AZN Q3-2024 Earnings Call

Operator

Good morning to those joining from the U.S. Good afternoon to those in the U.K. and Central Europe, and good evening to those listening in Asia. Welcome, ladies and gentlemen, to AstraZeneca's 9 months and Q3 Results 2024 webinar for investors and analysts.

Before I hand over to AstraZeneca, I'd like to read the safe harbor statement. The company intends to utilize the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Participants on this call may make forward-looking statements with respect to the operations and financial performance of AstraZeneca. Although we believe our expectations are based on reasonable assumptions, by their very nature. Forward-looking statements involve risks and uncertainties and may be influenced by factors that could cause actual results to differ materially from those expressed or implied by these forward-looking statements.

Any forward-looking statements made on this call reflect the knowledge and information available at the time of this call. The company undertakes no obligation to date forward-looking statements. Please also fully review the forward-looking statements disclaimer in the slide deck that accompanies this presentation. There will be an opportunity to ask questions after today's presentation. [Operator Instructions] And with that, I will now hand you over to the company.

Andrew Barnett

executive

A warm welcome to AtraZeneca's year-to-date and third quarter 2024 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 the executive team, I would like to cover some important housekeeping points.

Firstly, all of the materials presented today are available on our AstraZeneca's Investor Relations website. Next slide, please. This slide contains our safe harbour statement, which i'll encourage you to take time to read. We'll 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. Next slide, please.

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

Pascal Soriot

executive

Thank you, Andy, and welcome, everyone. In the third quarter, total revenue grew by 21% driven by strong underlying global demand for our medicines. Core EPS increased 27% to $2.08, reflecting our continued focus on profitability. If you want to move to the next slide, please.

In the year-to-date, total revenue grew 19% and core EPS grew 11%. As a reminder, total revenue and core EPS in the first 9 months of 2023, benefited from onetime collaboration revenue and other core operating income totaling $1.1 billion, which makes the 2024 year-to-date growth rate even more impressive. Importantly, this performance is across all of our focused therapy areas with each delivering double-digit growth in both the third quarter and in the year-to-date.

Given the strength of our underlying business, I'm pleased to announce we have upgraded our full year guidance, and we now expect both total revenue and core EPS to increase by high teens percentages. Aradhana will provide you with additional detail. Please move to the next slide. Taking a closer look at our total revenue performance in the first 9 months of the year, we continue to benefit from our -- broad global presence. Our company is growing across all regions and we continue to strengthen our capabilities in many markets around the world, most notably in the emerging markets outside of China, where for another quarter, our performance is standing out from our peers with 30% growth in the year-to-date.

And you can see now the -- very good distribution of our revenue across the world, 43% in the U.S., 21% in Europe, 13% in China. It's very pleasing to see the emerging markets outside of China are now bigger than China with 14% of our revenue and 9% for the Established Rest of the World. So very strong distribution. But we want to see even more growth in the U.S. over the next few years as part of our 2030 ambition. And this is why we decided today here in New York to announce this $3.5 billion investment in the U.S. in manufacturing and R&D. U.S. is, of course, a very important market, and that supports innovation, and we will continue to invest to grow fast in this in this part of the world, but very, very good growth across the world in the emerging markets -- in China, but also very much outside of China.

With this chart, I'd like to take a moment to address recent developments in China, which of course -- have been the subject of a lot of speculation -- actually not privy to the details of any of this investigation. If requested we will cooperate fully as we have in the past. As you can imagine, our personally [indiscernible] this matter very seriously, and the whole company also takes it, of course, very, very seriously. It's important to realize we don't have many details. We haven't been approached as a company. We will, of course, collaborate with the authorities you've requested to do this. but we have very limited information. And today, we would like to focus on Q3 to the extent possible unless they are questions relating to China that haven't been answered before by Aradhana last week when she organized the call.

Importantly, we remain committed to our presence in China, and we will continue to invest in the country to support the discovery and the delivery of our life-changing medicines. And finally, we're doing what we can support our employees in China -- they're all hard at work. They're all very focused and continuing to develop our pipeline, but also our portfolio of marketed products. I just want to take a moment to thank all these employees for their continued dedication to our purpose. We have 17,000 employees in China and all these employees are working very hard and making us all happy with how they have developed our presence in China over the last few years. Please advance to the next slide.

Already this year, we delivered multiple high-value Phase III readouts. LAURA expands the reach of Tagrisso in early-stage lung cancer. Calquence advances into [indiscernible] cell lymphoma with ECHO, and with AMPLIFY now has the potential to be the only medicine in frontline CLL approved for both fixed and extended durations of treatment. DESTINY-Breast06 broke new ground for Enhertu it 1 line earlier into chemo naive metastatic breast cancer, and it showed clear benefit IN-HER-2 [indiscernible] disease. And Imfinzi is set to begin a new wave of growth in small cell lung cancer and bladder cancer following positive readouts for ADRIATIC and NIAGARA. Finally, as shared earlier today, KOMET has potential to extend Koselugo used beyond pediatric and NF1 PN patients to adults, and WAYPOINT has the potential to bring a first-in-class mechanism of action to patients with severe nasal polyps. If approved, these opportunities represent over $5 billion in combined peak year revenues on a non-risk-adjusted basis. With that, -- please advance to the next slide, and I will now hand over to Aradhana, who will take you through our financials.

Aradhana Sarin

executive

Thank you, Pascal, and hello, everyone. Next slide, please. I will start by highlighting our broad-based growth across our focus areas. As you can see on this slide, we delivered strong total revenue growth across the portfolio. with blockbusters in all key therapeutic areas, delivering strong growth in the year-to-date period. Next slide, please.

This is our reported P&L. Total revenue increased by 19% in the first 9 months. Product sales also increased by 19%, with strong growth across major regions. Alliance revenue increased by 50% to $1.5 billion, driven by increased sales for Enhertu and Tezspire in regions where our partners book product sales. In order to remain focused on our growth products, we undertake a regular portfolio prioritization. And in the third quarter, this resulted in an impairment and related charges for Andexxa. Next slide, please. This is our core P&L. As anticipated, our core product sales gross margin declined slightly in the third quarter versus the first half.

We anticipate a lower product sales gross margin in the fourth quarter, partly due to the seasonality of FluMist and increased Beyfortus supply to Sanofi following a very successful launch. We have previously said that for the full year, we expect a slightly lower product sales gross margin percentage compared to 2023. Operating expenses increased by 15% year-to-date, well below the pace of total revenue growth. R&D expenses increased by 18%, in part due to the integration of recent acquisitions, including grace. [ Fusion ] and [ Amolet ] for which we incurred additional costs this year. We've also accelerated a number of R&D projects and saw rapid patient enrollment across many of our clinical trials. This is expected to continue in the fourth quarter.

For the full year, we still anticipate R&D costs to be towards the upper end of the previously indicated low 20s percentage range of total revenue. This would imply a step-up in R&D costs in the fourth quarter. SG&A costs increased by 13%, partly driven by investments behind our new launches and growth brands, including Air Supra, Breastree and TruCap. However, as we've previously highlighted, while we expect to see some growth in SG&A costs in the fourth quarter, we do not anticipate it would be to the same extent as we saw in the fourth quarter of 2023. Core EPS of $6.12 represents a growth rate of 11%. Recall that the comparative period last year benefited from almost $1.1 billion in onetime collaboration revenue and other operating income, impacting year-over-year growth rates. Please turn to the next slide.

Our net cash inflow from operating activities improved by $989 million in the first 9 months, driven by improved business performance. We still expect CapEx for 2024 to increase by about 50% versus 2023 and have incurred $1.2 billion year-to-date. This includes investments in our new cell therapy manufacturing plant in Rockville, Maryland and a new manufacturing plant in Qingdao, China for our inhaled respiratory portfolio. Net debt increased by $3.8 billion, mainly reflecting the acquisitions completed earlier this year and $4.6 billion in dividend payments. Our net debt-to-EBITDA ratio currently stands at 1.8x.

As previously indicated, finance expenses are expected to be higher in 2024 compared to 2023, given the $6.5 billion of bond issuances earlier this year, which came at higher interest rates. As Pascal mentioned, following strong performances from both product sales and alliance revenue year-to-date and increased confidence in achieving certain sales-based milestones. We are upgrading our fiscal year guidance today. We now anticipate total revenue and core EPS to grow by high teens percentage at CER. An increase from our prior expectations for mid-teens growth, which was upgraded at half year.

Heading into 2025, we expect to continue to see strong underlying revenue growth driven by indication expansion opportunities and continued strong global demand for our medicines, and are entering a catalyst-rich period for our company. We remain focused on creating P&L leverage, and taken together, we are confident in our 2025 outlook. As usual, we will issue guidance for next year in February at our full year results. And with that, please advance to the next slide, and I will hand over to Dave, who will take you through Oncology performance.

David Fredrickson

executive

Thank you, Aradhana. Next slide, please. In the first 9 months of the year, Oncology total revenues grew 22% to $16 billion, driven by strong demand in the U.S., Europe and emerging markets. Turning to our key medicine performance in the third quarter.

Tagrisso's global revenues grew 17% with sequential growth of 4%, reflecting strong demand for DoT and lengthening duration of therapy in the metastatic setting. In the U.S., initial adoption for FLORA 2 has been encouraging in the first 9 months following launch. Calquence total revenues increased 25% in the third quarter, driven by sustained BTKi inhibitor leadership in frontline CLL and continued international expansion. Imfinzi delivered 16% and Imjudo 22% growth in the third quarter, supported by adoption GI cancers, Topaz has rapidly achieved peak market share as the standard of care in biliary tract cancer and HIMALAYA continues to make gains in advanced liver cancer.

As expected, we realized an impact from the two mandatory price reductions in Japan earlier this year, which is reflected in established rest of world performance in the first 9 months. We look forward to a new wave of Imfinzi growth driven by key indication expansion opportunities, including a Gn and once approved ADRIATIC and NIAGARA, which will contribute meaningfully to peak year revenues.

Lynparza remains the leading PARP inhibitor globally across all tumor types, delivering product sales growth of 13%, driven primarily by demand growth in the U.S. and Europe. Enhertu is now the established standard of care across both HER2-positive and HER2-low metastatic breast cancer, delivering total revenue growth of 55% and sequential growth of 8% in the third quarter. We saw some spontaneous use in the chemo-naive setting following presentation of the DESTINY BREAST-06 data at ASCO and publication in the New England Journal of Medicine in September. NCCN guideline inclusion and potential approval will be important catalysts for expanded adoption.

Finally, we continue to see encouraging early uptake in tumor agnostic, particularly in gynecologic tumors. Truqap delivered $125 million in the third quarter, supported by strong adoption in the biomarker altered population and further use in the late line setting. Since half year results, we received a number of key regulatory approvals, including [indiscernible] and LAURA in the U.S., which accelerate Imfinzi and Tagrisso into early-stage lung cancer.

In Europe, we received approval for Imfinzi and Lynparza in endometrial cancer. And in China, we received additional Enhertu approvals in gastric and lung cancers. Taken together with the performance of our existing medicines, these new indication expansion opportunities give us confidence in the continued growth of our global oncology portfolio in 2025. With that, please advance to the next slide, and I'll hand over to Susan to cover key R&D highlights from the quarter.

Susan Galbraith

executive

Thank you, Dave. In September, we showcased important data at the World Congress on Lung Cancer and the European Society for Medical Oncology Congresses, with 5 presidential plan areas and 8 simultaneous publications, including 3 in the New England Journal of Medicine.

At ESMO, we presented the results from the Phase III NIAGARA trial of Imfinzi in a presidential session. This is the first perioperative IO regimen to show a significant improvement in overall survival versus standard of care in muscle invasive bladder cancer. Together with the ongoing VOLGA Phase III trial of Imfinzi in combination with enfortumabvedotin, Imfinzi's based regimens will look to address the full spectrum of muscle invasive bladder cancer. We continue to advance our next-generation IO bio-specifics as well as our novel in-house ADC programs, and we shared key data updates on both of these, both World Congress and Lung Cancer and ESMO.

We've now initiated 10 Phase III trials with our IO bio-specifics [ Borustomag ] and [ Ribagostomig ], and we continue to progress our late-stage ADC portfolio. Importantly, we shared a key data update for our novel QCS technology. A retrospective analysis of the TROPION Lung-01 data set shows a trip-2 QCS NMR biomarker is predictive of progression-free survival outcomes with Dato-DXD, and recent analysis shows it's also predictive of OS outcomes. We look to prospectively validate this biomarker in multiple ongoing Phase III trials. We believe that the novel advancement in the field of computational pathology will have applications across ADC portfolio, enabling better patient identification and unlocking opportunities in multiple tumor types.

We will share data from the Phase III AMPLIFY trial at the American Society of Hematology meeting in December. In this trial, fix duration Calquence in chronic lymphocytic leukemia delivered a clinically meaningful improvement in progression-free survival, a trend to overall survival and differentiated safety in an all-oral regimen. HCPs prefer finite therapy for around 50% of patients, including those that are more fit or have IGHV mutations. AMPLIFY has the opportunity to drive BTK inhibitor class expansion in frontline CLL by offering both fixed and extended duration options as monotherapy and in combination. Also at ASH, we'll be sharing new data for our CD19/CD3 T-cell engager, AZD-0486 -- in relapsed/refractory diffuse large B-cell lymphoma and in follicular lymphoma. CD19 is expressed across a broader range of B cells compared with CD20, and therefore, this asset has the opportunity to be differentiated from CD20 engagers.

It was also designed to have lower affinity to CD3 -- with the hope that this improves tolerability compared with other engager platforms. We believe that AZD-0486 has the potential to be a foundational therapy across multiple hematologic indications. Next slide, please. tgr remains the backbone TKI for the treatment of EGfR mutated lung cancer, spanning early to late metastatic settings. Earlier this year, we received U.S. approval for the LAURA study in Stage III un-resectable lung cancer, expanding Tagrisso's presence in early-stage disease. Last month, we read out the registrational Phase II SAVANNA trial of Tagrisso with Orpathys in second-line EGFr mutated lung cancer. This oral regimen demonstrated a durable high response rate. Importantly, the addition of Orpathys for continued use of Tagrisso in the roughly 1/3 of patients that have high met expression. We've shared these data with regulatory agencies and await the readout of the confirmatory Phase III SAFFRON trial in the second half of next year. SAVANNA is one of several trials that looks to explore novel combinations which can extend Tagrisso across multiple lines of therapy. We're also exploring Tagrisso and Dato-DXD in first and second-line settings with the TROPION Lung-14 and 15 trials. We see potential to replace systemic chemotherapy whilst maintaining Tagrisso use for patients with EGFR mutated lung cancer.

Finally, I'd like to provide an update on the TROPION Lung-01 filing. Following discussions with the FDA, we submitted a biologics license application for approval in later line EGFR mutated non-small cell lung cancer. With the encouragement of the FDA, we've also applied for breakthrough therapy designation for this indication. In parallel, we've decided to withdraw the application for the broader non-squamous non-small cell indication. The FDA has noted the favorable benefit risk profile in EGFR mutated lung cancer based primarily on the data from the single-arm TROPION Lung-05 with supportive data from the TROPION pan-Tumor-01 and the randomized data from the TROPION-Lung-01 EGFR-mutated subset. The ongoing TROPION-Lung-15 study will serve as a confirmatory trial. Also, we plan to conduct an additional registrational trial in the second line TROP2-QCS-NMR biomarker positive population, complementing the ongoing Avanza and TROPION 10 trials in first-line non-small cell lung cancer.

We remain committed to our ongoing Dato-DXd program in lung cancer and look forward to next year's readout for Avanza, the first Phase III data for Dato-DXd in first-line lung cancer. And with that, please advance to the next slide, and I'll pass over to Ruud to cover biopharmaceuticals performance.

Ruud Dobber

executive

Thank you so much, Susan. Next slide, please. Our Biopharmaceuticals medicines delivered total revenue of $15.9 billion in the first 9 months of 2024, representing growth of 20%. In the third quarter, total revenue increased 25%, with every biopharma therapy area growing in every major region. CVRM total revenue increased 20% in the third quarter. Farxiga delivered 27% growth with double-digit growth in all major regions, driven by continued market leadership in the expanding SGLT2 class. In the third quarter, our recently launched medicine for ATTR polyneuropathy Wainua grew 44% sequentially to $23 million with prescribers coming from a broad range of specialties. Wainua secured positive CHMP opinion in Europe during the quarter as well as multiple approvals in other markets. Our R&I business is expected to be a substantial driver of our growth through 2030. R&I delivered total revenue of $2 billion in the quarter, an increase of 29%. Growth was particularly strong in the United States at 43% and Europe at 30%, reflecting increased demand for our biologics and in health medicines.

The strong growth momentum we have seen for the Tezspire in Breztri continued with both medicines on track to achieve around $1 billion sales in global sales in 2024. The long-term outlook for Breztri is very promising with potential to expand into asthma, and we're also progressing the development of our next-generation propellant with near zero global warming potential. Our ongoing [indiscernible] trial is the only in the class to examine both pulmonary and cardiac endpoints and, if successful, could be transformative for this medicine. Our other in-health medicines, Symbicort and Airsupra are also experiencing strong demand. Well, it is unclear to what extent Symbicort's recent growth in the United States will continue in 2025. We expect to see continued strong demand in the emerging markets. Airsupra revenues grew 50% sequentially and the launch is progressing very well with more than 50,000 health care practitioners in the U.S. having prescribed Airsupra to date. Lastly, we are very pleased to see V&I return to growth in the quarter, with a 49% increase in total revenue. Demand for Beyfortus is strong, supported by real-world evidence of Beyfortus value in preventing infant hospitalizations and also the recent clinical data from the HARMONY trial, which demonstrates its sustained efficacy to 180 days. We are highly encouraged to see such a strong performance from all areas of biopharmaceuticals in the year-to-date, and we anticipate this growth momentum will continue into 2025. We I will now hand over to Sharon to discuss the latest developments from the biopharmaceuticals pipeline. Next slide, please.

Sharon Barr

executive

Thank you, Ruudy. Today, I'm excited to share more about our ambitions to build the next wave of transformative medicines addressing cardiovascular, renal and metabolic diseases.

We have established a robust foundation with Farxiga our leading SGLT2 inhibitor in heart failure, chronic kidney disease and Type 2 diabetes, and we are progressing a number of key NMEs. We remain focused on delivering novel targeted mono-therapies, including baxdrostat our selective aldosterone synthase inhibitor, which we believe has the potential to be the first-in-class medicine for uncontrolled hypertension, and we look forward to a Phase III readout next year.

Earlier this year, we presented results from our Phase I trial for AZD-0780, our oral PCSK9 inhibitor, demonstrating an additional 52% reduction LDL-C on top of standard-of-care statins. Furthermore, we are investigating multiple modalities in cardiac amyloidosis, including 2 molecules for ATTR cardiomyopathy. [indiscernible], a TTR gene silencer and ALXN-2220, a TTR protein depleter, which has the potential to address the broad spectrum of cardiac amyloidosis. To pioneer in an evolving landscape, we have intentionally built our pipeline to investigate novel combinations to simultaneously target complex conditions and address comorbidities.

We recently presented early data from 3 assets across our weight management pipeline at ObesityWeek earlier this month. Promising Phase I data from AZD-5004, our small molecule oral GLP-1 receptor agonist demonstrated good target engagement, safety and tolerability. As a once-daily option, AZD-5004 is being developed as both the monotherapy as well as in combination with other small molecules in our portfolio such as dapagliflozin and AZD-0780, our oral PCSK9 inhibitor. We are rapidly progressing AZD-5004 in Phase IIb trials in Type 2 diabetes and obesity or overweight.

Data from AZD-6234 our once-weekly long-acting amylin agonist peptide, also demonstrated encouraging safety and tolerability as well as a robust profile designed to promote fat specific weight loss while preserving lean muscle mass. We have progressed AZD-6234 into Phase IIb to evaluate body weight reduction for those living with obesity or overweight. Additionally, we believe the triple mechanism combination of AZD-6234 with AZD-9550, our GLP-1 glucagon dual agonist has the potential to achieve optimal weight loss lean mass sparing and organ protection. We are working at pace to deliver the next wave of transformative medicines across cardiovascular, renal and metabolic diseases, across a range of modalities and pathways designed to address the inter-connectiveness of disease. Please move to the next slide.

Last week, we announced positive results from the WAYPOINT Phase III trial of Tezspire in patients with chronic rhinosinositis with nasal polyps. There is a significant burden and unmet need for patients living with nasal polyps with over 7 million patients treated for this disease, of which 3 million are uncontrolled. Tezspire demonstrated statistically significant and clinically meaningful reductions in both co-primary endpoints, reducing the size of nasal polyps and the level of diesel congestion.

We look forward to sharing these data with regulatory authorities and at an upcoming medical meeting. Beyond nasal polyps, we have several other Phase III trials ongoing or announced across multiple indications, including severe asthma, eosinophilic esophagitis and COPD, and we look forward to updating you on our progress. And with that, please move to the next slide, and I will hand over to Marc to cover our rare disease portfolio.

Marc Dunoyer

executive

Thank you, Sharon. Can I get the next slide, please. Rare Disease grew 14% to $6.4 billion in the first 9 months of the year, driven by growth in neurology indications, increased patient demand and continued global expansion. Ultomiris achieved its first blockbuster quarter with revenue growing at 35% and primarily driven by neurology indication. The NMOSD launch is progressing very well. And by the end of the year, we expect the majority of patients in major markets will have switched from Soliris to Ultomiris.

In Europe, we saw a minimal increase of Soliris biosimilar utilization across PNH and atypical [indiscernible] U.S. Beyond complement, Strensiq and Koselugo grew 21% and 39%, respectively, driven by continued patient demand and new launches. We are highly encouraged by the strong performance from our rare disease medicine in the year-to-date, and we anticipate this growth momentum to continue into 2025. Please advance to the next slide. Today, we announced positive results from the Phase III KOMET trial in adult patients with NF1 PN the largest placebo-controlled Phase III trial ever conducted in the disease. NF1 PN is a rare progressive genetic condition impacting multiple body systems characterized by benign tumors that develop along nerve sees throughout the body. NF1 PN affects over 60,000 in both the U.S. and the EU, 80% of whom we estimate our adults.

In the KOMET trial, Koselugo a statistically significant and clinically meaningful reduction in patient tumor volumes as well as an encouraging effect across pain severities, rapid response from patients and low discontinuation rates. These data support the potential to explain Koselugo into the adult population. We look forward to sharing the data with regulators globally and will present at an upcoming conference. And with that, please advance to the next slide, and I will hand back to Pascal.

Pascal Soriot

executive

Thank you, Mark. Next slide, please. In addition to the high-value trial readouts that I mentioned at the start of this call, we are entering a remarkable catalyst rich path for our company. Within the coming year, we will see the results of significant indication expansion opportunities for our marketed medicines, including Truqap, Enhertu, Imfinzi and Fasenra as well as pivotal trial readouts for several important potential best-in-class novel medicines shown here on this slide. We're also making excellent progress advancing key disruptive technologies with potential to drive growth well beyond 2030. And we look forward to multiple earlier-stage data readouts over the course of 2025.

Next slide, please. As I had mentioned earlier, our strong delivery in the first 9 months of this year, together with our upgraded full year 2024 guidance sets a strong foundation for continued growth next year. And while we will provide formal guidance with full year results in February, we're confident that the headwinds we anticipate next year will be substantially offset by global demand for our portfolio of medicines. The strong commercial performance, together with continued pipeline delivery and our focus on profitability means we are on track to achieve the strategic conditions later out at our Investor Day this past May.

We remain confident in our ability to generate $80 billion in total revenue by 2030. And as a reminder, this is a risk-adjusted number. We are also managing our P&L to deliver the mid-30s percentage operating margin by 2026, as we previously communicated. Of course, pipeline regeneration is critical to delivering leading growth and long-term value creation. To that point, we've launched 6 names towards our goal of at least 20% by 2030. And with that, please advance to the next slide, and we will go to the Q&A.

As Andy mentioned at the start of the call, please limit the number of questions you ask to allow other a fair chance to participate. For those online, please use the raise hand function on Zoom. And with that, we'll move to the first question, which is from James Gordon and JPMorgan.

Over to you, James.

J

James Gordon

analyst

James Gordon JP Morgan. First question was U.S. election implications and where you're investing. So do you see any impact from the U.S. presidential election on Astra's business in terms of higher tariffs or maybe lower corporate tax or anything else?

And I saw the USD 3.5 billion investment in manufacturing research. Is there any connection there? Are you going to shift more of your investment into the U.S.? Is that even more of a focus now? I assume, for instance, the U.K. election doesn't make much difference, and that's going to be potentially an area of less investment?

And the second question was confidence in the 2025 outlook. So if I look the 2025 consensus of the new updated 2024 implied EPS level is looking for low double-digit EPS growth. So how comfortable are you with that growth outlook? I can hear comments on top line strength and leverage over SG&A, but also we've had a pull forward of the Lynparza milestone. There's questions on China, IRA -- financial expense and maybe the election depending on what you said on the first question. So should we be a bit more cautious than that in 2025? Or is that achievable maybe?

Pascal Soriot

executive

Okay. Thanks, Jim. So the first question, the pharmaceuticals typically are not subject to those import duties. Having said that, it's academic in our case because we don't import pharmaceuticals into the U.S. from China. So that is really a question that doesn't apply to us because we source our products for the U.S. We source them either from the U.S. directly or from Europe typically. So there's really no issue of sourcing products from China. And so that's the first point.

And as we explained in the past, we've really tried over the last few years to build supply chains that can, on the one hand, supply what you might call the Western world, U.S., Europe and a few others. And then we have a separate supply chain for China and some of the emerging markets. So that's the answer to the first question.

The second question -- actually -- on your first question about the U.S. elections, I mean the -- the reason we invest very substantially in the U.S. is that we all know the U.S. is a very important market, both in terms of providing our medicines to patients, but also in terms of innovation. And we really want to be at the heart of this country in terms of manufacturing but also R&D. I mean, we are building this new site in Kendall Square in Boston because it's an important location for research and development.

Now we see the economy should actually continue to grow strongly in the U.S. next year and the year after. And then a number of economy -- a number of participants in the economy seem to obey that too. And a strong economy will support a strong health care, which, of course -- assumably will also support the delivery of medicines. So all of that makes us makes us really enthusiastic about the U.S. market. In our plan, the U.S. should increase its participation to our total revenue. The other area that is growing very nicely, of course, the emerging markets out of China.

Now in terms of your other question with 2025, it's relatively simple, actually. I mean, look at where we are today, we are growing almost 20% in top line, right? So we've got enormous momentum moving into the Q4, but also next year. So we've got this momentum into next year running at sort of 20% growth rate. Now we know what the headwinds are. I mean we know about I -- we know about VBP, Farxiga in China. We don't know exactly when, but we know it's going to happen next year. And so those are headwinds.

But on the other hand, we have enormous momentum across the entire portfolio but also across the entire world. So I'm not saying next year, we will go by the same amount of this year, of course, not. But even if you decelerate this a little bit, and then you assume some leverage because we've been working on P&L leverage for many years. It's relatively easy to get to a conclusion that -- confirms what Aradhana was saying before. We are very confident with the outlook for next year. Not only for next year, but the year after, actually. So net-net is we are actually confident for the outlook next year. Aradhana, do you want to add anything to that?

Aradhana Sarin

executive

You covered it very well. And also just to make sure the investments we announced in the U.S. today, we've been working on them for several years, and the incremental investment that was announced is partly this year, partly the next 2 years, and it's really driven by the growth and the momentum that we see, whether it's in clinical trials and clinical trial supply or the cell therapy. And so it's really a continued process. And I know we made the announcement today since we are in New York, but that's been part of the plan.

Pascal Soriot

executive

And maybe just going back to the U.S. question is, if you think about -- I mean if you look at our position around the world, in most cases, we are in the top 3 companies in most markets -- not in the U.S. And the reason is the U.S. market is the market that actually rewards innovation the most. And -- but to do this, to be rewarded for your innovation, you have to have new products, and that's what we've done with oncology, but there's more to come outside of oncology in the next few years. And so that's why we believe that the share of global revenue coming out of the U.S. over the next few years should grow because our participation in the U.S. and hopefully, our ranking in the U.S. will improve.

Should we move to the next question, Richard Parkes?

R

Richard Parkes

analyst

Richard Parkes from BNP Parbas Exane. So a couple of questions. Firstly, just one for you, Pascal. Just wondered if you could comment on what you would suggest investors assume in terms of materiality of impact to your China business at this stage from the investigation? Obviously, it's -- we've all got very little visibility on China -- so is it safer to assume there will be some negative implications? And how would you characterize the materiality of that at this stage? I'm just wondering what you would assume if you had to present an updated 10-year plan to the Board tomorrow for the China outlook.

Then secondly, on Dato-DXd on for Susan. I just wondered if there was -- if was anything that was raised in -- during the FDA review that investors should be aware of that maybe undermine your confidence in Dato-DXd or the TROP2 to biomarker. Obviously, the decision to withdraw the filing raises question of the confidence in your hypothesis of where the drug works well. I'm just wondering if we should assume that or was the FDA's requirement for approval simply a higher bar than you originally assumed?

Pascal Soriot

executive

So the first question, Richard, thank you. For -- for China, I think really, the answer -- the answer to your question is, it's too early to judge. I think it's reasonable to assume that there will be some impact. But today, we cannot judge that. I mean it's much too early. We don't have enough data. We need to wait a little longer and see the trend. And on top of it, then we would have to see if there was an impact, is it a short-lasting or long-lasting impact. So much too early to judge. But I think maybe what I can say is that China today is about 12%, 13% of our total revenue.

As I said, the U.S. will continue to grow. Europe is growing. China will grow for sure. But next year, we know we have Farxiga VBP, and so for next year, the growth in China, in any case, will be slower than what we see this year, which this year is a very good growth, by the way. So -- we have -- the assumption is the share of sales is not going to be the 20% -- we saw a few years ago, we are at 12%, 13% today and the rest of the world will grow much more. So I guess what I'm saying is we will navigate this difficult period. And we think we can actually manage and to continue to grow across the world even if there was some impact in China.

We hope there won't be a time impact. [indiscernible] the team in the country in China is working very hard to continue moving our products. We know our research and development in China is very appreciated. We are probably -- I think we are the largest company in terms of R&D investment. This is well appreciated. So we believe that we should be able to manage this difficult period. But again, as I said, very difficult to comment at a very early stage. Susan, do you want to take the second one?

Susan Galbraith

executive

So thanks for the question. So obviously, with every review, there's ongoing discussions. I think it's fair to say that over the last period of time, the FDA has been increasingly interested in looking at subgroups within clinical trials. And this isn't the only example of that. the FDA is interested in the particular subgroups where the greatest benefit is seen. And of course, there's -- not just within the TLO-1 study, but obviously, within the single-arm TLO-5 study. really very robust activity that we've seen within the patients with actionable genomic alterations and in particular, those with EGFR mutations. So I think what you're seeing is a reflection on trying to focus initially on the subgroup, where is the greatest benefit. But I think there's also interest in the potential of the patients that have the biomarker positive subgroup that we've seen in the [indiscernible] -- we've had ongoing discussions about the potential route for validation of that biomarker. Of course, we've incorporated those plans into our ongoing Phase I trials which Avanza, as I've said, is the first one that we'll read out next year. But TROPION lung-10 is another example. And then again, in combination with [ osimertinib ] in TROPION Lung-14 and 15 studies. So that we build out really a robust set of indications for Dato-DXd in lung cancer. So your question was about confidence in the profile that we have with Dato-DXd.

As I've said a number of times, I think we've learned a lot from the Chopin data set. -- not just about the level of activity in the EGFR mutant, but this potential for the broader patient population. These were things that we didn't understand at the time that the TROPION Lung-01 study was designed. And that's the nature of development that you learn as you go. So what we've done is taken those learnings and adapted the program to maximize that potential benefit. What I would say is in terms of looking to the first line, which is obviously the biggest indication that we've got for non-small cell lung cancer, that given the safety and efficacy that we've seen from the TROPION Lung-02 and the TROPION Lung-04 studies, for combination and the ability to combine with platinum-based chemotherapy as well as IO, we're very confident about that profile.

And also, as I indicated as well, the biomarker data that we've seen in TROPION Lung-01, we've looked in other data sets as well. We also think we've got evidence that, that will translate across different data sets, including from internal data sets in earlier line settings as well. I think the overall profile that we have with Dato-DXd and the potential to maximize the benefit using the biomarker in broader patient populations is something that we're now probably increasingly confident about given the latest data that have emerged.

Pascal Soriot

executive

Thank you, Susan. So the next question is from Sachin Bank of America .

S

Sachin Jain

analyst

Same two topics, if I may, please. So firstly on a Dato -- you indicated a [indiscernible] with FDA around changing Avanza. I just wonder how far progressed you are with that and whether the TLO01 debate is input at all. And the second 1 is just back on '25, just get a bit more color, if I could, from Pascal -- around there. You've listed 2 main headwinds, Farxiga VBP and IRA. But you just give us your best quantification or expectations around those. We have asked a question Crestor did better than expected on VBP. IRA, you've historically framed as manageable to neither seem like material headwinds, the existing high teens growth adjustment revenues could continue to double digit for next year. So just any perspective there.

Pascal Soriot

executive

So maybe let me cover the second one and then I think, Susan, we can go back to that, too. And Rod and Dave, if you want to comment on the. So on the China side, the -- what you should expect for Farxiga is what we saw with [indiscernible], which is a decline and then stabilization in the growth because our plan is to do with Farxiga what we did with [indiscernible]. And there is a market for these products. that patients actually buy directly online with an electronic prescriptions essentially and then get it delivered to their home.

Now the sales will not be at the same level as they are today, for sure, just like happened with [indiscernible], but we believe we can go down and then grow again and keep Farsee for quite some time to come. But next year, you should expect a decline. I mean we can't give you a specific indication for for 2025 Farxiga, but you should expect a substantial decline. And then Ruud, do you want to cover IRA and anything, Dave, you would want to add?

Ruud Dobber

executive

Yes, of course. And once again, currently, we are not assuming that Farxiga in our guidance for this year that Farxiga will be in the VBP, -- it's not -- it hasn't been announced, but that's a clear assumption and let's see how it works for 2025, as Pascal mentioned Sachin.

Regarding the IRA, I think it's a little bit of a mixed bag. On one hand, we know that the out-of-pocket cost will be lower. It will also be smooth over the full year, in the course of 2025. So patient adherence probably will be better than what we have seen in the past. But of course, the liability for some of our products, and I will hand over in a second to Dave regarding the oral oncology products, we will see a certain impact.

But when we will give the guidance in the beginning of 2025 that will be part of the way we will guide for that specific year. But overall, I think it's fair to say that from a biopharma perspective, the IRA impacts will be manageable. We have good programs in place to drive further volume. We've seen that clearly with the Symbicort performance but Farxiga is still performing very well in the U.S. market. And we don't think that as well substantially slow down in the course of 2025. Dave?

David Fredrickson

executive

Sachin, I think that again, we've talked about this in the past, but I also believe that IRA is manageable coming into next year. We know that IRA has resulted in important improvements in affordability for Medicare patients in the United States. That's resulted in increased adherence also lower reliance on free drug programs. We've seen that. I think that you've also seen that in other earnings announcements that have come out from other companies on their oral if you will, kind of more expensive specialty medicines. And you've seen that across the board.

Obviously, next year, we take on the 20% liability in the catastrophic phase for the first time. So that's a mechanic that we haven't experienced in 2024. But also within that, the affordability improves even further. And I think that we would hope and expect more patients to be able to afford to be on commercial drug and the capping is something that can benefit. And I think importantly, our oral oncolytics, Pascal talked about this, as did Susan in the slides. We've got really excellent growth drivers on Tagrisso and Calquence. And I think that, that's where I'm focusing my efforts in the year ahead on making sure that we get those to patients as quickly and rapidly as we can.

Pascal Soriot

executive

It really is important, as Dave said, to consider the new indications, because as we launch those new indications for instance, Tagrisso or Calquence, patients will have the ability to benefit from those indications without having to ask for free products. So we really have in part only, of course, a partial shield to the negative effect of IRA. That's why we keep -- I mean, we've never quantified it externally, but we've said many times, it's manageable, and we continue to believe it's manageable -- 0having gone through our planning process now and our budgeting process, we continue to believe it's manageable.

There is an online question coming from Christopher.

Go ahead.

Susan Galbraith

executive

So Sachin had a -- thank you for the question on data about Avanza. So just as a reminder, once we saw the initial results from TROPION Lung-01, we made some modifications to Avanza. We've increased the sample size, 1,280 patients. we capped the number of squamous patients so that we ensured that we had good power within the non-squamous patient population, in both the ITT and biomarker groups within Avanza. And to answer your question specifically, have we discussed these changes with the FDA? Yes, of course, we've discussed those changes with the FDA.

Pascal Soriot

executive

Data, you've covered, but the question is -- the second question is Lynparza. And it's an online question.

It says, what are you seeing in ovarian in the wake of Prima -- bombing on OS. It's probably more a question for Dave actually. What share do you think you can capture? And how confident are you in a positive outcome from [indiscernible] as well as [indiscernible] one might we expect to see OS results. So a bit of Dave and a bit for Susan.

David Fredrickson

executive

Why don't I start first on Lynparza. I think very importantly, when we take a look at the year, following second half of last year, where the class, particularly in the U.S., was really undergoing a lot of second line from FDA mandated changes to labels. We've now seen in 20242 consecutive quarters of sequential growth in Q2 and Q3.

We've got the highest levels of sales for Lynparza globally that we've experienced to date and historically, and I think we're on a good growth trajectory. That growth is predominantly coming from ovarian cancer, and from breast cancer, and that's true across the globe. Of course, within Europe, we are seeing uptake within prostate cancer, less on prostate within the U.S. Certainly, the PRIMA news represents an important opportunity.

We do already have pretty substantial market share in that ovarian setting. But we're also at a place with this medicine where we are leaving no stone unturned. And that represents an opportunity and one where we believe that we've got a great story to tell and a differentiated one with PALA-1, and we'll stay focused in on that to continue on our growth trajectory for Lynparza. Do you want to address the [indiscernible]?

U

Unknown Executive

The DUO, the mature OS is anticipated in 2025. I don't think we've guided more specifically before that. And of course, that will be event-driven for OS. And in a number of our own ovarian cancer studies with Lynparza, we faced slowing event rates. So it depends a little bit on that event rate coming in about the timing of that. For the [indiscernible] study, I also think that the latest clinical trial appendix is the latest time lines for that. which is really in the second half of next year.

Operator

Next question is from Gonzalo Artiach at Danske Bank. Over to you, Gonzalo. It sounds like we don't have the connection to Gonzalo. Let's move to Steve Scala at [indiscernible]. Over to you, Steve, and we'll come back to Gonzalo maybe later.

U

Unknown Analyst

Two questions. Dave, you spoke on the second quarter call about a robust [indiscernible] acceleration in the second half of the year. In Q3, do you think a robust acceleration was achieved? And should we look for further acceleration in Q4? So that's the first question. Second question is, could you give us some clarity on the likely regulatory timing of Dato-DXd with the addition of TL05? For instance, when was it filed? And given FDA is familiar with some of the data and presumably the filing strategy -- this new filing strategy was their idea, could approval come by mid-2025? Or is that completely unrealistic?

U

Unknown Executive

So Steve, on your question on [indiscernible], I think we remain very focused in the quarter on driving against both DESTNY-Breast03 in the HER2-positive setting as well as with DESTINY-Breast. What I was hoping that we would see in the quarter, and we haven't seen yet is an inclusion of DESTINY-Breast06 into the guidelines. I think that, that is a catalyst that is important to be able to really see a change in the growth trajectory within ENHERTU. That maybe begs the question, then why do I think that we haven't seen yet the guidelines change yet. And I think that the primary reason in the answer on that is that I do think that in instances of a new biomarker population where ultra-low is, I think, while something we've talked a lot about, something that is really a new population. I think oftentimes, the guidelines wait both for FDA and also for the pathology community to play more of a leading role in helping the definition there. So I look forward to Enhertu going through a change in trajectory as we're able to both see 06 within both the guidelines and also then ultimately approval so that we can promote to it.

U

Unknown Attendee

And to answer the question on Dato, we submitted really very recently. And normally, of course, we announce a file acceptance. But given the special circumstances around Dato, we've made an exception to make that announcement now. For the -- as I said in my prepared remarks, with the encouragement of the FDA, we have also applied for breakthrough therapy designation. If breakthrough therapy designation were to be granted, that would also give us encouragement about the opportunity for a potential priority review. So we'll have to wait and see for that file acceptance and for the breakthrough therapy designation decision in order to be clearer on the time lines.

Operator

Thank.

So next question is from Rajan Sharma at Goldman Sachs.

R

Rajan Sharma

analyst

So just on Farxiga VBP. So you mentioned that you're expecting the inclusion in 2025, but I think you previously expected it in 2024, which hasn't materialized. So it would be just helpful to understand why that could be '25 and not, in fact, '26 or beyond. And then second question is just on operating margins into next year. I realize you're not going to guide on the numbers specifically, but just your comfort around current consensus estimates. So the trajectory is implying a slightly stronger accretion into '25 and then more moderated accretion into '26. Is that how you're expecting it to materialize? Or should we expect that to be more linear?

U

Unknown Executive

Yes, let me take the first question. So first of all, once again, we have assumed our guidance assumed that Farxiga will not be included in VBP 10. In fact, the list hasn't been announced yet. So we are still waiting for that. And of course, then the big ticket item is when VBP 11 will be announced. And at this stage, I think it's too speculative in order to give any answer on that. It can be the beginning of next year, but it can also be later. So we are a little bit in the dark there. So overall, we will give hopefully a little bit more guidance in the beginning of 2025 when we have our first full year results. But so far, we are not able to provide any more clarity for Farxiga in 2025. It will not happen. I think that's highly likely now in the course of 2024.

And then your question on 2025 and 2026 operating margins. Again, we obviously will give guidance when we do our full year results and guide to 2025. But what I'd point out is if you look at the third quarter results and the revenue growth rate at 21% versus the operating expense growth at 15% and the SG&A growth only at 9%. That gives you a sense of the focus on operating leverage and obviously growing SG&A at a much lower pace than the revenue growth, while at the same time, continuing to invest in the R&D portfolio.

U

Unknown Attendee

So Arjan, I mean, essentially, keep in mind, we will continue working on leverage. And again, if you look at what kind of top line growth we can deliver next year based on the momentum we have and considering the headwinds and you look at a bit of leverage, you can immediately conclude that we are very comfortable with the outlook in 2025. I mean, so we are in a good place really based on the momentum we have today.

[ Etzer ] at BMO, over to you, Etzer.

E

Etzer Darout

analyst

Great. Yes. Just one quick follow-up question on Dato-DXd. Just wondering if maybe there's any read-through to the TROPION-Breast01 upcoming regulatory decision in first half 2025. Just given that you think about the application, statistical benefit on PFS, directional OS benefit, I guess, similar to the non-squamous cell population from TROPION-Lung01. Just wondered if there's any read-through there. And then on the QCS biomarker strategy and the decision, the QCS biomarker strategy have any impact on the decision on TROPION-Lung01? And is there any read-through positive or negative on EvenNSAR based on those decisions?

U

Unknown Executive

Okay. So the TROPION-Breast01 filing is still under review. Again, what we've seen there is a clinically meaningful improvement in progression-free survival. We've said at the high-level results that we didn't see static overall survival in that setting. And again, I think there's -- in the context of that setting, there's both crossover with patients treated with other ADCs in that setting, which I think has the potential to affect the later readouts such as that. So we're really in ongoing discussions with the FDA, and I don't have any new updates at the moment. The regulatory decision is really expected in the first half of next year, as you've said. The QCS biomarker in terms of did the biomarker strategy affect the discussions about the plans for the indication? No, I don't believe so. What we said is when we saw the TL data that, that biomarker would require prospective validation in another trial. So I don't think it's affected that. I do think there's strong interest across the community, investigators included in this potential for identifying a patient population that's particularly sensitive. And I think it does help to explain, as we said before, the difference in the -- by histology in non-squamous versus squamous population. So I think there's a high level of interest in that, but we've always said it would require prospective validation, and that's why we've had those plans and discussions with regulatory authorities about the plans for validation of that biomarker in subsequent studies.

Operator

Simon Baker at Redburn.

S

Simon Baker

analyst

Two questions, if I may. The first one on China, but on the bit of China where you do have visibility. I just wonder if you could update us on your usual dialogue with Chinese authorities. Is that unaffected by what's going on with these investigations? I mean you clearly have a very strong relationship with the authorities over there. Has that been disrupted at all by what we're seeing here? And then just a very quick rider on the end. Any color on that ex-China emerging markets growth on a regional country basis would be quite handy. And then secondly, a question that we've received quite a lot in the last couple of weeks, which is on the question of buybacks. I know your view over more than a decade has been very clear on that. But in light of recent moves and the egregious reaction to what's happened in China, is the buyback any more attractive at sub 100 than it was at.

U

Unknown Executive

That's great. Thanks, Simon. The first question, maybe I can quickly comment on China and Rod, you can comment on -- well, China, if you want, but also the emerging markets. And then Ada, will you take the buyback, knowing that, of course, this will be a Board decision, but certainly, Ada can give you some early thoughts. The -- so far, we haven't been approached. So in terms of the case, as we said before, we haven't got any any details as to the cases. We have -- as a company, we haven't been approached. Our operation is actually -- and our company is operating as usual, including the work we do at the regional or central level and the various discussions with authorities. So we are really operating as business as usual. I mean China remains a very important country for us, both from the viewpoint of delivering medicines to the many patients who need our products, but also in terms of the innovation that can take place in that country. And we haven't seen so far any sign that we are not operating as business as usual. Having said that, as I said a bit earlier, it would be logical to assume some impact for at least a period of time, but it really is too early to say anything at this point in time. We really don't have data to say anything. Rod, do you want to comment on that?

U

Unknown Attendee

Just to add -- sorry, I forgot to mention, and I should mention it is Rod is actually, as you know, on an interim basis, managing the whole of international, including, of course, China, but also non-China.

Yes. Thank you, Pascal. Coming back to China for one second, if you take the NRDL discussions as a proof point, so far, that is really going business as usual. So once again, it's too far -- too early to speculate about any potential impact in the near future. But so far, I think the teams are very, very dedicated in order to deliver a strong performance also moving forward. Having said that, very pleasing to see the growth in ex China that remains a very strong story for AstraZeneca and, of course, the people working in those parts. The LatAm region specifically is doing extremely well, but also Middle East and Africa region is performing very well. And we have good hopes that, that will continue in the foreseeable future. The portfolio we are having in those markets is really fit for purpose in order to help those patients, whether it is in biopharma, oncology and more and more also in rare diseases. So we continue to see strong growth in that. And equally in 2025, we don't see big hiccups in that -- in those parts of the world.

I think it would be fair to say that every region with international is growing strongly. I mean Latin America, strong growth. Brazil, Mexico, in particular, Strong growth in the Middle East, which is really a big opportunity in terms of growth potential. I was personally in South Asia recently. I mean the team is very excited. The growth rates there are pretty good. So across the whole of international regions, we are doing very, very well. Arnaud, do you want to talk about buybacks?

U

Unknown Executive

Yes, sure. So you're absolutely right. Generally, our view around buybacks has been we've done buybacks generally to offset the dilution from the share issuances, the employee stock issuances in the past. I'll take a moment to remind you of our capital allocation priorities, which remain the same, which is, first and foremost, obviously, investing in the business. That includes the CapEx, including stuff we have announced today, but really supporting the business from both a clinical and commercial standpoint. Second is on business development. You've seen us do very strategic and opportunistic business development, which is continuing to progress. The third is to maintain a progressive dividend. You saw that we increased our dividend this year. And -- but given the circumstances now and what we believe is an overreaction in the market, we will consider and think about buybacks as well as part of our overall capital allocation priorities.

Operator

So the next question is Emmanuel Papadakis at Deutsche Bank.

E

Emmanuel Papadakis

analyst

Perhaps a quick follow-up on [ AVANZAR ], if I may. Just to clarify, is all comers still the intent for the primary analysis? And do you have agency alignment on that? And then maybe a question on the outlook for the respiratory franchise, very strong quarter for Symbicort and Breztri. Maybe you could talk a little bit about the sustainability of the former Symbicort. Can that continue to be a source of growth in 2025 and indeed beyond? And then Brezdri, what about the potential to accelerate that in 2025 given only the IRA tailwind, but more importantly, the asthma readouts you have coming in the first half of the year?

U

Unknown Executive

Susan, do you want to take the first one and I will you take that? So AVANZAR is powered for both ITT and biomarker positive group, as we said. And I think they're well powered in both of those groups given the N of 1280 in that group. So we're confident about the confidence to see benefit in both groups.

U

Unknown Attendee

Okay. So thank you so much, Emmanuel, for the questions regarding the respiratory portfolio. Indeed, a very strong growth. Equally, I'll say a few words about Symbicort and breast in a moment, but also the biologic portfolio is growing very fast as we speak. both Fasenra as well as Tezspire. Tezspire is on its way to become a $1 billion brand together with our colleagues of Amgen. Specifically regarding Symbicort, I think it's fair to say it's a great question, but difficult really to give a lot of guidance here in such a way that the mix of the different business -- book of business is favorable as we speak. And we don't know how that will evolve in the course of 2025. We're following it. It is also clear that our strategy in order to launch an authorized generic as well as lowering our list price, the WACC price in the United States is benefiting us clearly at the moment. But there are also uncertainties about the number of generics coming into the marketplace. So all in all, a very promising 2024, whether that will continue in 2025 needs to be seen. But of course, it also clearly indicates that Symbicort is really one of the cornerstone medicines for the treatment of asthma and COPD in the United States. The brand loyalty is extremely, extremely strong. [indiscernible] is clearly a different story. It's still what we call in the early launch phases, very strong growth across the board, not only in the United States, but more and more in other parts of the world as well. I think 2025 is a crucial year because we are expecting the readout of the pivotal COPD -- the asthma -- sorry, the asthma trial, the ReSolute, the trial for Breasttri. So that's an important one as well. And equally, we are putting a lot of resources behind the product in order to make that a multibillion-dollar opportunity. And equally, of course, we're also looking forward to the outcome trial of [indiscernible] moving forward in the cardiovascular space. So that's -- I need to make one small point. It was not the [indiscernible] trial. The RESLUute trial is the [indiscernible] COPD trial. It's the [indiscernible] and trial reading out, hopefully also next year, the outcome trial in asthma. So all in all, I think a very promising start, and we are looking forward to see even better results moving forward.

My questions go back to topics we've already covered, I'm afraid. But just to follow up and make sure I understand this on Dato-DXd. You've clearly learned that there's more of a benefit in EGFR patients. But in AVANZAR, which is reporting next year, you've deliberately excluded AGA patients. Does that increase the risk of the trial? I appreciate you've altered the study design after TROPION-Lung01, but presumably, that doesn't impact the fact that you've excluded the AGA patients who are potentially the ones that this drug works best in? So that's my first question. And the second one is, I'm afraid to go back to China. I've had investor questions, those people who unfortunately weren't able to hear a [indiscernible] give that very helpful call themselves. So the questions that we get are of the roughly 100 reps that you talk about that have been, in your view, potentially identified and charged, how many of those did you identify and get rid of for having discovered potential malpractice yourselves, which would show confidence in your internal compliance and how many of them were only found to have potentially done something after they had voluntarily left your employment? And has the current situation in China impacted any senior management plans to actually -- for people who are based outside of China to travel in China?

U

Unknown Shareholder

So Joe, we still have -- thank you for those 2 questions. We still have a lot of questions waiting, and we have limited time. So for China, can I just refer everybody to the transcript. I had a lot of good answers to those questions. Let me just say only that the point you raised about people being -- some people not being with the company actually highlights the difficulty we've had to identify the number of people because a lot of those people were not with the company anymore. So we don't have any precise data. We have data based on what we can put together based on what we know from employees, but also what the families could tell us of people who've left us. But in terms of the rest, I think the transcript will address your questions. And on the Dato question.

U

Unknown Executive

Yes. So thanks for the question. So yes, you're, of course, right that the first-line studies exclude the patients with actionable genomic alterations because the appropriate therapies for those patients are the therapies directed against those actionable genomic alterations. But the TROPION-Lung02 and 04 studies that look at the combination of Dato with platinum-based chemotherapy and IO give you confidence about what you can potentially achieve in terms of the response rate, progression-free survival and later outcomes. And that's what that is built upon for the ITT population. And as those data sets continue to mature, I think we continue to have confidence that we've got a good probability of success in the ITT population, particularly when focused on the non-squamous patient population, which is what we've done when we learned about the TROPION-Lung01 data set. The opportunity to then also look in the biomarker positive, again, based on the effect size that we saw in that group in the TROPION-Lung01 is further confidence that you can build. And as I've said, looking at internal data sets, we think that the biomarker that we identified in TROPION-Lung01 can also enrich for activity against those endpoints of both response rate and progression-free survival in the earlier line setting. So when you look at it as a totality, I think we've got the safety profile, the efficacy profile and the opportunity to enrich within those first-line studies, and that's what underpins the confidence in the AVANZA study.

U

Unknown Attendee

I think, Joe, if I could add 2 points on your question. The first one, I think, is an important reminder is that in TROPION-Lung01, we didn't have a preplanned stats plan for non-squamous. And I think that, that's an important part of how the data set was then being interpreted. But I think that had we shown the results that we did in a statistical analysis, those would have been statistically significant and clinically meaningful. And I think that we've applied the lessons from that into the front line. So I think that's an important piece. And I think that your question on the AGA patients coming out, I mean it's a really different population when we're talking about EGFR TKI naive population. And so we are interested in that population, and that's TROPION-Lung 14, which is looking at Tagrisso plus Dato in addition to the other studies that are being looked at in the non-AGA population.

U

Unknown Executive

Two great points. And maybe can just one more, which is really these combinations of Tagrisso and Dato, I think, will represent a great opportunity to defend Tagrisso and extend the treatment duration. So not only they will be good for Dato, but they will be good for Tagrisso. And we know that there is combination out there, but we will be the only company with -- or the only EGFR subgeneration with a combination with Dato. So that would be very material to the life cycle of Tagrisso as well.

Operator

[ Mattias Häggblom ] at Handelsbanken

M

Mattias Häggblom

analyst

For the question one, please. on China, and I don't think it was covered on Ada's call. So on back of the medical insurance fraud case in 2021, it was clear that AstraZeneca tightened and changed its compliance system in China with more compliance officers and a new whistleblower system put in place. My question goes, what's been the main change in your view from then and today?

Pascal Soriot

executive

Yes. If I got your question correctly, Matthias, I'm not 100% sure I do. Let me just make a few comments and then you can say whether I've not addressed your question. First of all, you need to understand that the series of cases that have unfolded over time, they have unfolded over time as a result of the investigation that we conducted, but also importantly, the authorities conducted, and it's important to remember, the authorities have access to a lot more data than we do because we cannot actually check people's personal web chat systems. We don't know what they do with the telephone. They -- their personal telephones, et cetera, et cetera. So a lot of this data has come about over time. And the cases refer back to this period of time that when we had reimbursement for T790M mutation, but no reimbursement for Tagrisso. And I think it's also important to keep in mind in the whole context is we had with this one and also with the illegal importation, we had a temporary situation. illegal importation really happened because Enhertu was not approved in China, and that is now gone because it's approved in China. So hopefully, moving forward, those -- for the lack of a better word, temptations, if you want to -- that some of our reps in the field can have are gone. So that's maybe one point. In terms of -- yes, so the testing opportunity ended in March 2021, just like the opportunity to import [indiscernible] from Hong Kong disappeared also early '24 when we launched in China. So all those things are no longer there. So the environment is suddenly a lot more a lot simpler, if you want, right? In terms of the improvements we've made to our systems, we've really retrained everybody. We have all sorts of measures in place to improve compliance. But the most important ones, I believe, are the compliance changes we've implemented more recently that go beyond our systems because I think we have really top-notch systems to monitor our internal data. So monitor expense reports, monitor internal e-mails. And by the way, people now really are told to use our internal systems only and not their external, their own systems. But we have lots of policies and systems in place to track expense report, use of credit cards, use of certified food suppliers, et cetera, et cetera. Now we have to look at what's happening outside our system and 2 changes we've made that I think are important is we now have a number of compliance officers in the field. Every region has a compliance officer because those people will be close to our sales force and able to identify, hopefully, by talking to people on a daily basis, identify early anything that could happen that is not controlled by the policy of our systems. The second thing we've done is we are rotating -- we're going to be rotating the regional sales directors, so they don't stay too long in the same place. because, of course, if you stay in the same place, you can actually be impacted in your behavior. So those are -- I mean, we've made many other changes, but those are maybe the 2 most, I think, fundamental and they relate to people because you have systems and the systems you can track. Then you have people in what they do and that you have no way to track them unless you really are close to them in the field. So hopefully, I address your questions. And if not, maybe you can come back later.

Operator

And the next question is Eric Le Berrigaud at Stifel.

E

Eric Le Berrigaud

analyst

First question relates to CapEx. Maybe a question for [indiscernible]. You mentioned after 9 months, EUR 1.2 billion in CapEx this year, which would analyze around EUR 1.8 billion. And today, you're announcing a EUR 3.5 billion CapEx investment in the U.S. spread over 2 years, nonetheless, represent about doubling CapEx for each of the next 2 years, if that's incremental. Maybe you can elaborate of how we should think about modeling CapEx into the second part of the decade. You were roughly between EUR 1 billion and EUR 1.5 billion a year. Now you're moving into roughly EUR 2 billion. Should we think about getting up to EUR 3 billion or more? -- every year into the second part of the decade. You also talked about increased CapEx on the weight loss management call. So just to put that into perspective. And a shorter question on Hirsupra, maybe for Rud. At the very end of last year, you made significant investment in commercial marketing to support the launch of Hirsupra. And you're now 1 year into the launch. You're pleased with how the drug is doing from a prescription and number of prescribers and et cetera, but it's not fully reflecting in numbers yet. Are you still confident in reaching blockbuster status with this drug? And when should we expect an inflection point?

Pascal Soriot

executive

Great. Thank you. So I'll address the -- I think there were several subparts to your CapEx question. So first of all, CapEx for 2024. We always see in every year, a big spike in fourth quarter CapEx. So I think that's still to be expected this year. But the guidance we had given for the full year was it would be a 50% increase over our CapEx in 2023, again, driven by several projects that I had listed. Also, we had mentioned that these projects that we started are multiyear projects. So it's not like we start a facility this year and it's built and ready next year. So these are multiyear investments, whether it's the cell therapy facility or the API facility in Ireland or the respiratory inhaled facility in Qingdao. These are all multiyear, anywhere between 3- to 5-year type projects that we've started. So that's one element and how you can think about on a going-forward basis. I think the second question was around how do we think about CapEx broadly speaking. And I'd say, as our portfolio expands, and you mentioned the GLP-1, we will again need to make the investments to support our portfolio. So the announcement today is also related to some of the investments we would need to make for clinical trial manufacturing. But again, there's not only manufacturing investment, there are also R&D investments. So in Kendall Square in Cambridge, we're building brand-new labs and bringing together all the researchers that we have in the Boston area and growing that footprint. So it's both investments in labs as well as in capital from a manufacturing standpoint. And again, the portfolio success will drive some of that investment and many of the new technologies, as you know, require investment at risk. So that's what we'll continue to do. And then I'll hand over to [indiscernible]

U

Unknown Analyst

So first of all, to answer your question about do we still believe it's a $1 billion-plus opportunity. The short answer is a clear yes. I think also the recent [indiscernible] data further emphasize the importance of these medicines for the treatment of asthma as a rescue medication. Secondly, yes, we are very pleased with the progress we are making with [indiscernible], as I said in my prepared remarks, we have now more than 50,000 prescribers in the United States, more than 200,000 patients are on the drug. And this is all about getting more access. At the moment, we have roughly 60% commercial access that will increase in the next few months. But more importantly, also from the 1st of January, we are expecting our first Part D access as well, and that will further boost the product. We're buying down very substantial amount of scripts as we speak, and that will diminish in the course of 2025. So my clear remark is stay tuned, but we are very committed and this product will move to $1 billion over the next few years.

Pascal Soriot

executive

Thank you, Rod. And by the way, we're also exploring opportunities outside of the U.S., which certainly gives further confidence in the product on a global basis. Next question is Rajesh Kumar at HSBC.

R

Rajesh Kumar

analyst

Come to a question related to China, but not China itself. I appreciate you don't know much about China and you have tightened a lot of compliance policy around there. Should investors think about any other regions where you might have to tighten your compliance policies? Or was there something peculiar about incentive structures in China that drove that behavior, which does not exist elsewhere? And the second one is on Dato. I appreciate you have a biomarker. Your confidence seems to have gone up. It's great to see a setback has not detracted you from trying out again. How can you give investors confidence that this time, this confidence is not misplaced, but is rooted in a lot more data or information that has informed decision to double up on Dato.

Pascal Soriot

executive

Thank you, Rajesh. Let me cover the China question and Susan, you could cover the Dato question. So yes, there was something peculiar in China, but it has nothing to do with the sales force targets. In fact, if you look at the last few years, last 6 years, China achieved its target overall, except during the COVID period. But COVID, we knew that the reasons, everybody was wearing mask or we had lockdown, et cetera. And the sales force actually reached their bonus -- the target bonus. The peculiar thing -- and so the target in China were not especially stretched. And then if you look at it, in fact, our biopharma business has no issue. So the peculiar thing is very simple. It is that, unfortunately, we had a period of time when there was a -- not a disconnect, but a difference in reimbursement. Tagrisso was only reimbursed for T790M. And as you can imagine, patients who were not positive and then wanted or could benefit from Tagrisso wanted it if they were EGFR mutants. And that created an issue in terms of creating an incentive for people to try and misbehave on this front, unfortunately. The other peculiar thing was launching new products in Hong Kong. that were not yet approved in China Mainland. Over the next period of time, this won't happen again because we're not launching new products in Hong Kong that will not be approved on the Mainland simply because we don't have new products to launch. In the future, we'll try to time align if we can, those 2 launches. And what is giving us hope is China's approval is happening much faster now than in the past. And if we cannot time align, we will certainly make sure we really follow supply very, very closely. But those are -- this is what was peculiar is that a specific environment around a few products in oncology. I think that specific peculiar environment is no longer there, but suddenly, we are tightening our compliance outside our systems, as I explained. Now we run a very large organization. I don't have any reason to believe there are issues anywhere else. But the whole industry has had issues in the U.S. many years ago. So this -- you can never say we'll never have any issue. But today, we think we have a very good compliance system. We have people who actually follow our code of ethics. Compliance is a priority everywhere. I also want -- I mean, I don't want to underestimate the issue we've had. And trust me, we take it very seriously. But I also want to make sure that we realize there's another -- I mean we have 12,000 people in Salesforce. We have another 11,900 people in Salesforce that are doing a good job in a compliant manner. And we should not throw all these people, all this team in the same bag as the 100 whom is behaved. And then also, we have several thousand people outside the sales force that are also doing a good work every day. So that's all I can say, but we, of course, will continue to manage compliance. We have more than 200 people in our global compliance team around the world. And then we have local compliance people also that are connected and report to the global teams. So this is certainly a big priority for us. Suzanne, Dato?

U

Unknown Attendee

Yes, sure. So one of the reasons why I enjoy my job so much is that I've constantly got the opportunity to learn. That's the nature of drug development and what we do. We're constantly learning. And the reason why I'm more confident about Dato-DXd now is that we know more than we did at the time that we designed the TROPION-Lung01 study. At that point, we didn't understand that there was going to be a difference in outcome between patients with non-squamous versus squamous cancer. And we didn't have the biomarker data that we currently have now. We also didn't have as much data about the -- from the studies that I've mentioned a couple of times, the TROPION-Lung02 and 04 studies, which show the ability to combine safely with platinum, the increase in response rate that, that gives and the ability to combine safely with the I-O drugs. So we know much more now than we did at the time that the TROPION-Lung01 study was designed. And we're taking those learnings and embedding them into the first-line studies in non-small cell lung cancer, but also taking those principles and embedding them across the rest of the Dato program. And I think the computational pathology technology is something that will help us optimize the benefit risk profile for our antibody drug conjugates across our portfolio. These are inherently targeted medicines. They're targeted to the cell surface receptor. In the case of TROP-2, though, just immunohistochemistry alone doesn't give you all the information that you need about the patients that are most likely to benefit. And we've mentioned a few times that we need to look at the internalization rate as well. So we know a lot more, and that's what gives me confidence about the ability to maximize the potential of Dato-DXd, which I think is -- has the potential to be a very important medicine.

Maybe going back very quickly to the previous question. I said we have more than 200 people in the global compliance team around the world. In China itself, we have more than 200 people doing compliance-related work, either in the global compliance team or in finance functions, people doing really compliance work and checking on our internal systems on a regular basis. Gonzalo at Danske.

G

Gonzalo Artiach Castanon

analyst

Can you hear me now?

Pascal Soriot

executive

Yes.

G

Gonzalo Artiach Castanon

analyst

Great. Just one on Dato-DXd filing. I'm not sure if I missed it, but could you clarify if you will also follow up after approval of this Dato initial indication outside the U.S. based on current available data? And if so, are you planning to file in the near term?

Pascal Soriot

executive

Okay. So thanks for the question. So we announced in the last quarter that we had submitted the European filing in particular. That review and that regulatory review is ongoing. So I don't have any more information to share with you at this point. Obviously, the background regulations in the U.S. and other regions do differ in some regards. So we have to wait for the feedback from the regulatory authorities in other regions.

Thanks, Susan. For the last few questions, can I ask everybody to try and stick to one question. And maybe I remember that we have more than one product, more than Dato in our portfolio. But over to you, Peter [indiscernible] Jefferies.

U

Unknown Analyst

Very quick, 2 questions. One, just on -- I'm afraid it's China and Dato, but China, can you just confirm, is Lon still an employee of AstraZeneca at this moment in time? And then secondly, on Dato, is there any plan to change at all the TL07 and TL08 trials because they're the ones with KEYTRUDA to include a QCS biomarker analysis, the primary endpoint as has done with AVANZAR?

U

Unknown Executive

So first question, in the interest of time, it's in the transcript. So I would refer you to it. And second question, [indiscernible], you want...

U

Unknown Attendee

So again, I would just say for TL08, which is in the PD-L1 high patient population, I think that's a different context in terms of the opportunity there. For TL07, the primary endpoint for that study is obviously in an intent-to-treat patient population. So again, in contrast to AVANZAR, where we had designed the study with the opportunity to look in a biomarker-positive patient population, I think, is a little different for TROPION-Lung07.

Operator

Thank you. Next question. I think we still have a couple of questions, Emily Field. We can't hear you. Okay. Could we try the next question? Sounds like [indiscernible]

U

Unknown Analyst

So my question is linked to the FDA focus that we've seen for some time now on the subgroups looking for patients that really see the benefit. So could you remind us the rationale for running SERENA-4, which is in a smaller subgroup and then SERENA-6 and perhaps your levels of confidence ahead of those trials and how we should think about those 2 potential outcomes?

Pascal Soriot

executive

Thanks, Lisa. Very happy to talk about [indiscernible], our next-generation SERD inhibitor. And as you rightly point out, 2 important catalysts that are upcoming with -- it's SERENA-6 that's in the selected patient population, patient with ESR1 mutations. So this study is a novel trial design, which is guided by circulating tumor DNA detection of rising ESR1 mutation levels. Obviously, right at the beginning of patients' journey with ER-positive breast cancer, there's low levels of this mutation, but it tends to be clonally selected over time, particularly on aromatase inhibitors. So the trial design is camizestrant plus the CDK4/6 inhibitor versus continuation on the aromatase inhibitor and a CDK4/6 inhibitor. And I think given the data that's been seen with this class of drugs in ESR1 mutants, we've got a high probability of success here. It's also built off the had a one data set where we looked at fulvestrant, which isn't as potent a SERD inhibitor versus continuation on aromatase inhibitor in this setting. And again, that gives us confidence about that trial. However, the actual target for camizestrant is the estrogen receptor. The original targeted therapies were hormonal therapies targeting the estrogen receptor. So it's not just those patients with ESR1 mutations that are likely to benefit. It is the broader wild-type patient population that are endocrine sensitive that are likely to benefit. And again, we've previously seen that improving endocrine therapy can improve the outcomes. And that's really the -- across in a range of both adjuvant as well as first-line, in particular, metastatic ER-positive breast cancer. So I think the data that we've seen from the SERENA-2 data set, which was a randomized study in the second line, if you look at the subgroup that was endocrine sensitive with that group, we also saw a very positive hazard ratio compared with fulvestrant, which was the previous best SERD that was available. So I think both the SERENA-2 data and then the SERENA-3 data in the window opportunity study give us confidence that we've got a really best-in-class profile here from a safety and efficacy perspective that gives us good probability of both those studies being positive, and that would be a big combination of indications.

Operator

So one last question, Emily Field at Barclays.

E

Emily Field

analyst

Thank you so much for getting to me. I really appreciate it. And hopefully, this is a good fun one to end on. So I know you said earlier in the year that by the end of 2025, we'll have a good idea of the achievability of the 2030 $80 billion revenue target. And you have so many catalysts coming up next year. What would you consider to be the most important ones in determining the achievability of that target?

Pascal Soriot

executive

Dev, do you want to get started for oncology?

.

U

Unknown Executive

Great question, Emily, by the way. But a long answer, I suppose, yes. But go ahead, Dev.

It'd be my pleasure. I I think just as we kind of go through and do a little bit of roll call here, I think in hand already, Emily, really importantly, we've got AMPLIFY, which is very important for Calquence, opportunity to really establish both a finite and a treat-to-progression leadership opportunity with Calquence and I think that this is going to be an important part of that medicine going forward. Luisa's question just teed up another really important piece. I think that SERENA-6 and then following SERENA-4, that's a major readout in 2025. I think that certainly, those studies give a read-through into the Cambria studies as well. So in terms of longer-term unwind of risk. And then I would really then just highlight if I was to pick one other additional one on here, EnHER2 moving into earlier lines with DB09 -- we know based on what we saw with the 03 study and how it compares to the frontline studies that we had seen before that there's a really great opportunity to move in the front line. The trial design allows for with and without Perjeta. And I think that this represents another very important growth opportunity in the near term.

Yes. First of all, I think [indiscernible], I think it's a great opportunity if the study is positive in a very difficult-to-treat hypertensive population. Clearly, also our entry potentially of [indiscernible], which I mentioned in the asthma indication. And last but not least, Fasenra in the COPD indication. So all of them are very large, either new molecules or new indications. So very exciting to move into 2025.

And last but not least, Mark, for rare disease.

Yes. I mean my expectation is we have -- we presently have 10 ongoing Phase III on different molecules for complement. And most of them are going to read out in 2025. So I would expect that we beat the statistical average of the Phase III clinical trials and demonstrate that these products are safe and active. So this is going to be a very interesting period for rare disease in 2025.

Thank you, Mark. Beyond C5, we also have aboparatide that will read out next year, which is clearly an important product for for rare disease, but also for the company overall. So thank you very much for all your great questions and your interest. Let me just quickly conclude. First of all, I want to say regarding the matters in China, we are really taking this matter seriously. I mean, I've said it a few times today, but I want to say it again. I also want to say the investigations are directed at individuals as we understand it now.

So we haven't been really given access to many details. In fact, we have very limited information, which explains why we give you the answers we give you. Aradhana gave a great call last week, and you have the transcript that will give you more information if you are interested. Again, the fact is we are trying to be as transparent as we can, but we have very limited information. And last point is we are really strengthening our compliance to make sure that we learn from this issue, we learn from this situation and then continue to improve and become even stronger in China, but anywhere in the world. Second quick closing comment is we had tremendous results in Q3 and in 9 months. So we're very excited with the actually momentum we have to the extent that we are doing better than we expected actually, and we've been able to increase to raise our guidance for the year. And I think it's important to think about that kind of momentum. I mean, we have a company that is on an annual basis, around $50 billion now growing at 19%, 20%. So this is the kind of momentum we are taking into 2025 with headwinds for sure, but also new indications to launch, new products that are approved. And we also will continue working on leverage. So when you take all of this together, you can see why we are confident in the outlook both from a revenue, but also an EPS viewpoint. And we are on track to achieve our long-term strategic ambitions. As we said before, not everything is going to go perfectly. Of course, this is not an easy business we're in, and we will have, of course, issues, setbacks in our pipeline, but also we expect to deliver a lot of new news and new products, new indications. And so there's really all -- every reason to believe we are on track and can deliver on our long-term strategic ambitions. So with this, thank you again, and I wish you a good rest of the day.

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AstraZeneca PLC
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AstraZeneca PLC LSE:AZN

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Earnings Call Transcript 2024-Q3

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AstraZeneca PLC
LSE:AZN

Q3-2024 Analysis
AstraZeneca PLC

Earnings Call Transcript
2024-Q3