AstraZeneca Q1 2025 Earnings Report

AstraZeneca EPS Results

• Actual EPS: $1.24
• Consensus EPS: $1.10
• Beat/Miss: Beat by +$0.14
• One Year Ago EPS: $2.06

AstraZeneca Revenue Results

• Actual Revenue: $13.59 billion
• Expected Revenue: $13.71 billion
• Beat/Miss: Missed by -$119.43 million
• YoY Revenue Growth: +7.20%

AstraZeneca Announcement Details

• Quarter: Q1 2025
• Date: 4/29/2025
• Time: Before Market Opens
• Conference Call Date: Tuesday, April 29, 2025
• Conference Call Time: 6:45AM ET

AstraZeneca (NASDAQ:AZN), a biopharmaceutical company, focuses on the discovery, development, manufacture, and commercialization of prescription medicines. The company's marketed products include Tagrisso, Imfinzi, Lynparza, Calquence, Enhertu, Orpathys, Truqap, Zoladex, Faslodex, Farxiga, Brilinta, Lokelma, Roxadustat, Andexxa, Crestor, Seloken, Onglyza, Bydureon, Fasenra, Breztri, Symbicort, Saphnelo, Tezspire, Pulmicort, Bevespi, and Daliresp for cardiovascular, renal, metabolism, and oncology. Its marketed products also comprise Vaxzevria, Beyfortus, Synagis, FluMist, Soliris, Ultomiris, Strensiq, Koselugo, and Kanuma for covid-19 and rare disease. The company serves primary care and specialty care physicians through distributors and local representative offices in the United Kingdom, rest of Europe, the Americas, Asia, Africa, and Australasia. It has a collaboration agreement with Neurimmune AG to develop and commercialize NI006; BenevolentAI for drug discovery for systemic lupus erythematosus; and Absci Corporation for AI-driven drug discovery against an oncology target. The company was formerly known as Zeneca Group PLC and changed its name to AstraZeneca PLC in April 1999. AstraZeneca PLC was incorporated in 1992 and is headquartered in Cambridge, the United Kingdom.

AstraZeneca Q1 2025 Earnings Call Transcript

Key Takeaways

• 10% total revenue growth in Q1 2025, driving a 12% rise in core operating profit and 21% core EPS expansion, with full-year guidance for high single-digit revenue and low double-digit EPS growth reiterated.
• 13 regulatory approvals secured since February and five positive Phase III trial readouts—including NMEs camisestrant and enevoparatide—advancing toward the goal of 20 novel medicines by 2030 (nine delivered to date).
• Bolstered pipeline and capabilities via strategic moves: proposed acquisition of Esobiotech’s cell therapy platform, exclusive ALT-B4 licensing for subcutaneous oncology, new novel modalities portfolio and a Beijing R&D center.
• 31 global manufacturing sites with dual-source supply and most U.S.-sold medicines made domestically, providing resilience to disruptions and minimizing potential tariff impacts.
• Strong geographic momentum with emerging markets ex-China up 17% and China growth of 5% (9% excluding Pulmicort), while navigating U.S. headwinds such as Medicare Part D redesign and sustaining growth across all regions.

Presentation

[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 ladies and gentlemen to AstraZeneca's Q1 twenty twenty five results conference call 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.

[Operator]

This meeting may contain forward looking statements with respect to the operations and financial performance of AstraZeneca. Although we believe our expectations are based on reasonable assumptions, by their very nature, forward looking statements involve risks and uncertainties and may be influenced by factors that could cause actual results to differ materially from those expressed or implied by these forward looking statements. Any forward looking statements made on this call reflect the knowledge and information available at the time of this call. The company undertakes no obligation to update forward looking statements. Please also carefully review the forward looking statements disclaimer in the slide deck that accompanies this conference call.

[Operator]

There will be an opportunity to ask questions after today's presentations. Please use the raise a hand feature to indicate you wish to ask a question at any time during the call. I must advise you this presentation is being recorded today. And with that, I will now hand you over to Andy Barnett, Head of Investor Relations.

[Andy Barnett, Head of Investor Relation at AstraZeneca]

A warm welcome to AstraZeneca's first quarter twenty twenty five presentation, conference call and webcast for investors and analysts. I'm Andy Barnett, Head of Investor Relations. And before I hand over to Pascal and other members of our executive team, I'd like to cover some housekeeping items. Firstly, all of the materials presented today are available on AstraZeneca's Investor Relations website. This slide contains our Safe Harbor statement, which I'd encourage you to take the time to read.

[Andy Barnett, Head of Investor Relation at AstraZeneca]

We will be making comments on our performance using constant exchange rates, or CER, core financial numbers and other non GAAP measures. A non GAAP to GAAP reconciliation is contained within the results announcement. All numbers quoted are in millions of U. S. Dollars unless otherwise stated.

[Andy Barnett, Head of Investor Relation at AstraZeneca]

This slide shows our agenda for the call. And following our prepared remarks, we'll open the line for questions. As usual, we'll try to address as many questions as we can during the call, although please limit the number of questions you ask to allow others a fair chance to participate in the Q and A. And with that, I'll hand over to Pascal.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

Thank you, Andy, and welcome, everybody. We have made a strong start in the first quarter of the year, building on the momentum through 2024. Total revenue growth was 10% in the quarter, reflecting increasing demand for our Innovative Medicines. Core operating profit increased by 12% and core EPS increased by 21%, reflecting our continued focus on operating leverage. Although core EPS in the first quarter did benefit from a lower tax rate due to settlements in certain jurisdictions.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

Since our full year results in February, we secured 13 approvals in key regions across our diverse portfolio, a clear illustration of the value our medicines bring to patients globally. In addition, we continue to see strong delivery from our pipeline and in the past few months, announced five positive Phase III results, including two NMEs, camisestrant and enevoparatide, and multiple high value indication expansion opportunities across gastric and breast cancers. We're making excellent progress towards our ambition to deliver at least 20 NMEs by 02/1930 with the recent approval of BeYontra, formerly known as Zekoramidis, marking the ninth novel medicine approval towards our goal. We continue to benefit from our broad based diverse business with a robust growth outlook for each of our therapy areas and across key geographies. We saw strong performances across key regions despite anticipated headwinds, including Medicare Part D redesign in The U.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

S. Importantly, we continue to deliver impressive growth in the emerging markets with ex China revenues up 17%, reflecting the benefit of our sustained presence in these markets. Our growth in China was also encouraging, up 5% or 9% when adjusting for the decline of Pulmicort sales. This growth is driven by increasing demand for innovative medicines with additional launches in China achieved in the first quarter. We are aiming to deliver sustained growth well beyond 02/1930, investing in transformative technologies.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

In the first quarter, we announced several business development transactions that strengthen our pipeline and our capabilities, which we believe have potential to support our long term growth ambitions. Our proposed acquisition of EsobioTech brings the potentially best in class in vivo cell therapy platform in house, increasing accessibility of potentially curative cell therapies with applications across oncology and autoimmune diseases. Next, we announced our portfolio of novel modalities, accelerating the development of multi specific biologics and microcyclic peptides across a wide range of diseases. We also announced an exclusive license for ALT B4 with Altiogen to deliver subcutaneous formulations of multiple oncology assets with the aim of making our treatments easier to administer and more convenient for patients. Finally, we announced a recent investment in Beijing, China, where we established our six strategic R and D center.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

The pace of medical and scientific innovation in Beijing is impressive, and our new R and D center will enable us to foster and strengthen collaborations within the local ecosystem as well as attract world class talent in China to discover and develop new transformative medicines. To support our growth across the major geographies around the world, over the last few years, we have been building a broad manufacturing network covering The U. S, Europe and China. Our global presence makes our business highly resilient to regional disruptions, effectively providing a natural hedge. We now have 31 manufacturing sites globally and dual source supply for the vast majority of our medicines.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

Our supply chains for China and The U. S. Are largely segregated, and we have very limited commercialized finished medicines imported from The U. To China, meaning that our exposure to the current China tariffs on pharmaceuticals is not material in the context of the group. We have a substantial and growing manufacturing footprint in The U.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

S. We currently have 11 manufacturing sites in the country, and the vast majority of our medicines sold in The U. S. Are made domestically. We do import a minority of medicines sold in The U.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

S. From Europe. However, mitigations are already underway. As a result, we believe that if tariffs were implemented in the range we've seen recently in other industries on medicines imported from Europe to The U. S, we would remain within the guidance range we indicated for 2025, in part due to our ongoing inventory management.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

Beyond 2025, the impact on the minority of medicines imported from Europe would be time limited as we are shifting manufacturing of these medicines to sites in The U. S. We will, of course, provide updates as appropriate. And with that, I will hand over to Ahad Nath to take us through our financials. Please advance to the next slide.

[Aradhana Sarin, CFO & Executive Director at AstraZeneca]

Thank you, Pascal, and good morning, everyone. As usual, I will start with our reported P and L. Next slide. As Pascal highlighted, total revenue grew by 10% in the first quarter. Product sales grew by 9% with growth seen in all major regions.

[Aradhana Sarin, CFO & Executive Director at AstraZeneca]

Alliance revenue, mainly consisting of Enhertu and Tesspire profit shares, increased by 42% to $639,000,000 Starting this quarter, we are presenting a new line in our P and L called product revenue. This is the sum of product sales and alliance revenue, which better characterizes the performance of sustainable revenue, both from products sold by AstraZeneca and revenue share from partnered products. Product revenue grew by 10% in the first quarter. Next slide. Turning to our core P and L, we saw a total revenue gross margin of 84% in the first quarter, benefiting from product sales mix and some favorable FX movements.

[Aradhana Sarin, CFO & Executive Director at AstraZeneca]

Please note that we will report gross margin based on total revenue going forward rather than product sales. The gross margin percentage based on total revenue reflects the totality of the costs associated with creating it, including payaways to our alliance partners of gross profit shares that are booked in the cost of sales relating to markets where AstraZeneca leads commercialization and books product sales. As previously stated in relation to product sales gross margin, we anticipate that total revenue gross margin will decline around 60 to 70 basis points in 2025. The decline is driven by the Part D redesign, anticipated VBP inclusions in China, SOLIRIS biosimilar competition and increased profit share relating to partnered products. We anticipate a lower gross margin in the second half of the year, driven by some of these such as VBP as well as the usual seasonal pattern for certain medicines such as FluMist.

[Aradhana Sarin, CFO & Executive Director at AstraZeneca]

Total operating expenses increased by 9% in the first quarter, below top line growth of 10%. Core R and D costs increased by 16% and represented 23% of total revenue, driven by new trial starts and investments in transformative technologies such as cell therapy. We continue to anticipate core R and D costs to be in the low 20s percentage range for the full year. Core SG and A costs increased by 4% and as anticipated continued to grow at a slower rate than total revenue. The core operating profit margin was 35%, supported by favorable cost phasing and a higher gross margin this quarter.

[Aradhana Sarin, CFO & Executive Director at AstraZeneca]

Similar to prior years, we anticipate a lower margin in the following quarters, primarily relating to the gross margin effects I mentioned above. The core tax rate was 16% benefiting from a favorable settlement in the quarter and is anticipated to remain 18% to 22% for the full year. Core EPS of $2.49 represents a CER growth rate of 21%. Next slide. Our cash flow continues to improve.

[Aradhana Sarin, CFO & Executive Director at AstraZeneca]

Cash inflows from operating activities increased to $3,700,000,000 in the quarter. We saw CapEx of approximately $500,000,000 which will increase in future quarters and we continue to anticipate CapEx to increase by around 50% this year versus 2024. Deal payments of around $800,000,000 included $175,000,000 milestone payable to Daiichi Sankyo for Enhertu Destiny Breast of Six U. S. Approval.

[Aradhana Sarin, CFO & Executive Director at AstraZeneca]

Our net debt increased by $1,500,000,000 to $26,100,000,000 with the increase driven by the dividend payment of $3,300,000,000 in the first quarter. We remain comfortable with our level of debt and the current net debt to adjusted EBITDA ratio stands at 1.5 times. Building on Pascal's comments earlier, we are reiterating our full year 2025 guidance, anticipating total revenue growth of high single digit percentage and core EPS growth of low double digit percentage at constant exchange rates. Based on the March average FX rates, we continue to anticipate a low single digit percentage adverse impact on total revenue and have updated our FX guidance for core EPS to low single digit adverse impact, previously mid single digit. With that, please advance to the next slide and I will hand over to Dave who will take you through the performance of our Oncology and Hematology business.

[David Fredrickson, Executive Vice-President of Oncology Business Unit at AstraZeneca]

Thank you, Aradhana. Next slide, please. Oncology total revenues grew 13% in the first quarter to $5,600,000,000 with strong double digit growth across The U. S, Europe and emerging markets. Turning now to quarterly performance for our key medicines, I'd like to talk first about our oral oncolytics performance in The U.

[David Fredrickson, Executive Vice-President of Oncology Business Unit at AstraZeneca]

S, which includes Tagrisso, Calquence, Lynparza and TruCap. Across these medicines, we saw an increase in the proportion of Medicare Part D patients following implementation of the 2,000 co pay cap, which led to fewer patients on free goods and increased adherence. These dynamics helped to partially offset the gross to net impact following Part D redesign. Tagrisso delivered 8% growth in the first quarter, reflecting strong demand across all indications, including accelerating demand for FLORA two in The U. S.

[David Fredrickson, Executive Vice-President of Oncology Business Unit at AstraZeneca]

And Europe and strong launch uptake for Lora in an unresectable Stage three setting. Strong underlying demand in Europe was partially impacted by pricing pressure in certain major markets and we anticipate continued growth over the balance of the year across all indications. Calquence total revenues increased 8% in the first quarter. Starting with The U. S, volumes increased over 20%, reflecting sustained BTK inhibitor leadership in frontline chronic lymphocytic leukemia and accelerating launch momentum for Echo in mantle cell lymphoma.

[David Fredrickson, Executive Vice-President of Oncology Business Unit at AstraZeneca]

Following recent Medicare affordability improvements, the proportion of Medicare Part D Calquence patients has increased by 10 percentage points over the past year. In Europe, Calquence continues to gain market share in an increasingly competitive environment. Looking ahead, we see potential for meaningful new growth opportunities, including the fixed duration AMPLIFY regimen in CLL and continued demand for echo in MCL. Lynparza remains the leading PARP inhibitor globally with 5% growth in the first quarter. We anticipate further volume growth globally, which will help offset pricing pressure in Europe and the potential impact of VBP inclusion in China, which we expect from the middle of the year.

[David Fredrickson, Executive Vice-President of Oncology Business Unit at AstraZeneca]

TruCap delivered 132,000,000 in first quarter revenues and is now approved in all major markets. In The U. S, continued market leadership in the second line biomarker altered population was offset by destocking of the blister pack following the inventory buildup in the fourth quarter. Impressively, one year post launch, TruCap has achieved nearly 100% market share in the AKT P10 biomarker altered population with additional opportunity for growth in the PIK3CA population. Turning now to the rest of our portfolio, Imfinzi and Imjudo delivered 1613% growth respectively, reflecting continued demand in lung and liver cancers across major markets.

[David Fredrickson, Executive Vice-President of Oncology Business Unit at AstraZeneca]

We look forward to expanding Imfinzi adoption in bladder and lung cancers following recent approvals for Niagara, Adriatic and Aegean in The U. S. And Europe. In HER2, total revenues grew 34% in the first quarter, reflecting continued market leadership for DESTINY ABREST-three and four as well as impressive growth in China following NRDL enlistment in January. We continue to see encouraging launch momentum for Destiny Breast six in The U.

[David Fredrickson, Executive Vice-President of Oncology Business Unit at AstraZeneca]

S. And are excited about the recent European approval, which will help move in HER2 into chemo naive and HER2 ultra low settings. We're off to an encouraging start with the launch of DATROA, a hormone receptor positive, HER2 negative breast cancer. Feedback from the breast cancer community reinforces the improved convenience and favorable GI toxicity profile seen with DATROAY in the TROPEON BREST-one trial. We're excited about the outlook for our oncology portfolio over the balance of the year as we continue to expand the reach of our transformative medicines.

[David Fredrickson, Executive Vice-President of Oncology Business Unit at AstraZeneca]

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

[Susan Galbraith, Executive Vice President of Oncology Research & Development at AstraZeneca]

Thank you, Dave. Over the past few months, we've had several key oncology data readouts that mark important steps towards achieving our 2030 ambition. In February, we were very excited to announce the positive high level results for camisestrant, the first next generation oral SERD to have a positive readout in the first line setting in hormone receptor positive metastatic breast cancer with emerging ESL one mutations. SERENNA six demonstrated a highly statistically significant and clinically meaningful improvement in progression free survival. And whilst time to second progression and overall survival remain immature, a trend to improvement in time to second progression was also observed.

[Susan Galbraith, Executive Vice President of Oncology Research & Development at AstraZeneca]

This trial also demonstrated the combinability of camisestrant with three CDK four six inhibitors and showed that the combinations are well tolerated. SERENNA six is the first step to establishing camisestrant as the endocrine backbone of choice across ER positive breast cancer settings and has the potential to redefine treatment for patients with HR positive metastatic breast cancer and emerging ESL one mutations. Last month, we were delighted to share positive high level results for Matterhorn, a key indication expansion opportunity for Imfimzi. In Matterhorn, perioperative Imfinzi in combination with flock chemotherapy demonstrated a statistically significant and clinically meaningful improvement in event free survival as well as a strong trend in overall survival versus perioperative chemotherapy alone in patients with resectable early stage and locally advanced gastric and gastroesophageal junction cancers. Matterhorn is the third successful perioperative trial for Imfimzi, following on from Aegean and Niagara, and it underscores the value of this approach to treatment.

[Susan Galbraith, Executive Vice President of Oncology Research & Development at AstraZeneca]

This trial represents another blockbuster opportunity, expanding our presence in GI cancers and unlocking further potential for Imfimzi. The practice changing data from Serena six and Matterhorn will both feature as ASCO plenaries this year, making this the seventh year in a row AstraZeneca data has been included in the plenary sessions at ASCO. Finally, just over a week ago, we were also excited to share the high level results from the interim analysis of DESTINY breast o nine. This trial demonstrated the combination of Enhertu and patuzumab resulted in a highly statistically significant and clinically meaningful improvement in progression free survival versus standard of care three drug regimen, THP. There were no new safety signals for the combination.

[Susan Galbraith, Executive Vice President of Oncology Research & Development at AstraZeneca]

And whilst not mature, Enhertu plus birtuzumab, demonstrated an early trend to overall survival benefit. Destiny breast o nine is the only ongoing first line trial in a HER two positive metastatic breast cancer population in which investigational therapy is initiated upfront at the onset of treatment and moves in HER two align earlier in a broad HER two positive population with the opportunity to once again redefine management of this disease. We continue to follow-up in both the combination and monotherapy arms. In addition, we're delighted to share that our CHOP two NMR companion diagnostic codeveloped with Roche tissue diagnostics has now been granted breakthrough designation by the FDA for use in the tropon lung 17 trial, which will investigate DETRAway in the second line CHOP two NMR positive patient population. This underscores the potential of this practice changing technology both for Dachauway and the broader AstraZeneca portfolio.

[Susan Galbraith, Executive Vice President of Oncology Research & Development at AstraZeneca]

Next slide, please. We continue to progress our transformative technologies with the potential to disrupt treatment paradigms and deliver sustainable growth beyond 2030. At the Society of Gynecologic Oncology annual meeting this year, we shared phase one two data for pucitatou samratikan, also known as PSAM, in endometrial cancer. These data demonstrated an encouraging durable objective response rate of thirty five to thirty eight percent and a promising median progression free survival of seven months in a b seven h four IHC positive population alongside a manageable safety profile. These data provide us with additional confidence in PSAM and support our decision to start a phase three trial in endometrial cancer later this year.

[Susan Galbraith, Executive Vice President of Oncology Research & Development at AstraZeneca]

PSAM is one of our six AstraZeneca ADCs, all of which continue to progress at pace in the clinic. And with that, please advance to the next slide, and I'll pass over to Rude to cover biopharmaceuticals performance.

[Ruud Dobber, Executive Vice-President of BioPharmaceuticals Business Unit at AstraZeneca]

Thank you so much, Susan. Please move to the next slide. Our biopharmaceuticals medicines delivered a strong start to 2025, with total revenue reaching $5,600,000,000 in the first quarter, reflecting a growth of 12% compared to the first quarter of twenty twenty four. Farxiga revenues exceeded $2,000,000,000 for the first time, driven by continued demand across chronic kidney disease and heart failure. The strong foundation we have built with Farxiga will support the potential launch of three fixed dose Depakliflozin combinations already in Phase III development.

[Ruud Dobber, Executive Vice-President of BioPharmaceuticals Business Unit at AstraZeneca]

Total revenue in The United States was down 90% versus last year, when revenues benefited from the launch of an authorized generic and the stocking impact this brought with it. In China, we anticipate that Farxiga, along with roxadustat, will be included in the VBP program from the middle of the year. We're also expecting to see generic competition for Belinta enter The U. S. Market in the coming months.

[Ruud Dobber, Executive Vice-President of BioPharmaceuticals Business Unit at AstraZeneca]

Even so, we expect that the growth drivers in our biopharmaceuticals portfolio this year will clearly outpace the headwinds. Lokelma remains the market leader in an expanding potassium binder class, delivering $153,000,000 in the first quarter and growth of over 35% for the fourth consecutive quarter. R and I delivered another strong quarter, up 13% to $2,100,000,000 in revenue. Fasenra, Taspire, Savnelo, Breztri and AirSupra now make up just over half of our R and I total revenue, and their combined revenue contribution grew by 40% in the first quarter. Fasenra and TESPI both benefited from their strong positions within the fast growing market for respiratory biologics.

[Ruud Dobber, Executive Vice-President of BioPharmaceuticals Business Unit at AstraZeneca]

Fasenra increased its IL-five class leadership for severe eosinophilic asthma patients, supported by the recent launch in EGPA. TESPI achieved leading new to brand share in key markets with strong launches across Europe. Our older inhaled medicine, Pulmicort, saw a drop of 26%. The decline was driven by China due predominantly to a milder winter and continued generic competition. In VNI, Beifortis revenues more than doubled, supported by the recent expansion of manufacturing capacity.

[Ruud Dobber, Executive Vice-President of BioPharmaceuticals Business Unit at AstraZeneca]

This year, we are looking forward to several important readouts for biopharmaceutical medicines: breast strain asthma, Fasenra in COPD and Savnelo's subcutaneous formulation. We have completed regulatory submissions in all major markets for TESPI in nasal polyps. We will also have our first Phase III readout for bextrostat, a new molecular entity with the potential to deliver over 5,000,000,000 in peak year revenue. With that, I will now hand over to Sharon to share updates across our biopharmaceuticals pipeline in the quarter.

[Sharon Barr, Executive Vice-President of BioPharmaceuticals R&D at AstraZeneca]

Thank you, Rude. I would like to take a moment to highlight our progress this quarter within the biopharmaceuticals pipeline. At the American College of Cardiology, we were excited to present the positive Phase IIb data for our novel oral small molecule PCSK9 inhibitor, AZD078O, demonstrating a significant LDL cholesterol reduction on top of standard of care and a potential best in class profile in patients with hypercholesterolemia. The data from PURSUIT, which were also simultaneously published in the Journal of the American College of Cardiology, found AZD078O resulted in a 50.7% reduction in LDL C versus placebo when dosed once daily on top of standard of care statins. Similar efficacy was observed regardless of whether patients received moderate or high intensity statin doses at baseline, and AZD078O was well tolerated with a similar frequency of adverse events compared to placebo, consistent with the phase one data we shared last year.

[Sharon Barr, Executive Vice-President of BioPharmaceuticals R&D at AstraZeneca]

Importantly, as an oral small molecule, AZD078O offers the advantage of favorable once daily dosing with no food effect or need for fasting requirements. This convenient profile could enhance patient compliance and has the potential to expand access to this class of medicines beyond its reach today. Dyslipidemia remains a substantial public health concern, placing patients at risk of severe cardiovascular outcomes, including stroke and death, and results in approximately four point four million deaths per year. Based on the data from PURSUIT, we are progressing AZD078O into phase three at pace and we will simultaneously initiate three pivotal phase three trials in the coming months. The first will investigate LDL C reduction.

[Sharon Barr, Executive Vice-President of BioPharmaceuticals R&D at AstraZeneca]

The second will focus on heterozygous familial hypercholesterolemia. And the third is a cardiovascular outcomes trial. The outcome study will target the prevention of cardiovascular events in patients with a history of atherosclerotic cardiovascular disease and those at high risk of experiencing an ASCVD event. We look forward to updating on future opportunities to use AZD078O in combination with statins and other small molecules in our broad CVRM portfolio. We believe that AZD078O has the potential to be a $5,000,000,000 plus asset and an important option for patients who urgently need novel approaches to improve their outcomes.

[Sharon Barr, Executive Vice-President of BioPharmaceuticals R&D at AstraZeneca]

And with that, please go to the next slide and I'll pass over to Marc to cover rare disease.

[Marc Dunoyer, CEO of Alexion & Chief Strategy Officer at AstraZeneca]

Thank you, Sharon. Can I have the next slide? Rare disease delivered total revenues of $2,000,000,000 in quarter one, reflecting stable performance year on year. While patient numbers continue to grow across medicine and indication year on year, there are several factors impacting revenue growth in the first quarter. Ultomiris grew 25% driven by patient demand across indications, partially offset by competition in generalized MERSTEN AGRAVIS and paroxysmal nocturnal hemoglobinuria and to a lesser extent from Part D redesign in neurology indications.

[Marc Dunoyer, CEO of Alexion & Chief Strategy Officer at AstraZeneca]

We expect SOLIRIS revenues to continue to decline due to a successful conversion to ULTOMIRIS, which has launched in all four shared indications, as well as biosimilar pressure in Europe and unfavorable order timing in certain tender markets. As a reminder, biosimilars for Soliris have now launched in The United States for PNH, atypical HUS and Myasthenia gravis. Beyond complement, strength grew 14% driven by continued patient demand, more directly offset by some impact from Part D redesign. Kosilugo grew 8% driven by patient demand, partially offset by unfavorable order timing in tender markets. Despite these headwinds, we continue to expect growth across the rare disease portfolio in 2025, but at a slower pace than was seen in 2024.

[Marc Dunoyer, CEO of Alexion & Chief Strategy Officer at AstraZeneca]

During the quarter, Beyontra, formerly Acoramidis, was approved in Japan for the treatment of adult with transthyretin mediated amyloid cardiomyopathy. This is an exciting step forward in our progress to deliver an industry leading amyloidosis portfolio. Please advance to the next slide. During the quarter, we received positive news from a single arm pediatric study of Ultomiris in HTT TMA. HTTMA is a rare type of thrombotic microangiopathy, a severe complication of hematopoietic stem cell or bone marrow transplant, and is associated with significant morbidity and mortality.

[Marc Dunoyer, CEO of Alexion & Chief Strategy Officer at AstraZeneca]

In the Phase three study in pediatric patients, ULTOMIRIS demonstrated improvements in the individual components of TMA response, such as platelets, LDH, urinary protein creatinine ratio, as well as overall survival. We await high level result from the placebo controlled Phase III trial in adult and adolescent in the second half of the year, and look forward to sharing data with regulatory authorities. This is the first indication expansion opportunity for ULTOMIRIS beyond the SOLIRIS level, representing a potential blockbuster opportunity on a risk adjusted basis. As outlined on our Investor Day last year, we continue to build out a rare renal pipeline, expanding into post transplant diseases, we are initiating the Phase III AWAKE trial of ULTOMIRIS in delayed graft function or DGF. With ULTOMIRIS immediate sustained terminal complement inhibition, we believe it is uniquely positioned to help reduce inflammation in renal injury, ultimately extending kidney transplant organ longevity.

[Marc Dunoyer, CEO of Alexion & Chief Strategy Officer at AstraZeneca]

In the quarter, we also announced our Phase III CALIPSO trial studying eneboparatide in chronic hypoparathyroidism patients, which met the composite endpoint showing a statistically significant normalization of serum calcium whilst simultaneously reducing dependence on daily calcium and vitamin D supplements. We have made changes to the trial protocol to allow patient to receive a higher dose based on patient response and additional efficacy analysis will be measured at fifty two weeks. This will help to further characterize enapoPARATI's risk benefit profile. 2025 is a catalyst rich year for rare disease portfolio, with four Phase III trials due to readout, three of which are NME opportunities. And with that, please advance to the next slide, and I will hand back to Pascal.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

Thank you, Marc. Next slide, please. We've made a strong start to the year with several important readouts already in hand, but this is only the beginning. As you can see on this slide, the number of high value upcoming catalysts we have through the end of twenty twenty five is quite remarkable. And together, they represent over $10,000,000,000 in potential peak risk adjusted potential risk adjusted peak year revenue, sorry.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

Next slide, please. In closing, already this year, we are tracking well towards our 02/1930 ambition. We expect continued growth from all of our therapy areas over the balance of the year and across key geographies. Importantly, global demand for our medicines is expected to offset the known headwinds. As evident from our results in recent prior quarters, we remain focused on delivering operating leverage while continuing to invest in our pipeline and in transformative technologies to support our growth to 02/1930 and beyond.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

And lastly, we are on track to deliver at least 20 new medicines by 02/1930, with nine delivered already. An accelerating pace of new approvals is anticipated across our portfolio. Please advance to the next slide, and we will move to the Q and A. As Andy mentioned at the start of the call, please limit the number of questions you ask to allow others a fair chance to participate. For those online, please use the raise hand function on Zoom.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

With that, let's move to the first question. Sarita Kapila at Morgan Stanley. Sarita, over to you.

[Sarita Kapila, Analyst at Morgan Stanley]

It's Sarita at Morgan Stanley. So firstly, how should we think about the impact of the Medicare Part D redesign in The US as we move through the year? Was it mostly Q1 weighted or do you expect further impact from here? And if you could help frame or quantify the overall impact for the full year and comment on the underlying outlook for '25 in oncology, that would also be useful. Thank you.

[Sarita Kapila, Analyst at Morgan Stanley]

And then just a quick one on Avans. Perhaps you could talk about the confidence around the QCS biomarker and if there are any examples about a retro biomarker retrospective, sorry, biomarker translating to the prospective setting? And talk about the rationale for using Imfinzi as the backbone versus KEYTRUDA, please? And does that increase the risk of the trial?

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

Thanks, Haritha. Maybe, Dev, you could take the first question and Susan, the second one.

[David Fredrickson, Executive Vice-President of Oncology Business Unit at AstraZeneca]

Absolutely, Sririta. Thanks for the question. In terms of your specific question, I would think of Part D as a rebasing that happens at the beginning of this year. And then all volume growth that we're able to have from here is going to be against that rebased number. And the reason for that is that catastrophic is triggered on the very first fill within our oral oncology products.

[David Fredrickson, Executive Vice-President of Oncology Business Unit at AstraZeneca]

So it will not grow from here. It's a rebased number from here. Obviously, it grows as our volumes grow within Part D. But I think to put this into some context and maybe I'll just talk specifically about Tagrisso because I think it's a good example. In The US, we saw a 20% increase in volumes from our ongoing launches of Flora II, Adora, Laura, all going really, really well.

[David Fredrickson, Executive Vice-President of Oncology Business Unit at AstraZeneca]

Together with reduced free good utilization and some price increases, that offset the gross to net impact from Part D redesign. So we saw revenue growth of 9% in The US, volume growth of 20%. And I think that importantly, the new patient start and TRX data show that we're also really managing competition well with FLORA and FLORA two. And we expect continued revenue growth throughout 2025 within this. So I think full year outlook on our Oral Oncolytics remains strong.

[David Fredrickson, Executive Vice-President of Oncology Business Unit at AstraZeneca]

We've got good growth drivers that we're able to operate against. And as long as we continue to navigate against those key performance indicators as well, I'm confident that we will grow from this rebasing period.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

Thanks, David. Maybe just to add, Sarita, is that Dave said it, 20% volume growth on Tagrisso. We have more than 20% volume growth on Calquence. The important piece is that this year, we have this, of course, one off Part D price resetting, if you want. But the volume growth, further supported by new indications for both Calquence and Tagrisso, will really support well our growth into 'twenty six and beyond.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

So I think for those products, we can have a fairly optimistic outlook in The U. S. But also beyond The U. S. Susanne, you want to take the second question?

[Susan Galbraith, Executive Vice President of Oncology Research & Development at AstraZeneca]

Yeah. Sure. Thank you. So just as a reminder for Avansar, we have taken the learnings that we had from Tropium Lung-one and made changes to Avansar, which should include focusing on the clinically meaningful benefit that we saw with t l o one in the nonsquamous patient population and allowed us to enrich for that. And then what we also have done is is embed the QCS biomarker.

[Susan Galbraith, Executive Vice President of Oncology Research & Development at AstraZeneca]

So in terms of your question about that, the confidence that we have in in in QCS is based on our understanding of the mechanism that that we have with, which is dependent not just on the surface expression of of of trope two, but the amount that gets internalized. And that's embedded into into this NMR QCS positivity. I also have said that the the data that we have seen from the troponin lung o one, we have seen similar trends in in other data. I'll point out that we have an update on the troponin lung o two dataset that we presented at ASCO, which will include an analysis of the QCS data. Then and, of course, that's important because it's in troponin o o o two, it's the combination also of Imfinzi and with with an I O agent and with the combination with with platinum.

[Susan Galbraith, Executive Vice President of Oncology Research & Development at AstraZeneca]

So I think, you you know, the confidence is built on seeing the, similar effects in multiple datasets and embedded on the the mechanism that we understand for why Datruway is is active and differentiated. And in terms of Imfinzi activity, I I think that the number of positive Imfinzi trials in a number of different settings is is further proof of the of of the relevance of that mechanism of action. And, again, we have data in in troponin lung o four and troponin lung o two, which are very consistent across different checkpoint inhibitors. So, you you know, we we remain confident in the in the combinability of data array with Imfinzi and the application of that into the important patient population in first line non small cell lung cancer.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

Thank you, Susan. The next question is from James Gordon at JPMorgan. James, over to you.

[James Gordon, Vice President at JP Morgan]

Hello. James Gordon, JPMorgan. Thanks for taking the questions. First question was on the oral PCSK9. So you had strong Phase II data, and you've announced the Phase III program today and flagged the $5,000,000,000 plus peak sales.

[James Gordon, Vice President at JP Morgan]

But competitor injectable PCSK9 uptake has been slower than originally anticipated. So can you talk about how you're now thinking in terms of how much orals will expand the market and how dominant a share you think your product would have of the oral opportunity to get to a 5,000,000,000 plus? What are you thinking there? And when this could potentially launch? So you said what the three programs would be, but when could you have the pivotal data?

[James Gordon, Vice President at JP Morgan]

That's the first question, please. Second question, US manufacturing. So you source the majority of The US product from The US. Are you considering any incremental US manufacturing investments? And could that be accommodated within the existing circa €3,000,000,000 of CapEx per year?

[James Gordon, Vice President at JP Morgan]

Or might you need to step up? Or could it be about reallocation? And then if I could just find a clarification on IRA and Part D redesign. So should we assume you already had the full pricing mix here in q one, but we could see further volume expansion due to greater affordability through the year, so you could actually see revenues accelerate for some of these impacted products through the year? Or is it more like the absolute Q1 performance is the new run rate?

[James Gordon, Vice President at JP Morgan]

So you've got the pricing mix already and you've had the volume uplift already. So do things accelerate further through the year? Or this is just the new normal already at Q1?

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

James, so that's not two, but three questions. Thank you. So the first one is oral, I guess, oral PCSK. And Ruud, do you want to take this one? Aradhana, you could take the second.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

And Dev, back to you for the third one.

[Ruud Dobber, Executive Vice-President of BioPharmaceuticals Business Unit at AstraZeneca]

Yes. First of all, James, we need to realize that seventy percent of the patient population eligible for cholesterol lowering drugs are not at goal. So we firmly believe that a product like an oral PCSK9 will substantially unlock the opportunity in order to serve a very large population across the world. The second part is that we all know that the injectables were facing quite a bit of an issue from an access perspective. And Oral PCSK9 probably will be priced at lower level.

[Ruud Dobber, Executive Vice-President of BioPharmaceuticals Business Unit at AstraZeneca]

And hence, also in the emerging markets where we have a very strong footprint, I think the Oral PCSK9 will fulfill a huge unmet medical need. And last but not least, I think the uniqueness of our oral PCSK9 is it's a true small molecule, and I think Sharon articulated it very well. So we are also looking for, let's say, combinations of our oral PCSK9s, for example, with our own Crestor or Azetimibe, that makes, I think, the proposition potentially a very big one.

[Aradhana Sarin, CFO & Executive Director at AstraZeneca]

So James, on in terms of your question on CapEx and tariff related and what incremental investments there may be required. So two different things. One is, as it relates to some the minority of the products that we do import from Europe into The U. S, We're already starting to take action as it relates to tech transfers and building some of the capacity there. But also note that we do have always a dual source supply and so forth and also capacity within our existing facilities.

[Aradhana Sarin, CFO & Executive Director at AstraZeneca]

So the incremental investment required for that to happen will be manageable. In terms of the overall CapEx, so last year, as you know, we also announced a 3,500,000,000 CapEx and investments in The U. S. We have said this year that our CapEx would be 50% higher than last year. But going forward, we need to look at how the portfolio develops.

[Aradhana Sarin, CFO & Executive Director at AstraZeneca]

So for example, if the oral GLP-one is successful in Phase II as the PCSK9 progresses, as CAMI progress, as Baxterstat reads out, we will then start to plan for success for these molecules and we'll build and manage supply accordingly.

[Aradhana Sarin, CFO & Executive Director at AstraZeneca]

Dave?

[David Fredrickson, Executive Vice-President of Oncology Business Unit at AstraZeneca]

James, on your clarification question, so let me break down into the components. The first part is that at the beginning of the plan year, as we moved from a co pay cap of $3,300 to $2,000 we saw an increase in the number of patients or reduced number of patients in free drug program, an increase in the number of patients that came off of free drug and into the commercial program. I think that is a one time effect that you won't see the volume grow over the course of the year. However, the reduced abandonment rate, I do think grows over the year.

[David Fredrickson, Executive Vice-President of Oncology Business Unit at AstraZeneca]

And very much the revenue growth and the volume growth that we're seeing from Flora II, Adora, Laura on Tagrisso is growth that we'll continue to see moving forward from this new rebased level that we're at in terms of where the Part D impact came from reform. I would also note that there is one other dimension on Calquence. And we had spoken about this, or I spoke about it last quarter. There are some contracting decisions that we took to secure preferred formulary access. Those are one time impacts in terms of to gross to net that we probably will see in the quarter and we'll grow volume against that as we pull through those contracts and get opportunity to really make sure that that preferred access is translating into continued leadership in CLO.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

James, maybe if I can come back very briefly to your first question on PCSK9. I think it's important to keep in mind, you have twenty four million people patients, people in The U. S. Who have cardiovascular disease. Seventy percent of them are not a target.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

They have a cholesterol level above 70%. So it's a huge number of people who have established cardiovascular disease are not a target. And then I'm not even speaking about the population that has elevated cholesterol above 100 in the general population and are not treated. So potential for an oral agent that is priced at the right level, as Ruud explained, is really very, very large. So if our studies deliver, of course, that we have to have good results.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

But we have good reasons to believe the product will deliver. The opportunity to help patients and grow the product is quite enormous in The U. S, but also beyond. Remember, injectable PCSK9 are great products. But in Europe, they're very limited in terms of access because of cost mostly.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

So again, if we bring a product that is more affordable, the potential there is quite enormous. Should we move to Rajan Sharma at Goldman Sachs? Rajan, over to you.

[Rajan Sharma, Executive Director at Goldman Sachs]

Hi. Sorry, hopefully, you can hear me now. Forgot to unmute. So thanks for taking my questions. Firstly, on DB-nine, could you just talk to the potential filing strategy there?

[Rajan Sharma, Executive Director at Goldman Sachs]

Do you think you will file the combination on before the monotherapy on data are available? And then secondly, just on a follow-up to a comment that Susan made on ASCO data. Just to clarify, will that be QCS biomarker analysis of OS from Tropi and LUNGO-one that's available at ASCO? Thank you.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

Thanks, Rajan. For you, Susanne?

[Susan Galbraith, Executive Vice President of Oncology Research & Development at AstraZeneca]

Okay. So just for the second one, to clarify. What I was talking about, we're going to present within the Tropion Lung-two dataset biomarker data looking at the the QCS biomarker within that study, which I think will be helpful in addition to the data that we had from tropon lung o one. And

[Susan Galbraith, Executive Vice President of Oncology Research & Development at AstraZeneca]

in

[Susan Galbraith, Executive Vice President of Oncology Research & Development at AstraZeneca]

terms of DESTINY breast o nine, obviously, we're in discussions with regulatory authorities. As we said, you know, I think the data show, you know, a highly clinically meaningful results, and I think that will, you know, influence regulators. But those discussions are ongoing. And we also, you know, I would just say, are optimistic in terms of the potential for presentation of DESTINY breast o nine data at ASCO.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

Thank you, Sudan. Sachin Jain, Bank of America. Over to you, Sachin.

[Sachin Jain, Vice President at Bank of America]

Hi, Matt. Two questions, please. So firstly, Pascal, if just high level on US pricing, any high level perspectives on Trump executive order and how you're thinking about U. S. Pricing?

[Sachin Jain, Vice President at Bank of America]

It's been a lot from yourself and others in the media. So I if you could just touch on that. And then secondly, for Onc, I guess this is more for Dave, Serena says congrats on the plenary. Wonder if you could just reappraise us on how you're thinking around the commercial opportunity relative to the €5,000,000,000 you framed for the molecule as a whole. Obviously, assuming the majority is $3.00 4, but if you could just comment to how you're thinking about strategic size and factors that we should be thinking around adoption in terms of testing, duration of therapy, etcetera?

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

So maybe let me quickly comment on the first question, Sachin. I mean U. S. Pricing, of course, lots of potential outcomes here, but it's not very easy to comment because nobody really knows. But it is clear that this is an issue that will be on the radar screen of many people.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

The reality, I think, is that there has to be a rebalancing. In fact, The U. S. Has been funding innovation for our industry for a long time. And we believe that Europe has to invest a greater share of their health care expenses, and that share has been declining steadily over the last number of years, down to 7% of health care budget being allocated to innovative medicines in The UK.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

What can you do with 7% of your health care costs allocated to innovating medicines? Of course, not much. So the investment in innovation in pharmaceuticals in Europe has to go up. And what that means is for some products, prices that are closer to higher suddenly than they are today, maybe closer to The US, but importantly, also faster access and better access for patients. So at the end of the day, what happens in The U.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

S, we'll have to see. Of course, there are ongoing discussions, as you can imagine. But I really think the key piece is that Europe, at least the richer countries in Europe, have to contribute more to pharmaceutical innovation, just like they have to contribute more to their own defense. So it's a reallocation of GDP, which actually, in terms of pharmaceutical innovation, would be relatively modest. But that would enable a lot of accelerated access and suddenly a pricing level that would enable to rebalance in the funding of that innovation between The US and Europe.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

And second question, Dev, do you want to cover that?

[David Fredrickson, Executive Vice-President of Oncology Business Unit at AstraZeneca]

Yes. CAMI broadly and really talking about the Serena six opportunity. So as we think about camisestrant, Sachin, obviously the program comprises early adjuvant breast cancer trials as well as metastatic studies. I think that if we're able to unlock an opportunity within the adjuvant setting and within to the point that you raised, that really is going to do the lion's share of the work to get us to that $5,000,000,000 plus. But SERINA six is such an important study.

[David Fredrickson, Executive Vice-President of Oncology Business Unit at AstraZeneca]

And the reason it's important is that there's eighty five thousand patients with frontline drug treated hormone receptor positive, HER2 negative metastatic breast cancer in the G7. And two thirds of those patients are considered endocrine therapy sensitive and they're treated today with a CDK foursix and an ET in the frontline setting. And we know that thirty percent of those, so this is a pretty significant number developed the ESR1 mutation during the course of their frontline treatment. And that ESR1 mutation is something that can be today detected with NGS testing. And NGS, least in The United States, is fairly common among this population.

[David Fredrickson, Executive Vice-President of Oncology Business Unit at AstraZeneca]

So there is going to be work that we're going to need to do to incorporate this testing as part of the regular blood work that's being done. But the access to the test and the test itself is something that is already incorporated into the workflow and into the practice. And it allows for us to, in addition to moving earlier than the other next generation surge, which gives us an opportunity for early experiences, I think the likelihood that those experiences are going to be good ones is high. And I also think that the fact that we can use this on a backbone of multiple CDK foursix is also really important. So those are the elements of Serena six that I think are most noteworthy.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

Maybe to add back again to your earlier question, Sachin, want to make sure that everybody understands this price difference between The U. S. And Europe is not true for every product. I mean, there are lots of products that have a similar net prices. I mean, in Europe, you have a you have a single price.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

In The US, you have commercial, you have Medicare, you have VODOD, you have also Medicaid. And then in commercial and Part D, we provide a large amount of rebates. And those rebates can be very, very large for some products. So if you look at things on a net basis, net of rebates, incorporating Medicaid, VODOD, and sort of calculate the net price for The United States that you could compare to the price in Europe, for many medicines, the difference is actually very small and sometimes zero, actually, no difference or very little. So really, we're talking about a few products.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

And as I said, Europe has to fund this innovation in a better way. Steve Scala at Cowen. Over to you, Steve.

[Steve Scala, Pharmaceutical Analyst at TD Cowen]

Thank you so much. I have two questions. Pascal, to sum up your tariff commentary in the prepared remarks, is it fair to say that under all contemplated scenarios and in light of AstraZeneca's actions over the next two to three years, tariffs are not material at the group level. Is that a fair conclusion? And then the second question is for Dave.

[Steve Scala, Pharmaceutical Analyst at TD Cowen]

On DB-nine, the press release stated that safety was consistent with the known profile of Enhertu, but it could be argued that in first line setting, it needs to be better, especially regarding ILD. So what should be our expectations for the full data set? And will DB-nine contribute to sales in 2025? Thank you.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

Thanks, Steve. So quick first question. I mean, I'm not able to forecast every potential scenario in the world we live in. We have to assume any scenario is possible, even scenarios we can't even imagine today. So it's hard to answer your question.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

But what I can say is that, yeah, I mean, within a period of time, which maybe two years, any impact we have would actually be managed. As I said, first of all, the impact is not is limited. But importantly, the impact we have is time limited because we are redeploying manufacturing instead of globalizing the manufacturing of one product in The US for the world or in Europe for the world. We can actually share and sort of manufacture one product for The US and The US and the rest in Europe and vice versa. So we have because of our cap our network, we have the ability to shift manufacturing around.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

So, yes, within a relatively short period of time, I mean, basically, these issues could be managed and are suddenly not material long term as we based on what we can see today.

[David Fredrickson, Executive Vice-President of Oncology Business Unit at AstraZeneca]

Steve, on your DBO9 question, I mean, you'll have to go to the presentation to get into the details on the specific data within it. But I do think that what I would point to is that when we speak to the results being statistically significant and clinically meaningful, that is an overall assessment of the benefit risk. And I think that the trend in overall survival that we commented to is also something that underscores the entire benefit risk within that population. It's a very important study, twenty five thousand G7 frontline drug treated HER2 positive patients. This is a study in a broad population.

[David Fredrickson, Executive Vice-President of Oncology Business Unit at AstraZeneca]

And on your question on use in 2025, obviously, we won't promote to anything before it's approved. We certainly do know that guidelines and presentations can result in markets, particularly The U. S, where it's allowed for spontaneous use. But we'll have to see what the reaction is to the data after it's presented.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

Thanks, Steph. Matthias Ekblom at Anders Banken. Matthias, over to you.

[Mattias Häggblom, Equity Research Analyst at Handelsbanken]

Thanks so much. Two questions, please. Firstly, for Pascal on tariffs and drug pricing, but perhaps a different angle. Over the last couple of years, a handful of members, including AstraZeneca, has left different industry associations like pharma. In recent weeks, we've seen a number of individual pharma executives shared their perspective on the best path forward.

[Mattias Häggblom, Equity Research Analyst at Handelsbanken]

My question goes, to what extent do you anticipate the industry to come together more in the near future in order to perhaps better leverage its message to different stakeholders and up the odds of a favorable path forward for the industry? And then secondly for Radna, it's now almost a year since the company shared its $80,000,000,000 revenue target for 02/1930, an ambition sometimes described as conservative within the investment community. From your perspective, any particular areas you'd like to point us to whether companies internal modeling still deviates materially from company compiled consensus? Thanks so much.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

It's interesting to hear the €80,000,000,000 as conservative. First time I hear it as described as conservative matters, but it's still nice to hear that you believe in our portfolio. So I'll leave that answer to Arna. The tariffs, yes, I think the industry is coming together. I mean, basically, we have a common we have a couple of issues to resolve as an industry.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

One is tariffs. And of course, there are ongoing discussions that are industry discussions. But the other piece is, I think, is really important long term, it's probably less relevant near term, but it's mid- to long term relevant, is addressing this imbalance that exists in between Europe and The US as it relates to funding innovative medicines. Again, as I said, it's a question for Europe. It's a question of sovereignty and sovereignty of the health sovereignty for their European citizens.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

It's not only a question of price. People think it's a question of price sometimes. No, it's also a question of delay. I mean, in many countries in Europe, patients have to wait two years, three years to get access, or it's very restrictive. So I think with a reasonably modest increase of the share of GDP allocated to innovative medicines, a lot of these things could be addressed and disappear.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

And I think that's an issue the industry is addressing collectively. And I believe, I hope that we can continue working together to address those two issues. Aravna?

[Aradhana Sarin, CFO & Executive Director at AstraZeneca]

So yes, thank you so much for your confidence in our $80,000,000,000 number. We are working hard to achieve that. I think as we've mentioned both this time and when we announced our full year results, 2025 will really be a very important year. And this time next year, we should have a very good sense of where we stand on the trajectory to that $80,000,000,000 ambition. The $80,000,000,000 is a risk adjusted number.

[Aradhana Sarin, CFO & Executive Director at AstraZeneca]

So this year, we will be reading out several studies, multiple in the rare disease portfolio, several in the biopharma portfolio and, of course, in oncology as well as the oral GLP product, which is in Phase II. So again, not everything will work. But on a risk adjusted basis, by this time next year, we'll have a very good idea and confidence as to where we are on that $80,000,000,000 ambition. To your question on where we see variances versus our own plan, I think there are multiple products, particularly in the biopharma portfolio. I think some of the respiratory products, some of the CVRM products, the oral PCSK9, I think now people are starting to appreciate that opportunity, the amyloidosis.

[Aradhana Sarin, CFO & Executive Director at AstraZeneca]

So I think there are several products in the biopharma and the rare disease portfolio as well as in the oncology portfolio, I think we are not really getting any credit for the investments we're making in our own ADC pipeline that Susan highlighted as well as other investments we're making in cell therapy. So there are several areas of variances, but those are the major ones. Thank you.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

Thank you, Arna. Mathieu Weston, UBS. Mathieu, over to you.

[Matthew Weston, MD - Pharmaceutical Research at UBS Group]

Thank you, Pascal. Two questions, please. The first for Susan on Avansar. Based on our feedback, a lot of investors are nervous and would like to basically see this one out of the way so they can concentrate on the rest of the rich catalyst path, that you and Pascal laid out. Now clearly, might disagree, but I wonder if there's any color you can give us on how events are tracking and when we might see the data within the second half of the year.

[Matthew Weston, MD - Pharmaceutical Research at UBS Group]

And then a second one for Eradna, please. The 2024 annual report calls out 561,000,000 of benefit of intellectual property incentive regimes in your tax paid. President Trump has called out low US tax payment by farmers of frustration alongside manufacturing locations. Pascal obviously has made the reassuring comments around manufacturing and tariffs. But have you had any interaction with U.

[Matthew Weston, MD - Pharmaceutical Research at UBS Group]

S. Authorities on how you use IP licenses to take profit out of The U. S?

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

Avenza, Susan, you could cover this. And of course, Aradna, second one, I don't want to steal the Aradna's thunder, but I think it's important maybe to signal that of our distribution of taxes around the world. In The U. S, we have a fair amount of our proportion of taxes paid in The U. S.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

So I don't think we are in a position where people could say we are optimizing tax to the extent we don't pay our fair share of taxes in The U. S. We do pay our fair share of taxes in The U. S. And sure, Aradhana doesn't want to give the details, but I can tell you we pay a fair share of taxes in The U.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

S. Avenza, for Susan. And the second question, Aradhana?

[Susan Galbraith, Executive Vice President of Oncology Research & Development at AstraZeneca]

Yeah. Thank you, Matthew. So so in terms of Avanza, just a couple of things. You know, Avanza accrued ahead of time, which shows the enthusiasm that the investigator population had for this study. We guide by half, and we expect we do expect the results in the second half of this year.

[Susan Galbraith, Executive Vice President of Oncology Research & Development at AstraZeneca]

And I see no reason why that's going to be delayed beyond the end of the year.

[Aradhana Sarin, CFO & Executive Director at AstraZeneca]

On your second question, as Pascal mentioned, we do pay our fair share of taxes in proportion to our revenues in The U. S. We do take advantage obviously of transfer prices, but I think the numbers you are mentioning that are mentioned in the annual report relate much more to things like patent boxes and where governments do provide incentives for research and so forth and R and D funding. We're always trying to optimize how we manage and plan our taxes globally. So that's all the detail we can provide at this time.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

Matthieu, I mean, I don't think I would disagree with you that AVANZA is an important event for us this year, but we have many other events. Bags for Stat is another major event. We have major quite a number of major events throughout the year in the pipeline. We've already there is the major one with GB09, of course. So it's an important event.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

I don't disagree. And we all are waiting for that readout for sure, but we have many others. So next question is from Justin Smith at Bernstein.

[Justin Smith, Director at Bernstein]

Just a quick one for Mark Ultomiris. Just wondered if you could just provide a bit more color with regards to increased competition. Is that potentially due to price? Just asking because, obviously, one of your competitors, particularly in the MG space, is emphasizing that more innovation should be driving market expansion? So

[Marc Dunoyer, CEO of Alexion & Chief Strategy Officer at AstraZeneca]

so first of all, thank you for the question. The competition that we have is obviously from on ULTOMIRIS is mostly from novel medicines. The category of Myasthenia gravis, as an example, has grown dramatically over the last three or four years. The branded part of the market is growing very strongly every year. The ULTOMIRIS has a key position in this market, but obviously, other mechanisms have an attraction for people who are switching from the steroids or immunosuppressant as a first line treatment.

[Marc Dunoyer, CEO of Alexion & Chief Strategy Officer at AstraZeneca]

Ultomirase is also competing in that segment, but it's not the only mechanism available. So we have it's mostly a competition from novel medicine rather than biosimilars. Biosimilars obviously competes against SOLIRIS. But as we have now converted mostly SOLIRIS to ULTOMIRIS in the four indications, the competition in the future will be coming from the novel medicines.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

Thank you, Mark. Seamus Fernandez at Guggenheim. Over to you, Seamus.

[Seamus Fernandez, Senior Managing Director at Guggenheim Partners]

Thanks for the question. So two quick questions. So Pascal, you commented on the pricing dynamics and concerns that have been raised. But you haven't commented on the opportunity for the HHS secretary to work with congress to align the incentives for small molecules, with large molecules. Just wondering your thoughts on that as well as kind of a backward looking dynamic with regard to already negotiated, small molecules in the context, including Calquence.

[Seamus Fernandez, Senior Managing Director at Guggenheim Partners]

And then separately, just wanted to ask a little bit, for directional predictions that you believe DB-nine may have as it relates to potential success of Enhertu in the adjuvant setting. Thanks so much.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

Thank you, Seamus. Yes, I mean, the first point, thank you for reminding us of this. I mean, it is definitely I mean, Congress still has to vote on this, of course, and confirm it. But it is definitely something that goes in the right direction for the industry in general and for us in particular. I mean, of course, our existing medicines, but I can think of Camisestron, which will be a very major medicine, we believe, would certainly benefit from this.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

I think also we can take heart of what we could see as potential willingness to address these 340B issues. I mean, it is something that we, as an industry, but certainly we as a company, have been pushing back on because we believe that a number of participants have abusing this have been abusing this 340B regulation. And it was nice to see that there is a report now that has been provided to the Congress that confirms what we have been saying for a long time. So there's a couple of things that actually are going in the right direction. You're absolutely right.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

And and I think the industry would benefit, and we would benefit. GB GB o nine, do you want to Susan, you wanna cover that?

[Susan Galbraith, Executive Vice President of Oncology Research & Development at AstraZeneca]

Yeah. Sure. So just as a reminder, in in in the d b o nine study, you're taking on a three drug regimen there. I think the fact that we've seen highly statistically significant and clinically meaningful improvement with the combination of patuzumab and Enhertu speaks to the, you know, the power of Enhertu to address that and builds on the data that we have with d b o three, d b o four, and d b o six. Know, if you look at the other early trials, d b eleven, is in patients that are in the neoadjuvant setting, and, again, aims to improve on the current, standard of care in that neoadjuvant setting, which, you know, has multiple drugs.

[Susan Galbraith, Executive Vice President of Oncology Research & Development at AstraZeneca]

It's actually five drugs is the current standard of care with a a c as well as the the the the THP regimen. And then d b o five is in patients who have residual disease after surgery. So post neoadjuvant, and around half of those are considered high risk, which is the node positive patients. So that's a subgroup where the Catherine child with the trastuzumab d m one demonstrated less benefit. And given the d b o three data where we've already had a head to head comparison with that, we do believe that that a hint Enhertu can make a difference in both of those settings.

[Susan Galbraith, Executive Vice President of Oncology Research & Development at AstraZeneca]

So I hope that gives you context for the potential readouts for DB05 and DB11.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

Thank you, Susan. Next question is from Simon Becker of Redburn. Over to you, Simon. You may be on mute.

[Simon Baker, Partner at Redburn Atlantic]

Can you hear me now?

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

Go ahead. Thank you.

[Simon Baker, Partner at Redburn Atlantic]

Apologies. I hit the wrong button. Two questions, if I may, please. Firstly, one for Dave. You talked about the gradual impact on discontinuation rates from Part d redesign.

[Simon Baker, Partner at Redburn Atlantic]

I appreciate it's it's a bit early to start talking about what the impact is. But could you talk about the point from which we start in terms of where we are now in terms of, financially motivated discontinuation rates? And then secondly, one for for Sharon. I I noticed from the the trial appendix that MEDI, one eight one four in Alzheimer's and MEDI o six one eight in migraine have both been removed from the pipeline. As far as I can see, that removes all neuroscience assets from the biopharma pipeline.

[Simon Baker, Partner at Redburn Atlantic]

Is that just coincidence or does that mark a strategic shift in R and D priorities? Thanks so much.

[Ruud Dobber, Executive Vice-President of BioPharmaceuticals Business Unit at AstraZeneca]

Dave?

[David Fredrickson, Executive Vice-President of Oncology Business Unit at AstraZeneca]

Simon, we have seen in the past and we haven't given specific percentages on this, but we've seen, I would say, kind of an important minority of the total oral packs that we ship are historically free drug that we ship. And so those are things that historically we've seen as abandonment. Now whether or not that's been abandoned at the first script or that's at a refill because there's a discontinuation that happens down the road, that's much more difficult to parse out. But we've absolutely seen, and we've put into place a number of measures as co pay capping came down from uncapped to last year's 33 to this year's 2,000. We have absolutely seen a reduction in that free goods utilization.

[David Fredrickson, Executive Vice-President of Oncology Business Unit at AstraZeneca]

I don't have a big expectation of seeing a lot of further improvement in free goods because it's really come down pretty significantly. I think that the best opportunities for us to grow coming from here is going to be as always new indications. Tagrisso continuing to drive FLORA two, Laura, Adora, Amplify and Echo on Calquence. That's our opportunities to really come from this rebaseline spot that we're at to now drive growth from here over the course of the period of the multiple quarters that sit in front of us.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

Thank you, Dave. And just to repeat again, so that you don't forget this, the message is Tagrisso is growing by 20% in volume, Calquence by more than 20% in volume. So take this and this momentum, add what Dave just said in terms of new indications. And you can imagine that as we weather this Part D repricing, which is a one off this year, that will take us into 'twenty six, 'twenty seven with a renewed momentum for these very important medicines. Sean?

[Sharon Barr, Executive Vice-President of BioPharmaceuticals R&D at AstraZeneca]

Thanks for the question, Simon. In R and D, prioritization is always important. So as you noticed, we have closed our neuro programs and identified partners for some of them. This represents a closure of our neuroscience group at AstraZeneca. And importantly, it allows us to focus on our core therapeutic areas and fund our high value programs.

[Sharon Barr, Executive Vice-President of BioPharmaceuticals R&D at AstraZeneca]

You've heard our excitement about things like weight management, about dyslipidemia, about our very important respiratory portfolio and our growth in immunology. And so this prioritization helps us to reinvest in the programs that we think are important for AstraZeneca.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

Thank you, Shine. Yeah, we have things that you haven't seen yet because they're in early development, and we don't speak much about this. But things like inhaled biologics, the immune portfolio that has been really progressing and is shaping up nicely. So there's a lot of things we can fund, and we cannot be everywhere. So CNS really is probably better managed by other companies that have a focus on that.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

Rajesh Kumar, HSBC. Rajesh, over to you.

[Rajesh Kumar, Analyst at HSBC]

Hi there. Thanks for taking the question. Just on PCSK9, if you could give us some idea on the time lines of when are we expecting the trials and updates in terms of the development timelines, similarly on Surinostics as well, filing timelines, if we have any clarity on that one. And a second slightly broader question. Appreciate there's a lot of interest on Avansar, and, you know, we are all nervously waiting for the readout.

[Rajesh Kumar, Analyst at HSBC]

But, you know, we can easily confuse, you know, the details for the bigger picture. So can you, you know, elucidate your broader strategy around data? What where do you think what is the total potential of the product across indications? And how do you see that develop? Would appreciate that.

[Rajesh Kumar, Analyst at HSBC]

Thank you.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

So the first question maybe Sean, you can take SIRNA6 for Susan and the last one is for you Dave, I guess.

[Sharon Barr, Executive Vice-President of BioPharmaceuticals R&D at AstraZeneca]

Sure. So thank you for your interest in PCSK9. You hear our excitement about this molecule. And as I mentioned today, we are launching three phase three studies and moving at pace. We expect to have our pivotal study in LDL lowering initiated by the end of this year.

[Sharon Barr, Executive Vice-President of BioPharmaceuticals R&D at AstraZeneca]

Now we won't comment broadly on the readout timelines for these pivotal studies, but you heard us tell you that we're moving forward with a sense of urgency, that we are running a combined primary and secondary outcome study, and that we think that we'll be able to launch with our LDL lowering study while moving ahead in parallel with our outcome study that will help facilitate market uptake. So continue to watch this space.

[David Fredrickson, Executive Vice-President of Oncology Business Unit at AstraZeneca]

Rajesh, on the bigger picture question on DATROA, and I appreciate you asking it. I think that understandably because Avansar is the first frontline lung cancer study to read out, there's a lot of interest within it. But I do think it's important to not look at it just within isolation. There's multiple opportunities for data as a monotherapy, particularly as we take a look at studies like TL17 that now look at prospective definition of a biomarker population. And Susan commented on this before, we've quite a lot in the past.

[David Fredrickson, Executive Vice-President of Oncology Business Unit at AstraZeneca]

The work that we've done with the QCS biomarker, I think, is really evidence to how we're leveraging this convergence of science, data, and technology to be able to try to better and more precisely identify patients who can benefit potentially from DATRA Way. Also though in combination and there's multiple combinations that we look at. There's combinations with IO. There's also combinations with Tagrisso and EGFR mutated. And we're looking at combinations not just with PD-onePD L1, but also with our bispecific portfolio.

[David Fredrickson, Executive Vice-President of Oncology Business Unit at AstraZeneca]

So I think that that's the context within which I'd put data. We're underway already in The U. S. In breast cancer. I would note that we are seeing that over half of the accounts that have placed their first order for DATROA have also had repeat utilization.

[David Fredrickson, Executive Vice-President of Oncology Business Unit at AstraZeneca]

So that's a really encouraging sign. And it also underscores the high unmet need and willingness to be able to bring a more precise chemotherapy with a profile like DATROWAYS to replace classical chemotherapy in settings where classical chemotherapy has long been relied upon. And I guess Pascal made the last point, which is let's not look at it in isolation. There's an entire portfolio of many readouts that we've got an opportunity also. And you've already seen whether it's Matterhorn, Serena six, DB09, Amplify that also go alongside that.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

Thanks, Steph. Luisa Hector, Berenberg. Luisa, over

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

to you.

[Susan Galbraith, Executive Vice President of Oncology Research & Development at AstraZeneca]

Hang on a second.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

Pascal, sorry. The six, Susan, go ahead, Yael.

[Susan Galbraith, Executive Vice President of Oncology Research & Development at AstraZeneca]

So thank you for the question about Serena six. But we're very excited to see the data come to the ASCO plenary. And I think, you know, selection for the ASCO plenary just reflects, you know, what, you know, they they are seeing about the the overall benefit risk that's seen in in in that trial. So, obviously, as we always do when we've got a a readout, we'll be in discussions with regulatory authorities, and I can't comment on on that specifically because that's ongoing. But what I do what I would say is that when you see compelling data, you know, first of all, we will work very diligently to get the submission happening, you know, rapidly.

[Susan Galbraith, Executive Vice President of Oncology Research & Development at AstraZeneca]

And then we'll also get you know, we've we've had other examples of when we see compelling data. We get opportunities for things like priority review. So, you know, let's wait and see how how that progresses, and I'm very happy to talk about the Sweden Six data once you've seen the the data at ASCO. And and if I could just take one more opportunity, just want to say that as well, the overall enthusiasm from investigators about the cannabis program is is substantial. The adjuvant studies are, a really exciting opportunity, and I'm very pleased to to share that we've actually achieved our target sample size in the CAMBRIA one study just very recently, which is also ahead of plan.

[Susan Galbraith, Executive Vice President of Oncology Research & Development at AstraZeneca]

So I think it just reflects the enthusiasm that we're seeing about this overall program. Thanks.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

Thanks, Susan. So I'm sure you've all heard that Susan loves chemisastron. So, Luisa, over to you now.

[Luisa Hector, Head of Global Pharma Equity Research at Berenberg]

Thank you, Pascal. I have two questions, please. On obesity, has your perspective on the market and AstraZeneca's potential role in that market evolved given recent competitor data? And then on China, thank you for the update there in the press release. Do you think we can draw a line here under all the investigations, or is there anything else we should have in mind as we go through the year?

[Luisa Hector, Head of Global Pharma Equity Research at Berenberg]

And perhaps just a quick comment on your market shares holding up in Q1 in China. Is that all intact? And your latest expectations on the timing of Park Seed JVP? You.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

Roed, do you want to take the first one?

[Ruud Dobber, Executive Vice-President of BioPharmaceuticals Business Unit at AstraZeneca]

Absolutely. So Luisa, we are very excited about our weight management portfolio. Last time, Sharon explained in quite a bit of detail why we are so excited. I think we have, first of all, a broad portfolio. I think our oral GLP-one potentially is fit for purpose in order to combine it with other products in our portfolio, clearly, our SGLT2.

[Ruud Dobber, Executive Vice-President of BioPharmaceuticals Business Unit at AstraZeneca]

The market size in itself is very, very substantial. As you know yourself very well, analysts are forecasting anything between €50,000,000,000 and 150,000,000,000 And I think our strategy is differentiated in such a way that, yes, we are looking in what we call the hardcore obesity market, so patients with a BMI of over thirty five. But equally, patients with a BMI between twenty seven and slightly above that are going to benefit substantially from losing a certain amount of weight. And if you combine that with other products in our portfolio, whether it is potentially an oral PCSK9, NASH DRT2, I think we have a very powerful combination, only in order to reduce weight, but also to move to protection of different organs. Now having said that, I think the other opportunity is clearly the footprint we are having in the emerging markets.

[Ruud Dobber, Executive Vice-President of BioPharmaceuticals Business Unit at AstraZeneca]

Likelihood that an oral PCSK9 will be priced at a lower level versus the current available injectables is a reasonable assumption. And hence, we're also aiming for a very large population in the emerging markets. So all in all, very exciting. Of course, the ongoing Phase II trials are running as we speak, both in obesity and diabetes. So we need to wait for that.

[Ruud Dobber, Executive Vice-President of BioPharmaceuticals Business Unit at AstraZeneca]

But we are ready in order to move with speed to start our Phase III trials if the data is successful.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

Thank you, Odd.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

And just maybe one additional point is that, as Rut said, we have a big footprint, Risa. And our mission is always to try and bring our medicines to as many people as possible. And if you look at the cholesterol market, the PCSK9 market, it's a good parallel. Injectable PCSK9 are great products. But outside The U.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

S, I mean, their penetration is more limited because of cost and injections. So an oral agent will enable us to bring this type of medicines to a lot more patients around the world. The other benefit maybe to add is that an oral agent is probably a better option in term of compliance long term. I think overweight or obesity are chronic conditions. You have to take those medicines for a long, long time.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

Otherwise, you regain weight. And we've seen this over and over again. So an oral agent that you take in combination with your other medicines is more likely to enable patients to stay on treatment for a long period of time, especially if the price is affordable, of course.

[Iskra Reic, Executive Vice-President of Vaccines & Immune Therapies at AstraZeneca]

Yes. So thanks, Luisa, for the question. Let me first start with a comment on the update on the investigation. As you recognize, we announced two important updates in our results announcement. And from what we Custom Office and Public Security Bureau have really concluded their respective investigation, both related to the drug importation allegations as well as the personal information infringement allegation.

[Iskra Reic, Executive Vice-President of Vaccines & Immune Therapies at AstraZeneca]

And these cases are now have now been referred to prosecutor. Important update that we provided in our result announcement is that we have been informed that there was no illegal gain to the company from the personal information infringement allegations. On your second question about the market share, as you saw in our quarter one announcement, we saw the strong performance in China strong quarter in China with 5% of the growth. And our underlying business is basically performing even better because if you adjust for the Pulmicort, which is declining due to the low infection season and the market decline, our underlying business in China is growing 9%. And that is driven primarily by the continuous strong performance of Orsiga and I would argue outstanding launch of it and here too followed by inclusion in NRDL in the January and our ability to basically achieve 800 hospital listings in first quarter and clearly help a lot of patient with huge unmet needs in China in that space.

[Iskra Reic, Executive Vice-President of Vaccines & Immune Therapies at AstraZeneca]

On top of that, we are seeing continuous improvement of the market share. We are still leading in the respiratory field, both with Symbicort and Breztri. We see very encouraging data and market share increase from Breztri as well as improvement in the usage of the triple therapy. And given the huge unmet need in China related to the COPD, we do see that we do see a huge unmet need going forward. When we look at other important growth drivers, as you all know, Tagrisso is an important growth driver in China, and we do see continuous growth of Tagrisso given by the new indication as well as improvement in the market share despite of fearless competition and six third generation TKIs from the local companies that are available in the market.

[Iskra Reic, Executive Vice-President of Vaccines & Immune Therapies at AstraZeneca]

So all in all, we feel very comfortable and confident in the team performance in the first quarter. And as we always talked about, we see we feel confident and comfortable with the opportunity going forward in China, given the unmet need and given our portfolio and pipeline that fits that need.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

Thank you. Ishra, maybe just to add something that Ishra will not tell you because she's modest, but she's done an amazing job and the team is very motivated. Locally, I was there not long ago. And it's important because that's really what is going to sustain our growth moving forward. The team has gone through a period of trauma.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

As you can imagine, we've all been sort of traumatized by this event. But people have quickly recovered, and they're very much focused on delivering on our goals. And everybody is very committed and very energized today. Maybe we'll take the last question, Peter Verdult at BNP. Peter, over to you.

[Peter Verdult, Managing Director - Pharmaceuticals Equity research at BNP Paribas]

Yeah. Thanks. Pascal Piedler, BNP. Two questions. Just firstly, for you, we've seen the first PDUFA delay from FDA this week that wasn't due to the need for further clinical or manufacturing data.

[Peter Verdult, Managing Director - Pharmaceuticals Equity research at BNP Paribas]

So just in light of all the personnel changes, are you noticing any worrying disruptions or delays with respect to Astra's interaction with the agency? And then, look, I know you recorded out what we had the question lined up, Bactristat, ahead of that upcoming phase three readout. Does the sort of recent lorandostat data from Minauralis, is that the right way of thinking about setting the bar, or are you hoping to show something more? I just wanted to get a sense of your expectations going into that readout. Thank you.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

So can I propose maybe, Susan, you cover the first question in general? And then, Sharon, if you have anything to add to FDA, and you can also cover bacostat.

[Susan Galbraith, Executive Vice President of Oncology Research & Development at AstraZeneca]

Yeah. Thank you. So obviously, we continue to monitor the situation. But just based on the facts, we haven't seen any delays in the interactions that we've had with the FDA across our programs to date. Just to remind you that Niagara was approved ahead of the PDUFA date.

[Susan Galbraith, Executive Vice President of Oncology Research & Development at AstraZeneca]

We have multiple interactions with the FDA across our extensive portfolio, and all of those meetings are happening in the timelines that we would expect and with the level of interaction that we would expect. Thank you.

[Sharon Barr, Executive Vice-President of BioPharmaceuticals R&D at AstraZeneca]

So with regards to the FDA, I will echo Susan's comments that to date, we have had, you know, on time conversations with the regulatory authorities. And to date, we haven't seen delays. That said, we continue to be very alert to this and continue to move forward with our programs with a sense of urgency. To address your question about Bactristat in light of the Mineralis data that was revealed earlier this month, We first think it's very encouraging to see momentum in aldosterone targeted therapies. It validates the critical unmet medical need that we have been focused on for some time.

[Sharon Barr, Executive Vice-President of BioPharmaceuticals R&D at AstraZeneca]

We think that this is a valuable mechanism of action in which we are targeting aldosterone at its source, which we think is a very important mechanism for helping to control hypertension. We continue to believe that our molecule, Bactrastat, has the potential to be best in class and has a very competitive profile. We've shown data for this in Brighton, where we saw a placebo corrected reduction of 11 millimeters of mercury in systolic blood pressure at the two milligram dose. With this molecule, we think we are seeing impressive mercury lowering at a low dose. This sets us up well for treatment with both monotherapy and combinations.

[Sharon Barr, Executive Vice-President of BioPharmaceuticals R&D at AstraZeneca]

Our molecule has a half life that is at least double that of competitors. And we think that's really important for twenty four hour control of hypertension. And we don't see clinically relevant drug drug interactions with Baxterstat, which again, we think highlights its potential to be a best in class molecule. So we think we're in a very competitive position. We look forward to reading out the phase three pivotal data for BACS HTN later this year.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

Thank you, Sean. So I'd like to maybe conclude, first of all, thanking you for all your interest and your great questions. And maybe in closing, just like to say again, we have started very well the 2025. We have a growth momentum that continues. We are on track to achieve our expectations and our guidance.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

And importantly, we are entering a catalyst rich period. As we said many times before, by the end of this year, early next year, we'll have a very good sense for the driving factors for our growth to 02/1930. So far, so good. We have five positive Phase III studies, in particular, important ones like SER-six, METOHN and, of course, more recently, DB-nine. We've had 13, one-three regulatory approvals across the major regions in the quarter.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

Our revenue is up 10% and very much on track with what we expect. Our expenses are well managed, and I know there's been a focus on SG and A. So I'd like to attract your attention that SG and A grew by 5%, even though we have many launches. So everybody is really working hard to manage those launches and control SG and A growth. And as a result, our operating profit is up 20 sorry, 12% and our EPS 21%.

[Pascal Soriot, CEO & Executive Director at AstraZeneca]

So that's really is a series of messages I wanted to leave you with because, again, we are very much on track. So with that, thank you so much again, and I wish you a good rest of the day.

Participants

Executives

• Andy Barnett, Head of Investor Relation
• Pascal Soriot, CEO & Executive Director
• Aradhana Sarin, CFO & Executive Director
• David Fredrickson, Executive Vice-President of Oncology Business Unit
• Susan Galbraith, Executive Vice President of Oncology Research & Development
• Ruud Dobber, Executive Vice-President of BioPharmaceuticals Business Unit
• Sharon Barr, Executive Vice-President of BioPharmaceuticals R&D
• Marc Dunoyer, CEO of Alexion & Chief Strategy Officer
• Iskra Reic, Executive Vice-President of Vaccines & Immune Therapies

Analysts

• Sarita Kapila, Analyst at Morgan Stanley
• James Gordon, Vice President at JP Morgan
• Rajan Sharma, Executive Director at Goldman Sachs
• Sachin Jain, Vice President at Bank of America
• Steve Scala, Pharmaceutical Analyst at TD Cowen
• Mattias Häggblom, Equity Research Analyst at Handelsbanken
• Matthew Weston, MD - Pharmaceutical Research at UBS Group
• Justin Smith, Director at Bernstein
• Seamus Fernandez, Senior Managing Director at Guggenheim Partners
• Simon Baker, Partner at Redburn Atlantic
• Rajesh Kumar, Analyst at HSBC
• Luisa Hector, Head of Global Pharma Equity Research at Berenberg
• Peter Verdult, Managing Director - Pharmaceuticals Equity research at BNP Paribas