to go?

Speaker #4: Yeah. Sarita, I think that the best way to address this is that when we laid out a $5 billion plus ambition on Thatchaway, we continued to see the opportunity being just that.

Speaker #4: And we've got a series of really important readouts that are going to be happening over the course of the next several quarters. Obviously, we've got Avanza, TL07, TL08, but also we've got Tropion Lung 15 and then that'll be followed afterwards by Tropion Lung 14 and a series of data studies incorporating with Next Wave IO.

Speaker #4: So 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 is positioned us well to be able to have multiple shots on goal within the Avanza in the forecasts that we've got at this time.

Speaker #1: Yeah. It's important to really keep in mind our view hasn't changed over the potential of this agent. Since the time when Dave talked about it, back a little while ago.

Speaker #1: Of course, all these studies have to work in particular Avanza. But our view hasn't changed. Mark, do you want to cover the second?

Speaker #2: Yes. So maybe I take the second question first. In my prepared remarks, I had indicated that the pediatric cases are about 20%. The adult with pediatric onset would be 60%.

Speaker #2: And then the remaining 20% are covered by adult with adult onset. So these are this is basically the breakdown of the populations. Suffering from HPP.

Speaker #2: 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.

Speaker #2: And the third one is on adolescent and adults. With as a primary endpoint, six minute work test. But there are many other endpoints which are measured in this trial.

Speaker #2: And we have concluded that this study is clinically meaningful. And therefore, we are going to submit this data to the regulators.

Speaker #1: Thank you, Mark. Rajan Sharma, Goldman Sachs, over to you, Rajan.

Speaker #5: Hi. Thanks for taking the question. So just a couple more on Thatchaway. Just wanted to understand the rationale for adding the QCS biomarker primary endpoint to TL07 and then also including it in TL08.

Speaker #5: 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?

Speaker #5: And then related to that, is there any reason why control arms across these Thatchaway lung trials, including Avanza, may perform better or worse than you expected in a QCS positive population specifically?

Speaker #5: Thank you.

Speaker #6: Thanks for the question. So in terms of the rationale for including the biomarker in TL07, it's similar to the rationale for including it in Avanza.

Speaker #6: 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.

Speaker #6: So that's the logic that says that it makes sense to include in TL07 as well. As we did with Avanza, our colleagues at Deutsche, thank you, went and approached the regulatory authorities and had discussion about this approach.

Speaker #6: So similar for TL07, similarly to Avanza. There's an opportunity in the ITT and in the biomarker positive patient population in TL07, which is a reminder is in the PD-L1 less than 50% of the patient population.

Speaker #6: 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, 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.

Speaker #6: But of course, assuming that Avanza does show an improvement in the biomarker positive, of course, everybody, including regulators, will want to know what the performance is in the biomarker positive patient population.

Speaker #6: So 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 08.

Really important element of this. Uh the work that we've done on qcs with this positioned us well uh to be able to have multiple shots on goal within the avonza 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 over the past since the time when they've talked about it. A while ago, of course, uh all these Studies have to work in particular. Our view hasn't changed Mark, do you want to? So maybe I take this first the in my prepared remarks at the indicated that the biotic cases are about 20%. The width speeds would be 60% and then the remaining 20% are covered by adults with adult onset. So, these are, this is basically the, the program of the population.

Speaker #6: In terms of your question about event rate, the event rates for these trials are determined by the event rate and the overall ITT patient population.

From AC.

Speaker #6: So whilst it's possible that the patient population that's biomarker positive has a different event rate, that isn't what determines the cut point. So it's really the event rate and the overall population that's determining when we can do the data cutoff and therefore report the results.

In terms of data, as I've explained, we have three files, which we are going to submit to authorities.

Speaker #1: And we have no way to predict how the control arm will behave, right? So they have to wait for the end of the study.

Speaker #1: The next question is Mikhail Oyster, over to you. Jeffrey's, over to you.

The first 2 are on the billions population and the third 1 is on Adolescent and adults with, uh, as a primary end point 6, we need to work best but the only other endpoint which are measured in this file and have concluded that this uh speed clinically meaningful and therefore we able to submit this data to The Regulators.

Speaker #5: Oh, thank you. One question maybe too. On the delays, so you've got a TL07 delay just linking back to the last questions because of the inflammation of implementation of QCS.

Thank you Mark. Um, I've had John shama go over to you.

Speaker #5: 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 a firm view and a readout.

Speaker #5: And then a question on clerometoic, the depleter. There's also the delay here. What's driving that, please?

Speaker #6: So the timing of the results for TL07, I'll 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.

Um, hi. Thanks for taking the question. So, um, just a couple more data way. Um, just wanted to understand the rationale for adding the qcs biomarker. Uh primary end point to t7. And then also including it in T8, does this increase the probability of success of the trials in your view? Or is it more about building a moat around the potential, facial opportunity given that you have the biomarker and then related to that, is there any reason why control arms are crossed these data? Lung trials, including a van law May perform better or worse than you expected in a in a qcs positive population. Specifically thank you.

Speaker #6: There's no further delay to the event rate on TL07.

Speaker #4: 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.

Speaker #4: 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.

Speaker #4: There's a lot of enthusiasm across regions to incorporate computational pathology into the way in which care is being delivered. And it also gets to the previous question that Rajan asked.

Speaker #4: 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.

Thanks for the question. Um, so, uh, in terms of rationale for including the Bayou Market in t07, it's the, it's similar to the rationale for, including it in in a vanza, based on the totality of data that we've seen so far across, um, multiple data sets within concern Improvement in performance for both PFS and Os. Um, in the biomarker positive patient population both as monotherapy and in combination with, uh, IO in the first line setting. So that that's the logic that that says that, um, you know, it makes sense to include in t7 as well. Um, as we did with avanza, um, uh, our colleagues at DHI. Thank you. When an approach to the military authorities had discussion about this uh, this approach, um, similar picture, 7, similar to um Anar. Um, there's an opportunity in the

Speaker #1: Yeah, that's a really important point. And we've made that point before, but maybe just to remind you, if you assume that the ITT population will be positive, it's possible to assume that the QCS population might be even more positive.

Speaker #1: And the positive scenario overall, of course. So in the US, we would expect ITT use everywhere. In some countries where payers are more difficult, then QCS gives us another chance to get reimbursement if we cannot achieve it in the ITT population.

Speaker #1: So it's really we have two shots on goal in terms of reimbursement. So the next question is Matt, a second. Sorry.

Speaker #7: So first of all, the just remind you that clerometoic is not an event-based trial, but a time-bound trial. And 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.

The it and in the biomarker positive um patient population in t07, which is a reminder is in the pdl1 less than 50% of the patient population. I think I've mentioned previously that for tl8 which is in the greatest and 50% patient population given them. That's a smaller segments already. Um, you know the numbers that are accrued in that trial means that it makes sense to only include at some point. Not not part of the um uh the the the primary answers. But of course, um, assuming that avanza does show an improvement in the biomarker positive, of course. Um, you know, everybody including Regulators will want to know what the performance is in the biomarker positive patient population. So that addresses your question about, you know, why we're doing it in t7 and T8 and why it's different in the, um, statistical analysis in t07 versus I think in terms of your question about event, the event rates for these trials and determined by the event rate in the overall, it patient population. So, um, whilst it's possible that, um, the patient population is biomarker positive,

Speaker #7: It's not an event-based, but we wanted to return to the targeted medium exposure.

Has a different event rate that isn't what determines the cut point. So it's really the event rate in the overall population that's determining when we, when we can do the data cut off and therefore report the results.

Speaker #1: Thank you, Mark. Matt Weston, UBS.

Speaker #5: Thank you, Pascal. Two questions, please, if I can, on Epilon Tersin. The first is now that Tafamedis generics are delayed to 2031. If the combo is superior in cardiotransforms, is it realistic to expect reimbursement of a double-branded regimen in that setting?

And we have no way to predict how the Contra we have right now—so we have to wait for the end of the study next quarter. Next question, is my lot on over to Jeffrey? Over to you.

Speaker #5: And then the second question is around way newer in ATTRPN. One of your other differentiations potentially is going to be the home administration claim in the US.

Speaker #5: So can you update us on the commercial performance in the US market in the PN setting so we can understand how advantageous home administration really is?

Applicated is to run the test over existing um tissue samples and and whether they could slip any further, whether that say a firm View and a readout, and a question on the plate, there's also the delay here. What's driving that please?

Speaker #8: 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 effective defect size is very, very substantial.

So, the timing of the, um, uh, results for t7. I, I just... based on the, uh, uh, requirements for implementation of the biomarker within the clinical trial, that was the required—an amendment—as other, um, effects of that, we have to actually sort of run the analysis on the, um, on the samples that are available. Um, this is a further delay to the event rate on t07.

Speaker #8: I truly believe that payers, certainly in the United States, will be open to reimburse both branded products for this debilitating disease. So let's not forget that the mortality rate of patients with ATTRCM is very high.

Speaker #8: So 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.

Speaker #8: 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 United States.

Speaker #8: Of course, with the registration of the competitor also in the CM trial, there's not always to capture all those patients. But if you look at pure PN patients, we are clearly, clearly leading the pack here.

Maybe Michael also just uh 1 of the maybe questions that embedded within your question. Uh gets to the commercial Readiness. Um, and how we think about testing in a post-approval world, uh, 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 a lot of enthusiasm, uh, across regions to incorporate computational, pathology into the way in which care is being delivered. Um, and it also gets to the previous question that that Rogan 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 very important point and we've made that point before but just to remind you

You know.

Speaker #8: 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.

If you assume that the ITT population will be positive, it's possible to assume that the qcs cooperation will be even more positive in the positive scenario of all of us.

Speaker #8: So 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 the PN indication.

Operator: Good morning to those joining from the UK and the US. 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.

So in the US, we would expect it to use everywhere in some countries where, where failures are more difficult and qcs, give us gives us another chance to get around B. If we cannot achieve it, it population. So it's really, uh, uh, you know, we have 2 2 shots on go in term of reimbursement.

Speaker #1: Thank you, Ruud. Peter Verdult at Exine. Yeah, go ahead.

So, next question is Matt's second. So, first of all, just to remind you, this is not an event-based clear, but a time-bound trial.

Speaker #9: Yeah, sorry, Pascal. Yeah, I hear from PNP. Just Sharon and Ruud, can we come back to Tazo quickly? Sorry to label the point, but just coming at a different angle.

And as a trial, recruited faster than expected in order to reach the target medium, exposure of the trial, we decided to extend the study by 6 months.

Speaker #9: Just wanted to explore maybe potential upside scenarios to your three to five billion peak sales assumption. So are you assuming that you will see higher L33 competition or competitors eventually making it to the market when you provide that peak sales target?

It's not an even base, but we wanted to return to the targeted, a medium exposure.

Thank you, ma'am. MS.

Thank you, Pascal 2 questions please. If I can on ten.

Speaker #9: And do you have any plans to explore Tazo beyond COPD or lower tract respiratory disease? I'm thinking maybe nasal polyps or bronchiectasis. And then 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 Stonia?

Operator: 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.

Um, the first is now that the family generics are delayed to 2031. If the combo is Superior in cardio transforms is it realistic to expect reimbursement of a double branded regimen in that setting?

And then the second question is around way, newer in attr, PN.

Speaker #9: Thank you.

Speaker #1: Thank you, Peter. So Sharon, do you want to start the second one and then Ruud, you can cover the first one?

Speaker #3: Sure. Yeah. So you're spot on. The endpoint for Prospero was different than for Oberon and Titania. And Prospero, we specifically looked at selectively severe exacerbations.

1 of your other differentiations, potentially is going to be the home Administration claim in the US. So can you update us on the commercial performance in the US market in the PN setting? So we can understand how advantageous home Administration really is.

Speaker #3: 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.

Joris Silon: 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 US dollars unless stated otherwise. Next slide, please. This slide shows our agenda for today's call.

Speaker #3: And it really provides us with a point of differentiation for Tozoracimab. We have a differentiated molecule in terms of its bifunctional inhibition. And we also have a differentiated clinical trial program.

Yeah, thank you. Thank you for both questions. First of all, regarding the combination, of course, it's fully depends in my view. And our view on the, the the size of the effect of the effect size is is, is very, very substantial. I I truly believe that there is certainly in the United States. We all be open to reimburse both products for this debilitating disease. So, let's not forget that the mortality rate of patients with attr-cm is very high.

Speaker #3: Ruud, would you like to take the rest?

Speaker #8: Yeah, of course. So first of all, Peter, we have indicated once again that this product in our view is a three to five billion dollar opportunity in COPD alone.

Speaker #8: Of course, the competitive environment has changed somewhat, and we don't know exactly what they are going to do moving forward. Now, having said that, based on the results, of course, we are also thinking about potential other indications.

Speaker #8: You are mentioning bronchiectasis, potentially asthma. We haven't taken any decision yet on that. But if everything moves well, of course, we will have a look.

Joris Silon: 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. Although, 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.

Speaker #8: But it makes sense also to move Tozoracimab in other indications where there is still a high medical need. On top of that, overall, the biopenetration of the current biologics in COPD is still relatively limited.

Pascal Soriot: Thank you, Joris, and 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 4 positive Phase III programs, including two NMEs, tozorakimab and efzimfotase alfa.

Speaker #8: This is below the 10%. So it also shows the potential in COPD, which is a very heterogeneous disease, in order to use a completely new biologic specifically designed for COPD in order to capture the full potential in COPD.

Speaker #1: Thank you, Ruud. Christopher, oh, sorry, Peter, did you want to say something?

Speaker #9: I just want to say thank you. Thanks, Pascal.

Speaker #1: All right. Cool. Christopher Ruder at SEB.

Speaker #10: Yes. Thank you for taking my questions. So my first is on MFN, if you wouldn't mind commenting. So how are you forecasting the future impact?

Times a year to a hospital in order to get the drug administered by, uh, the The Physician. So I think the combination of a higher quality of life or a better quality of life home Administration and a very strong Affinity in general. I think is is is is 1 of the reasons we see a very strong, strong uptake in in the United States, in another countries for the be an indication.

Thank you, uh, Peter. That concludes the exam.

Speaker #10: Let's say across the seven major markets or how would you recommend we do it? Perhaps is the question you'll answer. And then is this for should we be thinking about it applying to only future launches as some of the competitors have said?

Hello, can you hear me? Yeah, go ahead. Yeah, um, just Shannon Rudd. Can we come back to ToSo quickly? Sorry to, uh, to labour the point, but just coming in at a different angle. Just want to explore maybe potential upside scenarios to your—

Speaker #10: And then on aisle five, we've got a competing long-acting aisle five that's launched and tracking rapid growth. So Ruud, what are you seeing on the competition?

Pascal Soriot: 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.

Speaker #10: What are your thoughts then on the long-term future? I guess that part's for Sharon of the role of aisle five in the RNI therapeutic area and how are you working to adapt to play a key part in that going forward?

Speaker #10: Thank you.

Speaker #8: Yeah. Let me take the first one, or the second one, sorry, the aisle five. Yeah. First of all, we are very pleased with the performance now for quite some time of Fasenra.

3 to 5 billion something. So are you assuming that you will see? I 33 competition competitors. I think making for the market when you give, when you get, we provide that Peak sales Target and do you have any plans to explore toso Beyond CPD or lower track refrigerators? I'm thinking maybe nasal polyps or bronchitis. Um, and then, just a quick clarification, Shannon on, on the Prospero question earlier, uh, am I wrong thinking that the end point? Uh, there was a bit different to say, thank you.

Sean, do you want to start with the second 1 and then what you can call the first 1?

Speaker #8: It's clearly the leading anti-aisle five 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.

Speaker #8: There's now a long-acting anti-aisle five. Now, having said that, the Nimble study was not specifically successful regarding the switch from Fasenra our aisle five to the long-acting one.

Speaker #8: It was even getting worse. So I think what we need to do is to cement our position as the leading aisle five. I think the molecule is doing extremely well.

Pascal Soriot: Revenues in China increased by 2%, with VVP implementation impacting Farxiga, Lynparza, and Roxadustat growth. We are confident in our growth outlook in China based on the positive 2026 and NRDL outcomes. Next slide, please. In Q1, we saw a continuation of the successful clinical trial delivery seen in 2025. We announced 4 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.

Sure. Yeah, so you're spot on the end point for Prospero was different than Oberon and Titania. In Prospero, we specifically looked at selectively severe exacerbations, which is different and 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 and it really provides us with a point of differentiation for Tozer aab. We have a differentiated molecule in terms of its by functional inhibition and we also have a differentiated clinical trial program.

Speaker #8: And I think the mode of action we've sometimes forgot that is fundamentally different from the other anti-aisle fives. We are depleting eosinophils. And we have seen very, very strong traction across the world.

Rude, would you like to take the rest? Yeah, of course. Uh, so, first of all, Peter, we have indicated once again that this product in our view is 3 to 5 billion dollar opportunity in Co alone,

Speaker #8: And there's no reason to believe that we will not continue and last but not least, what I said in my prepared marks, we have just launched Fasenra in China.

Speaker #8: China is a high medical need. And the potential of Fasenra in China is very, very substantial as well.

Speaker #3: Sure. So 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 eosinflammation and reducing the risk for patients.

Speaker #3: We've got a winner in Fasenra. And we have an eight-week dosing regimen that delivers that sustained control and really stands out for its high adherence.

Aradhana Sarin: 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 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.

Of course, the competitive environment has changed somewhat and we don't know exactly what they are going to do moving forward. Not having said that based on the results, of course, we are also thinking about potential other indications, you are mentioning from the actresses potentially asthma. We haven't taken any decision yet on on on that. But if if everything moves, well, of course, we we will have a look, but it makes sense also to move those around in other indications where there's still a medical needs. On top of that overall, the the bio penetration of the current biologics and COPD is still relatively

Speaker #3: We've got about 80 to 90 percent of patients remaining on Fasenra through our pivotal studies, which is really remarkable, as well as in our real-world studies.

Limited this below the 10%. So it also shows the the potential in 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 the full potential and COPD.

Speaker #3: And it remains the only biologic with clinical evidence proven to reduce for both oral and inhaled background therapy. So we've got strong molecule there.

Thank you. Thank you Christopher. Oh sorry. Peter. Did you want something?

Speaker #3: 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, but we think about how to continue to leverage the success that we've seen in this program.

I just want to say thank you. Thanks Pascal. All right. Cool. Um Christopher Huda had said

Speaker #8: So the first question, I mean, you can take a very conservative approach and remove the 7 plus DG7 plus. I mean, DG7 being six countries and two.

Speaker #8: From the forecast, if you want a very, very conservative approach, knowing that the last two are smaller markets, but we are working very hard, not only we, but the whole industry to improve the access and pricing environment in all of those countries.

Aradhana Sarin: 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 Q1. For the full year, we continue to expect Core R&D costs to be at the upper end of the low twenties percentage range. Core SG&A costs increased by 7% in Q1. This was partly driven by pre-launch investments behind Baxdrostat, which has a US PDUFA date in Q2 2026.

Speaker #8: I should remind you all that it's only for new products. Future new products. And it will also be different 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 US.

Thank you for taking my question. So, um, my first is on mfn, if you wouldn't mind commenting. So, how are you forecasting? The uh, future impact. Um, let's say across the 7 major markets or or, how would you recommend we do it. Perhaps is the question you'll answer. And then, um, is this for, should we be thinking about it applying to only future launches or some of the, uh, competitors that said, um, and then on, um, il5. Um, we've got a competing long-acting, uh, il5, that's launched and tracking rapid growth. So, um, rude. What are you seeing on the competition? What are your thoughts then? Um, on the long term future, I guess that part's for for Sharon of the role of Isle 5 in the rni therapeutic area and and how are you working to adapt to play a key part in that um, going forward? Thank you.

Speaker #8: But 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.

Speaker #8: You've seen some movements in the UK already. Discussions based on the 301 investigation will start with other countries. I think in the next few weeks, several 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.

Aradhana Sarin: As you've seen, we have had a great start to 2026 in terms of R&D, with success in 4 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 strong underlying performance. Core EPS grew by 5% to $2.58, with growth rate impacted by low tax rate in Q1 in 2025. Next slide, please.

Speaker #8: And we are getting positive response in some countries. And more wait and see in other countries. But we have it. This is going to play out over the next 18 months, two years.

Speaker #8: So we have time to hopefully reshape the environment. So I've given you the most conservative approach in terms of forecasting, but I don't think it's going to be like this.

Speaker #8: And as it is today, you have to remember the whole of Europe represents 20 percent of our global sales. So take a fragment out of this.

1. It was even getting worse. So I think what we need to do is to set our position at the leading our 5. I think the molecule is doing extremely well. I think the mode of action we sometimes forget that it's fundamentally different from the other anti-alias. We are depleting Us in the fields. Um, and and and we, we have seen very, very strong traction across the world. And there's no reason to to believe that that will not continue. And last, but not least, what I said in my prepared marks, we're just launched for sunrise in China China, there's a high metcom need and the potential of of a center. In China is very, very substantial as well.

Speaker #8: This is not huge. And so 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.

Aradhana Sarin: Cash flow from operating activities of $3.4 billion was a slight decline versus the same period last year due to large milestone received 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 licensing 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.

Sure. So building on that route, I'll just restate that we have a lot of faith in Torah. It's a fantastic molecule. That provides targeted complete and fast. Sustained, eosinophil removal, effectively, treating EOS, inflammation, reducing the risk for patients. We've got a winner in finra.

Speaker #8: Siemens Fernandes, Guggenheim. Thanks, Pascal. So our question is actually on the positioning of the GLP-1 and how you're thinking about that. So 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?

And we have an 8-week dosing regimen that delivers that sustained control and really stands out for its high adherence. We've got about 80 to 90% of patients remaining on for Stendra through our uh our pivotal studies, which is um really remarkable as well as in our real world studies and it Remains the only biologic with clinical evidence proven to reduce

Speaker #8: Maybe help us understand the safety supporting the aggressive advancement into phase three. And 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 schemes.

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, but we think about how to continue to leverage the success that we've seen in this program.

Aradhana Sarin: The recent CSPC deal closed in April, so will be booked in 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-digit 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.

so, the first question, um,

Speaker #8: So just trying to get an understanding of how these data coming at ADA are really going to wrap around the very broad phase three program that you've initiated.

I mean, you can take a very conservative approach and uh, remove the

Speaker #8: Thanks so much.

Surprise G7 plus, I mean, G7 being 6, countries and 2 uh from the forecast if you want a very, very conservative approach.

Speaker #4: Yeah. Thank you, Siemens. This one is for Sharon. And maybe Ruud, you can also jump in. I just want to be clear, fully de-risk is a bit ambitious.

Uh, knowing that two are smaller markets, um, but we are working very hard—not only we, but the whole industry.

Speaker #4: We will fully de-risk when we are at the end of the phase three program. But we are moving as fast as we can into phase three.

Uh, to improve the access and pricing environment in all of those countries.

Speaker #4: So over to you, Sharon.

Speaker #3: Yeah. And thank you for the question, Siemens. As you know, those data are upcoming at ADA in June. So I cannot tell you what the data say.

Should remember remind you all that. It's only for new products, future new products.

Speaker #3: The conference organizers would frown on that. But we did announce that we completed the phase two B trials for elecoglipron and that the data that we saw in those phase two B trials, one for obesity and one for patients with type 2 diabetes, gave us the confidence that we need to move into a very comprehensive phase three development program.

Aradhana Sarin: 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.

And 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 and the US. But 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.

Speaker #3: 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 fully on weight loss, but on being able to address complex interrelated comorbidities.

You've seen some movements in the UK already.

Uh, discussions based on the 31 investigation will start with other countries. I think in the next few weeks or months.

Speaker #3: And AstraZeneca is in a unique position with our broad portfolio. We are ideally suited to creating both monotherapies and fixed-dose combinations with elecoglipron that allow us to address comorbid disease.

Dave Fredrickson: Thank you, Aradhana. Next slide, please. Oncology total revenues grew 16% in Q1 to $6.8 billion, with double-digit growth across all reported geographic segments. Performance in the US 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 US and Europe, partially offset by higher than historic destocking in the US. 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.

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, and in their respective countries.

and, you know, we

Speaker #3: So at ADA, we look forward to sharing the data and continuing this conversation. But what we saw in those data gave us the confidence that we needed to fully invest in our comprehensive program.

are getting, um,

Speaker #8: No, it is not a lot to add of what Sharon has said. I think the focus on outcomes I think our strength with fixed-dose combinations and we have articulated a few of those potential combinations and one of them is clearly with our SGLT2 Farxiga.

uh, positive response in some countries and, you know, more wait and see in other countries. But, you know, we have it. This is going to play out over the next 18 months, 2 years. So we have time to hopefully reshape the environment. So, 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.

Speaker #8: And 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.

Speaker #8: And there's still an incredible high medical need in those markets. Regarding obesity treatment, but clearly also diabetes.

Um and you know as it is today you have to remember the whole of Europe represents 20% of our Global sales. So take a fragment out of this this is this is not huge and so we truly hope we are going to get better pricing and better access and and uh, be able to launch our products everywhere. Which is of course, the ultimate goal sheet, Google and I

Speaker #4: We're going to add that the we have a very ambitious phase three program that is excellent, really. The team has done an amazing job.

Dave Fredrickson: 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. 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 US, Calquence continues to maintain its share leadership position in the frontline CLL setting despite intense competition.

uh,

Speaker #4: And so 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.

Speaker #4: But we will have a very strong set of data across a very broad phase three program to launch this product. So next question is from Lusa Hector at Berenberg.

Speaker #4: Over to you, Lusa.

Speaker #5: Thank you, Pascal. A couple, please. So on chemisestrant, are there interim analyses still pending for the Cambrias or even Serena 4? And then given that we've had some discussion on phase three trials which are in flight, but you've been making some changes such as TL07, 08, I wonder whether you could give us some more color around your work with the FDA on real-time clinical trials because I see Astra mentioned as one of two companies working with the FDA there.

Dave Fredrickson: 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 US, 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.

Wrap around the very broad phase 3 program that you've initiated thanks so much.

Speaker #5: So what kind of benefits could this ultimately bring in terms of timing and savings? Thank you.

Speaker #4: I think Siemens, for you, it's a question is really a real-time collaboration. Study collaboration with ADA.

Speaker #6: Yeah, sure. Thanks for the question, Luisa. So for interim analyses, you know we don't comment on those. So I can't really address that question anymore.

Yeah, I think. Thank thank you, this. This 1 is for shahan and maybe I would you can you can also jump in. I just want to you know be clear. Fully the risk is a bit ambitious. We we will fully risk when we are at the end of the phase 3 program but we're moving as fast as we come into phase. 3 to you Sean

Speaker #6: But the real-time clinical trials, I think this is an exciting first step towards this future. So the we're collaborating with the FDA on is the Traverse trial, which is with a well-established medicine calibutinib in a mantle cell lymphoma setting.

Dave Fredrickson: We're also seeing encouraging early signs of adoption of Enhertu in first-line HER2-positive breast cancer in the US 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 Q1 represents 47% growth over the prior year. We expect some further growth to be delivered in ex-US markets, and we see US market share at peak. Datroway revenues of $43 million in Q1 reflect ongoing demand in the US in later line EGFR-mutated lung cancer, with more than 1 in 3 third-line patients now treated with this medicine. Following its acceptance for priority review, we look forward to the US approval of TROPION-Breast02 later this Q1.

Speaker #6: So what this enables us to do is literally to as the adverse events and things come in, we'll get notified simultaneously with the FDA.

Speaker #6: So 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.

Speaker #6: 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.

Yeah, and thank you for the question Sheamus. Um, as you know, those data are upcoming at 8 a.m. June. So I cannot tell you what the data say. The conference organizers would frown on that. But we did announce that, we completed the phase to be trials for a lack of run. And that the data that we saw in those phase 2B trials 1 for obesity and 1 for patients with type 2 diabetes. Gave us the confidence that we need to move into a very comprehensive phase. 3 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 fully on weight loss but on being able to address complex interrelated comorbidities and astroica is in a unique position with our broad portfolio. We are ideally suited to creating both monotherapy and fixed combinations. With the Leo grip. Runs that allow us to address comorbid disease. So at ABA, we look forward to sharing the data and continuing this conversation. But what we saw in those data gave us the confidence that we needed to fully invest.

In our comprehensive program.

Speaker #6: And then 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.

Dave Fredrickson: 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 will hand over to Susan to cover key R&D highlights from the quarter.

Speaker #6: So 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.

Speaker #4: Thank you, Suzanne. 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.

Speaker #4: Let's move to Matthias Hagblom at Anders Banken. Matthias, over to you.

Susan Galbraith: 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.

Speaker #7: Thanks so much, Matthias Hagblom, Handelsbanken. One question, please. Can you talk about CAR-T and specifically how you feel about the Grasell BCMA CAR-T program, but also Grasell FastCAR as a platform in light of industry's rapidly growing interest?

No, it is not a lot to to to add or what Sharon has said. I think that the focus on the outcomes, I think our strength is fixed those combinations and and we have articulated a few of those potential combinations. And 1 of them is really with our sdr2 FAA. And last but not least, I think also is quite uniquely positioned. Uh, regarding our Global Footprints. There we have a very strong presence as as we all know in the international markets and there's still an incredible High medical needs in those markets, regarding obesity treatment, but clearly also, uh, a diabetes right on the add that the we have a very ambitious Facebook program. That is excellent. Really, the team has done an amazing job. And, uh, so we have a very, very strong data set. Assuming, of course, the studies are positive which uh, we believe we have a good chance for that, of course. But we will have a very strong set of data across a very broad phase 3 program to launch this product.

Speaker #8: So the line was not very good, Matthias, but hopefully, Suzanne, you got it. It's about AZ10120, but I'm not sure that.

So, next question is, from Losa ha at berenburg over to you ran.

Speaker #6: Yeah, 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 AZ0120, the lead product.

Speaker #6: Did I get that right? I can't hear the answer. So I'll answer what I thought the question was. So one of the differentiations of AZ0120 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.

Thank you, Pascal. Um, a couple please so on Kanis, restaurants are there? Interim analyses, still pending for the Cambria or or even Serena 4 and then, uh, given that we've had some discussion on phase 3 trials, which are in flight, but you've been making some changes, such as pl7, 08. Um, I wonder whether you could give

Susan Galbraith: 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 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.

Decimal color around your work with the FDA on Real Time clinical trials because I see Astra mentioned as 1 of 2 companies working with the FDA there. So what what kind of benefits could this ultimately bring in terms of timing and savings? Thank you. Thanks for your question is really a real time collaboration study collaboration with

Yeah, sure. Um, thanks for the question, Lisa. Um, so for interim analyses, um,

Speaker #6: That reliable and shorter delivery time is really important for sites. And for the operationalization, but there were other factors that were involved in here as well.

Speaker #6: 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.

Susan Galbraith: In the H2 of this year, we have two data sets 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, PACIFIC-9 which looks to consolidate and deepen our leadership in stage 3 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 Puxtucim, our B7-H4-directed ADC in endometrial and ovarian cancers.

Speaker #6: 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 know what the timing of the cytokine release syndrome is can be prepared for that.

Speaker #6: And then the patient can go back after that period of time. So it's not just the FastCAR process in itself. It also is the dose that you end up with and the timing of the CRS that also make it differentiated.

You know, we don't comment on those. So, I can't really address that question anymore. But the real time, clinical trials, I think this is an exciting, um, first step, um, towards this, uh, this this future. So, the, the trial that we're, uh, um, collaborating with the FDA on is, is the Traverse. Um, trial which is, um, with a, with a, you know, well established medicine, uh, caliber nib, um, in a mantle cell lymphoma setting. So, you know what this enables us to do is, is is literally to, you know, the as the Adverse Events and the things come in, um, we'll get notified simultaneously with the with the FDA. Um, so I think this will enable us to have learnings. I think the opportunity though is um, in a future World um where you're not submitting based on documents but you are submitting based on access to data this could save time. Um, in terms of preparation for submissions, um,

Speaker #6: I think the other factor, of course, is that it's a dual car. It's got CD19 and BCMA targeting. I think that's important for avoidance of the escape mechanisms from downregulation of one target or the other.

Susan Galbraith: 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, Tograsum, in ovarian cancer later this year. We will also share further data for SunnyV, including 18.2 positive gastric cancer from a broad global population, which supports the ongoing Phase III CLARITY Gastric-01 trial, now expected to read out in H2 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's lymphoma population, strengthening our expanding hematology pipeline.

Speaker #6: So overall, we're delighted with the profile that we've got with 0120. It was presented in detail at the ASH meeting. And we now have ongoing DERGA4 study phase three study in later line multiple myeloma.

Speaker #6: And you'll see further studies in the coming months as we open up those program more broadly.

Against Steve scalies. If Steve is back? Can you hear me, Steve?

Speaker #4: Thank you, Suzanne. The next question is from Simon Becker, Redburn, over to you, Simon.

Speaker #7: 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 wholesale ED stocking.

Okay, he's giving up, or he has technical difficulties. Let's move to—

match sagra at Andre's bank and matches over to you.

Speaker #7: And related to that, is that wholesale ED stocking specific to Tagrisso or are you seeing that anywhere else in the portfolio? Thanks so much.

Thanks so much. And 1 question, please. Can you talk about party and specifically how you feel about the gel business party program. But also,

Speaker #8: Thanks, Simon, for the question. Just within the US, 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.

Susan Galbraith: 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.

Yourself first call as a platform in light of industries rapidly growing in platform.

Ruud Dobber: 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 US approval for asthma.

Speaker #8: The demand growth for the quarter for Tagrisso was mid-teens. And so 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.

So, the line was not very good matches, but I, hopefully Susan, you got it, it's about az1 0120. But I'm not sure that. Yeah, I think, um, I just want to clarify the question a little bit. I think you were asking about how the fast car process. Helps the differentiation of acid do 1 to the lead. Um, product did I get that right?

Speaker #8: Now, specific to your question, we have seen some suggestion of this on other orals but it didn't include cowplants that could be because of a buildup for Amplifi.

Speaker #8: So not entirely sure, but we are seeing some destocking across the oral agents that's taking place. But it was particularly noteworthy on Tagrisso. I think the most important piece, though, is that I don't see that going any further down.

Speaker #8: The demand growth is very strong. We're seeing a clear preference for Flora II. Very importantly, on Mariposa, we have not seen any impact from the subcutaneous launch on US Tagrisso shares.

I can't hear the answer, so I'll answer what I thought the question was. Um, so 1 of the differentiations of az12 is that it's developed with this fast car process, which enables the um, you know, the uh XV of growth of the of the of the cells you know, in a 3-day T um and process which means that you can get a um a turnaround time reliably in around uh as as a 16 day time frame because you know, after the sales

Speaker #8: So 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.

Ruud Dobber: 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 United States, 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.

Speaker #4: Thank you, Dave. And the last question is Justin Smith, Advanced Team, over to you, Justin.

Speaker #5: Yeah, thank you, Pascal. I've got one for Ruud. Ruud, if I remember correctly, during the August call last year, post-ESC, Baxterstat, you said it could be above 5 billion.

Speaker #5: 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.

Speaker #8: Yeah, no, I think that they are still the same as. So once again, what we have indicated during the investor data, this is potentially a $5 billion asset.

Speaker #8: That's not to forget that we are investigating and the 5 billion is built roughly half of that is in the fixed dose combination. That study will reroute beyond 2027.

Have been produced. There's still some quality, um, testing that needs to be done before the, um, the, the cells are shipped to to the patient that reliable. Um, and shorter delivery time is really important for sites. Um, and for the operationalization, but 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 tea cells than it can. It can then expand in in the patient's body, in Vivo, um, more more rapidly. What that also delivers is a predictable time of onset of any Saito release syndrome and enable it to be positioned as a potentially outpatient, um, uh, treatment. Um, because people that, you know, know what the timing of the Cy release syndrome is can be prepared for that. Um, and then, the patient can can can go back after that period of time. So, so, you know, it's not just the fast car process in itself. It also is the, um, you know, the, um, the, the dose that you end up with and the time,

Speaker #8: And the other one is the mono components. But we are also looking into CKD for Baxterstat. So 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.

Ruud Dobber: CVRM total revenue for 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 established the rest of the world and also with the implementation of VVP in China. As expected, gene-generic manufacturers entered the US market in April. Our US 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 decision set for Q2.

Speaker #4: Very good. Let's end on that, Justin. You're making Ruud nervous. We're moving into budget timing. But Baxterstat is definitely a big product. And we're all excited to see it launch in many countries very soon.

Of the COS to make it differentiated. I think the other factor, of course, is that it's a dual CAR. It's got, um, CD19 and BCMA targeting. I think that's important for avoidance of, uh, the escape mechanisms from downregulation of one, uh, target or the, or the other. Um, so overall, we're delighted with the, um, profile that we've got with 0120. It was presented in detail at the ASH meeting, and we now have ongoing YOGA-4 study in Phase 3. Um, study in, um, later line, um, more

Speaker #4: So 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.

Put my alarm on, you'll see further studies, um, in the coming months. Uh, um, as we open up this program more, broadly, thank you Suzanne. The next question is from Simon Becker, Redbarn over to you Simon,

Thank you, Pascal just 1 from me. Uh, if I may please, uh, for Dave, uh, I was wondering if you could give us um an idea of the underlying uh demand growth for tagrisso, as you said it was, it was distorted by uh wholesale LED stocking and related to that is that wholesale stocking um specific to to gristle. Or are you seeing that anywhere else in the portfolio? Thanks very much.

Thanks Simon for the question. Um,

Ruud Dobber: 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 and Asthma, the anticipated Baxdrostat launch, the recent success of Tozorakimab phase III COPD program, and the upcoming results from Wainua ADCRCN 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.

just within the us, we have really seen tagrisso with, uh, strong Frontline leadership, uh, just to build and quantify some of the comments that I made. Uh, in the prepared remarks, the demand growth for the quarter for its aggressor was mid teens.

And so, you can see that the really truly kind of higher than historical. Uh, D stocking levels is, what brought the net results down to where they were now specific to your question. Uh, we have seen some suggestion of this on other orals, uh, but it didn't include cow prints. That could be because of A build-up for amplify. Um, so not entirely sure. But we are seeing some, uh, some D stocking across, uh, the oral agents, that's taking place, but it was particularly noteworthy, onto griso. I think the most important piece though is, is that I don't see that. Going any further down. The demand growth is very

Sharon Barr: 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.

Very strong. We're seeing a clear preference for Flora 2. Very importantly on Mariposa. We have not seen any impact from the subcutaneous launch on us cigarettes. Our shares.

So the subcutaneous launch is cannibalizing IV, but it is not, uh, having impact on, uh, Tagrisso shares. And, by the way, that same is true in Germany and in Japan.

And over to you, Justin.

Um, yeah. Thank you, Pascal. I've got 1 for rude. Um, rude. If I remember correctly during the August call. Last post ESC back to start. You said it could be above 5 billion, it could be above 10 billion. Time would tell just wondered over 6 months on for that if those remarks are the same or if you would qualify those remarks at all,

Sharon Barr: 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.

Yeah, no I think that they are still the the same as so once again, what we have indicated during the investor data, this is potentially a 5 billion dollar asset. That's not forget that we're investigating and the price building is built roughly. Half is of, that is in the fix. Those combination that study will react, will read out Beyond 2027, and the other 1 is the mono components, but we are also looking into CKD, uh, for for, for back to steps. So there are 4 other indications which potentially, if successful can move that number up to, to potentially, uh, 10 billion. And and that view hasn't changed at all.

Very good. Let's and on that Justine. You're making Road nervous. We're moving into budget timing. So, but back to study is definitely a big product and we are all excited to see it launched in in many countries very soon. So, 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.

Sharon Barr: 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 2-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 3 pivotal trials that enrolled broad populations. These results are further supported by PROSPERO, the long-term extension study of OBERON and TITANIA.

Sharon Barr: 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 6 billion biologic-eligible patients globally, Tozorakimab has the potential to address the broadest population of COPD patients. With that, please proceed to the next slide, and I'll pass over to Marc to cover rare disease.

Marc Dunoyer: 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. You recall, Q1 2025 performance include the 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.

Marc Dunoyer: 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. Asfotase alfa, our next-generation enzyme replacement therapy, demonstrated positive result from the global Phase III clinical program for patients with HPP. The Mulberry trial in treatment-naive pediatric HPP patients 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.