Growth momentum and pipeline delivery set AstraZeneca on a strong trajectory towards 2030 ambition

CAMBRIDGE, England--(BUSINESS WIRE)--Apr. 29, 2025-- AstraZeneca:

Revenue and EPS summary

Key performance elements for Q1 2025

(Growth numbers at constant exchange rates)

• Total Revenue up 10% to $13,588m, driven by double-digit growth in Oncology and BioPharmaceuticals
• Growth in Total Revenue across all major geographic regions
• Core Operating profit increased 12%
• Core Tax rate of 16% in the quarter due to timing of settlements. Expectations for the full year Core tax rate are unchanged at 18-22%
• Core EPS increased 21% to $2.49
• Five positive Phase III readouts and 13 approvals in major regions since the prior results

Pascal Soriot, Chief Executive Officer, AstraZeneca, said:

"Our strong growth momentum has continued into 2025 and we have now entered an unprecedented catalyst-rich period for our company.

Already this year we have announced five positive Phase III study readouts, including most recently the highly anticipated DESTINY-Breast09 for Enhertu, as well as SERENA-6 for camizestrant and MATTERHORN for Imfinzi; the latter two of these will feature in the ASCO 2025 plenary sessions, reflecting the significance of these data to the oncology community.

Our company is firmly committed to investing and growing in the US and we continue to benefit from our broad-based source of revenue and global manufacturing footprint, including elevenproduction sites in the US covering small molecules, biologics as well as cell therapy. Additionally, we have even greater US investment in manufacturing and R&D planned, leveraging our two large R&D sites in Gaithersburg MD and Cambridge MA.

Overall, we are making excellent progress toward our ambition of eighty billion dollars in Total Revenue by 2030."

See Table 1 for details of clinical trial results since the prior earnings announcement, including DESTINY-Breast09, MATTERHORN, and SERENA-6.

See Note 4 for the locations of the eleven US manufacturing sites.

Guidance

AstraZeneca reiterates its Total Revenue and Core EPS guidance⁵ for FY 2025 at CER, based on the average foreign exchange rates through 2024.

Total Revenue is expected to increase by a high single-digit percentage

Core EPS is expected to increase by a low double-digit percentage

– The Core Tax rate is expected to be between 18-22%

– If foreign exchange rates for April 2025 to December 2025 were to remain at the average rates seen in March 2025, it is anticipated that compared to the performance at CER, FY 2025 Total Revenue would incur a low single-digit percentage adverse impact (unchanged from prior guidance), and Core EPS would incur a low single-digit percentage adverse impact (previously mid single-digit).

Results highlights

Table 1. Milestones achieved since the prior results announcement

Phase III and other registrational data readouts

Regulatory approvals

Regulatory submissions or acceptances* in major regions

* US, EU and China regulatory submissions denotes filing acceptance

Other pipeline updates

For recent trial starts and anticipated timings of key trial readouts, please refer to the Clinical Trials Appendix, available on www.astrazeneca.com/investor-relations.html.

Table 2: Key elements of financial performance in Q1 2025

For monetary values the unit of change is percent; for Gross Margin, Operating Margin and Tax rate the unit of change is percentage points.

In the expense commentary above, the plus and minus bullets denote the directional impact of the item being discussed, e.g. a '+' symbol beside an R&D expense comment indicates that the item resulted in an increase in the R&D spend relative to the prior year.

China

In April 2025, there are following developments in relation to the China investigations:

First, in relation to the illegal drug importation allegations, AstraZeneca received an Appraisal Opinion from the Shenzhen City Customs Office regarding suspected unpaid importation taxes amounting to $1.6 million. To the best of AstraZeneca's knowledge, the importation taxes referred to in the Appraisal Opinion relate to Enhertu. A fine of between one and five times the amount of unpaid importation taxes may also be levied if AstraZeneca is found liable.

Second, in relation to the personal information infringement allegation, AstraZeneca received a Notice of Transfer to the Prosecutor from the Shenzhen Bao'an District Public Security Bureau (the 'PSB') regarding suspected unlawful collection of personal information. The Company has been informed that there was no illegal gain to the Company resulting from personal information infringement.

AstraZeneca continues to fully cooperate with the Chinese authorities.

Corporate and business development

FibroGen
In February 2025, FibroGen announced the sale of FibroGen China to AstraZeneca.

Under the terms of the agreement, FibroGen will receive an enterprise value of $85m plus FibroGen net cash held in China at closing, estimated at the date of signing to be approximately $75m, totalling approximately $160m. The transaction is expected to close by mid-2025, pending customary closing conditions, including regulatory review in China.

Upon closing, AstraZeneca will obtain all rights to roxadustat in China, including manufacturing in China.

EsoBiotec
In March 2025, AstraZeneca entered into a definitive agreement to acquire EsoBiotec, a biotechnology company pioneering in vivo cell therapies that has demonstrated promising early clinical activity. The EsoBiotec Engineered NanoBody Lentiviral (ENaBL) platform could offer many more patients access to transformative cell therapy treatments delivered in minutes rather than the current process which takes weeks.

AstraZeneca will acquire all outstanding equity of EsoBiotec for a total consideration of up to $1bn, on a cash and debt-free basis. This will include an initial payment of $425m on deal closing, and up to $575m in contingent consideration based on development and regulatory milestones. The transaction is expected to close in the second quarter of 2025, subject to customary closing conditions and regulatory clearances.

Alteogen Inc
In March 2025, AstraZeneca and Alteogen Inc. entered into an exclusive license agreement for ALT-B4, a novel hyaluronidase utilising Hybrozyme™ platform technology. Under the terms of the agreement, AstraZeneca has acquired worldwide rights to use ALT-B4 to develop and commercialise subcutaneous formulations of several oncology assets. Alteogen will be responsible for clinical and commercial supply of ALT-B4 to AstraZeneca. AstraZeneca has made an upfront payment to Alteogen and may make additional payments, conditional on achievement of specific development, regulatory and sales-related milestones. Additionally, Alteogen will receive royalties on the sales of the commercialised products.

Beijing R&D centre
In March 2025, AstraZeneca announced it will establish its sixth global strategic R&D centre, to be located in Beijing, China. It will be AstraZeneca's second R&D centre in China, following the opening of the Shanghai R&D centre, and will advance early-stage research and clinical development, enabled by a state-of-the-art artificial intelligence and data science laboratory. The new R&D centre will be located near leading biotech companies, research hospitals, and the National Medical Products Administration in the Beijing International Pharmaceutical Innovation Park (BioPark).

Harbour BioMed
In March 2025, AstraZeneca executed a global strategic collaboration with Harbour BioMed to discover and develop next-generation multi-specific antibodies for immunology, oncology and beyond. The strategic collaboration includes an option to license multiple programs utilizing Harbour BioMed's proprietary fully human antibody technology platform in multiple therapeutic areas, together with an equity investment in Harbour BioMed, which closed in April 2025. Upfront payments for the collaboration and equity investment total $175m. AstraZeneca may incur additional fees and contingent milestones for each program it elects to license, along with tiered royalties on future net sales.

BioKangtai
In March 2025, BioKangtai and AstraZeneca entered into a strategic partnership to establish a joint venture that focus on researching, developing, and producing innovative vaccines.

The joint venture will serve as AstraZeneca's first and only vaccine production hub in China, with a registered capital of RMB 345m (approx. $50m) and a total investment of approx. $400m (RMB 2.76bn). BioKangtai and AstraZeneca will each hold 50% equity in the venture.

Syneron Bio
In March 2025, AstraZeneca executed a strategic collaboration with Syneron Bio to develop potential first-in-class macrocyclic peptides for the treatment of chronic diseases. Under this collaboration, AstraZeneca will gain access to Syneron Bio's innovative macrocyclic peptide drug research and development platform to support research programmes exploring possible future treatments of chronic diseases, including rare, autoimmune, and metabolic disease. AstraZeneca will pay an upfront payment of $55m, with option exercise fees and contingent milestones of over $3bn if all programs are optioned, along with tiered royalties on future net sales. AstraZeneca will also make an equity investment in Syneron Bio.

Tempus AI and Pathos AI
In April 2025, AstraZeneca, Tempus AI, Inc. (Tempus) and Pathos AI, Inc. (Pathos) entered into a series of agreements regarding the development of a foundational large multimodal model in the field of oncology. The model will be used to gather biological and clinical insights, discover novel drug targets, and develop therapeutics. AstraZeneca will pay Tempus a fee, and a syndicate of investors, including AstraZeneca, will contemporaneously execute a stock purchase agreement with Pathos.

Sustainability highlights

In preparation for new reporting regulations, AstraZeneca combined its 2024 sustainability and annual reporting into one integrated publication. Details of performance against targets can be found in the 2024 Sustainability Data Annex.

AstraZeneca published its first Taskforce on Nature-related Financial Disclosures report, and its Sustainable use and sourcing of raw materials report.

Reporting calendar

The Company intends to publish its H1 and Q2 2025 results on 29 July 2025.

Conference call

A conference call and webcast for investors and analysts will begin today, 29 April 2025, at 11:45 UK time. Details can be accessed via astrazeneca.com.

Reporting changes

Product Revenue
Effective 1 January 2025, the Group has updated the presentation of Total Revenue on the face of the Statement of Comprehensive Income to include a new subtotal 'Product Revenue' representing the summation of Product Sales and Alliance Revenue.

Product Revenue and Collaboration Revenue form Total Revenue.

Product Sales and Alliance Revenue will continue to be presented separately, with the new subtotal providing additional aggregation of revenue types with similar characteristics, reflecting the growing importance of Alliance Revenue.

Full descriptions of Product Sales, Alliance Revenue and Collaboration Revenue are included from page 152 of the Group's Annual Report and Form 20-F Information 2024.

Gross Margin
Effective 1 January 2025, the Group has replaced the measure of 'Product Sales Gross Margin' with the measure of 'Gross Margin'. Previously, the measure excluded margin related to Alliance Revenue and Collaboration Revenue. The new measure is calculated using Gross profit as a percentage of Total Revenue, thereby encompassing all revenue categories, and is intended to provide a more comprehensive measure of total performance.

Notes

1. Constant exchange rates. The differences between Actual Change and CER Change are due to foreign exchange movements between periods in 2025 vs. 2024. CER financial measures are not accounted for according to generally accepted accounting principles (GAAP) because they remove the effects of currency movements from Reported results.
2. Effective Jan 1 2025, the Group has updated its presentation of Total Revenue, adding a new subtotal of Product Revenue, the sum of Product Sales and Alliance revenue. For further details, see Note 1: 'Basis of preparation and accounting policy' in the Notes to the Interim Financial Statements.
3. Core financial measures are adjusted to exclude certain items. The differences between Reported and Core measures are primarily due to costs relating to the amortisation of intangibles, impairments, legal settlements and restructuring charges. A full reconciliation between Reported EPS and Core EPS is provided in Table 9 in the Financial Performance section of this document.
4. The eleven manufacturing sites in the US (or territories of the US) are:
   - Bogart, GA
   - Coppell, TX
   - Frederick, MD
   - Mt Vernon, IN
   - Newark, DE
   - Philadelphia, PA
   - Puerto Rico
   - Redwood City, CA
   - Rockville, MD *
   - Santa Monica, CA
   - Tarzana, CA

* Opens in May 2025

5. The Company is unable to provide guidance on a Reported basis because it cannot reliably forecast material elements of the Reported results, including any fair value adjustments arising on acquisition-related liabilities, intangible asset impairment charges and legal settlement provisions. Please refer to the cautionary statements section regarding forward-looking statements at the end of this announcement.
6. Effective Jan 1 2025, the Group has updated its presentation of Gross Margin. For further details, see Note 1: 'Basis of preparation and accounting policy' in the Notes to the Interim Financial Statements
7. Income from disposals of assets and businesses, where the Group does not retain a significant ongoing economic interest, is recorded in Other operating income and expense in the Group's financial statements.

To read AstraZeneca’s Q1 2025 Financial Results press release in full click here.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250428918895/en/

Global Media Relations team
global-mediateam@astrazeneca.com
+44 (0)1223 344 800

Source: AstraZeneca