AstraZeneca PLC Q1 FY2025 earnings call

Management Statement and Operational Highlights

• Revenue Growth: Total revenue grew 10% in Q1, product revenue up 10%, core operating profit up 12%, core EPS up 21%.
• Approvals and Pipeline: Secured 13 approvals in key regions, had 5 positive Phase III results, including camizestrant and eneboparatide, and made progress towards 20 novel medicines by 2030 (9 approved so far).
• Geographic Performance: Strong performances in key regions, emerging markets ex-China up 17%, China up 5% (adjusting for Pulmicort decline) due to increasing demand for innovative medicines.
• Business Development: Announced acquisition of EsoBiotec, portfolio of novel modalities, exclusive license for ALT-B4, and new R&D center in Beijing to foster collaborations and attract talent.

Segment Performance

• Oncology and Hematology: Oncology total revenues grew 13% in Q1 to $5.6 billion, with strong double-digit growth across the U.S., Europe, and emerging markets. Key medicines like Tagrisso saw 8% growth, Calquence 8%, Lynparza 5%, Truqap had $132M in Q1 revenues, Imfinzi and Imjudo grew 16% and 13% respectively, and Enhertu grew 34%.
• Biopharmaceuticals: Total revenue reached $5.6 billion in Q1, up 12% y-o-y. Farxiga exceeded $2B, Lokelma grew over 35% for the fourth consecutive quarter, Fasenra and Tezspire contributed to growth, while Pulmicort declined 26% due to China's milder winter and generic competition.
• Rare Disease: Revenues were $2B, stable y-o-y. Ultomiris grew 25%, Soliris declined due to conversion to Ultomiris and biosimilar pressure, Strensiq grew 14%, and Koselugo grew 8% but faced headwinds from order timing.

Guidance

• Reiterated full-year 2025 guidance: total revenue growth high single-digit, core EPS growth low double-digit at constant exchange rates. Anticipated low single-digit adverse impact on total revenue from March average FX rates, and updated FX guidance for core EPS to low single-digit adverse impact (previously mid-single-digit).

Risks

• Impact of Medicare Part D redesign in the U.S., anticipated VBP in China, Solaris biosimilar competition, potential tariff impacts on imported medicines, and competition in rare disease (e.g., Ultomiris facing competition in MG and PNH).

Q: On FDA interactions and baxdrostat readout?

A: Susan Galbraith and Sharon Barr noted ongoing FDA interactions with no delays, and baxdrostat's potential with positive Phase IIb data and upcoming pivotal studies.