On Monday, AstraZeneca (NASDAQ:AZN) discussed second-quarter financial results during its earnings call. The full transcript is provided below.
This content is powered by Benzinga APIs. For comprehensive financial data and transcripts, visit https://www.benzinga.com/apis/.
View the webcast at https://astrazeneca.zoom.us/webinar/register/WN_nIGsY4mdS1Gu2IFLmTfarA#/registration
Summary
AstraZeneca reported a 6% growth in total revenue for the first half of 2026, driven by strong demand for innovative medicines, with an 11% growth when excluding the impact of generics on Farxiga and Brilinta.
The company achieved positive results from six key Phase 3 programs and secured 30 major market approvals, including new approvals in breast cancer and hypertension, enhancing its pipeline toward the 2030 target.
AstraZeneca reiterated its full-year guidance, expecting total revenue to increase by mid- to high-single-digit percentages and core EPS to grow by low double-digit percentages.
The Oncology segment saw a 15% revenue increase, fueled by double-digit growth in major regions and strong performances from key medicines like Tagrisso and Calquence.
BioPharmaceuticals faced a 5% decline in total revenue primarily due to loss of exclusivity for some products, although respiratory and immunology segments showed promise with 11% growth.
The Rare Disease portfolio grew by 11%, with Ultomiris and Strensiq driving growth, supported by new launches and increased patient demand.
The company emphasized its strategic focus on transformative technologies and platforms that will support growth beyond 2030, including advancements in ADCs and next-generation IO bispecifics.
Management expressed confidence in achieving its 2030 revenue target of $80 billion, citing the strength and diversity of its pipeline and continued strategic investments.
Full Transcript
OPERATOR
Good morning to those joining from the UK and the US, good afternoon to those in Central Europe and good evening to those listening in Asia. Welcome 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 utilise the Safe Harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Participants on this call may make forward-looking statements with respect to the operations and financial performance of AstraZeneca.
Although we believe our expectations are based on reasonable assumptions, by their very nature forward-looking statements involve risks and uncertainties and may be influenced by factors that could cause actual results to differ materially from those expressed or implied by these forward-looking statements. Any forward-looking statements made on this call reflect the knowledge and information available at the time of this call. The company undertakes no obligation to 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.
Joris Silon, Head of Investor Relations
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 slide. 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.
Pascal Soriot, Chief Executive Officer
Thank you, Joris, and welcome everyone. I'm really pleased to report that in 1H26 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. We also saw strong growth in core EPS, increasing 11% in the first half.
We announced positive results from six key Phase 3 programs including three new molecular entities. We secured 30 major market approvals across our diverse portfolio, including the first approvals for two Etkama in breast cancer and Bexfendi in hypertension, and increasing our number of approved NMEs 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 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 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 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 inherent risk and that not every program will succeed.
Our pipeline however continued to deliver during the first half with positive results from six high-value Phase 3 programs including the first pivotal data for three new molecular entities: tozorakimab in COPD which we look forward to presenting at ERS, EPCIM, Fortese alpha in HPP and, as announced today, our first wholly owned ADC Soniv including 18.2-positive gastric cancer. We also received eight major market approvals across important indications including two additional NMEs.
We're very happy to see first approvals for ETC 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 US FDA approval for Bexfendi 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 are also working very hard 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.
Aradhana Sarin — Executive Director and Chief Financial Officer
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 and HER2 Datraway and Tezspire 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 lower gross margin in the second half consistent with prior years, reflecting seasonal demand patterns for lower margin medicines such as FluMist and Bifortis. 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 elekoglipron, we have now initiated a 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 CVRM 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 the anticipated launch of tozorakimab following positive Phase 3 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 11% in the first half in line with our guidance for the full year. Point 2 billion in the first half, a decline versus comparator period. This primarily reflects the Lynparza milestone received in the first quarter of 2025, skewing comparisons, as well as working capital impact associated with US loss of exclusivity for Farxiga.
We expect these working capital effects to persist through the remainder of the year before normalizing. Capital expenditure was 1.5 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 the 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 US$2 billion in upfront payments year to date, including the most recently announced diesel transaction.
Our lease liabilities also increased as we opened our new Kendall Square R&D centre 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 mid- to high-single-digit percentage and core EPS to increase by low double-digit percentage at 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 our oncology business. Next slide please.
Dave Fredrickson, Executive Vice President, Oncology Business Unit
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, Tagrisso 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 FLAURA2 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 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. Imfinzi and Imjudo 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 Imfinzi's reach. Turning to Enhertu, 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-Breast09 setting in the United States following its approval late last year. Together with the recent simultaneous US approvals of DESTINY-Breast05 and DESTINY-Breast11 in the curative setting, these growth drivers will become increasingly important through the remainder of the year.
Truqap 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-US markets, with the US opportunity at peak in the breast indication. Beyond breast, we are looking forward to bringing Truqap to patients with PTEN-deficient metastatic hormone-sensitive prostate cancer following the recent approval of CAPItello-281 in the US, and a near-term priority is to establish testing in the setting, which today is not common practice.
Datrowa 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 US. We're excited for the ongoing launch of Datrowa in patients with triple-negative breast cancer who are not candidates for immunotherapy following the US approval of TROPION-Breast02 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. 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 FLAURA2 the clear market leader in the highly competitive US market. FLAURA2 holds around three-quarters of this growing segment. We were pleased to announce the in-licensing of Xigfrovi, a novel oral EGFR inhibitor, earlier this month. Xigfrovi is already approved in the US 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 US. 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. Now, I'll hand it over to Susan to discuss some more of the specific near-term pipeline opportunities.
Susan Galbraith, Executive Vice President, Oncology R&D
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 3 trials due to read out later this year investigating combinations in the sizable post-TKI second-line setting. TROPION-Lung15 evaluates Datrowa alone and in combination with Tagrisso, building on the growing position Datrowa already has in later-line lung cancer based on TROPION-Lung05.
SAFFRON then evaluates Tagrisso combined with Orpathys, offering a differentiated combination approach in patients with MET-driven resistance, supported by the encouraging data we've already seen from SAVANNAH and SAACHI. Looking further ahead, TROPION-Lung14 then aims to bring the combination of Datrowa and Tagrisso into the first line, building directly on the success of FLAURA2. 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 3 trial readouts. Back in May, we announced positive results from the planned interim analysis of the Phase 3 VOLGA trial for Imfinzi 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 enfortumab vedotin and Imfinzi, plus or minus Imjudo, can improve outcomes for the 50% of patients who are not candidates for cisplatin. Importantly, in this regimen, enfortumab vedotin is only given in the neoadjuvant setting, aiming to optimise outcomes whilst balancing the overall benefit-risk profile.
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 Imjudo-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 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 Imfinzi'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-01 trial evaluating suniticatib vedotin, or SunnyV, in previously treated patients with advanced gastric cancer expressing Claudin 18.2.
CLARITY Gastric-01 is the first Phase 3 trial to demonstrate an overall survival benefit with a Claudin 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 Claudin 18.2–positive, non–HER2-positive tumours. 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 investigator's choice of therapy in patients treated with at least two prior therapies. 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 Claudin 18.2 expression as low as 25% at any staining intensity, a lower threshold than that required by other Claudin 18.2–targeted therapies, meaning that SunnyV 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-01 represents a landmark milestone for our oncology portfolio. SunnyV is our second ADC to demonstrate an overall survival benefit in gastric cancer following Enhertu, and our third positive Phase 3 readout in this tumour type in just two years following MATTERHORN for Imfinzi and DESTINY-Gastric04 for Enhertu.
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 ADC space. We look forward to presenting the data later this year. Together with VOLGA, these data strengthen our conviction in 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-02, our first-line gastric cancer trial evaluating SunnyV in combination with capecitabine with or without rilvegostomig or nivolumab.
With that, please advance to the next slide, and I'll pass over to Ruud to cover BioPharmaceuticals performance.
Ruud Dobber — Executive Vice President and President, BioPharmaceuticals Business Unit
Thank you so much, Susan. Next slide, please. Our BioPharmaceuticals 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 Farxiga, Brilinta and roxadustat, 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 in on the quarter, Respiratory & Immunology total revenue grew by 11%. Fasenra grew 13% to $570 million, driven by its continued leadership of the IL‑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, Tezspire 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 inhaled portfolio, Breztri continued on its positive trajectory with 20% growth to $346 million. Breztri received its first approval for eosinophilic asthma this year in the United States and last week received a positive recommendation for eosinophilic 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 million were down 8% due to the price pressure in the United States, reflecting a new generic competitor entering the market.
Saphnelo 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 Saphnelo'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 $1.8 billion 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 Baxfendi in the US, and we are now building early market access through affordability programs. We anticipate commercial access for Baxfendi will broaden over the next few quarters and, in anticipation of Medicare Part D reimbursement from 2028, we're also making an early start on our launch preparations for tozorakimab.
We are encouraged by the data which showed highly clinically 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.
Sharon Barr, Executive Vice President, BioPharmaceuticals R&D
Thank you, Ruud. Next slide, please. I'd like to start by acknowledging the Phase 3 cardioTransform trial for Wainua in transthyretin‑mediated amyloid cardiomyopathy. 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 57% 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 prespecified subgroup analysis of patients treated with Wainua 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 olekoglipron, 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 olekoglipron 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. Olekoglipron 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 olekoglipron 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 olekoglipron monotherapy in patients with obesity or overweight, with or without type 2 diabetes. The Illuminate program, which includes five Phase 3 trials, evaluates olekoglipron both as monotherapy 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 Embold and Illuminate programs. Beyond these, we also plan to initiate Elevate, an indication‑seeking outcomes program designed to demonstrate the value of olekoglipron 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.
Staying in 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 liraprostat in the first half of 2027 and are advancing our first fixed‑dose combination of laraprostat with rosuvastatin 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 tozorakimab 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 TSLP Sunakament, which was formerly referred to as AZD8630, read out its Phase 2 study, and we are discussing plans for Phase 3 with our partner Amgen.
Additionally, we entered into an exclusive license agreement with CTTQ, a subsidiary of Sinobiopharmaceuticals, for the development, manufacturing and commercialization of TQC3721, an inhaled small‑molecule PDE3/4 inhibitor currently in Phase 3 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 Mark to cover Rare Disease.
Marc Dunoyer — CEO, Alexion (AstraZeneca 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 across all key medicines. This is driven by increased patient demand and continued global expansion following launches in the second quarter. Ultomiris grew 12% driven by patient demand across indications, including the competitive MG and PNH markets. Soliris revenues continue 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 asfotase alfa and future franchise growth. Koselugo continues to deliver strong global momentum supported by expansion in adult patients with NF1-PN and uptake of the granule formulation in recently launched markets.
Koselugo remained the market leader for pediatric patients with NF1-PN. 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 3 data presentation across rare disease indications, highlighting the breadth of our portfolio and the strength of our late-stage execution in IgA nephropathy. Phase 3 data from the ICANN trial for Ultomiris showed a 43% reduction in proteinuria, with 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 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 for asfotase alfa in hypophosphatasia. Data from our Phase 3 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 switch safety study. Chestnut showed asfotase alfa was well tolerated and demonstrated a favorable safety profile in pediatric patients.
In a pooled analysis of the Phase 3 Mulberry and Ecore trials, including pediatric, adolescent, and adult patients, treatment with asfotase alfa resulted in a median of 361 days per year free from injection site reactions, and injection site reaction rates were five times lower than with Strensiq. Data from the Mercury 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 HPP patient population.
Also, data from the Calypso Phase 3 trial was presented in May at ECE. [Drug name] paratide demonstrated maintenance of serum calcium within the target range, normalization of urinary calcium, and restoration of normal bone turnover in patients with hypoparathyroidism. And on selinexumab 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 Mayo stage disease.
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. And finally, an update on our Phase 3 trial in adults with thrombotic microangiopathy after ACT. High-level results show that Ultomiris did not achieve statistical significance for the primary endpoint of event-free survival through 26 weeks compared to placebo in adults and adolescents aged 12 years and older with ACT 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 in pediatric patients with ECT 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 diseases where complement is believed to play a central role in disease pathophysiology, with limited treatment options available today.
It reflects 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.
Pascal Soriot, Chief Executive Officer
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 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 Saru Parib 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 Sean mentioned, we expect the first Phase 3 data for lauropostat in first half of 2027 and we have now initiated five Phase 3 trials for helico Glipram. So you can see here a portfolio that 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 hydroligand, we continue to make strong progress as highlighted today. We've just had the first positive Phase 3 readouts for Suniv and we anticipate Phase 3 data for our second wholly owned ADC Puxisam next year. We also continue to advance our broader program, having dosed patients in our first Phase 3 trials for Torvusam and also for Zadagoo this quarter. So very good progress across ADCs and hydroligand. For our next generation IO bispecifics, we now have 16 Phase 3 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. AZD0120 Emanvatamig 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 program progress across those two products. Beyond these lead programs, we're 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 late-stage pipeline of multi-blockbuster opportunities that will underpin our next wave of growth. Move to the next slide. The strength of that opportunity is reflected in this slide. We have three recent launches that Huawei at Kama Baxendi, each with peak year potential of more than $5 billion. We wanted 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 80 billion is risk-adjusted. If everything worked 100% we would be much above the 80 billion of course, 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 Tozo Akima, 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 Suniv today, we estimate that this ADC could reach peak 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 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 pipelines in the industry, one that can now more than offset losses of exclusivity and fuel our strategic high goals 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 Tagrisso, and shows you the strengths of the pipeline and the geographical trend. Six percent growth overall. So strong growth in the first half.
The breadth and depth of our pipeline remain exceptional and our confidence in reaching 80 billion revenue by 2030 is intact. But what excites me most is what comes next. Late-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 Hutchan Sharma at Goldman Sachs. Over to you.
Hutchan Sharma, Analyst at Goldman Sachs
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 Merckx Litfendra? And maybe you could just comment on your expectations for pricing in that market given we now have a list price for your competitor. And then secondly on Suniv, you're going into 3 to 5 billion in peak sales now. 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.
Pascal Soriot, Chief Executive Officer
Thank you very much. Maybe Ruud could take the first question.
Ruud Dobber — Executive Vice President and President, BioPharmaceuticals Business Unit
And yes, of course, Pascal. Overall, I think we are excited about our oral PCSK9. 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 work. But I think the breadth of our portfolio for cholesterol-lowering medicines is broader than only the oral PCSK9. As Sharon has mentioned, we have started the first combination with rosuvastatin. I think we have a unique opportunity because it's a true oral medicine 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 will not change dramatically our own outlook. Of course, I'm not going to disclose our pricing strategy moving forward. It also depends on what we are 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.
Dave Fredrickson, Executive Vice President, Oncology Business Unit
Thanks, Ruud. So just picking up on the question about Sunny V and Clarity Gastric, and after I'm done, turn it over to Susan who can talk a bit more about life cycle plan beyond CG01. But we're very excited about these results and look forward to getting an opportunity to present them soon. Specifically, the CG01 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 data set looks good. We look forward to sharing it. I think a couple of important points. First, we will pursue discussions across all major markets: Europe, China, Japan, and throughout the emerging markets. This data set, we think, supports those discussions. Secondly, as you saw, overall survival being an absolute gold standard within a second, well positions Sunny V for uptake upon approval, and we expanded the definition of Claudin 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 cancers.
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 CG01?
Susan Galbraith, Executive Vice President, Oncology R&D
Yes. So obviously in the first line there's an opportunity to combine with IO agents as I've discussed, with both ... backbone of cytotoxic, and the Clarity Gastric-02 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 Sunny V 5-FU-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 IO and ADC combination in 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 with method, there's an opportunity to go into the earliest, not just expression in gastric cancer but also in pancreatic cancers and biliary tract cancers. And we're exploring those in our ongoing phase one, and we're encouraged by the data that we've seen to date. So I think this can be a broad program for SODV across all of these GI-based cancers.
Pascal Soriot, Chief Executive Officer
Thank you, Susan. Maybe one thing I could add to the PCSK9 is that another fixed-dose combo we are developing is together with GLP-1, because if you have high, elevated cholesterol, typically you also need to lose a bit of weight. This is a good example of how we can differentiate our PCSK9 candidates to differentiate our GLP-1 by providing convenient formulations to patients who are typically polymedicated in these circumstances. So the next question is, I think, Richard.
Yes, Richard. Thanks.
Richard, Analyst
Pascal, one question, please, on camizestrant just now. We've seen the Persevera data in D2 ASCO. I don't think when we last spoke we'd seen it. Could you give us your latest thoughts around how SERENA-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.
Susan Galbraith, Executive Vice President, Oncology R&D
Yeah, okay, thanks. 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, 1,370 patients enrolled, compared to Persevera. And I think, you know, what you see with the Persevera 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 will wait for that readout to really see.
But again, we have striven to enrich that endocrine-sensitive population. We're happy with the SERENA-6 data as the overall tolerability profile that we're seeing with camizestrant: 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 3 trials. And we're very happy to share the data with you soon.
Pascal Soriot, Chief Executive Officer
Thanks, Susan. Next question is from Simon Baker. Simon, over to you.
Simon Baker, Analyst
Thank you, Pascal. One for me on sunvozertinib. The profile based on the data we've seen so far looks very impressive indeed against the competition. But just wanted to get your perspectives on how you see the profile of sunvozertinib 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 far-loop. Is that a significant factor or is that less important than perhaps it might seem?
Thanks so much.
Susan Galbraith, Executive Vice President, Oncology R&D
Okay, so you're talking about sunvozertinib. Pascal, do you want me to take this one?
Pascal Soriot, Chief Executive Officer
Yes, please, if you don't mind. Please.
Susan Galbraith, Executive Vice President, Oncology R&D
Okay, so sunvozertinib is obviously the asset that we've licensed from Dizal for exon 20 mutations and a group of mutations that are non-classical as well, which is about a similar-sized patient population. So I think what the profile is that we see overall, first of all, it's potent against the exon 20s; 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 mutation... ask her 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 the high response rate that we've seen and really good progression-free survival, which was obviously the primary endpoint in that randomized trial. So yeah, I think if you look at that compared with the other competitors in this space, it's, you know, oral, easy to administer at home.
Other agents' potencies are also competitive. So again, we're excited to have this as another agent to build on our legacy in EGFR-mutant.
Pascal Soriot, Chief Executive Officer
Thanks, Susan. It may be good to hear also from Dave, telling you about what we're trying to do to solidify the Tagrisso franchise. Because we're under, of course, two major competitive threats. One in China, which is the multiplicity of EGFRs in the market and a very, very competitive market. We're doing well, but it's competitive. And the second is, of course, the Mariposa regimen which, again, you know, we are still doing well. As Dave mentioned before, market share is still very strong for Tagrisso, but beyond that we are actually trying to build a variety of ways to differentiate.
So maybe, Dave, if you can give us the whole picture again, that would be useful.
Dave Fredrickson, Executive Vice President, Oncology Business Unit
Yeah, it'd be my pleasure. And let me use this as just an opportunity also to comment that the strength of FLAURA2 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 backbone in order to improve outcomes in EGFR-mutated lung cancer. And as Susan quite nicely articulates, sunvozertinib adds to the group of patients that we now have an opportunity to be able to engage physicians about and offer a new therapy.
I think just very, very importantly, you know, we're seeing double-digit volume growth and, in fact, double-digit revenue growth in the US 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 Dato and the Orpathys combinations, which we're looking forward to. I think that with Dato, obviously we've got TROPION-01-15 in the later lines and also TROPION-01-14 in the frontline setting.
And relative to what we see with the other TROP2 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. We've got SAFFRON on the horizon, and that's with the Orpathys combination. And we are very enthusiastic about Tagrisso continuing to be an important driver of growth and contributing meaningfully to the 2030 ambition that we've laid out.
Pascal Soriot, Chief Executive Officer
Thank you, Dave. So this is a very good example of what we've told you before: the ability we have to combine products through our portfolio to defend our various franchises and build beyond where we are. And then with the addition of sunvozertinib, we're 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. So the next question will be from Sarita Kapila, Morgan Stanley.
Sarita, over to you.
Sarita Kapila, Analyst at Morgan Stanley
Thanks, Pascal, for taking my questions on AVANZAR. We notice it has the PFS and OS endpoints in both TROP2-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 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 Dato-DXd's profile versus sacituzumab, particularly post the positive OPTIMIZE-TROPICS Lung-06 data and ahead of the PD-L1 data in 2027? Thank you.
Pascal Soriot, Chief Executive Officer
Thanks. Two good questions for you, Susan.
Susan Galbraith, Executive Vice President, Oncology R&D
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, whether the ITT or within the biomarker-positive group. So that answers your first question. Obviously, you know regulators will be interested in the effect size, the meaningfulness, and the differentiation between those groups.
In discussion of the competitors, I think we have the best-in-class TROP2-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 low rate of bone marrow toxicity, because you see higher rates of bone marrow toxicity with more exposure to the free payload. That, I think, underpins the data that we've seen in triple-negative breast cancer where we saw differentiated activity with high 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 TROPION trials in lung cancer underpin the potential 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 AVANZAR study with that 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 caveat, as we do with all of our phase 3s.
Whilst we're confident in the hypothesis that we've got, we obviously have to wait for the phase 3 trials, and nobody is keener than I am to see the data. And as soon as we've got it, we'll share it with you.
Pascal Soriot, Chief Executive Officer
Thank you. Next question is from Gonzalo Artash. Over to you, Gonzalo.
Gonzalo Artash, Analyst
Hi. Thank you for taking a question. I have one for Sharon and one for Mark. For Sharon, on your TTR depleter: I know the phase 3 study with monotherapy keeps moving as planned, but could you give us some color on how you are seeing this drug moving forward in case the phase 3 hits the line? Is it something that you could put out as monotherapy, or the ideal would be to give in combination with, for example, Amvuttra, given the failed CARDIO-TTRansform studies?
I'm just trying to figure out what you're thinking on this model from today. And a second question on Strensiq for Mark. You guys are confident on these 3 to 5 billion peaks for asfotase alfa 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 Strensiq and Symphonase alfa. How should we expect the future playing out in the market? Thank you so much.
Pascal Soriot, Chief Executive Officer
Thanks. Gonzalo, it's probably two questions for Mark, actually, because the depleter is developed by Alexion. Over to you, Mark.
Marc Dunoyer — CEO, Alexion (AstraZeneca Rare Disease)
Thank you for the two questions. Let me take the first one. So to your question on the add-on design: the trial we're doing on the depleter is as an add-on to either stabilizers—tafamidis or acoramidis—and silencers. So the trial is not done as a monotherapy. What is very important to understand is the difference of mechanism. As the class indicates, a depleter removes the amyloid burden in the tissues and the amyloid plaque in the tissues. This has been confirmed during our phase 1b studies over one year.
We have also read across from another depleter that we are developing in another disease called light-chain amyloidosis. 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 improvements of many, many cardiac functions. So it's not the same disease exactly, but we have a reasonably good read-across of the depleter mechanism in the treatment of amyloidosis.
So for the therapy we are expecting the results in the future, and we look forward to demonstrating again the same benefit—improvement of cardiac remodeling, improvements—and outcome benefit in both mortality and cardiovascular hospitalization. And we look forward to these results. To the second question on Strensiq: Strensiq today has been on the market since 2015. We do not have a very wide coverage, and I think this is what the new product is going to bring us.
It's going to have a much wider coverage in terms of countries. Possibly we will have a wider label than Strensiq, but this remains to be discussed with regulatory authorities. The big difference between those two products is the better tolerability of the new enzyme, which is, I remind you, administered every two weeks instead of administered either daily or every other day for Strensiq. So there are big differences for the patient's utilization and in terms of tolerability.
Just to give you some numbers, patients who are on asfotase alfa 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 Strensiq. We also know that the retention of Strensiq is often impacted by this issue of tolerability. So that's why we remain confident that the new physiology will grow in terms of number of countries, number of patients, and also in the retention of patients once they are on therapy.
Pascal Soriot, Chief Executive Officer
Thank you, Mark. And maybe going back to the TTR question, Gonzalo, you see from Mark's response that the depleter can be used on top of silencers but it can be used on top of stabilizers. Of course, you know, we'll have to show that it adds something, but that's potentially a broad use for this agent. Next question is Sachi. Hi there.
Sachi, Analyst
Thanks. My questions—one financial and one pipeline. So financial: can you talk about balancing the investment in pipeline and launches that Aradhana talked to versus delivering margin expansion? So as we think about 2H26 and 27, cost growth is 1% and SG&A cost growth of 6% a good proxy, or should we think about acceleration into second half this year into next year? And then quick hits on one biopharm and 27 pipeline. So Cambria-1, the switch study, due next year—perhaps, Susan, you could just talk to how you think about the probability of success relative to SERENA-4 and where it sits on the endocrine-sensitivity continuum.
And then one for Ruud: Farxiga life-cycle 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?
Pascal Soriot, Chief Executive Officer
Thank you. You're very ambitious with many questions, but we like ambition. So maybe Aradhana could cover the first one, then Susan, and then Ruud. Is that okay?
Aradhana Sarin — Executive Director and Chief Financial Officer
Great, thank you, Sachi. So for 2026 we've given, obviously, a revenue and an 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 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 PIL- (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. So we'll give more view on that when we do that early next year.
Susan Galbraith, Executive Vice President, Oncology R&D
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 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 a CDK4/6 inhibitor—which is this switch design—and randomising them to continuation of AI or endocrine therapy.
This is a 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 who were likely already cured with current standard of care. So I think it does select for an endocrine-sensitive population as has already been proven with other trials. So I think from that perspective, and given the profile that we've seen with camizestrant in terms of tolerability and efficacy within the SERENA-6 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.
Ruud Dobber — Executive Vice President and President, BioPharmaceuticals Business Unit
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 patient populations where there's a high risk, where there's almost no current treatment. If I take one example, it's in phase 3, it has recruited very fast, clearly showing the high medical needs in proteinuric CKD. Those patients are very ill, the kidney function is declining, and we know the beneficial effects of dapagliflozin.
On top of that, we hope to see a beneficial effect of an endothelin receptor antagonist. The other one is in heart failure patients with a low eGFR where mortality is very high—normally twice as you see in a heart failure population—and there's no data available. So again, it's a highly, highly risky patient population. The estimates of the EPI data have shown that more than 12 million patients in the top eight markets are eligible for treatment like this.
So it clearly shows the potential, if the study is reading out. For both of those fixed-dose combinations, we're expecting to see data in the first half of 2027. And then, last but not least, another combination with dapagliflozin in a high-risk population in chronic kidney disease and hypertension—so the development of chronic kidney disease—and we hope to see a slowdown of the progression of kidney disease. So again, high-risk patients, and I think not everyone is addressing and seeing the potential of all those new combinations.
Those are really new molecular entities if they are successful. Building on the massive experience we have with dapagliflozin—60 million patients are currently treated with dapagliflozin—I think it's the backbone of heart failure and chronic kidney disease patients, and adding those novel mechanisms hopefully will lead to a much more beneficial effect, both from a mortality perspective and from a kidney disease progression perspective.
Pascal Soriot, Chief Executive Officer
Thank you. I had not realized we had many more questions in the line. So if we can stick to one question per person, that would be great. Graham Perry at Citi—over to you, Brian. Are you on mute? Maybe.
Brian, Analyst at Citi
Great. Yeah, thanks for taking the question. So I had one on Escobatase alfa filing for a broad label. Can you confirm that that does include adults? And was that based on any discussion with regulators to date—the acceptability of the PIC-free trial and the trend benefit in the paediatric-onset adult population? And does the 3 to 5 billion sales outlook include the adult population, or is that just in paediatrics? Thank you.
Marc Dunoyer — CEO, Alexion (AstraZeneca Rare Disease)
Thank you very much for the question. So the broad population. So the filing will be above 2 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 they would need to look at the detail of the clinical studies that we have completed and submitted. To your second question on the—so the adult population is segmented into two parts: adult with pediatric onset, which is in several countries already obtained with Strensiq, and adult onset where Strensiq is not approved.
To your second question on the 3 to 5 billion, even if we get less than the totality of a label that we have filed for, we expect to be within the range of 3 to 5 billion.
Joris Silon, Head of Investor Relations
Thank you, Marc. Next is James Gordon, Barclays. James, maybe unmute. James, can you hear me?
James Gordon, Analyst at Barclays
Yep. Great. Thanks for taking the question. Pascal called out—so the selective PARP in prostate cancer where we're getting data next year, and this has been described as a 5 billion plus product. There was something exciting 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 helped here, 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 OI. So the updated 2026 guidance implies higher OI and higher OPEX. And then you reiterate in 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 is most of this year's going to repeat again next year from an ongoing source?
Pascal Soriot, Chief Executive Officer
Thank you, James. Susan, do you want to cover the saruparib 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 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 saruparib is certainly one of the most important ones as well.
Suzanne, over to you.
Susan Galbraith, Executive Vice President, Oncology R&D
Thank you. So as you have seen from the clinical trials appendix, there's a significant effort that we've got with saruparib in prostate cancer. One of the key trials is the EVOPAR Prostate 01, which is a metastatic castration-sensitive prostate cancer, including both the HRR and we 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 earlier-line setting and powered the study for both the HRR and non-HRR.
And of course, having seen 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 PFS in HRR in the PROpel data set. 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 EVOPAR breast opportunity as well.
So when you look at the totality of the saruparib opportunity, it is significant and definitely in the $5 billion range and we're excited to see.
Joris Silon, Head of Investor Relations
Thank you, Suzanne. This one—let's 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. Christopher, go ahead.
Christopher, Analyst
Hi. Thank you very much for taking my question. I guess this one would be on baxdrostat, noting that you have the primary aldosteronism trial reading out next year now. So today screening for aldosteronism 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 brake on your launch? Thank you.
Pascal Soriot, Chief Executive Officer
Sean, you want to cover this?
Sean, UNKNOWN
Sure. So first I'll say thank you for noticing the potential for baxdrostat 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 is the leading cause of secondary hypertension.
We think it could affect as many as 5 to 10% of all hypertensives and up to 20% 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, our 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 baxdrostat 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 unmet medical need and the general enthusiasm of the clinical community.
Joris Silon, Head of Investor Relations
Thank you, Sean. Peter Verduld at BNP.
Peter Verduld, Analyst at BNP Paribas
Thanks. Two quick ones, Pascal. One follow-up on IL-33 and the 5 billion target for Taso. Are you anticipating any competition here? The reason for the question is we're hearing Sanofi and Regeneron might not undertake the third Phase 3 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 IL-33 and then secondly, the obligatory sort of MFN pricing question.
When you think about KAMI approved, how have your thoughts on pricing strategy evolved? If we compare it to historical precedents like Count Quince and to Grips, thank you.
Pascal Soriot, Chief Executive Officer
So do you want to cover the question and we return to the MFN pricing at the end?
Sharon Barr, Executive Vice President, BioPharmaceuticals R&D
Yeah, for sure. Now, I think, Peter, it's a fair question, but it's difficult for me to answer this one because I simply don't know what others are planning to do. What I can tell you is that the data set, hopefully you will see at the ERS, is very convincing, and we get many questions about why do we think that our IL-33 was successful in those two pivotal trials. We believe that the mechanism of action is very specific to our anti-IL-33. It's inhibiting the anti-inflammatory pathway, particularly 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, Analyst
Oh, 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 and Evans are presented at ESMO? Thank you.
Pascal Soriot, Chief Executive Officer
Thank you, Steve. So I'll cover the first question. I will return to the ESMO 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 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, it's not that—what we're doing is collaborating, also competing. You saw the competition in the Tagrisso market is very, very intense and in the LDC markets, very intense too.
So we learn to compete with them and certainly we'll take those learnings globally when they become global companies, as they do. We're still 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. And for instance, that readout 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, 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.
Colin White, Analyst at UBS
Hi, Colin White, UBS here. Thanks for taking my questions. I had quite a 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, and then just quickly if you could comment on the—before to start tradition in the US, the possible outcome to that, that'd be helpful. Thank you.
Pascal Soriot, Chief Executive Officer
Thank you. Marc, do you want to cover the C5 question and we'll cover the Fortress later?
Marc Dunoyer — CEO, Alexion (AstraZeneca Rare Disease)
Yes. So obviously there have been a number of competitors against the C5 franchise. We continue to grow, but obviously novel mechanisms or similar products on the C5 complement biology also will compete with us. What we have been doing with Ultomiris since the acquisition of Alexion was also to explore Biomedia in new indications and we are going to continue doing that. I mentioned today Ligan, we saw the results initially in TMA, we have other trials such as function, and then we will be developing several other areas in the renal disease, but also with other nodules of the other nodes of the complement biology to propose answers to diseases that have no response today. So we are continuing to compete in the C5 but also outside of the C5 from within the complement.
Pascal Soriot, Chief Executive Officer
Okay, Marc. And as you can see, I mean, NOGA team 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. Next question is Michael Lushkin at Jefferies.
Michael Lushkin, Analyst at Jefferies
Thank you, Pascal. Maybe if I could just go back to right now 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 a higher base that makes ’27 a little bit more challenging. Thank you, that's great.
Pascal Soriot, Chief Executive Officer
You got your question.
Aradhana Sarin — Executive Director and Chief Financial Officer
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 regional divestitures we've done again as we clean up the portfolio. And all of these are small legacy products that we continue to sell, consistent, and will likely continue into 2027.
Joris Silon, Head of Investor Relations
Thank you. So if we return to the—sorry, now there's a question from Seamus. Seamus.
Zach Dunn, Analyst (for Seamus Fernandez)
This is Zach Dunn for Seamus Fernandez. Thank you for the question. I just wanted 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 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.
Pascal Soriot, Chief Executive Officer
Well, I think on this one I can be very clear. The answer is no, we don't need mobility to deliver, but of course to deliver these goals post-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 very gate view of the pipeline. And if you look at that, the average probability of success across phase three for the industry, 60, 65%.
I think Anna mentioned it earlier, the probability, the aggregate probability of success, it's around 60%. So we are more or less planning as if we were going to deliver the industry average, in fact a little bit lower, but we have consistently delivered higher. Mentioned 75% price has been our record. So if we deliver what we have in our plan as a probability of success overall, then we actually don't need more BD. So the reason we 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. No, we don't need new BD to achieve this goal. I don't know where this idea comes from, probably from people who haven't analyzed the pipeline in detail, I have to say. Luisa Berenberg, do you want to go ahead?
Luisa Berenberg, Analyst
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 Toso and then Sonny B, and also hearing consistent messages from Susan on Serena for 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.
Aradhana Sarin — Executive Director and Chief Financial Officer
No, the— You're talking about the 2030 targets, right?
Luisa Berenberg, Analyst
No, the 10 billion peak sell potential from the readouts this year, 2026, you had at the full year.
Aradhana Sarin — Executive Director and Chief Financial Officer
Sorry. So the 10 billion was the peak year estimates with the risk unwind. So what that means is, you know, as risk unwinds for the 2026 cohort, we were still, you know, we would say 10 billion. 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 unwind, you know, close to 10 billion. Now that 10 billion is not a 2030 number.
That's a peak year sales number and the peak for some of these products may hit beyond 2030.
Pascal Soriot, Chief Executive Officer
Maybe the one thing I would add to this is that, you know, a 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 thought 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 where they are more industry standard because, you know, we had good reasons to believe based on what the entire cardiology community was saying, good very reason it was going to work.
So the net result is we've unlocked, and so the uplift in sales is much higher than the downlift 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 Manua we were going to share it with our partners at Iones. So, you know, clearly we gained more with Tozo than we lost with renovation. 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 cap and also the question of Alice 4 will be at this moment.
Dave Fredrickson, Executive Vice President, Oncology Business Unit
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 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 US now referencing a basket of countries and 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.
And as far as more— yeah, 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.
Pascal Soriot, Chief Executive Officer
Okay, thanks. And the last question is before— yeah,
Ruud Dobber — Executive Vice President and President, BioPharmaceuticals Business Unit
Pascal, there's not so much I can comment on this one. As we mentioned in our legal disclosures, we started the 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.
Pascal Soriot, Chief Executive Officer
Thank you, Ruud. So we'll close the Q&A here. Thank you so much for your great questions. And in closing, I want to thank you for joining us, for your interest in our company, and also restate that we are firmly on track for our 2030 goal, but also on track with our post-2030 growth ambition. And again, we don't need additional BD. Doesn't mean we will not do additional BD, but we don't need additional BD if we continue delivering as we expect to across the pipeline.
Again, thank you and have a good day.
Disclaimer: This transcript is provided for informational purposes only. While we strive for accuracy, there may be errors or omissions in this automated transcription. For official company statements and financial information, please refer to the company's SEC filings and official press releases. Corporate participants' and analysts' statements reflect their views as of the date of this call and are subject to change without notice.
Login to comment