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Astrazeneca Q1 Earnings Call Highlights

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Key Points

  • AstraZeneca reported a “strong Q1” with total revenue up 8%, operating profit up 12% and core EPS +5%, and reiterated full-year guidance for mid-to-high single‑digit revenue growth and low‑double‑digit core EPS growth at constant FX.
  • Oncology led growth—revenue rose 16% to $6.8B—driven by Imfinzi/Imjudo (+28%) and Enhertu (+34%, now annualizing as a ~$5B brand), alongside positive phase III EMERALD-3 data for Imfinzi combinations.
  • Key pipeline and commercial catalysts include a potential launch for Baxdrostat (management estimates $5B upside, potentially up to $10B), phase III success for Tozorakimab in COPD, and a positive interim ICAN readout for Ultomiris in IgA nephropathy with plans to seek accelerated approval.
  • Five stocks to consider instead of Astrazeneca.

Astrazeneca NYSE: AZN reported first-quarter 2026 results that management described as a “strong Q1” as the company built on momentum from 2025, with revenue growth supported by demand for its newer medicines and continued pipeline progress.

Quarterly financial performance and guidance reiterated

CEO Pascal Soriot said total revenue grew 8% in the quarter, while operating profit increased 12% as the company focused on operating leverage. Core EPS rose 5% to $2.58, though Soriot noted EPS growth was “held back by the low tax rate in the prior period.”

Aradhana (speaking during the financial review) said product revenue—product sales plus alliance revenue—rose 8%, and alliance revenue increased 26% due to “increased profit shares for our partnered products in HER2 and Tezspire” in regions where partners book sales.

On the cost side, she said core gross margin was 83% and the company still expects a “stable to slightly higher” core gross margin for the full year versus 2025. Core R&D expenses increased 8% as AstraZeneca accelerated investment in its pipeline; the company said the number of active clinical trials increased 10% and patient enrollment rose 30% year-over-year. Core SG&A expenses increased 7%, partly driven by pre-launch investments for Baxdrostat ahead of a U.S. PDUFA date in Q2 2026.

Cash flow from operating activities was $3.4 billion, down slightly versus last year due to a large milestone receipt in Q1 2025. CapEx was $600 million, including multi-year investments such as a new ADC manufacturing facility in Singapore and a new Qingdao, China plant for an inhaled respiratory portfolio. The company reiterated expectations that CapEx will increase by around a third in 2026.

Net debt rose by about $2.5 billion during the quarter, driven by payment of the second FY 2025 interim dividend in March. Management reiterated full-year guidance: total revenue is expected to increase by a mid-to-high single-digit percentage, and core EPS is expected to increase by a low double-digit percentage at constant exchange rates. Based on average March exchange rates, AstraZeneca anticipates a low single-digit positive FX impact on total revenue and a neutral FX impact on core EPS.

Oncology growth led by Imfinzi and Enhertu

EVP Dave Fredrickson said oncology revenue increased 16% to $6.8 billion, with double-digit growth in all regions and particularly strong performance in the U.S. and Europe.

Key brand performance highlights included:

  • Tagrisso revenue grew 5% to $1.8 billion. Fredrickson said demand growth in the U.S. was “mid-teens%,” but results were affected by “higher than historic destocking” in the U.S. He added the company expects continued growth and said physicians are increasingly opting for the FLAURA2 combination.
  • Imfinzi and Imjudo grew 28% in aggregate, with Imfinzi up 30%. Fredrickson cited increasing contribution from newer launches (including MATTERHORN in gastric cancer, NIAGARA in bladder, and ADRIATIC in lung cancer) as well as established indications such as HIMALAYA and TOPAZ-1.
  • Calquence grew 17% to more than $900 million, with Fredrickson saying it maintained “share leadership” in frontline CLL in the U.S. despite competition. He said the AMPLIFY-based finite regimen is gaining momentum in reimbursed European markets.
  • Enhertu (alliance view) grew 34% and is “annualizing as a $5 billion brand,” according to Fredrickson. He pointed to continued demand in HER2-positive and HER2-low breast cancer, strong performance in China after NRDL enlistment, and “encouraging early signs of adoption” in the U.S. following the DESTINY-Breast09 approval in December.
  • Truqap revenue was $198 million, up 47% year-over-year; Fredrickson said the company sees U.S. market share at peak.
  • Datroway revenue was $43 million, and Fredrickson said more than one in three third-line EGFR-mutated lung cancer patients are now treated with the medicine. He said AstraZeneca expects a potential U.S. approval of TROPION-Breast02 later in the quarter, which could drive additional growth.

In Q&A, Fredrickson said DESTINY-Breast09 data have been “very well-received” and noted early uptake is being driven more by academic physicians than community settings in the early post-launch period.

Pipeline updates: Imfinzi, Datroway biomarker strategy, and CAR-T

EVP Susan Galbraith highlighted positive phase III EMERALD-3 results in hepatocellular carcinoma for Imfinzi plus Imjudo in earlier disease settings alongside transarterial chemoembolization (TACE). She said the primary analysis showed “a statistically significant and clinically meaningful improvement in progression-free survival” for the STRIDE plus lenvatinib arm, with a “positive trend to overall survival.” She added the STRIDE-only arm showed a strong trend to PFS and OS but was not formally tested at that time. The company plans to present data at ASCO.

Galbraith also outlined additional 2026 readouts for Imfinzi across tumor types, including VOLGA in bladder cancer, and lung cancer datasets in the second half of the year (AVANZAR and PACIFIC-9).

On Datroway, Galbraith explained the rationale for including the QCS biomarker in ongoing lung cancer trials. She said multiple datasets have shown “consistent improvement in performance” for PFS and OS in biomarker-positive patients, supporting inclusion in trials such as TL07, while TL08 includes it as a secondary endpoint due to sample size and design considerations. She also addressed a timing shift for TL07 tied to implementation requirements for the biomarker, including protocol amendments and sample analyses.

In response to a question on AstraZeneca’s Gracell CAR-T platform, Galbraith said the FasTCAR process enables a three-day ex vivo cell growth process and a reliable turnaround time of about 16 days. She added that a lower dose of “fitter T-cells” may expand more rapidly in vivo and could support more predictable timing of cytokine release syndrome, potentially enabling outpatient positioning. She also emphasized AZD0120’s dual targeting (CD19 and BCMA) to reduce escape mechanisms, and noted an ongoing phase III study in later-line multiple myeloma.

BioPharma: respiratory growth offset by CVRM headwinds; Tozorakimab and Baxdrostat in focus

EVP Ruud Dobber said BioPharmaceuticals revenue declined 2% to $5.8 billion as growth in key brands was “mostly offset” by headwinds from Brilinta, Farxiga, and roxadustat. Respiratory & Immunology revenue increased 7% to $2.3 billion, led by 18% growth in key brands. Fasenra grew 11% to $483 million, supported by China NRDL uptake and 63% growth in emerging markets. Breztri grew 13% to $353 million and received a U.S. asthma label expansion, which Dobber said makes it “the first and only triple therapy in asthma approved for patients aged 12 and older.” Tezspire revenue rose 34% to $303 million and is now approved for chronic rhinosinusitis with nasal polyps in all major markets after approvals in Japan and China in the quarter.

CVRM revenue declined 6% to $3.3 billion. Farxiga revenue fell 3% to $2.2 billion, with Dobber citing loss-of-exclusivity impacts outside the U.S. and China’s VBP implementation; he said generic manufacturers entered the U.S. in April while AstraZeneca maintained market share leadership in the SGLT2 class. Lokelma grew 26% to $199 million.

Dobber said the company is preparing for a potential Baxdrostat launch, describing it as a possible first-in-class aldosterone synthase inhibitor for uncontrolled and resistant hypertension if approved. In Q&A, Dobber reiterated comments that Baxdrostat has been framed as a potential $5 billion asset, with additional indications and fixed-dose combinations that “potentially, if successful, can move that number up to potentially $10 billion.”

EVP Sharon Barr detailed high-level phase III results for Tozorakimab in COPD from the LUNA program. She said OBERON and TITANIA met their endpoints with “statistically significant and highly clinically meaningful reductions” in moderate-to-severe exacerbations, including in former smokers and in a broader overall population that included former and current smokers across eosinophil levels and lung function severity. MIRANDA, which tested an every-two-week regimen, also showed clinically meaningful exacerbation reduction. Barr said Tozorakimab was well-tolerated with a favorable safety profile across the program.

Addressing questions on the long-term extension PROSPERO study, Barr said it had a different primary endpoint focused on severe exacerbations (hospitalization or death) over 104 weeks. She noted the primary endpoint did not reach statistical significance in former smokers, but there was a numerical reduction in that population and a nominally significant reduction in the overall population.

Rare disease: growth in Ultomiris; efzimfotase alfa and IgAN updates

Marc Dunoyer, CEO of Alexion and AstraZeneca’s chief strategy officer, said rare disease revenue rose 15% to $2.4 billion, driven by neurology and metabolic growth, higher patient demand, and global expansion. Ultomiris grew 18%, while Soliris continued to decline due to conversions and biosimilar pressure. Strensiq grew 43% year-over-year, which Dunoyer attributed to underlying demand and an easier comparison versus the prior year.

Dunoyer also announced positive high-level results for efzimfotase alfa in hypophosphatasia (HPP). He said the pediatric Mulberry trial met its primary endpoint with meaningful improvements in bone health and other objective measures, while the Chestnut trial showed the therapy was well-tolerated in children switching from Strensiq while maintaining bone health benefits. In the HICKORY trial in adolescents and adults, efzimfotase alfa showed numerical improvement but did not achieve statistical significance on the primary endpoint (six-minute walk test) in patients not previously treated with Strensiq; Dunoyer emphasized clinically meaningful impacts on other measures including mobility, physical function, pain, and fatigue. He said the company plans to submit the data to regulators.

Separately, Dunoyer said a pre-specified interim analysis of the phase III ICAN trial showed Ultomiris met its primary endpoint in IgA nephropathy, with a statistically significant and clinically meaningful proteinuria reduction at week 34 and effects seen as early as week 10. AstraZeneca said it is seeking accelerated approval in key markets, while noting the eGFR endpoint will be assessed at week 106. Dunoyer also said the company is discontinuing Ultomiris in CSA-AKI high-risk patients due to “lack of consistent efficacy across CKD severities.”

Soriot closed by pointing to “strong commercial momentum and excellent pipeline execution,” citing multiple anticipated 2026 approvals and readouts as the company works toward its 2030 ambition and beyond.

About Astrazeneca NYSE: AZN

AstraZeneca plc is a global biopharmaceutical company headquartered in Cambridge, England. Formed through the 1999 merger of Sweden’s Astra AB and the UK’s Zeneca Group, the company researches, develops, manufactures and commercializes prescription medicines across a range of therapeutic areas. AstraZeneca positions itself as R&D-driven, investing in discovery science, clinical development and regulatory processes to bring new therapies to market.

The company’s commercial portfolio and late-stage pipeline emphasize oncology, cardiovascular, renal and metabolic (CVRM) diseases, and respiratory and immunology.

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