AstraZeneca PLC Q1 FY2026 earnings call

• Total revenue grew 8% in the quarter, supported by robust demand for innovative medicines. Operating profit increased 12%, core EPS grew 5%.
• Secured 14 approvals in major regions across diverse portfolio. Announced results from four positive phase 3 programs, including two NMEs. Continue to invest in commercial capabilities and R&D pipeline.
• Breadth of business remains a competitive strength, with solid growth outlook across therapy areas and key markets. Strong performances across key regions, with US growing double-digit, Europe and emerging markets growing at high single digits.
• Continuation of successful clinical trial delivery, announced four positive high-value programs. Oncology business saw strong revenues with double-digit growth across segments. R&D highlights with positive phase 3 trial results and upcoming data at ASCO. Biopharmaceuticals portfolio has growth in key brands offsetting headwinds. Rare disease shows strong revenue growth and positive clinical trial results.

Total revenue grew 8% in the quarter. Oncology and rare disease show strong double-digit growth. Oncology total revenues grew 16% in the first quarter to $6.8 billion. Biopharmaceuticals total revenue was broadly stable in the quarter, with growth in key brands mostly offsetting the anticipated headwinds from Berlinta, Frasica and Roxadustat, overall declining by 2% to $5.8 billion. Rare disease delivers total revenue of $2.4 billion in quarter one, up 15% year over year. Revenue contribution %: Oncology and rare disease show strong double-digit growth, while high demand in R&I was offset by loss of exclusivity in CVRM. Emerging markets ex-China revenues up 9%, China revenues increased by 2%.

• Total revenue is anticipated to increase by mid to high single digits percentage, and core EPS is anticipated to increase by low double digit percentage at constant exchange rates. Based on average March exchange rates, anticipate a low single digit positive FX impact on total revenue and a neutral impact on core EPS. Reiterating full year guidance.

Q: Characterization of toziracumab product profile relative to depiction to Nicala and breadth of activity differentiating so physicians wouldn't need to test for eosinophils anymore; A: Sharon and Dave discussed that toziracumab showed positive results in phase three studies, highly clinically meaningful results across populations, and hopes for a broad label.

Q: Ramp of NHER2, DB09 rollout and pace of uptake for adjuvant and neoadjuvant setting; A: Dave discussed HER2 with DDO9 bringing transformative benefit, early adoption in frontline population, and upcoming PDUFA dates for related studies.

Q: On camisesterin for hormonal breast cancer, roots of being $5 billion plus product, impact of Roche's Persevera trial, adjuvant hormonal breast cancer; A: Suzanne discussed camisesterin's differentiated asset, enriched patient population, large patient population in Serina 4, and adjuvant studies Cambria 1 and 2.

Q: On Cardiotransform, factors like TAF and SGLT usage at baseline, cross trial comparison vs AMVUCH, secondary TAF subgroup, commercial relevance; A: Sian and Ruud discussed baseline treatments, expected impact on event rates, secondary endpoints, and importance of hitting primary endpoint.

Q: Confirmation of toziracumab effect size across eosinophil groups, implication of Prospero missing; A: Sharon discussed expectation of broad label, Prospero's different primary endpoint and supporting clinical profile.

Q: Totality of commercial opportunity for Datraway, initial dialogue with FDA on ESO Alpha; A: Dave discussed commercial opportunity and Marc discussed initial dialogue and population breakdown.

Q: Rationale for adding QPS biomarker primary endpoint to TLO7 and TLO8, control arms across datroid lung trials; A: Rajen discussed rationale for including biomarker, statistical analysis in trials.

Q: Delay in TL07 and ClaramiTug, complexity of running test over existing tissue samples, driving factor for ClaramiTug delay; A: Michael and Matt discussed reasons for delays, implementation of biomarker and extension of ClaramiTug trial.

Q: Reimbursement of double-branded regimen in cardiotransforms setting, commercial performance in ATTR PN setting for Whenua; A: Matthew discussed expectation of reimbursement and positive performance in US market.

Q: Potential upside scenarios for Tozzo, exploration beyond COPD; A: Ruud and Sharon discussed free-to-find billion-dollar opportunity in COPD and potential for other indications.

Q: Forecasting future impact of MFN, competition in R&I therapeutic area; A: Ruud discussed conservative approach and Sharon discussed strength of Fasemra.

Q: Positioning of GLP-1, data at ADA for Aleko Goodron; A: Sharon discussed upcoming data at ADA and focus on outcomes and fixed dose combinations.

Q: Interim analyses for chemisestrant, real-time clinical trials with FDA; A: Suzanne discussed not commenting on interim analyses and benefits of real-time collaboration.

Q: CAR-T program, Grassell BCMA CAR-T and fast car platform; A: Susan discussed differentiation of AW0120 with Pascal process.

Q: Underlying demand growth for Tegresso, wholesaler destocking specific to Tegresso; A: Dave discussed mid-teens demand growth and noted destocking on some orals but not affecting Tegresso shares.

Q: Qualification of remarks on potential $5 billion to $10 billion product; A: Ruud stated remarks remain the same, potential $5 billion asset with other indications potentially moving to $10 billion.