Joris Silen
Head of Investor Relations
Replay available
AstraZeneca (LSE:AZN) Q2 2026 earnings call, held 2026-07-27. Watch the replay and read the transcript on 6ix.

On 6ix: 6ix.com/event/astrazeneca-plc-azn-q2-2026-earnings-call
Automated transcript · Written by software from the replay's audio. It can mishear names and figures; the replay is the record.
0:00 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 harbor statement. The company intends to utilize the safe harbor provisions of The United States Private Securities Litigation Reform Act of 1995. Participants on this call may make forward looking statements with respect to the operations and financial performance of AstraZeneca. Although we believe our expectations are based on reasonable assumptions by their very nature, forward looking statements involve risks and uncertainties and may be influenced by factors that could cause actual results to differ materially from those expressed or implied by these forward looking statements.
0:50 Any forward looking statements made on this call reflect the knowledge and information available at the time of this call. The company undertakes no obligation to update forward looking statements. Please also carefully review the forward looking statements disclaimer in the slide deck that accompanies this presentation and webinar. There will be an opportunity to ask questions after today's presentation. Please use the raise a hand feature to indicate you wish to ask a question at any time during the call. 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 twenty twenty six presentation conference call and webcast for investors and analysts.
1:36 I'm Joris Silen, 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 U. S. Dollars unless stated otherwise. Please advance slide. This slide shows our agenda for today's call.
2:22 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 and A. And with that, please advance to the next slide. And Pascal, I will hand over to you. Thank you, Juris, and welcome everyone. I'm really pleased to report that in the first half of twenty twenty six, 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 Farxiga and Brilinta, 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.
3:13 We also saw strong growth in core EPS increasing 11%. In the first half, we announced positive results from six key Phase III programs, including three new molecular entities. We secured 30 major market approvals across our diverse portfolio, including the first approvals for two enemies, Hetkauma in breast cancer and Baxfandi in hypertension, and increasing our number of approved enemies 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.
3:58 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 delivered 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, Farxiga and Brilinta. We delivered strong growth in The U. S, 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.
4:56 Move to the next slide, please. An important message for today is that when we set our €80,000,000,000 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 €80,000,000,000 is a risk adjusted forecast. If everything worked, we would be above the €80,000,000,000 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 inherent risk and that not every program will succeed.
5:45 Our pipeline, however, continued 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, Tosorakimab and COPD, which we look forward to presenting at ERS, Efsimphotase alfa in HPP, and as announced today, our first wholly owned AGC, Sony V, including 18.2. 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.
6:35 These approvals demonstrate the value of this innovative treatment approach, and we continue to have constructive discussions with the US FDA. We also saw US FDA approval for Baxfandi, 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.
7:22 Thank you, Pascal, and good morning and good afternoon, everyone. As usual, I will start with our reported P and 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 and HER2, DATRAWAY and Taspire in markets where our partners record product sales. Next slide, please. Turning to our core P and 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 lower gross margin in the second half consistent with prior years, reflecting seasonal demand patterns for lower margin medicines such as FluMist and Dufortis.
8:21 For the full year, we continue to expect a stable to slightly higher core gross margin versus 2025. Core R and D expense increased by 6% in the first half, reflecting continued investment in our pipeline. Following the positive Phase 2b results for oral GLP-one molecule, elacogipron, we have now initiated comprehensive Phase three program in both obesity and type two diabetes, with first patients dosed earlier this month. Core R and D represented 23% of total revenue in the first half, and we continue to expect R and 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.
9:18 Core SG and A expense also increased by 6% in the first half. During this period, we launched Baxendi in The U. S. Following FDA approval in May, and we continue to make prelaunch investments ahead of anticipated launch of Tosarakimab following positive Phase III data. Both medicines are expected to be important growth drivers supporting growth to 2000 and '30 and beyond, and we are investing accordingly to maximize their potential. Other operating income was $341,000,000 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 adjustment to deferred tax assets following certain internal legal entity changes.
10:11 Overall, core EPS grew by both 11% in the first half, in line with our guidance for the full year. $22,000,000,000 in the first half, a decline versus comparator period. This primarily reflects the Lynparza milestone received in the first quarter of twenty twenty five skewing comparisons as well as working capital impact associated with U. S. Loss of exclusivity for Farxiga. We expect these working capital effects to persist through the remainder of the year before normalizing. Capital expenditure was $1,500,000,000 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.
11:03 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 $3,300,000,000 and included both milestone payments and the $1,200,000,000 upfront payment for CSPC collaboration, which closed during the second quarter. For the full year, we continue to expect milestone payments of approximately 2,500,000,000 relating to prior business development transactions. We have announced new BD transactions totaling just over $2,000,000,000 in upfront payments year to date, including the most recently announced Diesel transaction.
11:48 Our lease liabilities also increased as we opened our new Kendall Square R And D Center in Cambridge. Our capital allocation priorities remain unchanged. Net debt increased by around $3,500,000,000 in the first half, primarily reflecting the payment of the second FY twenty twenty five 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 rates 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 mid to high single digit percentage and core EPS to increase by low double digit percentage at constant exchange rates.
12:46 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 our Oncology business. Next slide, please. Thank you, Aradhana. Next slide, please. Oncology total revenues grew 15% in the first half to $14,100,000,000 underpinned by double digit growth in all major regions. Growth in The U. S. And Europe was particularly notable at 1816%, respectively. Focusing in on the quarterly performance of our key medicines, Tagrisso delivered 6% growth in the second quarter to revenues of $1,900,000,000 supported by double digit growth in The US.
13:41 The share of combination regimens in the first line continues on an upward trajectory in key markets, with FLAURA II remaining the clear preference. Turning to Calquence, which grew 16% in the quarter, generating more than $1,000,000,000 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 US, 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.
14:29 Imfinzi and Emjudo delivered growth of 25% in aggregate in the second quarter. Imfinzi 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 Imfinzi in muscle invasive bladder cancer, and while The US market is evolving with competitive entrants, Volga will continue to expand Infinzy's reach. Turning to Enhertu, we delivered growth of 31% in the quarter, and reported revenues of $888,000,000 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.
15:21 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 awareness in the first line Destiny ABRSTO-nine setting in The United States following its approval late last year. Together with the recent simultaneous U. S. Approvals of Destiny ABRSTO-five and Destiny ABRSTO-eleven in the curative setting, these growth drivers will become increasingly important through the remainder of the year. TruCap revenues of $233,000,000 in the quarter represent growth of 37% over the prior year. As we've indicated previously, the majority of this growth is from ex US markets, with The US opportunity at peak in the breast indication. Beyond breast, we are looking forward to bringing TruCap to patients with PTEN deficient metastatic hormone sensitive prostate cancer, following the recent approval of Capitello two eighty one in The US, and a near term priority is to establish testing in the setting, which today is not common practice.
16:21 Dactuary revenues of $55,000,000 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 US. We're excited for the ongoing launch of DATROA 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, Tagrisso is the number one prescribed third generation EGFR TKI globally, approved across all stages of disease.
17:15 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 twelve months with FLORA2 the clear market leader. In the highly competitive US market, FLORA2 holds around three quarters of this growing segment. We were pleased to announce the in licensing of Zigfrovi, a novel oral EGFR inhibitor, earlier this month. Zigfrovi is already approved in The US and China for patients whose tumors carry exon twenty insertion mutations, following progression on or after platinum based chemotherapy. Based on the Wukong-twenty eight data presented at ASCO, filings for the first line have been submitted in China and The US.
18:01 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 Tagrisso 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. Tropium Lung fifteen evaluates DATRAWAY alone and in combination with Tagrisso, building on the growing position DATRAWAY already has in later line lung cancer based on Tropian Lung five.
18:57 SAFERON then evaluates Tagrisso combined with Orpathis, offering a differentiated combination approach in patients with MET driven resistance supported by the encouraging data we've already seen from Savanna and Saatchi. Looking further ahead, Tropion Lung 14 then aims to bring the combination of Dataway and Tagrisso into the first line, building directly on the success of FLORA two. This represents a significant long term opportunity to extend our first line leadership and improve outcomes with the 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 three trial readouts.
19:48 Back in May we announced positive results from the planned interim analysis of the phase three Volga trial for Imfimzi 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 Imfinzi as a key treatment option for cisplatin eligible patients. Volga explores whether the combination of Imfortumab vedotin and Imfinzi plus or minus Imjudo can improve outcomes for the fifty percent of patients who are not candidates for cisplatin. Importantly, in this regimen Enfortumab vedotin is only given in the neoadjuvant setting aiming to optimize outcomes whilst balancing the overall benefitrisk profile.
20:35 Imfinzi in combination with enfortumab vedotin 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 EMGUTO containing arm also demonstrated a statistically significant improvement in event free survival with a favorable trend in overall survival. Volga broadens our presence in bladder cancer enabling more patients to benefit from an Imfinzi based regimen complementing Niagara in muscle invasive bladder cancer and the recently U. S. Approved Potomac indication in earlier stage non muscle invasive disease. We also saw positive NILE results this quarter.
21:20 And whilst the landscape in the first line setting has evolved significantly since we started this trial, it further reinforces Imfinzi's value across the full spectrum of bladder cancer. Turning now to gastric cancer. We announced today positive results from the phase three CLARITY gastric-one trial evaluating suniscitabine, or SunnyV, in previously treated patients with advanced gastric cancer expressing Claudine 18.2. CLARITY gastric O1 is the first phase three trial to demonstrate an overall survival benefit with a Chlordan eighteen point two targeted antibody drug conjugate in the second line plus setting. This is a population with a particularly poor prognosis. Fewer than twenty percent of patients with advanced gastric cancer survive beyond one year.
22:07 And at present, there were no targeted options for Claudine 18.2 positive non HER2 positive tumors in this second line plus setting. The trial met its overall survival dual primary endpoint with Sunnyv demonstrating a statistically significant and highly clinically meaningful improvement in overall survival versus investigators' choice of therapy in patients treated with at least two prior therapies. There was also a trend to PFS benefit which should 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 Chlorine 18.2 expression as low as twenty five percent at any staining intensity.
23:00 A lower threshold than that required by other Chlorine eighteen point two targeted therapies. Meaning that Sunnyv could potentially benefit around fifty percent of patients with second line plus gastric cancer representing more than one hundred and eighty thousand patients across The US, EU5, China and Japan. Parasigastric one represents a landmark milestone for our oncology portfolio. Sunnyv is our second ADC to demonstrate an overall survival benefit in gastric cancer following in HER2 and our third positive phase three readout in this tumor type in just two years following Matterhorn for Imflimzi and Destiny gastric O4 for Inheritu. It is also the first phase three data from our wholly owned ADC portfolio marking an important step as we establish our independent position in this space.
23:46 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 Sunnyv in combination with capecitabine with or without rilvagostomy or nivolumab. And with that, please advance to the next slide, and I'll pass over to Rut to cover biopharmaceutical performance. Thank you so much, Susan. Next slide, please. Our biopharmaceutical business is in a transitional period, And in the first half of twenty twenty six, total revenue declined by 5% to $11,200,000,000 This reflected the loss of exclusivity headwinds for Farxiga, Brilinta and roxadustat, which were largely offset by the growth of our respiratory portfolio.
24:43 The strong momentum in respiratory was supported by our established biologics for severe asthma, which generated over $2,000,000,000 of in market sales in the first half. Focusing in on the quarter, respiratory and immunology total revenue grew by 11%. Fasenra grew 13% to five seventy million dollars driven by its continued leadership of the ALLO-five 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 spike grew by 45 to $390,000,000 with strong performances in The United States and Europe being supplemented by uptake in the emerging markets.
25:34 In our inhaled portfolio, BreastTree continued on its positive trajectory, with 20% growth to $346,000,000 BreastTree 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. Symbicort revenues of $671,000,000 were down 8% due to the price pressure in The United States, reflecting a new generic competitor entering the market. Salvenlo revenues increased 24% to $2.00 $9,000,000 driven by share gains in the intravenous segment for SLE patients.
26:22 The new subcutaneous formulation is now available in The U. S. And some European markets, which broadens Savnelo's reach to patients who favor self administration. As expected, generic competition for Farxiga 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 Farxiga decline by 90 overall, resulting in $1,800,000,000 of revenue for the quarter. Navigating these expected life cycle 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 Bagsfendi in The US, and we are now building early market access through affordability programs.
27:13 We anticipate commercial access for Bexendi will broaden over the next few quarters in anticipation of Medicare Part D reimbursements from 2028. We're also making an early start on our launch preparations for Tosarakimab. 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 and D pipeline. Thank you, Ruth. Next slide, please. I'd like to start by acknowledging the phase three cardio transform trial for WiNUA in transthyretin mediated amyloid cardiomyopathy.
28:02 This trial was conducted in a contemporary ATTR cardiomyopathy patient population designed to examine the role of WAINUA, 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 fifty seven percent on a stabilizer, adding WAINUA 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 WAYNUA monotherapy as compared to placebo, fewer primary composite events were observed, and this result was nominally significant.
28:47 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 dataset 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 elecogipron, where we are building strong momentum into phase three. At the American Diabetes Association meeting in June, we presented results from our Phase 2b VISTA and SOLSTIS trials, which demonstrated the potential of elecoglippron as a multi blockbuster asset for AstraZeneca.
29:40 In VISTA, we observed a clinically meaningful and statistically significant weight loss of up to 11.8% at week thirty six, importantly without evidence of a plateau. In Solstice, there was an up to 1.9% reduction in HbA1c at week twenty six, with the vast majority of patients with type two diabetes reaching their glycemic goals. Elicoglippron demonstrated a favorable safety profile with with no unexpected safety signals, low discontinuation rates, and tolerability consistent with the GLP-one receptor agonist class. It is worth emphasizing that elecogliprone 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.
30:33 Based on the strength of these data, we are advancing an ambitious phase three program. Mbold is studying oligocliplin monotherapy in patients with obesity or overweight with or without type two diabetes. The ILLUMINATE program, which includes five phase three trials, evaluates elecoglipprohn, both as monotherapy and in combination with dapagliflozin across broad patient populations with type two diabetes. I am pleased to say that we achieved first subject in for both the EMBOLD and ILLUMINATE programs. Beyond these, we also plan to initiate ELEVATE, an indication seeking outcomes program designed to demonstrate the value of elecoglippro in heart failure with preserved ejection fraction and chronic kidney disease on the background of dapagliflozin and other standard of care.
31:26 Finally, I want to highlight a few additional advancements in our pharmaceuticals pipeline during the second quarter. Staying and weight management, the Phase two APRICUS trial studying AZD-six thousand two hundred thirty four, our selective amylin receptor agonist, read out this quarter, and we are now initiating a phase three monotherapy trial. We look forward to sharing the phase two data with the medical community at EASD later this year. In dyslipidemia, we look forward to the phase three readout of our oral PCSK9, laroprostat, in the first half of twenty twenty seven and are advancing our first fixed dose combination of laraprostat with rosuvastatin into phase three, bringing together the benefits of a statin and a PCSK9 inhibitor in a single tablet.
32:13 Moving to our respiratory portfolio, we are excited to present the highly clinically meaningful results from the Oberon and Titania phase three studies for tozaracumab 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, sunakament, which was formerly referred to as AZD8630, read out its phase two study and we are discussing plans for phase three 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 PDE3four inhibitor currently in phase three trials in China for COPD.
33:14 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 $4,900,000,000 underpinned by double digit growth across all key medicines. This is driven by increased patient demand and continued global expansion following launches.
34:00 In the second quarter, Ultomiris grew 12% driven by patient demand across indications including the competitive MG and PNH markets. SOLIRIS revenues continued to decline due to successful conversion to Ultomiris as well as biosimilar pressure. STRENSIQ grew 36% year on year, reflecting strong patient demand. STRENSIQ 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 Zinsor Tezalpha and future franchise growth.
34:50 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. Kosilgo remained the market leader for pediatric patients with NF1PN. Overall, we continue to see great momentum across the rare disease portfolio. 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 Ultomiris showed a forty three percent reduction in proteinuria, with significant proteinuria reduction seen as early as ten weeks.
35:49 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 ERA 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 ULTOMIRIS established leadership across multiple complement mediated diseases. We have now filed in both The US and Japan.
36:37 Per Insulphate's alpha in apophosphatasia, data from our phase three 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 our single arm safety study, Chestnut, showed Insphinsodasalpha was well tolerated and demonstrated a favorable safety profile in pediatric patients. In a pooled analysis of the phase three Mulberry and ECHORI trials, including pediatric, adolescent and adult patients, treatment with azithromycin Tazalfa resulted in a median of three sixty one days per year free from injection site reactions and injection site reactions rates were five times lower than with Trendsiq.
37:40 Data from the MICORE 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 CALIPSO Phase three 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 hypoparathyroidism. On selenimab in kappa light chain amyloidosis patients, results from the CARES program demonstrated a sixty two percent reduction in all cause mortality and a seventy one percent reduction in cardiovascular hospitalization, with an overall survival benefit observed even in patients with advanced myo stage disease.
38:43 Taken together, this program illustrates the strength of our rare disease pipeline with multiple near and mid term catalysts with potential approvals and future launches across several high value rare disease indications. Finally, an update on our ULTOMIRIS Phase three trial in adults with traumatic microangiopathy after ACT. High level results show that ULTOMIRIS did not achieve statistical significance for the primary endpoint of event free survival through twenty six weeks compared to placebo in adults and adolescents aged 12 years older with ACG TMA. ULTOMIRIS showed a trend towards treatment benefit and discussions with health authorities are ongoing regarding the interpretation of this data, including in the context of real world evidence.
39:38 In pediatric patients with ECTMA, we are advancing regulatory filings based on data from the open label Phase three trial we reported in 2025 and data from an external control study. As pioneers in complement biology, we continue to explore and advance treatment approaches in diseases 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. 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 path ahead.
40:33 Over the next eighteen months, we have 25 key Phase III 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, for instance, saruparib is a big one, but there are many others very important readouts over the next eighteen 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 mid-twenty twenty four, we identified platforms that we said would drive our growth post-two thousand and thirty, what we called at the time, the day after tomorrow.
41:31 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 Sean mentioned, we expect the first Phase III data for laroprostat in the first half of twenty twenty seven. And we have now initiated five Phase III trials for elicogliprom. 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 Hydroconjugates, we continue to make strong progress.
42:19 As highlighted today, we've just had the first positive Phase III readouts for Sunnivi, and we anticipate Phase III data for our second wholly owned ADC, Puxisan, next year. We also continue to advance our broader program, having dosed patients in our first phase three trials for tovusam and also for Zadagou this quarter. So very good progress across ADCs and radioligands. For our next generation IO bispecifics, we now have 16 Phase III trials across eight tumor types, including five 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.
43:08 AZD0120 and Survatame both have multiple phase three 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're also investing behind on the shelf and in vivo cell therapies, which we believe will enable us to reach more patients across more of these areas. These programs continue to advance and are key components of our deep late stage pipeline of multiple robust opportunities that will underpin our next wave of goals.
43:55 Move to the next slide. The strength of that opportunity is reflected in this slide. We have three recent launches, DATROWE, CAMMA, AZNED, each with peak year revenue potential of more than $5,000,000,000 We opted to deliver pivotal data before 2030, including multiple programs with multi blockbuster potential. Together these assets provide a strong foundation for growth into the next decade. And really it's important to remember that CHF 80,000,000,000 is risk adjusted. If everything worked 100%, we would be much above the CHF 80,000,000,000 of growth. But we've also assumed some projects would not work and other projects would work. And a good example of this is the strong data we obtained for tozarakimab, a product that very few people thought was going to work. We ourselves had a low probability of success for it.
44:53 We tried because we saw 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 $5,000,000,000 In addition, with the positive readout for Sony V today, we estimate that this ADC could reach peak year revenue between 3,000,000,000 and $5,000,000,000 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. And 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 pipeline in the industry, one that can now more than offset losses of exclusivity and fuel AstraZeneca goes well into the next decade.
45:43 In closing, as we move to the next slide, I'd like to say that we delivered strong growth in the first half, again, 11% excluding Farxiga. And Brilinta shows you the strengths of the pipeline and the geographical footprint, 6% growth overall. So strong growth in the first half. The breadth and depth of our pipeline remain exceptional and our confidence in reaching CHF 80,000,000,000 revenue by 2030 is intact. But what excites me most is what comes next. First 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 go well into the next decade.
46:33 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 and 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 Rajan Sharma at Goldman Sachs. Hajjn, 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 data next year? And how do you expect this to compare relative to Merck's Libfendra? And maybe you could just comment on your expectations for pricing in that market, given we now have a list price for your competitor?
47:23 And then secondly, on SONYV, you're going to GBP 3,000,000,000 to 5,000,000,000 in peak sales now. Can you just help us understand how much that is in the first line versus the data that you've disclosed today? And maybe could you just talk about geographical split of patients and potential revenues? You. Great. Thank you very much, Raj. And maybe Ruud could take the first question and dive into the second question. Yes, of course, Pascal. Overall, I think we are excited about our PCSK9. We will see the first data reading out in the first half of twenty twenty seven. I think we will have and hopefully we will have a competitive profile versus the compounds of Merck. But I think the breadth of our portfolio for cholesterol lowering medicine is broader than only the oral PCSK9.
48:12 As Sharon has mentioned, we have started the first combination with rosuvastatin. I think we have a unique opportunity because it's the true oral medicine in order to combine that with all the other products in our portfolio, and hence, that will increase the level of competitiveness. Regarding the pricing, of course, we have seen the official first list price of our competitors in The United States. It's not changed dramatically our own outlook. Of course, I'm not going to disclose our pricing strategy moving forward. It also depends on what we're going to see in our clinical trials, but overall, I think we are well on track in order to develop a very competitive oral PCSK9 moving forward.
49:00 Thanks, Ruud. So just picking up on the question about Sunnyv and Clarity gastric, and after I'm done, I'll turn it over to Susan who can talk a bit more about the life cycle plan beyond CG-one, but we're very excited about these results and look forward to getting an opportunity to present them soon. Specifically, the CG-one opportunity has potential to be a blockbuster indication. Now some of that will depend, obviously, on indications that we are able to achieve. But the dataset looks good. We look forward to sharing it. I think a couple of important points. We will pursue discussions across all major markets, U. S, Europe, China, and throughout the emerging markets. This dataset, we think, supports those discussions.
49:53 Secondly, as you saw, overall survival being an absolute gold standard within the setting of THINK well positioned study V for uptake upon approval. And we expanded the definition of CLDM18.2 positivity with the cutoff that we're using in a study, and that cutoff is greater than twenty five percent, and that represents about half of the patients with gastric GEJ cancers. So it's a great opportunity and one that we're really looking forward to getting opportunity to launch as quickly as possible. Susan, do you want to talk a little bit about the life cycle plan beyond CG-one? Yes. So obviously in the first line there's an opportunity to combine with IO agents, as I've discussed, with both rilvagostomyc plus backbone of capecitabine.
50:46 And the Claritigastricone two study has two cohorts, one in the PD L1 greater than one percent, but also has a cohort in the less than one percent where we're looking at Cili V plus Faber fee based regimen versus standard of care as well. So I think that gives us an opportunity to have a broad first line opportunity to have that IO and ADC 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. Massive hormone there's an opportunity to go into the earliest, not just to express on gastric cancer, but also on pancreatic cancers and liver tract cancers. And we're exploring those in our ongoing phase one and we're encouraged by the data that we've seen today. So I think this can be a broad program for CEPI V across all of these GI based cancers. Thank you, Christian. And maybe one thing I could add to the PCS scan is that another thing that we are developing is together with medical GLP-one, because if you have a high rated cholesterol, typically you also need to lose a bit of weight. This is a good example of how we can differentiate our PCSK1, but also differentiate our GLP-one by providing convenient
52:17 formulations to patients who are typically pre medicated in these circumstances. So the next question is, I think, Richard. Richard. Thanks, Pascal. One question, please, on cam assessment. Just now we've seen the PERSOVIRA data in detail, ASCO, I don't think when we last spoke we'd seen it. Could you give us your latest thoughts around how SPEAR and FOUR 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.
53:10 Does that answer your question? Yeah, okay. Thanks. So thanks for the question. So as you said, the goal for SERENNA-four is to enrich for endocrine sensitivity. Again, as a reminder, we have a larger sample size, thirteen seventy patients enrolled compared to Perseverance. And I think, you know, what you see with the Perseverance data is evidence of activity which varies across the different subgroups there. I can't comment on the exact subgroups today. Obviously, you know, we're anticipating the trial readout and the second week for that readout to really see. But again, we have just driven to enrich for that endocrine sensitive population.
54:00 We're happy with SAMENA six data is the overall tolerability profile that we've seen with chemisestrant. 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 soon. Thanks for that. Next question is Baker at Advanced. Simon over to you. Thank you, Pascal. One for me on some of the. The profile based on the data we've seen so far looks looks. Impressive indeed against the competition. But just wanted to get perspectives on how you see the profile.
54:48 Some of those in that setting and also. Significance or otherwise of the follow-up versus near loop mutation performance. It appears to be particularly differentiated. On file. Is that a significant factor? Is that less important than perhaps you might have seen? Thanks so much. Okay, so you're talking about Pascal, do you want me to take this one? Yes please, if you don't mind, please. Okay, so Zafrovy is obviously the asset that we've licensed from Diesel for exon twenty mutations. A group of mutations that are non classical, as well, which is about a similar sized patient population.
55:41 So I think what the profile is that we see overall, first of all, it's potent against the exon twenty. 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 U. S. And China. In first line setting, the data presentation, ASCO if you 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 the progression free survival, which was obviously the primary endpoint in that randomized trial.
56:31 So yeah, I think if you look at that compared with the other competitors in this space, it's all easy to administer at home. Other agents and their potency is also competitive. So again, we're excited to have this as another agent to build on our legacy in the EGFR mutant. Thanks, Suzanne. It may be good to hear also from Dave telling you about what we're trying to do to solidify the Tagrisco franchise, because we're under, of course, two major competitive threats. One in China, which is the multiplicity of EGFR market and very competitive market. We're doing well, but it's competitive.
57:20 And the second is, of course, market post our demand, which again, we are still going well. As Dave mentioned before, market share is still very strong for But beyond that, we are actually trying to build a variety of ways to differentiate TEGR. So maybe, Dave, if you can give us the whole picture again, that would be useful. Yes, it'd be my pleasure. And let me use this as just an opportunity also to comment that the strength of FLORA two is really laying the foundation right now for the expansion of the clinical development plan to build off of the combination approach to a Tagrisso back bone in order to improve outcomes in EGFR mutated lung cancer. And as Susan quite nicely articulates, Zektrovy adds to the group of patients that we now have an opportunity to be able to engage physicians about and offer a new therapy.
58:17 I think just very, very importantly, 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 Tagrisso right now. What that's allowing us also then to do is get ready for both the Datto and the Orpathis combinations, which we're looking forward to. I think that with Datto, obviously, we've got tropium on 15 in the later lines and also Tropium Lung 14 in the frontline setting. And relative to what we see with the other Tropium Lung class players, This is a very differentiated position of having the Tagrisso combination as a way of bringing this set of therapies into these settings.
59:07 We've got Saffron on the horizon, and that's with the Orpathis combination. And we are very enthusiastic about Tegrysop continuing to be an important driver of growth and contributing meaningfully to the 2,030 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 we see addition of Zexprovy, we are also addressing a gap in our coverage of this EGFR market. So you can see we are really reducing the space where the competition could actually have an impact over time.
59:56 So the next question will be from Sajidak Kaffila at Morgan Stanley. Sajidak, over to you. Thanks, Pascal, for taking my questions. On Avansat, we noticed it has PFS and OS inputs in both TROP-two positive and ITT populations. Could you give us any more color on the testing hierarchy? So for example, are you looking at PFS and then OS in TROP-two 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 Trojanue positive patients be sufficient without a clear OS benefit? And there's just a quick one taking a step back. How should we think about Dactuase profile versus SAT TMT, particularly post the positive OptiTruck lung six data and ahead of the PD L1 VEGF data in 2027?
1:00:49 Thank you. Thanks, Ariana. A good question two good questions for you, Suzanne. 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. And the ITT or in the biomarker positive group. So I hope that answers your first question. Obviously, you know, regulators will be interested in the effect size and meaningfulness of the differentiation between those groups in discussion.
1:01:39 From the competitors, I think we have a best in class CHIP2 based ADC based on the design, which is based on the stable linker. And you can see that based on the half life of the molecule and also the lower rate of bone marrow toxicity because you see higher rates of bone marrow toxicity with a more exposure to the free payload. That I think, 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 in 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 line setting in combination with IO.
1:02:33 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 differentiation. As we do with all of our phase 3s, whilst we're confident in that hypothesis that we've got, we obviously have to wait for the phase three trials and nobody is keen to see this data. And as soon as we've got it, we'll share it with you. Thank you, Sudan. Next question is hits the line. Is it something that you could put out as one therapy or the idea is would be to be in combination with now, for example, given the failed study.
1:03:44 I'm just trying to figure out what you're thinking on this multiple from today. And the second question is on STENSIQ. You guys are confident on this 3,000,000,000 to 5,000,000,000 big sales for epzynphotase ALFAK 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 Trendsiq and ETHSYMFATACE ALPHA. How should we expect those to play out in the market? For Thank 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 is as an add on to either stabilizer, a family so I call remedies and sandwiches.
1:04:41 The trial is not done as a monotherapy. What is very important to understand is the difference of mechanism as the class indicates the diameter is a depleter and therefore depletes the amyloid burden in the tissues. This has been confirmed during our phase one of the one year. Have also crossed We have seen on this product a very outcome benefit both on mortality as well as cardiovascular events following cardiac remodeling as well as improvements of many many cardiac functions.
1:05:44 So it's not the same disease exactly, but we have a reasonably good with the cost of the. In the treatment of. For we're expecting the results. In the future and we look forward to demonstrating again the same benefit or improvement of cardiac and other improvements and outcome benefit in both mortality cardiovascular hospitalization and we look forward to these results. To the second question on Stantec, so Stantec today has been on the market since 2015.
1:06:30 We do not have a very wide coverage, and I think this is what the exchange for this is going to bring us. It's going to have a much wider coverage in terms of countries. Possibly we would have a wider label that's something that is remains to be discussed with regulatory authorities. But the big difference between those two products is the greater tolerability of extrinsertase which is, remind you administered every two weeks instead of administered either daily or every other day So there are big difference in the for the patients utilization.
1:07:18 In terms of tolerability, just to give you some numbers, patients who are on basically have five days of injection site reaction on average in a given year and this is many times lower than what is experienced with TransSeq. We also know that the retention of TransSeq is often impacted by this issue of tolerability. So that's why we remain confident that it's just that as we grow in terms of number of countries in the brands of patients, and also in the retention of patients once they're on therapy. Thank you, Mark. And maybe going back to Claramitro, because I already see from course, we'll have to show that it had something, but that's potentially a broad use for this agent.
1:08:35 Next question is Sachi Chiang. Hi there. Thanks for taking my questions. One financial and one pipe. So financial, can you talk about balancing the investment in pipe and launches that are out in the top two versus delivering margin expansion? So as we think about 2026 and '27 cost growth, is 1H R and D SG and A cost growth of 6% a good proxy, or should we think about acceleration into second half this year and into next year? And then quick hits on one on one biopharma '27. So, Cambria want to switch next year. Perhaps, if you could just talk to how you think about the success of that study relative to three and four and where it sits on the endocrine sensitivity And then one for Farxiga lifecycle management. Just a simple question.
1:09:23 You've got substantial peak sales of almost 10,000,000,000 across the various fixed dose combos. Consensus basically has nothing. Where did you think consensus is missing on these assets? Thank you. You are very ambitious with many questions, but we lack ambition. So maybe I'll cover the first one, then Susan and then Ruth. Is that okay? Arna, 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 not R and D or some of the other moving parts on gross margin and other income, etcetera. So 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 that in a few months.
1:10:30 And as you know, there's a lot more readouts still to come and investments still to make, whether it's on POZO or we'll see how some of the other events readout. So all of that is gonna be part of our planning. And we based our guidance for 2027 or any year we based our guidance on our budget and our planning process. So 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-one. Just as a reminder, CAMBRIA-one is an extended adjuvant trial in patients with intermediate to high risk hormone receptor positive and HER2 negative breast cancer. So it's already been well established that extension of duration improves outcomes.
1:11:21 By taking patients who've completed two to five years of adjuvant endocrine therapy with or without CDK4six inhibitor, which is this switch design, and randomizing them to continuation of AI or endocrine sensitive patient population. The patients that have got a higher risk risk 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 will likely already cure the current standard of care. So I think it does select for an endocrine sensitive patient that's already been proven with other trials. So I think from that perspective and given the profile that we've seen with chem recession in terms of tolerability and efficacy within the CYP2-six study, I think it has a good probability of success together with the data that we've seen from a competitor in the adjuvant setting. Okay, thanks, Susan. So let me quickly address the question of Sachin regarding the combinations. We have currently three combinations in development.
1:12:32 All those combinations are addressing the patient populations where there's a high risk and where there's almost no current treatment. So let's take ZBODAPA as one example, it's in phase three, it has recruited very fast, clearly showing the high unmet medical needs in proteinuria CKD. Those patients are very ill, their kidney function is declining. And we note the beneficial effects of Depagliflozin, and on top of that, we hope to see a beneficial effect of an Epstein receptor antagonist. 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.
1:13:31 The estimates of the Epi data have shown that more than twelve million patients in the top eight markets are eligible for treatments like this, so it clearly shows the potential if the study is reading out. Both of those fixed dose combinations, we're expecting to see data in the first half of twenty twenty seven. And then last but not least, bexorostats in combination with dapagliflozin, 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, high risk patients, and I think not everyone is, let's say, addressing and seeing the potential of those new combinations, those are really new molecular entities, if they are successful.
1:14:28 So I think building on the massive experience we are having with sixty million patients are currently treated with Depo Depo Cliplosan, I think it's the backbone of heart failure and chronic kidney disease patients, and adding those to the mechanisms hopefully will lead to a much more beneficial effect, both from a mortality perspective, but also from a kidney disease progression. Thank you, Richard. Have not realized we had many more questions in the line. So if we can stick to one question per person, that would be great. Great. Yes, thanks for taking the question. So, I had one on, SFD itself as basically filing for a broad label. Can you confirm that, that does include adults? And was that based on any discussion with regulators to date as to the acceptability of the HICARY trial and the trend benefit in the pediatric onset adult population?
1:15:35 And does the three to 5,000,000,000 cells that include the adult population or is that just in pediatrics? Thank you. Thank you very much for the question. So the broad population for the findings will be above two years of age for the board population as I said in my prepared remarks. This has been done in discussion with regulatory authorities but obviously they would need to look at the detail of the three studies that we have completed and submit to. To your second question on the adult population is segmented into two parts, adult with pediatric onset which is in several countries already obtained with Stantec and adult onset Your second question on the 3 to 5,000,000,000, even if we get less than the totality of available that we have filed for, we expect to be within the range of 3,000,000,000 to $5,000,000,000 Thank you, Mark.
1:16:55 Next is James Gold on Barclays. James? Maybe I'm good, James. Can you hear me? Yes. Great. Thanks for taking the question. ASCO called out subgroups of the selective PARP in prostate cancer where we're getting data next year, and this has been described as a 5,000,000,000 plus product. There was something about the asset a few years ago but then it wasn't partnered with Merck and maybe there was a thinking that Lynparza is a pretty high bar to beat. So helps you or does that need a lot of other trials to work and how excited are you by that readout? And then if I could just squeeze in a quick clarification, so other operating income or ROI.
1:17:42 So the updated 2026 guidance implies higher ROI and higher OpEx and then you're reiterating the guide because you're investing in ROI, but how much of this year's ROI is ongoing versus one off? So is that going to create a headwind next year when you don't have the ROI Or is most of this year is going to repeat again next year is from an ongoing source? Thank you, James. Susan, do you want to cover the Sharpen question? I mentioned it, James, just as an example of many projects in our pipeline that nobody talks about. We seem to be facing almost an obsessive for Curacao 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 Staubakari is certainly one of the most important ones as well. Susanne, over to you. Thank you.
1:18:37 So as you have seen from the clinical trials appendix, there's a significant effort that we've got with cerofib in prostate cancer. One of the key trials is the EVAPAR PROSPATE-one, which is a metastatic common sensitive prostate cancer, including both the HRM and RNA. Already have seen from the PROPEL study in a later line that we do have activity for PARP inhibition in combination with androgen receptor 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.
1:19:28 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 PARP and see benefits in both those subgroups. You will recall that we did see a positive effect on in the HRM in the PROPEL data set. But there was a lot of discussion with the design of this study and I think that's a significant opportunity. But it's also backed up by other studies in other segments in prostate cancer and also in the EVAPAR breast opportunity as well. So when you look at the totality of the Surapiv opportunity, it is significant and definitely in the 5,000,000,000 range. We're excited to see that. Thank you, Susana.
1:20:24 Revisit it at the end. So we give everybody a chance to ask one question and we may have a chance to go back as part of another financial question. The next is Christopher Wodder at Cell. Christopher, go ahead. Hi, thank you very much for taking my question. I guess this one would be on bexfendi, noting that you have the primary aldosteronism trial reading out next year now. Today screening for aldosteroneism is not really du jour or active. So what are you doing to try to ensure as rapid a rollout that would not be a break on your launch?
1:21:10 Thank you. Sean, you want to go on this? Sure. So first I'll say thank you for noticing the potential for Baxter stat in primary aldosteronism. You know, this is a really important and unmet medical need. It's really a group of disorders in which aldosterone production is unusually high for sodium status and it is relatively autonomous of the normal regulators. So this is a major unmet medical need and a key driver of cardiovascular damage and it is a leading cause of secondary hypertension. We think it could affect as many as five to ten percent of all hypertensives and up to twenty percent of resistant hypertension. And you're right, relatively few of those patients today are being screened because there hasn't been a therapy to give them. Now we have the first approved aldosterone synthase inhibitor with an excellent treatment profile or target product profile, and we think that this is gonna be pivotal in helping to drive uptake now that there is a recognized therapy that addresses aldosteronism.
1:22:17 So we're running that study, and as we have disclosed, it is, it has accrued very rapidly, so we're accelerating that timeline for primary aldosteronism. We're excited to see interest around Vaxplenty as a leading molecule. Increasing uptake will, I think, follow through naturally from what we hope will be a positive dataset, and the rapid recruitment that we're seeing for our studies really speaks to the major unmet medical need and the general enthusiasm of the clinical community. Thank you, Shaun. Peter Pardolt at BNP. Thanks, Peter O'Bairdoult at BNP. Two quick ones, Pascal. One for Root on IL-thirty three and 5,000,000,000 target for Tolso.
1:23:07 Are you anticipating any competition here? The reason for the question is we're hearing Sanofi and the Parliament General might not undertake the third phase three study that will be required for approval in light of your data and probably the fact you now enjoy a three year head start. So first quick question on Toledo 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 historic precedents like Calquence and to Gripsley? Thank you. Thanks. So Ruud, do you want to cover the AZN3S3OPD question and we return to the MFN pricing at the end. Yes, for sure. 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 is that the data sets of the ULC at ERS is very convincing, and we get many questions about why do we think that our IL-thirty three was successful in those two pivotal trials.
1:24:14 And we truly believe that the mechanism of action is very specific to our NTL-thirty three. It's inhibiting 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. Steve Scott, come in. 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?
1:25:01 And just a very brief question, should we view it as possible that Serena IV and Avanzor are presented at ESMO? Thank you. Thank you, Steve. So I'll cover the first question, and we'll return to the S-four question at the end. China, 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, innovation potential is also enormous as you've seen from the various deals we've made, but also other companies have made. And today, companies are innovating at great speed and they tend to partner with global companies like others to globalize the development and the commercialization.
1:25:48 But it's reasonable to expect that over time they will expand globally. Expanding globally is not that simple, right? I mean, because the 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, the ADC market is very intense too. So we learn to compete with them. And so we will take those learnings globally when they become global companies, still learning from them in terms of how they develop products and how fast they operate.
1:26:37 And we've made some changes in the way we operate. And for instance, that's really 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 strongly enables us to collaborate with companies, learn from them and you know, learn to compete as well. So the next one is Colleen White at UBS. Hi Colleen White from UBS. 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 like Regeneron's service plan? And then just quickly, if you could comment on before to start the treatment in The U. S, the timelines, possible outcomes of that, that would be helpful. Thank you.
1:27:31 You. Mark, do you want to cover the C5 question and we'll cover before two, so you're later? Yes, obviously there have been a number of competitors against the C5 franchise. We continue to grow but obviously other mechanism or similar products on the C5 complement value also will compete with us. What we have been doing with the Rutomirase since the acquisition of Alexion was also to explore and find the indications and we are going to continue doing that. Mentioned today, I began we saw the results in HTTMA.
1:28:16 We have other trials such as the D1 cross 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 propose answers to disease that have no response today. We are continuing to compete in the C5 but also outside of the C5. Thank you Mark and as you can see I mean Norgakin 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.
1:29:01 Next question is Michael Luxton and Jefferies. Thank you, Pascal. Maybe if I could just go back to Ratna 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. I don't know if 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, regional divestitures we've done again as we clean up the portfolio, again, all of these are small legacy products that we continue to sell consistent and will likely continue into 2027.
1:30:04 Thank you, Avan. So if we return to the sorry, no, there's a question from Koeghenheim. Seamus, go ahead. This is Zach Dunn on for Seamus Fernandez. Thank you for the question. I just wanted to touch on BD. More specifically, is the current phase three 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 has much less to do with 2030 and much more to do with 2032 and beyond, and that larger BD may be necessary to drive growth in that time frame. I think on this one, I can be very clear. The answer is no, we don't need morbidity to deliver.
1:30:51 But of course, to deliver this growth was 2030. But again, it assumes that the aggregate probability of success across our pipeline of new products would be at least as we plan it. Because again, there's no one or two projects, it's the aggregate view of the pipeline. And if you look at that, probability of success is around 62%. So we are more or less planning as if we were going to develop the industry average, in fact a little bit lower.
1:31:43 But we have consistently developed higher, and I mentioned 75% price, this has been our record. So if we deliver what we have in our plan as a point of success, And then we have actually, we 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 net is no, we don't need a new bid to achieve this goal. I don't know where the sale comes from, probably from people who haven't analyzed the pipeline in details, I have to say. We start, Berenberg, do you want to go ahead?
1:32:29 Thank you very much, Pascal. So at the start of the year, you highlighted over GBP 10,000,000,000 combined and risk adjusted peak sales from the 2026 readouts. And today, we see a couple of increases in torso and then, SONI B. And I'm also hearing consistent messages from Susan on Serena for Anvansal, 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, the well, you're talking about the 2,030 targets, right? No, the GBP 10,000,000,000 peak self potential from the readout this year, 26, the slides you had at the full year 25%. Sorry, so the 10,000,000,000 was the peak year estimates with the risk unwind.
1:33:30 So, what that means is, you know, as risk unwinds for the 2026 cohort, we were still, you know, we would say 10,000,000,000. Now some of them have unwound in a positive manner like it tells though, some of them have unwound in not so positive manner. All of those being probability adjusted, I still think we will unwind close to 10,000,000,000. Now that 10,000,000,000 is not a 2020 to 2030 number, that's a peak year sales number. And the peak for some of these products may hit beyond 2030. Maybe 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 would agree with that. Nobody thought it was going to work. We saw they had a good chance, but we still gave it a low PTS.
1:34:27 And then we had a higher sort of good PTS for Winua, more industry standard because we had good reasons to believe based on what the entire cardiology community was saying, good reason it was going to work. So the net result is we've unlocked Toso. And so the uplift in sales is much higher than the down lift in sales from Whenua, 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 Renoir, we are going to share it with our partners at Vionis.
1:35:14 Clearly we gained more with Tozo than we lost with Renoir. I think maybe we'll take that was the last question. So we'll take the questions we left with. And maybe Dave, you could cover both the MFN impact on the pricing of Kepi and also the question about S4 will be at this moment. 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 gonna be able to comment any 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 on MFN and don't plan to. That said, our pricing approach across all of launches now has really evolved in response to MFN, and with The U. S.
1:36:12 Now referencing a basket of countries in setting its price, we are seeing productive engagement 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, that funding for innovation needs to rise in line with the country's GDP per capita. We do anticipate that these will be 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 US for prices in wealthy nations to come up and US prices to come down a bit, we think is the direction of travel.
1:37:04 And as far as this move? Yes, I commented on that at the beginning and said we will share when we have the data, what the timing of the Congress will be. Okay, thanks. And the last question is moving forward about 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 the Fortis in The United States. And as we normally do, we are not commenting on either an arbitration or legal procedure. Thank you, Rohit. So we'll close the Q and A here. Thank you so much for your great question. And in closing, I want to thank you for joining us, for your interest in our company.
1:37:58 And also restate that we are firmly on track for our 2030 goal, but also on track with post-two thousand and thirty goals ambition. And again, we don't need additional bidding, it doesn't mean we will not do additional bidding, but we don't need additional bidding if we continue delivering as we expect to across the pipeline. Again, thank you and have a good day.
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