AstraZeneca PLC

Good morning to those joining from the UK and the US. Good afternoon to those in Central Europe and good evening to those listening in Asia. Welcome to AstraZeneca's half one and Q2 2026 webinar for investors and analysts. Before I hand over to AstraZeneca, I'd like to read the safe harbour statement. The company intends to utilise the safe harbour provisions of the United States Private Securities Litigation Reform Act of 1995. Participants on this call may make forward-looking statements with respect to the operations and financial performance of AstraZeneca. Although we believe our expectations are based on reasonable assumptions, by their very nature, forward-looking statements involve risks and uncertainties, and may be influenced by factors that could cause actual results to differ materially from those expressed or implied by these forward-looking statements. Thank you very much. And with that, I'd now like to hand the conference over to the company.

A warm welcome to AstraZeneca's half year and second quarter 2026 presentation conference call and webcast for investors and analysts. I'm Joris Silon, head of investor relations. And before I hand over to Pascal and members of our executive team, I would like to cover some housekeeping items. Firstly, all of the materials presented today are available on our AstraZeneca Investor Relations website. Please advance slide. This slide contains our forward-looking statements, including the safe harbor provisions, which I would encourage you to take the time to read. We will be making comments on our performance using constant exchange rates, our CER, core financial numbers, and other non-GAAP measures. A non-GAAP to GAAP reconciliation is contained within the results announcement. All numbers quoted are in millions of US dollars unless stated otherwise. Please advance line. This slide shows our agenda for today's call. Following our prepared remarks, we will open the line for questions. As usual, we will try to address as many questions as we can during the allocated time, although please limit the number of questions you ask to allow others a fair chance to participate in the Q&A. And with that, please advance to the next slide, and Pascal, I will hand over to you.

Thank you, Joris, and welcome, everyone. I'm really pleased to report that in the first half of 26, we saw strong growth momentum and continued pipeline delivery. Total revenue grew 6%, driven by strong demand for our innovative medicines, excluding the impact of Farciga and Brevinta, which are affected by generics, as you know. Total revenue grew 11%. That is a clear demonstration of the underlying strengths of our portfolio, and our broad geographical footprint. We also saw strong growth in core EPS, increasing 11%. In the first half, we announced positive results from six key phase three programs, including three new molecular entities. We secured 30 major market approvals across our diverse portfolio, including the first approvals for two enemies, head comma in breast cancer and backspin in hypertension. and increasing our number of approved NME to 11 since we outlined our target to achieve 20 by 2030. Our confidence in reaching our 2030 target is underpinned by the exceptional quality and momentum of our pipeline together with our proven track record of successful execution and launches. We continue to invest in our pipeline and commercial capabilities to bring innovative medicines to patients around the globe and to support growth through 2030 and beyond. So please move to the next slide. There you can see the breadth of our company remains a key competitive strength. Oncology and rare disease deliver strong double digit growth in the first half, while within biopharmaceuticals, we see continued momentum in respiratory and immunology that help mitigate the expected impact of loss of exclusivity in CVRM, in particular fast cigar and Brilinta. We delivered strong growth in the US, in Europe, and in the emerging markets outside of China. Growth in China was impacted by continued effects from volume-based procurement, and we expect the recent NRDL additions and new regulatory approval in 2026 to fuel future growth. Move to the next slide, please. An important message for today is that when we set our 80 billion revenue ambition for 2030, we did so based on the strengths of a broad and diversified portfolio, not on a single program. As you know very well, the 80 billion is a risk-adjusted forecast. If everything worked, we would be above the 80 billion. So we have, of course, expected setbacks to happen. Unfortunately, the results of the Cardio TTR Transform trial were not what we hoped, and they were disappointing for our team and, most importantly, for the patients we sought to help. This serves as a reminder that transformative science carries an inherent risk and that not every program will succeed. Our pipeline, however, continues to deliver during the first half, with positive results from six high-value phase III programs, including the first pivotal data for three new molecular entities, Tozorakimab in COPD, which we look forward to presenting at ERS, Epsinphotase Alpha in HPP, and as announced today, our first wholly-owned ADC, SonyV, including 18.2 positive gastric cancer. We also received eight major market approvals across important indications, including two additional enemies. We're very happy to see first approvals for EDKAMA in first-line hormone receptor-positive breast cancer with emergent ESR1 mutations in Europe and Japan and a few other countries. These approvals demonstrate the value of this innovative treatment approach, and we continue to have constructive discussions with the US FDA. We also saw USFDA approval for Bax Fendi, which has the potential to transform outcomes for patients with uncontrolled or resistant hypertension, and we continue our launch activities at pace. This, together with the more than 20 approvals we've achieved in the first half of this year, support our continued growth trajectory and strengthen our confidence in delivering the 2030 ambition. And as you will hear today, we're also working very hard and making great progress on our post 2030 growth. And with that, I will hand over to Aradhana to take you through our financials. Please advance to the next slide.

Thank you, Pascal, and good morning and good afternoon, everyone. As usual, I will start with our reported P&L. Next slide, please. As Pascal has highlighted, we delivered continued top-line momentum in the first half of the year. Total revenue increased by 6%, with product revenue also growing by 6%. Alliance revenue increased by 29%, reflecting higher profit shares from our partnered medicines in HER2, Datraway, and Tespire in markets where our partners record product sales. Next slide, please. Turning to our core P&L, core gross margin was 83% in the first half. While the margin improved in the second quarter compared to the first quarter, we expect a lower gross margin in the second half, consistent with prior years, reflecting seasonal demand patterns for lower margin medicines such as Flumist and Defortis. For the full year, we continue to expect a stable to slightly higher core gross margin versus 2025. Core R&D expense increased by 6% in the first half, reflecting continued investment in our pipeline. Following the positive Phase 2b results for oral GLP-1 molecule, Elecoglipron, we have now initiated comprehensive Phase 3 program in both obesity and type 2 diabetes with first patients dosed earlier this month. Core R&D represented 23% of total revenue in the first half, and we continue to expect R&D expenses to be at the upper end of the low 20s percentage range for the full year as we continue to build our pipeline for long-term growth opportunities, including bispecifics, cell therapies, T-cell engagers, in addition to our CBRM portfolio. Core SG&A expense also increased by 6% in the first half. During this period, we launched Bexfendi in the US following FDA approval in May, and we continue to make pre-launch investments ahead of anticipated launch of toziracumab following positive phase three data. Both medicines are expected to be important growth drivers, supporting growth to 2030 and beyond, and we are investing accordingly to maximize their potential. Other operating income was $341 million in the first six months, consisting of royalties and small regional divestitures, and we anticipate a broadly similar level in the second half. Our tax rate in the second quarter benefited from a one-time adjustment to deferred tax assets following certain internal legal entity changes. Overall core EPS grew by both 11% in the first half, in line with our guidance for the full year. 6.2 billion in the first half, a decline versus comparator period. This primarily reflects the Limparsa milestone receipt in the first quarter of 2025, skewing comparisons, as well as working capital impact associated with U.S. loss of exclusivity for Persica. We expect these working capital effects to persist through the remainder of the year before normalizing. Capital expenditure was $1.5 billion in the first half, underscoring our commitment to investing behind our long-term growth ambitions, and as previously communicated, we anticipate CapEx to increase by around a third in 2026. Key investments include our new ADC manufacturing facility in Singapore, along with several other strategic multi-year projects that will enhance our manufacturing network and support sustainable growth well into the next decade. Deal-related payments totaled $3.3 billion and included both milestone payments and the $1.2 billion upfront payment for CSPC collaboration which closed during the second quarter. For the full year, we continue to expect milestone payments of approximately $2.5 billion relating to prior business development transactions. We have announced new BD transactions totaling just over $2 billion in upfront payments year-to-date, including the most recently announced Dezell transaction. Our lease liabilities also increased as we opened our new Kendall Square R&D Center in Cambridge. Our capital allocation priorities remain unchanged. Net debt increased by around $3.5 billion in the first half, primarily reflecting the payment of the second FY 2025 interim dividend in March and the deal payments I just mentioned. We remain comfortable with our level of gross debt. As previously communicated following refinancing activities earlier in the year, resulting in higher than historic interest rate and lower interest income, we anticipate core finance costs to be higher in the second half compared to the first half. Turning to guidance, we are reiterating our outlook for the full year. We expect total revenue to increase by a mid to high single digit percentage and core EPS to increase by low double digit percentage as constant exchange rates. So to summarize, we delivered another period of strong financial performance while continuing to invest significantly in both our pipeline and our commercial capabilities. We remain on track to deliver on our priorities in the near term and support growth in the long term. With that, I'll hand over to Dave to take you through the performance of oncology business. Next slide, please.

Thank you, Aradhana. Next slide, please. Oncology total revenues grew 15% in the first half to $14.1 billion underpinned by double digit growth in all major regions. Growth in the US and Europe was particularly notable at 18% and 16% respectively. Focusing in on the quarterly performance of our key medicines, Tegrisa delivered 6% growth in the second quarter to revenues of $1.9 billion, supported by double digit growth in the US. The share of combination regimens in the first line continues on an upward trajectory in key markets, with Flora 2 remaining the clear preference. Turning to Calquence, which grew 16% in the quarter, generating more than $1 billion in revenue for the first time in a single quarter. Calquence maintains its position as the leading BTK inhibitor in frontline CLL across major markets, despite intense competition. Within the finite duration class, Amplify continues to gain share in reimbursed markets with encouraging early signs in the U.S. where it is uniquely positioned as the only BTK inhibitor with both finite and treat-to-progression options. We continue to see Amplify as a significant growth driver through the remainder of 2026, supported by the clear global trend towards adoption of finite duration treatments. Infinzi and Imgudo delivered growth of 25% in aggregate in the second quarter. Infinzi growth continues to be driven by a combination of new launches and increasing demand for established indications. Meaningful contributions from Matterhorn and gastric cancer reflect its rapid establishment as the standard of care in reimbursed markets, and in lung, Adriatic continues to be an important additional source of growth. We continue to see strong global momentum for Infinzi and muscle-invasive bladder cancer, and while the U.S. market is evolving with competitive entrants, Volga will continue to expand Infinzi's reach. Turning to Inher2, we delivered growth of 31% in the quarter and reported revenues of $888 million. Growth continues to be across all regions and reflects sustained market leadership in the HER2-positive and HER2-low breast cancer indications in major markets. This strong position is complemented by increased adoption and additional launches in emerging markets. We are seeing encouraging early signs of adoption and growing awareness in the first-line Destiny Breast 09 setting in the United States following its approval late last year. Together with the recent simultaneous U.S. approvals of Destiny Breast 05 and Destiny Breast 11 in the curative setting, these growth drivers will become increasingly important through the remainder of the year. TrueCap revenues of $233 million in the quarter represent growth of 37% over the prior year. As we've indicated previously, the majority of this growth is from ex-U.S. markets, with the U.S. opportunity at peak in the breast indication. Beyond Breast, we are looking forward to bringing TrueCap to patients with P10-deficient metastatic hormone-sensitive prostate cancer following the recent approval of Capitello 281 in the U.S., and a near-term priority is to establish testing in this setting, which today is not common practice. Doctorary revenues of $55 million in the second quarter demonstrate growing demand in later-line EGFR-mutated lung cancer, with signs of increasing utilization in the second-line setting in the U.S., We're excited for the ongoing launch of Datroi in patients with triple negative breast cancer who are not candidates for immunotherapy following the US approval of Tropion Breast O2 earlier in the quarter. Given its differentiated profile, we see this as a significant opportunity and look forward to additional market launches in the second half. With strong momentum demonstrated across our portfolio in the first half, we are well positioned for continued growth through the rest of the year as we deliver innovative oncology medicines to more patients. Please advance to the next slide. Focusing in on EGFR mutated lung cancer, Tegresso is the number one prescribed third generation EGFR TKI globally approved across all stages of disease. This leadership position is underpinned by the breadth of our clinical development plan and our differentiated product portfolio. In the first line combination setting, we've seen significant global market expansion over the past 12 months with FLORA II the clear market leader. and the highly competitive U.S. market, Flora 2 holds around three quarters of this growing segment. We were pleased to announce the in-licensing of Zygfrovi, a novel oral EGFR inhibitor earlier this month. Zygfrovi is already approved in the U.S. and China for patients whose tumors carry exon 20 insertion mutations following progression on or after platinum-based chemotherapy. Based on the Wukong 28 data presented at ASCO, filings for the first line have been submitted in China and the U.S. This deal complements our existing EGFR leadership and allows us to bring a differentiated treatment to patients with limited treatment options globally. Importantly, it's also a clear signal of our intent to remain the definitive leader in this space. I'll now hand it over to Susan to discuss some more of the specific near-term pipeline opportunities.

Thank you, Dave. Turning to the right-hand side of this slide, Our near-term pipeline readouts provide the opportunity to further strengthen our position in EGFR-mutated lung cancer with Tegresso as the backbone TKI, with two Phase III trials due to readout later this year investigating combinations in the sizable post-TKI second-line setting. Tropion Lung 15 evaluates data ray alone and in combination with Tegresso, building on the growing position data ray already has in later-line lung cancer based on Tropion Lung 05. Saffron then evaluates Tegresso combined with Orpathis, offering a differentiated combination approach in patients with MET-driven resistance, supported by the encouraging data we've already seen from Savannah and Saatchi. Looking further ahead, Tropion Lung 14 then aims to bring the combination of Datraway and Tegresso into the first line, building directly on the success of FLORA2. This represents a significant long-term opportunity to extend our first-line leadership and improve outcomes with a next-generation combination. Taken together, these opportunities represent a comprehensive strategy to maintain leadership in EGFR-mutated lung cancer for years to come. Next slide, please. I'm also delighted to share with you today the high-level results from two recent Phase 3 trial readouts. Back in May, we announced positive results from the planned interim analysis of the Phase 3 Volga trial for Infimsi in patients with muscle-invasive bladder cancer who are not candidates for cisplatin. Volga builds on our existing presence in this setting, where the Niagara Regimen has already established Infimsi as a key treatment option for cisplatin-eligible patients. Volga explores whether the combination of infortimab-vidotin and Infimsi, plus or minus Imgido, can improve outcomes for the 50% of patients who are not candidates for cisplatin. Importantly, in this regimen, infortimibidotin is only given in the neoadjuvant setting, aiming to optimize outcomes whilst balancing the overall benefit-risk profile. Infimsi in combination with Infortunavidotin demonstrated statistically significant and clinically meaningful improvements in both event-free survival and overall survival, underscoring the potential of this regimen to meaningfully improve outcomes in bladder cancer. The Imjudo containing arm also demonstrated a statistically significant improvement in event-free survival, with a favourable trend in overall survival. Volga broadens our presence in bladder cancer, enabling more patients to benefit from an Infimsi-based regimen, complementing Niagara in muscle-invasive bladder cancer and the recently US-approved Potomac indication in earlier stage non-muscle-invasive disease. We also saw positive Nile results this quarter, and whilst the landscape in the first-line setting has evolved significantly since we started this trial, it further reinforces Infimsi's value across the full spectrum of bladder cancer. Turning now to gastric cancer, we announced today positive results from the Phase 3 Clarity Gastric O1 trial, evaluating Sonicitatine, Bedotin, or Sunny V in previously treated patients with advanced gastric cancer expressing Claudine 18.2. Clarity Gastric O1 is the first Phase 3 trial to demonstrate an overall survival benefit with a Claudine 18.2 targeted antibody drug conjugate in the second line plus setting. This is a population with a particularly poor prognosis. Fewer than 20% of patients with advanced gastric cancer survive beyond one year. And at present, there are no targeted options for Claudine 18.2 positive, non HER2 positive tumors in the second line plus setting. The trial met its overall survival dual primary endpoint with Sunny V demonstrating a statistically significant and highly clinically meaningful improvement in overall survival versus investigators choice of therapy. There was also a trend to PFS benefit, which did not meet statistical significance. Critically, the trial also met its key secondary endpoint, demonstrating a highly clinically meaningful overall survival benefit in patients treated with at least one prior line, potentially extending the benefit to a broader patient population earlier in their treatment journey. Importantly, the survival data were demonstrated in patients with Claudine 18.2 expression as low as 25% at any staining intensity, a lower threshold than that required by other Claudine 18.2 targeted therapies, meaning that Sunny V could potentially benefit around 50% of patients with second-line plus gastric cancer, representing more than 180,000 patients across the US, EU5, China and Japan. Clarity Gastric O1 represents a landmark milestone for our oncology portfolio. Sunny V is our second ADC to demonstrate an overall survival benefit in gastric cancer following INHER2, and our third positive phase 3 readout in this tumor type in just two years, following Matterhorn for INFIMSI and Destiny Gastric O4 for INHER2. It is also the first phase 3 data from our wholly owned ADC portfolio, marking an important step as we establish our independent position in this space. We look forward to presenting the data later this year. Together with Volga, these data strengthen our conviction and the opportunity to combine IO with ADCs, an approach we believe could be transformative across multiple cancers. And specifically, these two readouts reinforce our confidence in Clarity Gastric O2, our first-line gastric cancer trial, evaluating Sunny V in combination with capecitabine, with or without rilvogostomic or nivolumab. 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. Our biopharmaceutical business is in a transitional period. And in the first half of 2026, total revenue declined by 5% to $11.2 billion. This reflected the loss of exclusivity headwinds for Fasiga, Pralinta and Roxodustat, which were largely offset by the growth of our respiratory portfolio. The strong momentum in respiratory was supported by our established biologics for severe asthma, which generated over $2 billion of in-market sales in the first half. Focusing on the quarter, respiratory and immunology total revenue grew by 11%. Fasenra grew 13% to $570 million, driven by its continued leadership of the Owl 5 class. In emerging markets, Fasenra grew 75% thanks to the ongoing success of its launch in China, where it entered the national reimbursement drug list at the start of the year. The SPY grew by 45% to $390 million, with strong performances in the United States and Europe being supplemented by uptake in the emerging markets. In our in-health portfolio, Brastree continued on its positive trajectory, with 20% growth to $346 million. Breast3 received its first approval for asthma this year in the United States, and last week received a positive recommendation for asthma from the CHMP in Europe. We are excited about this important new indication, which will help us bring this therapy to more patients. Semi-court revenues of $671 million were down 8% due to the price pressure in the United States, reflecting a new generic competitor entering the market. Savnello revenues increased 24% to $209 million, driven by share gains in the intravenous segment for SLE patients. The new subcutaneous formulation is now available in the US and some European markets, which broadens Savnello's reach to patients who favor self-administration. As expected, generic competition for FASIGA entered the US at the start of the quarter, and this, along with loss of exclusivity in some other markets and VBP in China, saw FASIGA decline by 90% overall, resulting in $1.8 billion of revenue for the quarter. Navigating these expected lifecycle transitions is a natural part of our business, and we remain confident in the long-term strength of our broader portfolio and pipeline. In May, we secured the approval and launch of VaxFendi in the US, and we are now building early market access through affordability programs. We anticipate commercial access for VaxFendi will broaden over the next few quarters in anticipation of Medicare Part D reimbursement from 2028. We are also making an early start on our launch preparations for Tosirakamab. We are encouraged by the data, which showed highly clinical meaningful benefits in the Oberon and Titania trials, representing a broad COPD population, and we are looking forward to bringing this innovation to patients around the world as soon as possible. I will now hand over to Sharon to take us through the latest developments in the biopharmaceuticals R&D pipeline.

Thank you, Ruud. Next slide, please. I'd like to start by acknowledging the Phase 3 CardioTransform trial for Wynua in transthyretin-mediated amyloid cardiomyopathy. This trial was conducted in a contemporary ATTR cardiomyopathy patient population designed to examine the role of Wynua, a gene silencer treatment, on top of today's standard of care in reducing recurrent cardiovascular events and CV mortality. In this contemporary patient population treated with standard of care, including 57% on a stabilizer, adding Wynua did not provide a statistically significant benefit on the composite outcome of CV mortality and recurrent CV events. However, in a pre-specified subgroup analysis of patients treated with Wynua monotherapy, as compared to placebo, fewer primary composite events were observed, and this result was nominally significant. In patients who were on stabilizer therapy at baseline, no treatment effect was observed. Although the trial did not meet its primary endpoint, we believe these results contribute meaningfully to the greater scientific understanding of treatment approaches for the hundreds of thousands of patients worldwide suffering from this progressive and often fatal condition. AstraZeneca and Ionis will analyze the full data set to further understand the results, and we look forward to presenting these data at the European Society of Cardiology Congress in August. Turning now to Alecoglipron, where we are building strong momentum into Phase 3. At the American Diabetes Association meeting in June, we presented results from our Phase 2b Vista and Solstice trials, which demonstrated the potential of Alecoglipron as a multi-blockbuster asset for AstraZeneca. In VISTA, we observed a clinically meaningful and statistically significant weight loss of up to 11.8% at week 36, importantly, without evidence of a plateau. In solstice, there was an up to 1.9% reduction in HbA1c at week 26, with the vast majority of patients with type 2 diabetes reaching their glycemic goals. Alecoglipron demonstrated a favorable safety profile with no unexpected safety signals, low discontinuation rates, and tolerability consistent with the GLP-1 receptor agonist class. It is worth emphasizing that Alecoglipron is an oral small molecule. This once daily treatment requires no fasting or fluid restrictions and critically can be combined with other oral small molecules to treat interconnected chronic diseases. Based on the strength of these data, we are advancing an ambitious Phase 3 program. EMBOLD is studying olecoglipron monotherapy in patients with obesity or overweight, with or without type 2 diabetes. The ILLUMINATE program, which includes five Phase 3 trials, Evaluates Alecoglipron both as bono therapy and in combination with dapagliflozin across broad patient populations with type 2 diabetes. I am pleased to say that we achieved first subject in for both the Imbold and Illuminate programs. Beyond these, We also plan to initiate Elevate, an indication-seeking outcomes program designed to demonstrate the value of olecoglipron in heart failure with preserved ejection fraction and chronic kidney disease on the background of dapagliflozin and other standard of care. Finally, I want to highlight a few additional advancements in our biopharmaceuticals pipeline during the second quarter. Deng and Weight Management, the Phase 2 APRICUS trial studying AZD6234, our selective amylin receptor agonist, read out this quarter, and we are now initiating a Phase 3 monotherapy trial. We look forward to sharing the Phase 2 data with the medical community at EASD later this year. In dyslipidemia, we look forward to the Phase 3 readout of our oral PCSK9, Lyraprostat, in the first half of 2027. and are advancing our first fixed-dose combination of Laraprostat with Rusuvastatin into Phase 3, bringing together the benefits of a statin and a PCSK9 inhibitor in a single tablet. Moving to our respiratory portfolio, we are excited to present the highly clinically meaningful results from the Oberon and Titania Phase 3 studies for toziracumab in COPD at the European Respiratory Society Congress in September, highlighting the compelling profile we have seen for this potential first and best-in-class asset. We have also made exciting progress in other areas of our respiratory portfolio this quarter. Our inhaled T-slip, Sunacament, which was formerly referred to as AZD8630, read out its Phase II study, and we are discussing plans for Phase III with our partner, Amgen. Additionally, we entered into an exclusive license agreement with CTTQ, A subsidiary of Sino Biopharmaceuticals for the development, manufacturing, and commercialization of TQC3721, an inhaled small molecule PDE3-4 inhibitor currently in Phase III trials in China for COPD. This licensing agreement strengthens our respiratory portfolio with a novel inhaled option for people living with COPD. A disease with continued patient need, particularly for those who remain symptomatic despite existing treatment options. And with that, please proceed to the next slide and I'll pass over to Marc to cover rare disease.

Thank you, Sharon. Can I get the next slide, please? Rare disease total revenues grew by 11% in the first half to $4.9 billion. Underpinned by double-digit growth, access all key medicines. This is driven by increased patient demand and continued global expansion following launches. In the second quarter, Ultomerase grew 12%, driven by patient demand across indications, including the competitive MG and PNH markets. Solaris revenues continue to decline due to successful conversion to Ultomerase, as well as biosimilar pressure. Strensic grew 36% year-on-year, reflecting strong patient demand. Strensic remains one of AstraZeneca's fastest-growing blockbuster medicines, supported by ongoing investment in commercial capabilities, infrastructure, and disease awareness. These investments are driving continued growth today, while also laying the foundation for the potential launch of the Sinsotez Alpha and future franchise growth. Cosilugo continues to deliver strong global momentum supported by expansion in adult patients with NF1PN and uptake of the granule formulation in recently launched market. Cosilugo remained the market leader for pediatric patients with NF1PN. Overall, we continue to see great momentum across the rare disease portfolio and please advance to the next slide. Turning to our rare disease pipeline, we have continued to build momentum with phase three data presentation across rare disease indications, highlighting the breadth of our portfolio and the strength of our late stage execution. In IgA nephropathy, phase three data from the ICANN trial for Eltomiris showed a 43% reduction in proteinuria, a significant proteinuria reduction seen as early as 10 weeks. Importantly, treatment effects were consistent across patient groups, including those at higher risk of progression and with more inflammatory disease. While IGAN is becoming an increasingly competitive treatment landscape, the heterogeneity of the disease underscores the importance of multiple treatment approaches, and the data we presented at IHRA further support the role of complement in disease pathophysiology. The IGAN opportunity represents an important step in the continued expansion and development of our C5 franchise, building on Ultomerase's established leadership across multiple complement-mediated disease. We have now filed in both the U.S. and Japan. For insulfates alpha in apophosphatase A, data from our Phase III pediatric trials, Mulberry and Chestnut, were presented at the International Conference on Children's Bone Health in June. Mulberry demonstrated clinically meaningful improvement in bone health, function, and quality of life. In her single-arm switch safety study, Chestnut stored in Sphinx for Desalpha was well tolerated and demonstrated a favorable safety profile in pediatric patients. In a pooled analysis of the phase III Mulberry and ECORi trials, including pediatric, adolescent, and adult patients, treatment with Synthetase-alpha resulted in a median of 361 days per year free from injection site reactions. And injection site reactions rates were five times lower than with Strensic. Data from the ICORE trial will be presented at the American Society for Bone and Mineral Research in October. We are progressing filings across major markets to support a broad SPP patient population. Also data from the Calypso phase III trial was presented in May at ECE. Enaboparatide demonstrated maintenance of serum calcium within the target range. Normalization of urinary calcium and restoration of normal bone turnover in patients with HEPO parathyroidism. Encelamimab in Kappa light chain amyloidosis patients results from the CARES program demonstrated a 62% reduction in all-cause mortality and a 71% reduction in cardiovascular hospitalization with an overall survival benefit observed even in patients with advanced myostasis disease. Taken together, this program illustrates the strengths of a rare disease pipeline with multiple near- and mid-term catalysts with potential approvals and future launches across several high-value rare disease indications. And finally, an update on our phase 3 trials in adults with thrombotic microangiopathy after LCT, high-level Results show that Lutomeris did not achieve statistical significance for the primary endpoint of even free survival through 26 weeks compared to placebo in adult and adolescents aged 12 years older with ACT-TMA. Lutomeris showed a trend towards treatment benefit and discussion with health authorities are ongoing regarding the interpretation of this data, including in the context of real-world evidence. In pediatric patients, which is CT-TMA, we are advancing regulatory filings based on data from the open-label phase 3 trial reported in 2025 and data from an external control study. As pioneers in complement biology, we continue to explore and advance treatment approaches in disease where complement is believed to play a central role in disease pathophysiology. With limited treatment options available today, It reflects our ongoing commitment to bringing innovative therapies to patients with severe complement-mediated disease. And with that, please advance to the next slide, and I will hand back to Pascal.

Thank you, Marc. Next slide, please. As the slide shows you, we carried strong momentum into the first half, six positive program readouts already delivered and a rich catalyst pass ahead. Over the next 18 months, we have 25 key phase 3 trial readouts that are planned, giving us multiple opportunities to add further value and conviction to our trajectory. We expect pivotal data readouts for six new molecular entities in 2027 alone across our portfolio. Some of them are really important, as you can see here, and for instance, Saruparib is a big one, but there are many others, very important readouts over the next 18 months or so. So move to the next slide. Our growth ambition extends well beyond 2030, and we continue to invest behind the transformative technologies that we believe will redefine how many diseases are treated. If you remember, back in May 2024, we identified platforms that we said would drive our growth post-2030, what we called at the time, the day after tomorrow. And I'm pleased to say that we have made very good progress across many of these platforms. As you can see here, the slide highlights the momentum we're building in our next wave of innovation. So if we start with weight management and cardio risk factor, As Charlotte mentioned, we expect the first phase 3 data for laroprostat in the first half of 2027 and we have now initiated five phase 3 trials for Helicoglyprome. So you can see here our portfolio is building both scale and optionality and focused on not only weight management but the risk factors that accompany excess obesity, in particular abdominal obesity. In ADC and radioconjugates, we continue to make strong progress. As highlighted today, we've just had the first positive phase 3 readouts for SunnyV, and we anticipate phase 3 data for our second wholly owned ADC, FuxiSan, next year. We also continue to advance our broader program, having those patients in our first phase 3 trials for Torvusam and also for Zadagu this quarter. So very good progress across ADCs and radioligands. For our next generation by IOBA specifics, we now have 16 phase 3 trials across 8 tumor types, including 5 in combination with our ADCs. This supports our ambition to replace the current generation of checkpoint inhibitors. Our Cell Therapy and T-cell Engager portfolios are also advancing very rapidly.

AZD-0120 and Serovatamig, both have multiple phase 3 trials underway across hematology, and importantly, both now have extended into autoimmune diseases, underscoring the broader therapeutic potential of these platforms. Very exciting progress across those two products. Beyond these lead programs, we are also investing behind off-the-shelf and in vivo cell therapies, which we believe will enable us to reach more patients across more disease areas. These programs continue to advance and are key components of our deep legislation pipeline of multi-blockbuster opportunities that will underpin our next wave of growth. Let's move to the next slide. The strength of that opportunity is reflected in this slide. We have three recent launches, Datraway, Adkama, BaxFendi, each with PQR revenue potential of more than $5 billion. Beyond it, today we have pivotal data before 2030. Thank you very much. A good example of this is the strong data we obtained for TozoAkima, a product that very few people thought was going to work. We ourselves had a low probability of success for it. We tried because we thought we have a different mechanism of action and we have a chance, and it actually worked. You will see the data very soon. As a result, we have increased our peak revenue expectation to more than $5 billion. In addition, with a positive readout for Sony V today, we estimate that this ADC could reach PQR revenue between $3 and $5 billion. This is an example of the strengths and the diversification in our pipeline. The likelihood that there will be puts and takes is part of how we plan. We've taken this into account in our growth ambition beyond 2030 as well. We have built what we believe is one of the most exciting pipelines in the industry, one that can now more than offset losses of exclusivity and fuel as Strasbourg grows well into the next decade, including as we move to the next slide. I'd like to say that we delivered strong growth in the first half. Again, 11% excluding Farciga. And in Berlin, that shows you the strength of the pipeline and the geographical footprint. 6% growth overall. And so, strong growth in the first half. The breadth and depth of our pipeline remains exceptional and our confidence in reaching 80 billion revenue by 2030 is intact. But what excites me most is what comes next. Stage development and transformative technology, platforms scaling rapidly, We're building a company that will not just deliver on its 2030 ambition, but continue to grow well into the next decade. We have the science, we have the pipeline, and we have the team to make that happen. And with that, please advance to the next slide, and we'll move to the Q&A. As Joris mentioned at the start of the call, please limit the number of questions you ask to allow us a fair chance to participate. Please use the raised hand function on Zoom. And now let's move to the first question, who actually is from Radjan Sharma at Goldman Sachs. Radjan, over to you.

Hi, thanks for taking my question. Firstly, just on the oral PCSK9, which you highlighted there, could you just outline your expectations ahead of the date next year? Thank you for joining us. Thank you very much, Aradhana. Maybe Ruud could take the first question and David the second one? Yes, of course, Pascal.

Overall, I think we are excited about our RPCSK9. We will see the first data reading out in the first half of 2027.

I think we will have, and hopefully we will have a competitive profile versus the compound of Merck. But I think the breadth of our portfolio for cholesterol lowering medicine is broader than only the oral PCSK9. As Sharon has mentioned, we have started the first combination with rosivastin. I think we have a unique opportunity because it's the true oral medicine. Thank you very much. Thanks, Ruud.

So just picking up on the question about SunnyV and Clarity Gastric, and after I'm done, turn it over to Susan who can talk a bit more about the life cycle plan beyond CGO1. But we're very excited about these results and look forward to getting an opportunity to present them soon. Specifically, the CGO1 Thank you very much. Secondly, as you saw, overall survival being an absolute gold standard within a set of well positions. Sunnyview for uptake upon approval, and we expanded the definition of Claudine 18-2 positivity with the cutoff that we're using in a study, and that cutoff is greater than 25%, and that represents about half of the patients with gastric GEJ cancer. So it's a great opportunity and one that we're really looking forward to getting an opportunity to launch as quickly as possible. Susan, do you want to talk a little bit about the life cycle plan beyond CGO1?

Yes, so obviously in the first line there's an opportunity to combine with IO agents, as I've discussed, we've both got to make a plus backbone of ketocitabine. And the Clarity Gastric Code 2 study has two cohorts, one in the PD-L1 greater than 1%, but also has a cohort in the less than 1% where we're looking at Silly V plus 5-FE based regimen versus the standard of care as well. So I think that gives us an opportunity to have a broad first-line opportunity to have that IONADC combination in the relevant patient population. And it is a big segment in gastric cancer. And then again, I think there are opportunities to consider based on the data that we've got in the master form, whether there's an opportunity to go into the earliest, not just experts on gastric cancer, but also on cell Pancreatic cancers and biliary tract cancers, and we're exploring those in our ongoing phase one. I'm encouraged by the data that we've seen today. So I think this can be a broad program for CERN-EV across all of these GI-based cancers.

Thank you, Susan and Ruth. Maybe one thing I could add to the PCS-CAN-9 is that Another fixed dose combo we are developing is together with medical glipron or glipronol. Because if you have elevated cholesterol, typically you also need to lose a bit of weight. This is a good example of how we can differentiate our PCS cannabinoids to differentiate our glipron by providing a convenient The next question is, I think, Richard.

Yes, Richard. Thanks, Pascal. One question, please, on camicestrant. Now we've seen the Persevera data in detail, I don't think when we last spoke we'd seen it. Could you give us your latest thoughts around How 3 and 4 could differ in terms of patients enrolled and how that impacts your thinking around potential benefit of CAMI, what it could deliver in the trial. And does the data you've seen change your view of the importance of endocrine sensitivity for generating a benefit? And how endocrine sensitive do you think you have in the trial? Thanks very much.

So thanks for the question. So as you said, the goal for Serena 4 is to enrich for endocrine sensitivity. Again, as a reminder, we have a larger sample size, 1370 patients enrolled compared to Persevera. And I think what we've seen with the Persevera data is evidence of activity which varies across the different subgroups that are I can't comment on the exact subgroups today. Obviously, you know, we're anticipating a trial readout in the second week for that readout to really see. But again, we have striven to enrich for that endocrine sensitive population. We're happy with the Serena 6 data is the overall tolerability profile that we've seen with camisestrin, low rates of GI, side effects that are seen and a very low discontinuation rate. Good tolerability overall in that trial. So I think we have to wait and see at this point. That's why we run phase three trials and we're very happy to share the data with you as soon as possible.

Thanks, Susan. Next question is from Simon Baker at Redburn. Simon, over to you.

Thank you Pascal. One if I may on some of the Zirtonib. The profile based on the data we've seen so far looks very impressive indeed against the competition. I just wanted to get your perspectives on how you see the profile of some of the Zirtonib in that setting and also the significance or otherwise of the far loop versus near loop mutation performance. It appears to be particularly differentiated On follow, is that a significant factor or is that less important than perhaps it might seem? Thanks so much.

Okay, so you're talking about Zeprovir. Pascal, do you want me to take this one?

Yes, please, if you don't mind.

Okay, so Zeprovir is obviously the asset that we've licensed from Diesel for 820 mutations in a group of mutations that are non-classical as well, which is about a similar size patient population. So I think what the profile is that we see overall, first of all, it's potent against the exon twins. It's delivering this high and durable response rate there and really has differentiated activity in that second line setting. which has already provided the label that we've got in the US and China. In the first line setting, the data rotation asker, if people want to have a look at that, and that will form the basis of the filing in the first line setting. So, you know, we look forward to having discussions with the regulatory authorities given a high response rate that we've seen in really good progression-free survival, which was obviously the primary endpoint in that randomised trial. So, yeah, I think if you look at that compared with the other competitors in this space, it's, you know, all easy to administer at home. Other agents and other potencies are also competitive. So, again, we're excited to have this as another example. Thank you, Susan.

It may be good to hear also from Dave telling you about what we're trying to do to solidify the Tagrispo franchise because we're under, of course, two major competitive threats. One in China, which is the multiplicity of EGFR in the market, a very competitive market. We're doing well, but it's competitive. and the second is of course Mariposa Regimen, which again, you know, we are still doing well. As Dave mentioned before, market share is still very strong for Tagreso. But beyond that, we are actually trying to build a variety of ways to differentiate Tagreso. So maybe Dave, if you can give us the whole picture again, that would be useful.

Let me use this as just an opportunity also to comment that the strength of FLORA2 is really laying the foundation right now for the expansion of the clinical development plan to build off of the combination approach. to a Tegrazo backbone in order to improve outcomes in EGFR mutated lung cancer. And as Susan quite nicely articulates, Zegprovi adds to the group of patients that we now have an opportunity to be able to engage physicians about and offer I think just very, very importantly, you know, we're seeing double digit volume growth and in fact, double digit revenue growth in the U.S. in the face of the competition with Tigristo right now. What that's allowing us also then to do is get ready for both the DADO and the ORPATHOS combinations, which we're looking forward to. I think that with DADO, obviously, we've got tropion long 15 in the later lines and also tropion long 14 in the frontline setting. I think relative to what we see with the other Trope II class players, this is a very differentiated position of having the tigrisol combination as a way of bringing this set of therapies into these settings. We've got saffron on the horizon, and that's with your pathos combination. And we are very enthusiastic about Tigriso continuing to be an important driver of growth and contributing meaningfully to the 2030 ambition that we've laid out.

Thank you, Dave. So this is a very good example of what we've told you before. The ability we have to combine products throughout our portfolio to defend our various franchises and build beyond where we are. And then with the addition of Zexprovi, we are also addressing a gap in our coverage of this VGFR market. So you can see we are really reducing the space where the competition could actually have an impact over time. So the next question will be from Sarita Kapila at Morgan Stanley. Sarita, over to you.

Thanks, Pascal, for taking my questions. On Vansar, we noticed it has the PFS and OSN points in both TROG2 positive and ITT populations. Could you give us any more colour on the testing hierarchy? So, for example, are you looking at PFS and then OS in TROP2, followed by PFS and OS in ITT? And what is the minimum outcome that would be filing, enabling? So, for example, would a PFS win in TROP2 positive patients be sufficient without a clear OS benefit? And just a quick one, taking a step back. How should we think about DATCH-OASIS profile versus SAT-TMT, particularly post the positive OCTU-TROC-LUNG-06 data and ahead of the PD-L1-VEGF data in 2027? Thank you. Thanks, Arianna.

That's a good question. Two good questions for you, Susan.

Okay, thanks, Pascal. Thanks for the question. So, as a reminder, what we previously said about Avanzar is that we have Both the ITT and the biomarker positive patient populations at the top of the multiple testing procedure for the ITT or in the biomarker positive group. So I hope that answers your first question. Obviously, regulators will be interested in the effect size, the meaningfulness of the differentiation between those groups in discussion from the competitors. I think we have a best-in-class choke-tip-based ADC based on the design, which is based on the stable linker. And you can see that based on the half-bite of the molecule and also the lower rate of bone marrow toxicity because you see higher rates of bone marrow toxicity with AD, so more exposure to the free payload. That, I think, underpins the data that we've seen in the triple negative breast cancer where we saw differentiated activity with higher response rate, progression-free survival, and leading to overall survival in that first-line triple negative breast cancer. So that underpins our confidence and the design of this ADC. I do think that the data that's been seen from the OptiTrop trials in lung cancer underpin the potential of line setting in combination with IO. But I think given the design that we have of the molecule and the design that we have of the advanced study with the ability to look in the ITT and the biomarker, we have the ability to be first into the first line and to be best based on those combinations and that differential. Thank you, Suzanne. Next question is from Gonzalo Atias at Danske. Over to you, Gonzalo.

Hi, thank you for taking my questions. I have one for Sharon and one for Mark. For Sharon, on Ketamitug, your TTRB clicker, I know that the study with Ketamitug monotherapy keeps moving as planned, but could you give us some color on how you are seeing this back moving forward in case the phase 3 hits the line? Is it something that you could I'm just trying to figure out what you're thinking from today. Question on Strensic for Mark. You guys are confident on these 3 to 5 billion big sales for S-Infotase Alpha based on the results presented so far. But I was wondering if you could give us some color on the dynamics across commercial regions expected between Strensic and S-Infotase Alpha. How should we expect the two playing out in the market?

Thank you so much. There was probably two questions for Mark, actually, because Claire took his developer direction. How about you, Mark?

Thank you for the two questions. So let me take the first one. So to your question on the add-on design. So the trial we're doing on Triramidig is as an add-on to either stabilizer, Afamidis or Acoramidis, and Salamisus. So the trial is not done as a monotherapy. What is very important to understand is the difference of mechanism as the class indicates. Tiramitug is a depletor and therefore depletes the amyloid burden in the tissues, the amyloid plaque in the tissues. This has been confirmed during our phase 1B studies over one year for Tiramitug. We have also read across from another product that We have seen on this product a very clear outcome benefit both on mortality as well as cardiovascular events following cardiac remodeling as well as improvement of many, many cardiac functions. So it's not the same disease exactly, but we have We look forward to demonstrating Again, the same benefit, improvement of cardiac model improvements and outcome benefit in both full-cause mortality and cardiovascular sputumization, and we look forward to these results. To the second question on Stransic. So, Stransic today has been on the market since 2015. We do not have a very wide coverage, and I think this is what the experience is going to bring us. It's going to have a much wider coverage in terms of countries. Possibly, we will have a wider coverage Label, Dan Strancic, but this remains to be discussed with regulatory authorities. What is the big difference between those two products is the greater tolerability of L-synthase, which is, I remind you, administered every two weeks instead of administered either daily or every other day. So there is a big difference for the patient's utilization. And in terms of tolerability, just to give you some numbers, Patients who are on a syncytosis alpha basically have five days of injection-style reaction on average in a given year. And this is many times lower than what is experienced with Strensic. We also know that the retention of Strensic is often impacted by this issue of tolerability. So that's why we are really confident that this field study will grow in terms of number of countries, in the breadth of patients, and also in the retention of patients once they're on therapy.

Thank you, Marc. And maybe going back to Clarmitu Gonzalo-Yussif from Marc's response, that Clarmitu can be used as monotherapy, but it can be used on top of... Vitricyan can be used on top of stabilizers. Of course, we'd have to show that it adds something, but that's potentially a broad use for this agent. Hi there, thanks for taking my questions.

One financial, one pipe. So financial, can you talk about balancing the investment in pipe and launches that are at the top two versus delivering margin expansion? So as we think about 2H26 and 2H27 cost growth, is 1H R&D SG&A cost growth at 60% a good proxy? Or should we think about acceleration into second half this year and into next year? And then quick hits on 1H1B27. So Canberra won the SWITCH study due next year. Perhaps, Susan, you could just talk to me about how you think about the probability of success in that study. Relative to Serena 4 and where it sits on the endocrine sensitivity continuum. And then one for Ruud, Farsiga Lifecycle Management. Just a simple question. You've got substantial peak sales of almost 10 billion across the various fixed dose combos. Consensus basically has nothing. Where do you think consensus is missing?

Thank you. You're very ambitious with many questions, but we like ambitions. So maybe I'll ask I could cover the first one, then Susan, and then Ruud. Is that okay, Aradhana, will you start?

Great, thank you, Sachin. So, for 2026, we've given, obviously, our revenue and EPS, and we give, I think, enough detail on other line items, as you've seen, whether it's on R&D or some of the other moving parts on gross margin and other income, etc. So, I I think for 2027, we will obviously give guidance for 2027. At the beginning of 2027, we will start our sort of annual budgeting process in a few months. And as you know, there's a lot more readouts still to come and investments still to make, whether it's on POSO or we'll see how some of the other events read out. So all of that is going to be part of our planning. and we base our guidance for 2027 or any year we base our guidance on our budget and on our planning process and we'll give more view on that when we do that early next year. Susan?

Okay, thank you. So thanks for the question about Cambria-1. Just as a reminder, Cambria-1 is an extended adjuvant trial in patients with intermediate to high risk of hormone receptor positive and HER2 negative breast cancer. So it's already been well established that extension of duration improves outcomes. By taking patients who've completed two to five years of adjuvant endocrine therapy with or without CDK4-6 inhibitor, which is this switch design, and randomizing them to continuation of AI or endocrine sensitive patient population, The patients that have got higher risk factors will likely have progressed through that initial period of adjuvant treatment. And by focusing on the intermediate or high risk, we're taking out those patients with low risk disease. were likely already cured with current standard of care. So I think it does select for an endocrine sensitive medication has already been proven with other trials. So I think from that perspective and given the profile that we've seen with care recession in terms of tolerability and efficacy within the 6th study, I think it has a good probability of success together with the data that we've seen from our competitors in the

Okay, thanks Susan. So let me quickly address the question regarding the combinations. We have currently three combinations in development. All those combinations are addressing the patient populations where there's a high risk, where there's almost no current treatment. So if I take Zibodepa as one example, it's in phase three. It has recruited very fast patients. are clearly showing the high medical needs in proteinuric CKD. Those patients are very ill, their kidney function is declining, and we know the beneficial effects of dapagliflozin, and on top of that, we hope to see a beneficial effect of NFC in receptor antagonists. The other one is Belcidepa in heart failure patients with a low EGFR, where mortality is very high, normally twice as you see normally in a heart failure patient, and there's no data available. So again, it's a highly, highly risky patient population. The estimates of the epi data show that more than 12 million patients in the top eight markets are eligible for a treatment like this. It clearly shows the potential if the study is reading out. Both of those figures, combinations, we're expecting to see data in the first half of 2027. And last but not least, back to the stats. and the combination with Depthyliflozin. Also that is in a high-risk population in chronic kidney disease and hypertension, so for the development of chronic kidney disease. And we hope to see a slow down of the progression of kidney disease, so again, a high-risk patient. And I think not everyone is, let's say, addressing and seeing the potential of all those new combinations. Those are really new molecular entities if they are successful. So I think building on the massive experience we are having with dapagliflozin, 60 million patients are currently treated with dapagliflozin. I think it's the backbone Thank you, Ruud. I did not realize we had many more questions in the line. So if we can stick to one question per person, that would be great. Graham Parry at CCTO. Thank you, Graham.

Grandma, are you on mute maybe?

Great, yeah, thanks for taking the question. So I had one on SNPT's office, they said you're filing for a broad label. Can you confirm that that does include adults? And is that based on any discussion with regulators to date, the acceptability of the Hickory trial and the trend benefit in the paediatric onset adult population? And does the three to five billion cells include the adult population or is that just in paediatrics? Thank you.

Thank you very much for the question. So the broad population, so the findings will be above two years of age for a broad population, as I said in my prepared remarks. This has been done in discussion with regulatory authorities. But obviously, we need to look at the details of the three studies that we have completed. To your second question, the adult population is segmented into two parts. Adult with pediatric onset, which is in several countries already obtained with SYN-seq. and adults with adult onset where Strensic is not approved today. The second question on the 3 to 5 billion, even if we get less than the totality of the label that we have filed for, we expect to be within the range of 3 to 5 billion. Thank you, Marc.

Next is James Gordon, Blacklade. James? Maybe I'll mute James.

Can you hear me?

Yep.

Great, thanks for taking the question. Pascal called out seruparib, so the selective part from prostate cancer, where we're getting data next year, and it has been described as a 5 billion plus product. There was some excitement about the asset a few years ago, but then it wasn't partnered with Merck, and maybe there was a thinking that Limpaz is a pretty high bar to beat. So how does that need a lot of other trials to work, and how excited are you about that readout? and then if I can squeeze in a quick clarification so other operating income or OI so the updated 2026 guidance implies higher OI and higher OPEX and then you're reiterating the guide because you're reinvesting the higher OI but how much of this year's OI is ongoing versus one-off so is that going to create a headwind next year when you don't have the OI or as most of this year's going to repeat together next year's from an ongoing source.

Thank you, James. Susan, do you want to cover the Syrah Parag question? I mentioned it, James, just as an example of many projects in a pipeline that nobody talks about. We seem to be facing an almost obsessive focus on two readouts that are important, of course. I don't want to underestimate them. But I just wanted to highlight the fact that we have many, many more projects. And what we showed you today are only the most important ones. And South of Paris is certainly one of the most important ones as well. Susan, over to you.

Thank you. So, as you have seen from the clinical trials appendix, there's a significant effort that we've got with soroparib in prostate cancer. One of the key trials is the Evapar Prostate O1, which is a metastatic common sensitive prostate cancer, including both the HRM and RNA. We already have seen from the Propel study in a later line that we do have activity for PARP inhibition. in combination with antireceptor inhibitors. And what we've done is taken the learnings from the PROPEL study and moved this into an early online setting and powered the study for both the HRM and non-HRM. and of course, having seen data sets coming out, I think there's significant opportunity in this setting to improve the tolerability profile, increase the potency of inhibition on POP and see benefits in both those subgroups. You will recall that we did see a positive effect on PFS in the IHRM data set. There was a lot of discussion at the with the design of this study, and I think that's a significant opportunity. But it's also backed up by other studies, other segments in prostate cancer and also in the evapar breast opportunity as well. So when you look at the totality of this opportunity, it is significant and definitely in the $5 billion range, and we're excited to see it.

Let's start with this one and revisit it at the end so we give everybody a chance to ask one question and we may have a chance to cover it as part of another financial question. The next is Christopher Woodard-Sebb. Christopher, go ahead.

Hi, thank you very much for taking my question. I guess this one would be on Beck's Fendi, noting that you have the primary aldosteronism trial reading out next year now. So today screening for aldosteronism is not really active, so What are you doing to try to ensure as rapid a rollout that that would not be a break on your launch? Thank you. Sean, you want to go first?

Sure. So first, I'll say thank you for noticing the potential for Baxter stat in primary aldosteronism. This is a really important and unmet medical need. It's really a group of disorders in which aldosterone production is Thank you for joining us. The first approved aldosterone synthase inhibitor with an excellent treatment profile or target product profile. And we think that this is going to be pivotal in helping to drive uptake now that there is a recognized therapy that addresses aldosteronism. So we're running that study. And as we have disclosed, it has accrued very rapidly. So we're accelerating that timeline for primary aldosteronism. I'm excited to see the interest around Vaxfendi as a leading molecule. So increasing uptake will, I think, follow through naturally from what we hope will be a positive data set. And the rapid recruitment that we're seeing for our studies really speaks to the major medical need and the general enthusiasm of the clinical community.

Thank you, Sharon. Peter Verdult at BNP.

Thanks people. Two quick ones, Pascal. One for Ruud. Are you anticipating any competition here? The reason for the question is we're hearing Sanofi in Nepal and Regeneron might not undertake. and the third faith-free study that would be required for approval in light of your data and probably the fact that you now enjoy a three-year head start. So first quick question on Tozzo and then secondly the obligatory sort of MFN pricing question. When you think about CAMI approval, how have your thoughts on pricing strategy evolved if we compare it to historical precedents like Calquence and DeGrisso? Thank you.

Thanks, so do you want to cover the L3COPD question and we return to the MFN pricing at the end?

Yeah, for sure. Now, I think, Peter, it's a fair question, but it's too difficult for me to answer this one because I simply don't know what Roche or Sanofi are planning to do. What I can tell you We really believe that the mechanism of action is This is very specific to our NKL33. It's the anti-inflammatory pathway, but equally the mucus pathway. And I think that combination makes this a quite unique molecule. So let's see how the competition is going to react to the data. But of course, we keep a close eye on it.

Thank you. What's Steve Scott's comment?

Thank you very much. Pascal, you have been bullish on China for years, although headwinds were clear in the quarter. All things considered, are you as confident as you have been in the past? And how threatening are the local companies on the global stage? and just a very brief question. Should we view it as possible that Serena 4 and Avanza are presented at ESMO? Thank you.

Thank you, Steve. So I'll go to the first question and we'll return to the S4 question at the end. China, you know, still very bullish for reasons that have evolved, I must say. I mean, the potential in China is still large. But on top of it, the innovation potential is also enormous, as you've seen from the various deals we've made, but also other companies have made. Today, Chinese companies are innovating at great speed, and they tend to partner with global companies like ours to globalize the development and the commercialization. But, you know, it's reasonable to expect that over time they will expand globally. Expanding globally is not that simple, right? I mean, because their profitability in China is not that high. The prices are low. So if you don't have a very strong domestic business from a profit viewpoint, it's not that. So what we're doing is collaborating, but we're also competing. You saw the... Competition in the Tagreso market is very, very intense, and the ADC market is very intense too, so we learn to compete with them, and suddenly we take those learnings globally, when they become global companies, if they do. We're also learning from them in terms of how they develop products, and how fast they operate, and We've made some changes in the way we operate. For instance, Sony V that we announced this morning is a good example of the role our Chinese team has played in the speed development of this product. So I think being present in China, very present and strong, enables us to collaborate with companies, learn from them and, you know, learn to compete as well.

So the next one is Colin White at UBS. Hi Colin, thanks for taking my questions. I had a quick question on the C5 franchise. I was wondering if you could talk about how much you expect to be impacted by the longer acting C5 and then just quickly if you could comment on before the sabotage in the US, the possible outcomes of that, that would be helpful. Thank you. Thank you.

Mark, do you want to cover the C5 question and we'll cover before the sabotage a little later? Yes.

So obviously there have been a number of competitors against the C5 franchise. We continue to grow, but obviously a novel mechanism or similar products from the C5, complement biology also, will compete with us. What we have been doing with Lutomir since the acquisition of Alexion was also to explore and buy media. We are going to continue doing that. I mentioned today IGAN. We saw the results in HTTMA. We have other trials such as the Delay Graph Function. And then we will be developing several other areas in the renal rare disease, but also with other nodes of the complement biology to Thank you, Marc. And as you can see, I mean, long acting could have a place, of course, but you have to develop every single one of those indications. So it takes time and it takes money.

Our next question is Michael Lushton and Jeff Rees.

Thank you, Pascal. Maybe if I could just go back to Aradhana on the other operating income questions that we have covered. How much of that is sustainable going forward? How much does the higher run rate cost and the higher base that makes 27 a little bit more challenging? Thank you.

That's great. Aradhana, you got your question.

So, again, we don't provide the split of other income, but there is a portion of that, obviously, that is relating to royalties and some milestones that we get. And then there's a portion for this year that also relates to, like I said, smaller projects. regional divestitures we've done again as we as we clean up the portfolio and all of these are small legacy products that we continue to sell and insist and will likely continue into 2027.

Thank you, Anna. So if we return to the, sorry, there's a question from Seamus, go ahead.

This is Zach Dunn on for Seamus Fernandez. Thank you for the question. I just want to touch on BD. More specifically, is the current phase 3 pipeline sufficient to deliver a stable profile during the main patent expiration period in 2032 plus? It seems to us that the current pressure on the multiple Thank you. Thank you. Thank you.

The aggregate probability of success across our pipeline of new products will be at least as we planned. Because again, there's no one or two projects, it's the aggregate view of the pipeline. And if you look at that, The average probability of success across Phase III for the industry is 60-65%. The aggregate probability of success It's around 60%, so we are more or less planning as if we were going to develop the industry average, in fact a little bit lower, but we have consistently developed higher, Aradhana mentioned 75% to us, it has been our record, so if we deliver what we have in our plan as a probability of success, and more and then we actually don't need more BD so the reason we don't need more BD is really to continue planning long term and continuously strengthen our franchises the most recent one we just talked about is How do we strengthen the net? The net is no, we don't need new media to achieve this goal. I don't know where this idea comes from, probably from people who haven't analysed the pipeline in detail, I have to say. Luisa Bernberg, do you want to go ahead?

Thank you very much, Pascal. So at the start of the year, you highlighted over 10 billion combined and risk-adjusted peak sales from the 2026 readouts. And today we see a couple of increases in Tozo and then Sonny B., and also hearing consistent messages from Susan on Serena 4 and Avanza are kind of balanced and consistent. So does that guidance still stand or have there been some risk adjustment changes maybe that were negative for the cohort? Thank you.

No, you're talking about the 2030 targets, right?

No, the 10 billion peak self-potential from the readouts this year, 2026. Oh, okay. The slide you had at the full year. Aradhana, do you want to go over this one? Yeah.

Sorry, so the 10 billion... was the peak year estimates with the risk unwind. So what that means is as risk unwinds for the 2026 cohort, we were still, we would say 10 billion. Now, some of them have unbound in a positive manner, like I told you. Some of them have unbound in not so positive manner. All of those being probability adjusted, I still think we will unwind close to 10 billion. Now, that 10 billion is not a 2020-2030 number. That's a peak year sales number. And the peak... For some of these products may hit beyond 2030.

The one thing I would add to this is that, you know, our probability of success in our risk-adjusted overall forecast, the probability of success we gave to Tozo was on the low side.

And I'm sure you will agree with that. Nobody thought it was going to work.

We saw it had a good chance, but we still gave it a low PTS. And then we had a higher, sort of a good PTS for Windwell, more industry standard because, you know, we had good reasons to believe, based on what the entire cardiology community was saying, good reasons it was going to work. So the end result is we've unlocked Tozo, and so the uplift in sales is much higher than the downlift in sales from Wenua, if you consider the low PTS we had for Tozo. That's one, and two is the profitability of Tozo is higher, we own this product 100%, whereas with Wenua we were going to share it with our partners at Ionist. So, you know, clearly we gained more with Stodon than we lost with Renoir. I think maybe we'll take, that was the last question, so we'll take the questions we left sideways. And maybe, Dave, you could cover both the MFN impact on the pricing of Capitani and also the question about S4 will be addressed more.

Thanks, Pascal. Well, on the second question, we will present it when we have our high-level results at whatever Congress we can make it to. So we're not going to be able to comment more specifically than that in terms of where we'll see the presentation of that. On MFN, we don't give brand-specific pricing commentary. Thank you for joining us. With payers in the wealthy nations within that context, with CAMA specifically, we're still early in the commercial life cycle in the markets where we have approvals, but the early negotiations are reflecting this new reality. Funding for innovation needs to rise in line with the country's GDP per capita. We do anticipate that these discussions that are going to take more time than perhaps sometimes in the past. But we do think that so far the objective that was set by the U.S. for prices and wealthy nations to come up and U.S. prices to come down a bit We think is the direction of travel.

And as far as ESMO?

Yeah, I commented on that at the beginning and said we will share when we have the data, but the timing of the Congress will be.

Okay, thanks. And the last question is before, but before.

Yeah, Pascal, there's not so much I can comment on this one. As we mentioned in our legal disclosures, we started an arbitration process regarding a fortress in the United States. And as we normally do, we are not commenting on either an arbitration or legal procedure.

Thank you, Ruth. We'll close the Q&A here. Thank you so much for your great question. And in closing, thank you for joining us, for your interest in our company. And also, we restate that we are firmly on track for our 2030 goal, but also Thank you and have a good day.