Q3 2024 AstraZeneca PLC Earnings Call
Speaker Change: Before I head over to AstraZeneca, I'd like to read the Safe Harbor Statement.
Speaker Change: The company intends to utilize the safe harbor revisions of the United States Private Securities Litigation Reform Act of 1995.
Speaker Change: Participants on this call may make forward-looking statements with respect to the operations and financial performance of AstraZeneca.
Speaker Change: Any forward-looking statements made on this call reflect the knowledge and information available at the time of this call.
The company undertakes no obligation to update forward-looking statements.
Speaker Change: Please also carefully review the forward-looking statements disclaimer in the slide deck that accompanies this presentation.
Speaker Change: There will be an opportunity to ask questions after today's presentation. Please use the raise a hand feature to indicate you wish to ask a question at any time and remember to unmute your line when invited to speak. You can also submit a written question using the Q&A tab on your screen.
Speaker Change: And with that, I will now hand you over to the company.
Speaker Change: A warm welcome to AstraZeneca'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.
Speaker Change: Firstly, all of the materials presented today are available on our AstraZeneca Investor Relations website.
Next slide, please.
Speaker Change: This slide contains our Safe Harbor Statement, which I'd 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, and non-GAAP-to-GAAP reconciliation is contained within the results announcement.
Speaker Change: All numbers quoted are in millions of U.S. dollars unless otherwise stated.
Speaker Change: 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.
Speaker Change: And with that, Pascal, I'll hand over to you. Next slide, please.
Pascal: Thank you, Andy, and welcome, everyone. In the third quarter, total revenue grew by 21 percent, driven by strong underlying global demand for our medicines. Core EPS increased 27 percent to $2.08.
Pascal: reflecting our continued focus on profitability, if you want to move to the next slide please.
Pascal: In the year to date, total revenue grew 19% and core EPS grew 11%.
Pascal: As a reminder, Total Revenue and Core EPS in the first nine months of 2023 benefited from one-time collaboration revenue and other co-operating income totaling $1.1 billion, which makes the 2024 year-to-date growth rate even more impressive.
Pascal: Importantly, this performance is across all of our focus therapy areas, with each delivering double-digit growth in both the third quarter and in the year to date.
Pascal: Given the strength of our underlying business, I am 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 details.
Please move to the next slide.
Pascal: Taking a closer look at our total revenue performance in the first nine months of the year, we continue to benefit from our broad global presence.
Pascal: Our company is growing across all regions and will continue to strengthen our capabilities in many markets around the world, most notably in the emerging markets outside of China, where for another quarter of our performance is standing out from our peers with 30% growth in the year to date.
Pascal: And you can see now the very good distribution of our revenue across the world, 43% in the US, 21% in Europe.
13% in China.
Pascal: It's very pleasing to see the emerging markets outside of China are now bigger than China with 14% of our revenue.
Pascal: 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.
Pascal: 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. The U.S. is, of course, a very important market that supports innovation, and we will continue to invest to grow fast in this.
in this part of the world.
Pascal: 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
Pascal: Of course, I've been the subject of a lot of speculation. We are actually not privy to the details of any of these investigations. If requested, we'll cooperate fully as we have in the past.
Pascal: As you can imagine, I personally take this matter very seriously, and the whole company also takes it, of course, very, very seriously.
Pascal: 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...
Pascal: We would like to focus on Q3, to the extent possible, unless there are...
Pascal: 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.
Pascal: And finally, we're doing what we can to support our employees in China.
Pascal: They're all hard at work, they're all very focused and continuing to develop our pipeline, but also our portfolio of marketed products.
Pascal: 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.
Pascal: in a happy way, 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: Laura expands the reach of TAGRISO in early-stage lung cancer. CalQuence advances into mantle cell lymphoma with ACO, and with Amplify now has the potential to be the only medicine in frontline CLL approved for both fixed and extended durations of treatment.
Laura: Destiny Breast 06 broke new ground for HER2, moving it one line earlier into chemo-naïve metastatic breast cancer, and it showed clear benefit in HER2-Ultra-Low disease.
Laura: And Infanzy is set to begin a new wave of growth in small cell lung cancer and bladder cancer following positive results for Adriatic and Niagara.
Laura: Finally, as shared earlier today, Cormet has potential to extend coselugo use beyond pediatric NF1PN patients to adults, and Waypoint has the potential to bring a first-in-class mechanism of action to patients with severe nasal polyps.
Laura: If approved, these opportunities represent over $5 billion in combined PQR revenues on a non-risk adjusted basis.
Laura: With that, please advance to the next slide and I will now hand over to Aradhana who will take you through our financials.
and the
Thank you, Pascal, and hello, everyone. Next slide, please.
Laura: Thank you for watching. I'm David. I'll see you next time.
Laura: 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 a reported P&L.
Total revenue increased by 19% in the first nine months.
Laura: Product sales also increased by 19% with strong growth across major regions.
Laura: Alliance revenue increased by 50% to 1.5 billion dollars driven by increased sales for Inhertu and Tespire in regions where our partners book product sales.
Laura: 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 INDEXA.
Next slide, please.
This is our core P&L.
Laura: As anticipated, our core product sales growth margins declined slightly in the third quarter versus the first half.
Laura: We anticipate a lower product sales growth margin in the fourth quarter, partly due to the seasonality of Flumist and increased Befortis supply to Sanofi, following a very successful launch.
Laura: We have previously said that for the full year, we expect a slightly lower product sales growth margin percentage compared to 2023.
Laura: Operating expenses increased by 15% year-to-date, well below the pace of total revenue growth.
Laura: R&D expenses increased by 18% in part due to the integrations of recent acquisitions including Graycell, Fusion, and Amoled for which we incurred additional costs this year.
Laura: 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.
Laura: 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.
Laura: SG&A costs increased by 13%, partly driven by investments behind our new launches and growth grants including AirSupra, Breaststreet, and TrueCap.
Laura: However, as we have 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%.
Laura: Recall that the comparative period last year benefited from almost $1.1 billion in one-time collaboration revenue and other operating income, impacting year-over-year growth rates.
Please turn to the next slide.
Laura: Our net cash inflow from operating activities improved by 989 million dollars in the first nine months, driven by improved business performance.
Laura: We still expect CapEx for 2024 to increase by about 50% versus 2023 and have incurred $1.2 billion year-to-date.
Laura: 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.
Laura: 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 1.8 times.
Laura: 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.
Speaker Change: 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.
Speaker Change: We now anticipate Total Revenue and Core EPS to grow by a high teens percentage at CER.
Speaker Change: an increase from our prior expectations for mid-teens growth, which was upgraded at half a year.
Speaker Change: 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.
Speaker Change: 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.
Speaker Change: And with that, please advance to the next slide, and I will hand over to Dave, who will take you through oncology performance.
Thank you, Aradhana. Next slide, please.
Dave: In the first nine months of the year, oncology total revenues grew 22% to $16 billion, driven by strong demand in the U.S., Europe, and emerging markets.
Dave: Turning to our key medicine performance in the third quarter, Tigriso global revenues grew 17%, with sequential growth of 4%, reflecting strong demand for Adora and lengthening duration of therapy in the metastatic setting.
Dave: In the U.S., initial adoption for Flora II has been encouraging in the first nine months following launch.
Dave: CalQuint's total revenues increased 25% in the third quarter, driven by sustained BTK inhibitor leadership in frontline CLL and continued international expansion.
Dave: Infinsi delivered 16% and Imjudo 22% growth in the third quarter supported by adoption in 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.
Dave: 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 nine months.
Dave: We look forward to a new wave of infancy growth driven by key indication expansion opportunities including Aegean and once approved Adriatic and Niagara which will contribute meaningfully to peak year revenues
Dave: Lymparza 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.
Dave: And HER2 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.
Dave: We saw some spontaneous use in the chemo-naive setting following presentation of the Destiny Breast Dose 6 data at ASCO and publication in the New England Journal of Medicine in September.
Dave: 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.
Dave: TrueCap delivered 125 million dollars in the third quarter, supported by strong adoption in the biomarker altered population and further use in the late-line setting.
Dave: Since half-year results, we received a number of key regulatory approvals, including AGEAN and LORA in the U.S., which accelerate infinxian tigriso into early-stage lung cancer. In Europe, we received approval for infinxian lymparza in endometrial cancer, and in China we received additional in HER2 approvals in gastric and lung cancers.
Speaker Change: 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: 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 five presidential plenaries and eight simultaneous publications, including three in the New England Journal of Medicine.
Susan: At ESMO, we presented the results from the Phase III Niagara trial of Mfimzi 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.
Susan: Together with the ongoing Volga Phase III trial of MFIMSI in combination with Emportum Abvodotum, MFIMSI-based regimens will look to address the full spectrum of muscle-invasive bladder cancer.
Thank you. Thank you.
Susan: We continue to advance our next-generation IO bi-specifics, as well as our novel in-house ADC programs, and we shared key data updates of both of these at both World Congress on Lung Cancer and ESMO.
Susan: We've now initiated 10 Phase III trials with our IO-Bi-Specifics Volvostamig and Rilvigostamig, and we continue to progress our late-stage ADC portfolio.
Susan: Importantly, we shared a key data update for our novel QCS technology.
Susan: A retrospective analysis of the Tropian Lung 01 dataset showed our TROPE2-QCS NMR biomarker is predictive of progression-free survival outcomes with DATO-DXD, and recent analysis shows it's also predictive of OS outcomes.
Susan: We look to prospectively validate this biomarker in multiple ongoing Phase III trials. We believe that this novel advancement in the field of computational pathology will have applications across our ADC portfolio, enabling better patient identification and unlocking opportunities in multiple tumour types.
Susan: We will share data from the Phase III Amplify trial at the American Society of Hematology meeting in December.
Susan: In this trial, six-duration calquins 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.
Susan: HCPs prefer finite therapy for around 50% of patients, including those that are more fit or have IGHV mutations.
Susan: 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.
Susan: Also at ASH, we'll be sharing new data for our CD19-CD3 T-Cell Engager AZD0486 in relapsed refractory diffused large B-cell lymphoma and in follicular lymphoma.
Susan: 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 in gauges.
Susan: It was also designed to have lower affinity to CD3, with the hope that this improves tolerability compared with other Engager platforms.
Susan: We believe that AZD0486 has the potential to be a foundational therapy across multiple hematologic indications.
Next slide please.
Susan: Tequiso remains the backbone, TKI, for the treatment of EGFR-mutated lung cancer, spanning early to late metastatic settings.
Susan: Earlier this year, we received U.S. approval for the LORA study in stage 3 unresectable lung cancer, expanding to Grisso's presence in early stage disease.
Susan: Last month, we read out the Registrational Phase II Savannah Trial of Tigriso with Orpathis in second-line EGFR-mutated lung cancer. This all-oral regimen demonstrated a durable, high response rate. Importantly, the addition of Orpathis allows for continued use of Tigriso in the roughly one-third of patients that have high MET expression.
Susan: We've shared these data with regulatory agencies and await the readout of the confirmatory Phase 3 SAFRON trial in the second half of next year.
and the
Susan: Serana is one of several trials that looks to explore novel combinations which can extend to grisa use across multiple lines of therapy.
Susan: We're also exploring Tegresso and DattoDXC in first and second line settings with the Tropian Lung 14 and 15 trials.
Susan: We see potential to replace systemic chemotherapy whilst maintaining to greater use for patients with EGFR-mutated lung cancer.
Susan: Finally, I'd like to provide an update on the Tropium Lung 01 filing.
Susan: 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.
Susan: The ongoing Tropion Lung 15 study will serve as a confirmatory trial.
Susan: Also, we plan to conduct an additional registrational trial in the second-line TROP2-QCS NMR biomarker positive population, complementing the ongoing Avanzar and Tropion Lung 10 trials in first-line non-small cell lung cancer.
Susan: We remain committed to our ongoing DataDxD program in lung cancer and look forward to next year's readout for Avanzar, the first phase 3 data for DataDxD in first-line lung cancer.
Speaker Change: And with that, please advance to the next slide and I'll pass over to Ruud to cover biopharmaceuticals performance. Thank you so much, Susan. Next slide, please.
Ruud: Our biopharmaceuticals medicines deliver a total revenue of $15.9 billion in the first nine months of 2024, representing growth of 20%.
Ruud: In the third quarter, total revenue increased 25%, with every biopharmacotherapy area growing in every major region.
CVRM total revenue increased 20% in the third quarter.
Ruud: Farsiga delivered 27% growth, with double-digit growth in all major regions, driven by continued market leadership in the expanding SGLT2 class.
Ruud: In the third quarter, our recently launched medicine for ATTR polyneuropathy, Renua, grew 44% sequentially to $23 million, with prescribers coming from a broad range of specialties.
Ruud: Waynoa secured positive CHMP opinion in Europe during the quarter, as well as multiple approvals in other markets.
Ruud: 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%.
Ruud: Growth was particularly strong in the United States at 43% and in Europe at 30%, reflecting increased demand for our biologic and inhaled medicines.
Ruud: The strong growth momentum we have seen for Tespi and BreastTree continued with both medicines on track to achieve around 1 billion dollar sales in global sales in 2024.
Ruud: The long-term outlook for breastfeeding 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.
Ruud: Our ongoing Thyrus Outcomes Trial is the only in the class to examine both pulmonary and cardiac endpoints and, if successful, could be transformative for this medicine.
Ruud: Our other in-health medicines, Symbicort and Asupra, are also experiencing strong demands.
Ruud: Well, it is unclear to what extent Symbicort's recent growth in the United States will continue in 2025. We expect to see continuous strong demand in the emerging markets.
Ruud: Supra revenues grew 50% sequentially, and the launch is progressing very well, with more than 50,000 healthcare practitioners in the US having prescribed Supra to date.
Ruud: Lastly, we are very pleased to see V&I return to growth in the quarter with a 49% increase in total revenue.
Ruud: Demand for Bayfortis is strong, supported by real-world evidence of Bayfortis' value in preventing infant hospitalizations and also the recent clinical data from the HARMONY trial which demonstrates it sustains efficacy to 180 days.
Ruud: 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.
Speaker Change: I will now hand over to Sharon to discuss the latest developments from the biopharmaceuticals pipeline. Next slide, please.
Thank you, Ruud.
Sharon: Today, I'm excited to share more about our ambitions to build the next wave of transformative medicines addressing cardiovascular, renal, and metabolic diseases.
Sharon: We have established a robust foundation with Farsiga, our leading SGLT2 inhibitor in heart failure, chronic kidney disease, and type 2 diabetes, and we are progressing a number of key NMEs.
Sharon: We remain focused on delivering novel, targeted monotherapies, including Daxtrostat, 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.
Sharon: Earlier this year we presented results from our Phase 1 trial for AZD0780, our oral PCSK9 inhibitor, demonstrating an additional 52% reduction LDL-C on top of standard of care statins.
Sharon: Furthermore, we are investigating multiple modalities in cardiac amyloidosis, including two molecules for ATTR cardiomyopathy.
Sharon: Aplanterson, a TTR gene silencer, and ALXN2220, a TTR protein depleter, which has the potential to address the broad spectrum of cardiac amyloidosis.
Thank you.
Sharon: 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 three assets across our weight management pipeline at Obesity Week earlier this month.
Sharon: Promising Phase I data from AZD5004, our small molecule oral GLP-1 receptor agonist, demonstrated good target engagement, safety, and tolerability.
Sharon: As a once-daily option, AZD5004 is being developed as both a monotherapy, as well as in combination with other small molecules in our portfolio, such as dapagliflozin and AZD0780, our oral PCSK9 inhibitor.
Sharon: We are rapidly progressing AZD5004 in phase 2b trials, in type 2 diabetes, and in obesity or overweight.
Sharon: Data from AZD6234, 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.
Sharon: We have progressed AZD6234 into Phase 2b to evaluate body weight reduction for those living with obesity or overweight.
Sharon: Additionally, we believe the triple mechanism combination of AZD6234 with AZD9550, our GLP-1 glucagon dual agonist, has the potential to achieve optimal weight loss, lean mass bearing, and organ protection.
Sharon: 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 interconnectedness of disease.
Please move to the next slide.
Sharon: Last week, we announced positive results from the Waypoint Phase 3 trial of Tespire in patients with chronic rhinosinusitis with nasal polyps.
Sharon: 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.
Sharon: TesPi are demonstrated statistically significant and clinically meaningful reductions in both co-primary endpoints, reducing the size of nasal polyps and the level of nasal congestion. We look forward to sharing these data with regulatory authorities and at an upcoming medical meeting.
Sharon: 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.
Sharon: And with that, please move to the next slide, and I will hand over to Mark to cover our rare disease portfolio.
Thank you, Sharon. Can I get the next slide, please?
Mark: Rare diseases grew 14% to $6.4 billion in the first nine months of the year, driven by growth in neurology indications, increased patient demand, and continued global expansion.
Mark: Ultimiris achieved its first Blockbuster quarter, with revenue growing at 35%.
primarily driven by neurology indication.
Mark: 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 Ultramiris.
Mark: In Europe, we saw a minimal increase of solid-risk biosimilar utilization across PNH and ATP-CoA2-S.
Beyond Complement.
Mark: Stremcyc and Koselugo grew 21 and 39 percent respectively, driven by continual patient demand and new launches.
Mark: We are highly encouraged by the strong performance from a rare disease medicine in the year to date.
And we anticipate this growth momentum to continue into 2025.
Please advance to the next slide.
Mark: Today, we announce positive results from the Phase III COMET trial in adult patients with NF1PN, the largest placebo-controlled Phase III trial ever conducted in this disease.
Mark: NF1PN is a rare progressive genetic condition impacting multiple body systems characterized by benign tumors that develop along nerve sheaths throughout the body.
Mark: And if 1 p.m. affects over 60,000 in both the U.S. and the EU, 80% of whom we estimate are adults.
Mark: In the COMET trial, coselugo showed 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.
Mark: These data support the potential to expand coselugo into the adult population.
Mark: We look forward to sharing the data with regulators globally and will present at an oncoming conference.
Pascal: And with that, please advance to the next slide, and I will hand back to Pascal.
Pascal: 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 period for our company.
Pascal: Within the coming year, we will see the results of significant indication expansion opportunities for our marketed medicines.
Pascal: including TrueCAP and HER2, IMFINZI, and Facenara, as well as pivotal trial readouts for several important potential best-in-class novel medicines shown here on this slide.
Pascal: 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.
Pascal: As Aradhana mentioned earlier, a strong delivery in the first nine months of this year, together with our upgraded full year 2024 guidance, sets a strong foundation for continued growth next year.
Pascal: And while we will provide formal guidance with full-year results in February, we are confident that the headwinds we anticipate next year will be substantially offset by global demand for our portfolio of medicines.
Pascal: This strong commercial performance together with continued pipeline delivery and our focus on profitability mean we are on track to achieve the strategy conditions laid out at our investor day this past May.
Pascal: 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.
Pascal: Of course, pipeline regeneration is critical to delivering leading growth and long-term value creation.
Pascal: To that point, we've launched six enemies towards our goal of at least 20 by 2030.
And with that, please advance to the next slide.
Speaker Change: 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 others a fair chance to participate.
Speaker Change: 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 at J.P. Morgan. Over to you, James.
Speaker Change: Hello, James Borden, Jake Morgan. Thanks for taking the two questions.
Speaker Change: The first question was U.S. election implications and where you're investing.
Speaker Change: Do you see any impact from the U.S. presidential election on Astrid's business in terms of higher tariffs or maybe lower corporate tax or anything else? And I saw the $3.5 billion U.S. 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?
Speaker Change: I assume, for instance, the UK 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.
Speaker Change: So if I look at the 2025 consensus of the new updated 2024 implied EPS level, it's looking for low double-digit EPS growth.
Speaker Change: So how comfortable are you with that growth outlook? I can hear comments on top-line strength and leverage over SG&A but also
Speaker Change: We've had a pull forward on the Nimpasa milestone. There's questions on China, IRA, financial expense, and maybe the election, depending on what you said in the first question. So should we be a bit more cautious than that on 2025, or is that achievable maybe?
Okay, thanks. Thanks, Jim. So, the first question.
You know the...
Thank you.
Speaker Change: 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.
Speaker Change: So, that is really a question that doesn't apply to us, because we source our products for the US. We source them either from the US directly or from Europe typically, so there's really no issue of sourcing products from China.
Speaker Change: 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.
Speaker Change: and a few others, and then we have a separate supply chain for China and some of the emerging markets.
Speaker Change: So that's the answer to the first question. The second question, actually, and your first question about the U.S. elections, I mean, the reason we invest very substantially in the U.S. is that, you know, we all know the U.S. is a very important market, both in terms of...
Speaker Change: providing our medicines to patients but also in terms of innovation.
Speaker Change: 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...
Speaker Change: We should actually continue to grow strongly in the U.S. next year and the year after.
Speaker Change: And then, you know, a number of participants in the economy seem to believe that too. And, you know, a strong economy will support a strong health care, which, of course...
Speaker Change: So all of that makes us really enthusiastic about the U.S. market. In our plan, the U.S. should increase its participation to our total revenue.
Speaker Change: The other area that is growing very nicely, of course, is 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 percent in top line, right?
Speaker Change: 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 IRA.
Speaker Change: We know about VBP Fast Cigar in China. We don't know exactly when, but we know it's...
It's going to happen next year.
Speaker Change: And so those are headwinds, but on the other hand, we have enormous momentum across the entire portfolio, but also across the entire world.
Speaker Change: So I'm not saying next year we will grow by the same amount as 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...
Speaker Change: confirms what Aradhana was saying before. We're very confident with the outlook for next year. Not only for next year, but the year after, actually. So, net-net is...
Speaker Change: We are actually confident for the outlook next year. Aradhana, do you want to add anything to that? No, no, I think 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.
Speaker Change: The incremental investment that was announced is, you know, partly this year, partly the next two years, and it's really driven by the growth and the momentum that we see, whether it's in clinical trials.
Speaker Change: and Clinical Trial Supply or, you know, the cell therapy. And so it's really, you know, 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.
Speaker Change: And maybe just going back to the U.S. question is, if you think about the...
Speaker Change: I mean, if you look at our position around the world, in most cases we are in the top three companies in most markets, not in the U.S.
Speaker Change: And the reason is the U.S. market is the market that actually rewards innovation the most.
Speaker Change: 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.
Speaker Change: 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, you know, our participation in the U.S. and hopefully our ranking in the U.S. will improve.
Thank you.
Speaker Change: Thanks for taking my questions. Richard Parks from BNP Paribas Exam. 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.
Speaker Change: 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?
Speaker Change: 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, one for Susan.
Speaker Change: I just wondered if there was anything that was raised in during the FDA review that investors should be aware of that maybe undermined your confidence in DattoDXD or the TROP2 QCS biomarker, obviously the decision to withdraw.
Speaker Change: The filing raises question over 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 approvals simply a higher bar than you originally assumed
Thank you.
Thank you for watching.
So the first question, Richard, thank you, for China.
Richard Parks: I think really the answer, the true answer to your question is it's too early to judge.
Richard Parks: 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 a long-lasting impact?
Richard Parks: much too early to judge. But I think maybe what I can say is that
Richard Parks: You know, China today is about 12-13% of our total revenue, and 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 Farsiga VBP.
Richard Parks: And so certainly 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.
Richard Parks: You know, we have, you know, the assumption is the share of sales is...
Richard Parks: 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...
Richard Parks: We will navigate this difficult period, and we think we can actually manage to continue to grow across the world, even if there was...
Richard Parks: some impact in China. We hope there won't be a sign impact, and certainly the team in the country and China is working very hard to...
continue moving our products.
Richard Parks: We know our research and development plant 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, you know, we believe that...
Richard Parks: We should be able to manage this difficult period, but again, as I said, very difficult to comment at the very early stage.
Richard Parks: Susan, do you want to take this question? Sure, 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.
Richard Parks: So, you know, the FDA is interested in the particular subgroups where the greatest benefit is seen. And, of course, there's...
Richard Parks: not just within the TLO1 study, but obviously within the single-armed TLO5 study, really very robust activity that was seen within the patients with actionable genomic alterations, and in particular those with EGFR mutations.
Richard Parks: So I think, you know, what you're seeing is a reflection on trying to focus initially on that subgroup where is the greatest benefit. But I think there's also, you know, interest in the potential of the patients that have the biomarker positive subgroup that we've seen in the CHOPI and LUNG-01.
Richard Parks: 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 1 trials.
Richard Parks: of which Avanzar, as I said, is the first one that we'll read out next year, but Tropian Lung 10 is another example. And then again, in combination with Osimertinib in the Tropian Lung 14 and 15 studies, so that we build out really a robust...
sets of indications.
Richard Parks: for DattoDXD in lung cancer. So your question was about confidence in the profile that we have with DattoDXD.
Richard Parks: As I've said a number of times, I think we've learned a lot from the Tropion-Long-01 dataset. 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 original Tropion-Long-01 study was designed.
Richard Parks: 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.
Richard Parks: 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've indicated as well, the biomarker data that we've seen in Tropium Longo 1, we've looked in other data sets as well. We also think we've got evidence that that will translate across different data sets.
Richard Parks: including from internal data sets in earlier line settings as well. So I think the overall profile that we have with DataDxD and the potential to maximise 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. Thanks.
Speaker Change: Thank you, Suzanne. So the next question is from Sachin, Bank of America.
Speaker Change: Hi there, thanks for taking my questions. Same two topics as I may, please. So firstly, for Susan, on data...
Speaker Change: It indicated at World Lung that you were in a debate with the FDA around changing the Avanzar stat plan.
Speaker Change: I just wonder how far progressed you are with that and whether the TLO1 debate has influenced that at all?
Speaker Change: And the second one is just back on 25, just to get a bit more colour if I could, from Pascal and Aradhana. You've listed two main headwinds, Fast Ego VVP and IRA. Will you just give us your best quantification or expectations around those? Please ask the question.
Speaker Change: Crestor did better than expected in VBP. IRA, you've historically framed as manageable, so neither seem like material headwinds to existing high teams' growth, suggesting revenues could continue to double digit for next year. So just any perspectives there. Thank you.
Speaker Change: So maybe let me cover the second one, and then I think, Susan, we can go back to that too. And Ruud and Dave, if you want to comment on the IRA. So on the China side...
Speaker Change: You know, what you should expect for FastFigure is what we saw with Crystar, which is a decline.
Speaker Change: And then the stabilization and the growth because our plan is to do with Farsiga what we did with Crestor. And there is a market for these products.
Speaker Change: that patients actually buy directly online with electronic prescriptions, essentially, and then get it delivered to their home. Now the cells will not...
Speaker Change: be at the same level as they are today for sure, just like happened with Crestor, but we believe we can go down and then grow again and, you know, keep Farsiga 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...
Speaker Change: And then, Ruud, do you want to cover IRA and anything that you would want to add? Yes, of course. And once again, currently we are not assuming that FASIGA, in our guidance for this year, that FASIGA will be in the VVP.
Speaker Change: It hasn't been announced, but that's a clear assumption, and let's see how it works.
Speaker Change: 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.
Speaker Change: when we will give the guidance in the beginning of 2025.
Speaker Change: 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...
Speaker Change: The IRA impact will be manageable. We have good programs in place to drive further volume. We've seen that clearly with the Symbicort performance, but the ICRI Farsiga is still performing very well in the US markets and we don't think that it will substantially slow down in the course of 2025.
Dave?
Speaker Change: Thanks, Ruud. 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.
Speaker Change: 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.
Speaker Change: Obviously, next year we take on the 20% liability in the catastrophic phase for the first time.
Speaker Change: I think importantly our oral oncolytics. Pascal talked about this, as did Susan. In the slides, we've got really excellent growth drivers on Tigrisso.
Speaker Change: and Calfquintz. 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. It really is important, as they said, to consider the new indications.
Speaker Change: Because as we launch those new indications for, for instance, Tegris or Kalkwens, patients will have the ability to benefit from those indications without having to ask for free products. So, we really have a...
Speaker Change: 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 we said many times. It's manageable and we continue to believe. It's manageable having gone through our
Speaker Change: Our planning process now and our budgeting process, we continue to believe it's manageable.
Speaker Change: There is an online question coming from Christophe Aoude... I haven't answered the... Oh, sorry, sorry, go ahead, Susan. Sachin had a... Thank you for the question on data about Avanzar. So just as a reminder, once we saw the initial results from Tropium Lung 01, we made some modifications to Avanzar. We've increased the sample size.
1,280 patients.
Speaker Change: 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 those changes with the FDA? Yes, of course, we've discussed those changes with the FDA.
Speaker Change: Sorry, Susan, I thought you were discussing further changes to the staff plan.
Speaker Change: And that's all you've covered, but the question is, the second question is Limparza.
Speaker Change: It's an online question, it says, what are you seeing in Ovarian in the wake of Prima bombing on OS?
Speaker Change: 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 for Mona Ola as well as Duo O and when might we expect to see OS results? So a bit of...
Speaker Change: Dave and a bit for Susan, yeah. Why don't I start first on LIMPARSA. I think very importantly, when we take a look at the year following
Speaker Change: second half of last year, where the class, particularly in the U.S., was really undergoing a lot of second-line headwinds from FDA-mandated changes to labels. We've now seen, in 2024, two consecutive quarters of sequential growth in Q2 and Q3. We've got the highest levels.
Speaker Change: sales for Lymparza 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.
Speaker Change: 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.
I'm
Speaker Change: 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.
Speaker Change: 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 Palo One. And we'll stay focused on that to continue on our growth trajectory for Limparzo.
Speaker Change: Do you want to address the Mono Ola and the Duo O? The Duo O, the mature ROS is anticipated in 2025. I don't think we've guided more specifically before that. Of course, that will be event-driven for ROS and in a number of our own ovarian cancer studies with Lumpasa, we've
Speaker Change: You know, we faced slowing event rates, so it depends a little bit on that event rate coming in, about the timing of that. For the Mona Ola study, I also think that the latest clinical trial appendix is the latest timeline for that.
which is really in the second half of next year.
Speaker Change: Thank you, Susan. Next question is from Gonzalo Artias at Damske Bank. Over to you, Gonzalo.
Thank you for listening.
Sounds like...
Speaker Change: We don't have the connection to Gonzalo. Let's move to Steve Scala at Corwine. Over to you, Steve, and we'll come back to Gonzalo maybe later.
Steve Scala: Thank you so much. Two questions. Dave, you spoke on the second quarter call about a robust in her to acceleration in the second half of the year.
In Q3, do you think a robust acceleration was achieved?
Steve Scala: 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 TLO-5? For instance, when was it filed?
Steve Scala: 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? Thank you.
So Steve, on your question on INHER-2, I think...
Speaker Change: We remained very focused in the quarter on driving against both
Speaker Change: Destiny Bresto 3 in the HER2 positive setting as well as with Destiny Bresto 4.
Speaker Change: What I was hoping that we would see in the quarter and we haven't seen yet is a inclusion of Destiny Breast 06 into the guidelines
I think that that is a catalyst that is important.
Speaker Change: Primary reason and 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, in HER2, going through a change in trajectory as we're able to both see O6 within both the guidelines and also then ultimately approval so that we can promote to it.
Speaker Change: And to answer the question on DATO, we submitted really very recently and you know normally of course we announce at file acceptance but given the special circumstances around DATO we've made an exception to make that announcement now.
Speaker Change: 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,
Speaker Change: Thank you, Susan. The next question is from Rajan Sharma at Goldman Sachs. Over to you, Rajan.
Thank you.
Rajan Sharma: Hi, thanks for taking my question. So just on FoxEagle VBP, so you mentioned that you're expecting inclusion in 2025, but I think you'd previously expected it.
Rajan Sharma: in 2024, which hasn't materialised. So it would be just helpful to understand why that...
Rajan Sharma: Could be 25 and not in fact 26 or 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 trajectories implying a slightly stronger accretion into 25 and then more moderated accretion into 26
Rajan Sharma: Is that how you're expecting it to materialise or should we expect that to be more linear? Thank you.
Thank you. Thank you.
Speaker Change: Yes, let me take the first question. So first of all, once again, we have assumed, our guidance assumed that...
Farsiga will not be included in VBP 10.
In fact, the list hasn't been announced yet, so...
Speaker Change: We're still waiting for that and of course then the big ticket item is...
Speaker Change: when VBP 11 will be announced, and at this stage I think it's too speculative in order to...
Speaker Change: 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.
Speaker Change: in the beginning of 2025 when we have our first four-year results. But so far we are not able to provide any more clarity for Farsiga in 2025. It will not happen. I think that's highly likely now in the course of 2024.
And then your question on...
on 2025 and 2026 operating margins.
Speaker Change: Again, we obviously will give guidance when we do our full year results and guide to 2025.
Speaker Change: But what I'd point out is if you look at the third quarter results and the
Speaker Change: revenue growth weighed at 21% versus the operating expense growth at 15% and the SG&A growth only at 9%.
Speaker Change: 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.
and the
Thank you, Aradhana.
Speaker Change: 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, considering the headwinds.
Speaker Change: And you look at a bit of a leverage, you can immediately conclude that we are very comfortable with the outlook in 2025. So we are in a good place really based on the momentum we have today.
Edzard Arad at BMO, over to you Edzard.
Thank you.
Thank you.
Thanks for taking the question. Can you hear me? Yep.
Great. Yeah, just a quick follow-up question on DattoDXC.
Speaker Change: I'm wondering if maybe there's any read-through to the TROPI on BREST-01 upcoming regulatory decision in first half 2025, just given that, you know, you think about the application, you know, statistical benefit on PFS,
Speaker Change: Directional OS benefit, I guess similar to the non-schemic cell population.
from Tropical Illinois 101, just wondered if there's...
Speaker Change: Any read-through there? And then on the QCS biomarker strategy and the decision, did the QCS biomarker strategy have any impact on the decision on Tropium-101, and is there any read-through positive or negative on Advenzar?
based on those decisions. Thank you.
The End
Speaker Change: is still under review. Again, what we've seen there is a clinically meaningful improvement in progression-free survival. We've said that the high-level results that we didn't see overall survival in that setting. And again, I think there's...
Speaker Change: 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.
Speaker Change: you know, 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.
Speaker Change: Plan for the indication. No, I don't believe so. What we said is when we saw the
The Tailor One
Speaker Change: data that that biomarker would require prospective validation in other trials. I don't think it's affected that. I do think there's strong interest across the community, investigators included.
Speaker Change: in, you know, this potential for identifying a patient population that's particularly sensitive. And I think it does help to explain.
Speaker Change: As we said before, the difference by histology in non-squamous versus squamous populations.
Speaker Change: 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.
Pascal: Thank you. Thank you, Susan. Simon Becker, Redburn. Simon, over to you. Thank you, Pascal. Two questions, if I may. The first one on China, but on the bit of China where you do have visibility. I just wondered if you could...
If you could...
Pascal: 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 colour on that ex-China emerging markets growth?
Pascal: on a regional country basis will be quite handy. And then secondly, a question that we've received quite a lot in the last couple of weeks.
Pascal: which is on the question of buybacks. I know your view over...
Pascal: 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 a buyback any more attractive at sub 100 than it was at 130? Thanks so much.
That's great. Thanks, Simon.
Speaker Change: First question, maybe I can quickly comment on China, and Ruud, you can comment on China if you want, but also the emerging markets, and then Aradhana, will you take the buyback, knowing that, of course, this will be a bold decision, but certainly Aradhana can give you some early thoughts.
Speaker Change: So far, we haven't been approached, in terms of the cases we said before, we haven't got any...
Speaker Change: Any details as to the cases, as a company, we haven't been approached. Our operation is actually, our company's operating as usual, including the work we do at the regional or central level.
and the various discussions with authorities, so we are...
Speaker Change: 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
Thank you.
Thank you very much.
Speaker Change: It's 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 enough data to say anything.
Speaker Change: Ruud, do you want to comment on that? Yeah, a little bit, and just to... Sorry, I forgot to mention, and I should mention, it is... Ruud is actually...
Speaker Change: As you know I on an interim basis managing the whole of international including of course China, but also non-China
Speaker Change: 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 early to speculate about any potential impact in the near future, but so far I think the teams are very dedicated in order to deliver a strong performance also moving forward.
And having said that, very pleasing to see the growth.
in ex-China, that remains a very strong story.
Speaker Change: for AstraZeneca and for, of course, the people working in those parts, the Latin region.
specifically is doing extremely well, but also Middle East.
Speaker Change: 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.
Speaker Change: 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 those parts of the world.
Speaker Change: 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.
Speaker Change: Strong growth in the Middle East which is really a big opportunity in terms of growth potential
Speaker Change: And I was personally in South Asia recently, I mean the team is...
Speaker Change: Very excited, the growth rates there are pretty good, so across the whole.
of international regions, we are doing very, very well.
Speaker Change: Aradhana, do you want to talk about buybacks? Yeah, 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.
Speaker Change: 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.
Speaker Change: The business from both the 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.
Speaker Change: 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. Thank you.
Thank you very much.
Thank you for taking the question.
Perhaps.
Speaker Change: A quick follow-up on Avanza, if I may, just to clarify, is all comma still the intent of the primary analysis?
Speaker Change: And do you have agency alignment on that? And then maybe a question on the outlook for the respiratory franchise, very strong quarter for Simbicort and Breast Tree, maybe you could talk a little bit about the sustainability of the former iSimbicort, can that continue to be a source of growth in 2025 and indeed beyond? And then Breast Tree, what about the potential to accelerate that in 2025 given
Speaker Change: apparently the IRA tailwind but more importantly the asthma readouts you have coming in the first half of the year. Thank you.
Speaker Change: Susan, you want to take the first one, and Ruud, will you take the second?
Susan: So, Avanzar's powered for both ITT and biomarker positive group, as we said, and I think very 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.
Speaker Change: Thank you so much, Manuel, for the questions regarding the respiratory portfolio. Indeed, a very strong growth. Equally, I'll say a few words about Symbicort and Breaststream in a moment, but also the biologic portfolio is growing very fast as we speak.
both to Sunra as well as to Spire.
Speaker Change: that Aspire is on its way to become a 1 billion dollar brand together with our colleagues of Amgen.
Speaker Change: 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, the mix of the different business of business, the book of business
is favorable as we speak.
Speaker Change: and we don't know how that will evolve in the course of 2025.
Speaker Change: We are following up. It is also clear that our strategy in order to launch and authorize generic...
Speaker Change: as well as lowering our list price, the WEG 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.
Speaker Change: So all in all, a very promising 2024, whether that will continue in 2025.
needs to be seen.
Speaker Change: But of course it also clearly indicates that Simbicort is really one of the cornerstone medicines for the treatment of asthma and COPD.
Speaker Change: in the United States, the brand loyalty is extremely, extremely strong.
Speaker Change: Breast Tree is clearly a different story, it's still what we call in the early launch phases, very strong growth.
the trial for breast treatment.
So that's an important one as well.
Speaker Change: And equally, we are putting a lot of resources behind the product in order to make that a multi-billion dollar opportunity. And equally, of course, we're also looking forward...
of breast three moving forward in the cardiovascular space.
Speaker Change: So that's, I need to make one small point, it was not the Resolute Trout, the Resolute Trout is the Fasenra.
Speaker Change: a COPD trial, is the K-loss 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.
Thank you, Ruud. Joe Barton, UBS.
Joe Barton: Thank you, 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
Joe Barton: 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.
01, but presumably that doesn't...
impact the fact that you've excluded the AGA patients?
Joe Barton: 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.
Joe Barton: have had investor questions. Those people who unfortunately weren't able to hear Aradhana give that very helpful call themselves.
So the questions that we get are...
Joe Barton: Of the roughly 100 reps that you talk about that have been, in your view, potentially identified and charged,
How many of those?
Joe Barton: Did you identify and get rid of, for having discovered a 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?
Joe Barton: and has the current situation in China impacted any senior management plans for people who are based outside of China to travel in China? Thank you.
Speaker Change: Thank you for those two 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? Aradhana had a lot of good answers to those questions. Let me just say only that...
Some people are not being with the company. Actually highlights.
Speaker Change: 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.
Speaker Change: But in terms of the rest, I think the transcript would address your questions.
Speaker Change: 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 Lung O2 and O4 studies that look at the combination of DATO with platinum-based chemotherapy and IO.
Speaker Change: give you confidence about what you can potentially achieve in terms of the response rate, progression pre-survival and later outcomes. And that's what that is built upon for the ITT population.
Speaker Change: And as those datasets 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 TropionLungO1 dataset.
Speaker Change: The opportunity to then also look in the biomarker positive, again based on the effect size that we saw in that group in the Tropium Longo 1, is further confidence that you can build. And as I've said, looking at internal data sets, we think that the...
Speaker Change: The biomarker that we identified, Entropion Longo 1, 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 Advanced R Study.
Speaker Change: I think, Joe, if I could add two points on your question. The first one, I think, is an important reminder, is that in Tropion Lung 01, we didn't have a pre-planned stats plan for non-squamous. And I think that that's an important part of how the data set was then being interpreted.
Speaker Change: 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 lines. So I think that's an important piece. And I think that your question on the AGA patients coming out.
Speaker Change: 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 Tigriso plus Datto in addition to the other studies that are being looked at in the non-AGA population.
Speaker Change: Two great points and maybe just one more, which is really these combinations of Tagriso and Datto, I think will represent a great opportunity to defend Tagriso and extend the treatment duration. So not only they will be good for Datto, but they will be good for Tagriso.
Speaker Change: And we know that there is a combination out there, but we will be the only company with, or the only EGFR third generation with a combination with Xato, so that would be very material to the life cycle of Tegris as well. Matthias Hackblom at Ondaatje Banken.
Speaker Change: Thanks so much for the question. One please, on China and I don't think it was covered on Aradhana's course. So on back of the medical insurance fraud case in 2021 it was clear
Speaker Change: but as a sudden get 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? Thanks so much.
Speaker Change: If I get your question correctly, I'm not 100% sure I do. Let me just make a few comments and then you can say whether I have not addressed your question. First of all, you need to understand that the series of cases that have unfolded over time
Speaker Change: 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...
Speaker Change: check people's personal WeChat systems. We don't know what they do with their telephone. They are more their personal telephones, etc., etc.
Speaker Change: So, a lot of this data has come about over time, and the cases refer back to this period of time when we had reimbursement for T790 and mutation, but no reimbursement for Tigriso.
Speaker Change: And I think it's also important to keep in mind in the whole context is we had
Speaker Change: 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 so that's maybe one one point
in terms of
Speaker Change: Yes, so the testing opportunity ended in March 2021, just like the opportunity to import an R2 from Hong Kong disappeared also in early 2004 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 will really...
You know, we trained everybody, we have...
Speaker Change: 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.
Speaker Change: 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 emails, and by the way people now really are told to use our internal systems only and not their external, their own systems.
Speaker Change: But we have lots of policies and systems in place to track expense reports, use of credit cards, use of certified food suppliers, etc., etc.
Speaker Change: 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.
Speaker Change: that is not controlled by the policing of our systems. The second thing we've done is we are rotating, we're going to be rotating the original search directors so they don't stay too long in the same place.
Speaker Change: because of course, if you stay in the same place, you can actually.
be impacted in your behavior?
Speaker Change: And so those are, I mean, we've made many other changes, but those are maybe the two most, I think, fundamental. And they relate to people, because you have systems, and the systems you can track. Then you have people and what they do, and that, you have no way to track them unless you really are close to them in the field, yeah? So hopefully I address your questions.
Speaker Change: If not, maybe you can come back later. And the next question is Eric Laberigo at State Farm.
Speaker Change: Thank you, Pascal. Good afternoon. First question relates to CapEx. Maybe a question for Aradhana. You mentioned after nine months, 1.2 billion in CapEx this year, which would analyze around 1.8 billion. And today you're announcing a 3.5 billion CapEx investment in the U.S.
Speaker Change: spread over two years. Nonetheless, we present about doubling CAPEX for each of the next two years, if that's incremental.
Speaker Change: Maybe you can elaborate on how we should think about modelling CAPEX into the second part of the decade. You were roughly between $1 and $1.5 billion a year, now you're moving into roughly $2 billion. Should we think about getting up to $3 billion or more?
Speaker Change: 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 UrsuPra, maybe.
or Ruud.
Speaker Change: At the very end of last year, you made significant investment in commercial marketing to support the launch of Asupra.
Speaker Change: And we're now one 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 bug versus status with this drug? And when should we expect an inflection point? Thank you.
Speaker Change: 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.
Speaker Change: We always see, 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.
Speaker Change: the API facility in Ireland, or the respiratory inhaler facility in Qingdao. These are all multi-year, anywhere between three to five year type projects that we've started. So.
Speaker Change: So that's one element and how you can think about on a going forward basis.
Speaker Change: I think the second question was around how do we think about CAPEX, broadly speaking.
Speaker Change: And, you know, I'd say as our portfolio expands, and you mentioned the GLIPP-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.
Speaker Change: We're building, you know, 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, you know, labs as well as in capital for manufacturing standpoint. And again, the portfolio success will drive some of that investment and many of the new technologies, as you know.
require, you know, investment at risk.
Speaker Change: So that's what we'll continue to do. And I'll hand over to Ruud on AirSupra. Yeah, okay. Thank you so much, Erik. So first of all, to answer your question about do we still believe it's a billion-dollar-plus opportunity, the short answer is a clear yes.
Speaker Change: I think also the recent Bitura data further emphasise the importance of these medicines.
Speaker Change: for the treatment of asthma as a rescue medication. Secondly, yes, we are very pleased with the progress we are making with Estupra, as I said in my prepared remarks. We have now more than 50,000 prescribers in the United States, more than 200,000 patients.
Speaker Change: are on the drug and this is all about getting more access.
Speaker Change: At the moment, we have roughly 60% commercial access that will increase.
Speaker Change: in the next few months, but more importantly, also from the 1st of January, we are expecting our first Part D.
Thank you very much.
Speaker Change: We're buying down a very substantial amount of scripts as we speak.
Speaker Change: 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.
Speaker Change: 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. Rajesh, over to you.
Good afternoon. Thanks for taking my question.
I will
Speaker Change: come to a question related to China but not China itself.
Speaker Change: I appreciate you don't know much about China and you have tightened a lot of compliance policy around there.
Should investors think about...
Speaker Change: Any other regions where you might have to tighten your, you know, 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
Speaker Change: Dato, appreciate you have a biomarker. Your confidence seems to have gone up. It's great to see, you know, a setback has not detracted you from trying out again.
Speaker Change: How can you give investors confidence that this confidence is not misplaced, but is rooted in a lot more data or information that has informed the decision to double up on data?
Speaker Change: Thank you. Let me cover the China question and Susan, you could cover the Dato question.
So...
Speaker Change: Yes, there was something peculiar in China, but it has nothing to do with the sales force target. In fact, if you look at the last few years, the last six years, China achieved its target of all except during the COVID period, but COVID, we knew that the reasons everybody was wearing masks or we had lockdown, et cetera.
Speaker Change: And the sales force actually reached their bonus, the target bonus. The peculiar thing, and so the targets in China were not specially stretched. And if you look at it, in fact, our biofarm business has no issue.
Speaker Change: So, the peculiar thing is very simple, it is that unfortunately we had a period of time when there was a disconnect, not a disconnect, but a difference in reimbursement. The GRISA was only reimbursed for T7 and TN, and as you can imagine, patients who
Speaker Change: were not positive and wanted or could benefit from TAGRISO, wanted it if they were GFR 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.
Speaker Change: We are not yet approved in China mainland. Over the next period of time, this won't happen again because we are not launching new products.
Speaker Change: New products in Hong Kong that will not be approved on the mainland, simply because we don't have new products to launch.
Speaker Change: In the future, we'll try to time align, if we can, those two launches and what is giving us hope is China's approval is happening much faster now than in the past.
Speaker Change: And if we cannot time our land, we will certainly make sure we really follow supply very, very closely. But this is what was peculiar, is that a specific environment around a few products in oncology, I think that specific peculiar environment is...
Speaker Change: are no longer there, but suddenly we are tightening our compliance outside our systems, as I explained.
Speaker Change: Now, you know, we run a very large organization. I don't have any reason to believe there are issues anywhere else.
Speaker Change: But, you know, the whole industry has had issues in the U.S. many years ago, so...
You know, follow our code of ethics.
Speaker Change: Compliances of 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.
Speaker Change: I also want to make sure that we realize there is 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 who misbehaved.
Speaker Change: And then also we have several thousand people outside the Salesforce that are also doing a good work every day.
Speaker Change: So, that's what 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.
Susan, is that all?
Speaker Change: So one of the reasons why I enjoy my job so much is that I've constantly got the opportunity to learn and that's the nature of drug development and what we do we're constantly learning and the reason why I'm more confident about
Speaker Change: data.dxd now is that we know more than we did at the time that we designed the Tropian Lung 01 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.
and a counsellor.
Speaker Change: And we didn't have the biomarker data that we currently have now. We also didn't have as much data about the, you know, from the studies that I've mentioned a couple of times, the Tropium LongO2 and OO4 studies, which show the ability to combine
Speaker Change: safely with platinum. The increase in response rate that that gives them the ability to combine safely with the with the IO drugs.
Speaker Change: 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 CHOPE-2, though, just immunohistochemistry alone doesn't give you all the information that you need about the patients they're most likely to benefit. And we've mentioned a few times that we need to look at the internalization rate as well.
Speaker Change: So, we know a lot more, and that's what gives me confidence about the ability to maximise the potential of Dastardix D, which I think has the potential to be a very important medicine.
Thank you.
Thank you very much.
on our internal systems on a regular basis. Gonzalo Adhanscu?
Go ahead.
Hi, can you hear me now?
Speaker Change: Yeah, great. Just one on DATO CSV 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 US based on current available data? And if so, are you planning to file in the near term? Thank you very much.
Speaker Change: Thanks for the question. 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 US and other regions do differ in some regards, so we have to wait for the feedback from the regulatory authorities in other regions.
Speaker Change: 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 the two in our portfolio, but over to you, Peter. Well further, Jeffrey.
Speaker Change: Hi, thank you. Very quick, two quick questions. One, just on, I'm afraid it's China and Datto, but China, can you just confirm, is Leon still an employee of AstraZeneca at this moment in time? And then secondly, on Datto, is there any plan to change at all the TLO7 and TLO8 trials, because they're the ones with Kutruda, to include a QCS biomarker analysis, the primary endpoint, as has done with the Banzar? Thank you.
Speaker Change: So, first question, in the interest of time, it's in the transcript, so I would refer you to it. And second question, Susan?
Speaker Change: So, you know, again, I would just say for Taylor Waite, which is in the PD-L1 high patient population, I think that's a different context, you know, in terms of the opportunity there.
Speaker Change: For TIL-07, 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 it's a little different for Tropion Lung 07.
Thank you.
Thank you. Next question.
Speaker Change: We still have a couple of questions. Oh, Emily Field. Emily, go ahead.
Emily, you may be on mute. We can't hear you.
Thank you.
Okay, could we try the next question?
Sounds like... Ah, Louisa Hector. Louisa, over to you.
Thank you. Can you hear me?
Louisa Hector: My question is linked to the FDA focus that we've seen for some time now on the subgroup.
Louisa Hector: 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 two potential outcomes. Thank you.
Thank you.
Thank you, Luisa.
Speaker Change: We're happy to talk about Camry Zestra, our next generation, third inhibitor, and as you rightly point out, two important catalysts that are upcoming with, it's Serena-6 that's in the selected patient population, patient with ESR1 mutations.
So this, this, um...
Speaker Change: There's low levels of this mutation, but it tends to be...
clonally selected over time, particularly on aromatase inhibitors.
Speaker Change: So the trial design is camidestrin plus the CDK-4,6 inhibitor versus continuation on the aromatase inhibitor and a CDK-4,6 inhibitor.
Speaker Change: Given the data that's been seen with this class of drugs in ESL1 mutants, we've got a high probability of success here.
Speaker Change: Padawan dataset, where we looked at Fulvestrin, which isn't as potent a third inhibitor, versus continuation on aromatase inhibitor in this setting. And again, that gives us confidence about that trial.
Speaker Change: However, the actual target for kamisestrin is the oestrogen receptor. The original targeted therapies were hormonal therapies targeting the oestrogen receptor. So it's not just...
Speaker Change: those patients with ESL-1 mutations that are likely to benefit, it is the broader...
Speaker Change: wild-type patient population that are endocrine sensitive that are likely to benefit.
Speaker Change: And, again, we've previously seen that, you know, improving endocrine therapy can improve the outcomes. And that's really the...
Speaker Change: across in a range of both adjuvant as well as first line in particular metastatic ER positive breast cancer.
Speaker Change: So I think the data that we've seen from the Serena 2 data set, which was a randomised study in the second line...
Speaker Change: for Vestren, which was the previous best SIRD that was available.
Speaker Change: So I think both the Serena 2 data and then the Serena 3 data in the window of 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.
So, one last question, Emily Field at Barclays.
Thank you for watching!
Speaker Change: Hi, 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, you know, 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? Thank you.
Gosh. Dave, do you want to get started for oncology?
Speaker Change: Great question, Emilie, by the way, but a long answer, I suppose, but go ahead, Dave. It would be my pleasure. I think just as we kind of go through and do a little bit of roll call here, I think in hand already, Emilie, really importantly, we've got Amplify, which is very important for CalQuintz, opportunity to really establish both a finite and a treat-to-progression leadership opportunity with CalQuintz, and I think that this is going to be an important part of that medicine going forward.
Speaker Change: Luisa's question just teed up another really important piece I think that Serena
Speaker Change: 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.
Speaker Change: 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, and her too, moving into earlier lines with DB09.
Speaker Change: We know, based on what we saw with the O3 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 frontline. The trial design allows for with and without progetta, and I think that this represents another very important growth opportunity in the near term.
Speaker Change: Thanks. Gordon. Yes, first of all, I think Baxterstat, 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 breast-free.
Speaker Change: which I mentioned in the asthma indication, and last but not least, Fasunra in the COPD indication.
Thank you for watching.
Speaker Change: yeah I mean my expectation is we have a we presently have 10 ongoing phase 3 on different
Speaker Change: molecules, the complement, and most of them are going to read out in 2025.
Speaker Change: So, I would expect that we beat the statistical average of the phase 3 clinical trials and demonstrate that these products are safe and active. So this is going to be a very interesting period for rare diseases in 2025.
an important product for
Speaker Change: 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.
Speaker Change: 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.
Speaker Change: You know 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.
Speaker Change: Again, the fact is we are trying to be as transparent as we can, but we have very limited information.
Speaker Change: And last point is, you know, 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.
Speaker Change: Second quick closing comment is we had tremendous results in Q3 and in 9 months, so we are very excited with...
Speaker Change: There is actually a momentum we have to the extent that we are doing better than we expected actually and we have been able to increase.
to raise our guidance for the year.
Speaker Change: 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%.
Speaker Change: 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.
Speaker Change: 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 strategy ambitions.
Thank you.
Speaker Change: As we said before, not everything is going to go perfectly, of course.
This is a...