Moderna Reports Third Quarter 2025 Financial Results and Provides Business Updates

On November 6, 2025 Moderna, Inc. (NASDAQ:MRNA) reported financial results and provided business updates for the third quarter of 2025.

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"We delivered strong commercial and financial performance in the third quarter, supported by COVID vaccine sales following the successful launch of mNEXSPIKE and a significant improvement in expected 2025 operating expenses from our ongoing cost-reduction initiatives," said Stéphane Bancel, Chief Executive Officer of Moderna. "We remain highly focused on operational excellence and financial discipline to advance our pipeline and expand the reach of our commercial portfolio. We look forward to sharing further updates on our business and pipeline at our annual Analyst Day on November 20."

Recent progress includes:

Commercial Updates

COVID-19: The Company reported $971 million in COVID vaccine sales in the third quarter of 2025, which includes $781 million of U.S. sales and $190 million of international sales. The Company has received approval in 40 countries of its 2025-2026 formula for Spikevax. Moderna has also received U.S. Food and Drug Administration (FDA) approval of its 2025-2026 formula for mNEXSPIKE, the Company’s new COVID vaccine in all adults aged 65 and older, as well as individuals aged 12-64 years with at least one underlying risk factor. mNEXSPIKE is also approved in Canada and the Company has filed and is targeting 2026 approvals in Australia, the EU, Japan and Taiwan.

RSV: The Company reported $2 million in mRESVIA sales in the third quarter of 2025. mRESVIA, the Company’s vaccine for the prevention of lower respiratory tract disease (LRTD) caused by RSV, is approved for all adults aged 60 years and older in 40 countries. It is also approved in 31 of those countries for individuals 18-59 years of age who are at increased risk for disease.

Third Quarter 2025 Financial Results

Revenue: Total revenue for the third quarter of 2025 was $1.0 billion, a 45% decrease from $1.9 billion in the same period in 2024. The decline was primarily driven by a $847 million, or 47%, decrease in net product sales, mainly due to lower COVID vaccine sales. In the U.S., the decrease reflected reduced vaccination rates year over year. The third quarter of 2024 also included an approximately $140 million positive adjustment related to prior-period sales provision estimates, which did not recur in 2025. During the quarter, the Company initiated commercial sales in the U.S. of mNEXSPIKE, as part of the 2025-2026 respiratory virus season.Outside the U.S., revenue decreased primarily due to the completion of certain government contracts and the timing of deliveries.

Cost of Sales: Cost of sales for the third quarter of 2025 was $207 million, which included third-party royalties of $43 million and inventory write-downs of $67 million. Cost of sales decreased 60% compared to the same period in 2024, primarily reflecting lower inventory write-downs and reduced unutilized manufacturing capacity, as well as lower sales volume. As a percentage of net product sales, cost of sales was 21% compared to 28% in the third quarter of 2024. The improvement was mainly driven by productivity gains and efficiencies across manufacturing operations despite lower volumes.

Research and Development Expenses: Research and development expenses for the third quarter of 2025 were $801 million, a 30% decrease compared to the same period in 2024. The reduction was primarily driven by continued investment prioritization and efficiency gains in the execution of clinical trials. Last year’s results also included an expense related to the purchase of a priority review voucher.

Selling, General and Administrative Expenses: Selling, general and administrative expenses for the third quarter of 2025 were $268 million, a 5% decrease compared to the same period in 2024. The decline was primarily driven by reductions in consulting and external services across multiple functions, as well as lower digital and facility-related costs, reflecting the Company’s continued cost discipline and ongoing efforts to streamline operations.

Income Taxes: Income tax provisions for both periods were not material, as the Company continues to maintain a global valuation allowance against most of its deferred tax assets.

Net Income (Loss): Net loss was $(200) million for the third quarter of 2025, compared to net income of $13 million for the third quarter of 2024.

Earnings (Loss) Per Share: Loss per share was $(0.51) for the third quarter of 2025, compared to earnings per share of $0.03 for the third quarter of 2024.

Cash Position: Cash, cash equivalents and investments as of September 30, 2025, were $6.6 billion, compared to $7.5 billion as of June 30, 2025. The decrease during the quarter was primarily driven by seasonal impacts on working capital.

2025 Financial Framework

Revenue: The Company narrowed its 2025 projected revenue range from $1.5 to $2.2 billion to $1.6 to $2.0 billion, reflecting third quarter results and expectations for the remainder of the year.

Cost of Sales: Cost of sales for 2025 is expected to be approximately $0.8 to $0.9 billion, lowered from $1.2 billion.

Research and Development Expenses: Research and development expenses for 2025 are anticipated to be $3.3 to $3.4 billion, lowered from previous expectations of $3.6 to $3.8 billion.

Selling, General and Administrative Expenses: Selling, general and administrative expenses for 2025 are projected to be approximately $1.1 billion.

Income Taxes: The Company continues to expect its full-year tax expense to be negligible.

Capital Expenditures: Capital expenditures for 2025 are expected to be approximately $0.3 billion.

Cash and Investments: Year-end cash and investments for 2025 are projected to be $6.5 to $7 billion, increased from previous expectations of approximately $6 billion.

Recent Progress and Upcoming Late-Stage Pipeline Milestones

Respiratory vaccines:

Seasonal flu vaccine: In October 2025, Moderna presented Phase 3 efficacy and safety data for its seasonal flu vaccine (mRNA-1010) at IDWeek 2025, and Phase 3 relative vaccine efficacy in a high-risk subset of patients at The European Scientific Working Group on Influenza (ESWI) Conference 2025. The Company expects to complete submissions for approval of mRNA-1010 in the U.S., Canada, Australia and Europe by January 2026.

Seasonal flu + COVID vaccine: The Company presented Phase 3 immunogenicity subanalyses for its flu/COVID combination vaccine (mRNA-1083) for adults aged 50 years and older at ESWI 2025. The Company expects to refile with Health Canada in 2025 and is awaiting further guidance from U.S. FDA on refiling. Currently, the Company’s mRNA-1083 filing is under review with the European Medicines Agency (EMA).

Latent and other vaccines:

Norovirus vaccine: Moderna’s ongoing Phase 3 safety and efficacy study of its trivalent vaccine against norovirus (mRNA-1403) has not accrued sufficient cases and will now enroll a second Northern Hemisphere season (2025-2026) for additional case accruals. The timing of the Phase 3 readout will continue to be dependent on case accruals.

Cytomegalovirus (CMV) vaccine: After announcing that the Phase 3 study of mRNA-1647 did not meet its primary efficacy endpoint, Moderna is discontinuing development of its congenital CMV program. The Company will continue to evaluate mRNA-1647 in an ongoing Phase 2 trial of bone marrow transplant patients.

Oncology therapeutics:

Intismeran autogene: Moderna continues to make progress on advancing mRNA-4157 in the clinic.In collaboration with Merck, the Phase 3 clinical trial for adjuvant melanoma is fully enrolled. Two non-small cell lung cancer (NSCLC) Phase 3 studies for those with and without prior neoadjuvant treatment are enrolling. Separate randomized Phase 2 studies for high-risk muscle invasive and high-risk non-muscle invasive bladder cancer are enrolling, a Phase 2 study of first-line treatment for patients with metastatic melanoma is also enrolling, and a randomized Phase 2 study for adjuvant renal cell carcinoma is fully enrolled. Further, Moderna and Merck have launched a new Phase 2 study of first-line treatment for patients with metastatic squamous NSCLC.

mRNA-4359: The Phase 1/2 study of mRNA-4359, Moderna’s investigational mRNA-based therapy designed to elicit T-cell immune responses against tumor and immunosuppressive cells, is ongoing. Phase 1b data for mRNA-4359 was recently presented at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress. The Phase 2 portion of the study, which includes cohorts in first-line metastatic melanoma and first-line metastatic NSCLC, is enrolling patients.

Rare disease therapeutics:

Propionic acidemia (PA) therapeutic: The Company recently presented final results from the Part 1 dose-escalation cohorts of its ongoing Phase 1/2 study and cumulative data from ongoing participants in the extension study of its investigational therapeutic for PA (mRNA-3927) at the International Congress of Inborn Errors of Metabolism (ICIEM) 2025. In the study, which is designed to evaluate safety and pharmacology in trial participants with PA, mRNA-3927 has been generally well-tolerated to date with no events meeting protocol-defined dose-limiting toxicity criteria. Previously presented results suggest potential decreases in annualized metabolic decompensation event (MDE) frequency compared to pre-treatment, and the majority of patients have elected to continue on the open label extension study. The Company’s PA candidate is in a registrational study and target enrollment has been reached.

Methylmalonic acidemia (MMA) therapeutic: Moderna recently shared interim data from the Phase 1/2 study of its investigational therapeutic for MMA (mRNA-3705) at ICIEM 2025. mRNA-3705 has been selected by the FDA for the Support for Clinical Trials Advancing Rare Disease Therapeutics (START) pilot program, and the FDA and Moderna have agreed on the pivotal study design. The Company expects to start a registrational study in 2026.

Moderna Corporate Updates

The Company opened its state-of-the-art manufacturing and R&D facility in the UK, which is now licensed by the Medicines and Healthcare products Regulatory Agency (MHRA)

Moderna announced the first made-in-Canada mRNA vaccines were delivered to Canadian provinces and territories

The Company’s manufacturing facility in Australia was recently granted its Good Manufacturing Practice (GMP) license from the Therapeutic Goods Administration (TGA)

Company Accolades

Moderna was recognized on BioSpace’s Best Places to Work in Biopharma ranking of large employers (fifth consecutive year)

Moderna was ranked as a top employer in the global biopharmaceutical industry by Science on the Science Careers’ 2025 Top Employers Survey (eleventh consecutive year)

Key 2025 Investor and Analyst Event Dates

Analyst Day: November 20

Investor Call and Webcast Information

Moderna will host a live conference call and webcast at 8:00 a.m. ET on November 6, 2025. To access the live conference call via telephone, please register at the link below. Once registered, dial-in numbers and a unique pin number will be provided. A live webcast of the call will also be available under "Events and Presentations" in the Investors section of the Moderna website.

Telephone: View Source

Webcast: View Source

The archived webcast will be available on Moderna’s website approximately two hours after the conference call and will be available for one year following the call.

(Press release, Moderna Therapeutics, NOV 6, 2025, https://feeds.issuerdirect.com/news-release.html?newsid=4949430645007740&symbol=MRNA [SID1234659611])

AstraZeneca results: 9M and Q3 2025

On November 6, 2025 AstraZeneca reported its results: 9M and Q3 2025.

Continued strong commercial performance and unprecedented pipeline delivery in the year to date

Revenue and EPS summary

9M 2025
% Change
Q3 2025
% Change

$m
Actual
CER1
$m
Actual
CER
– Product Sales
41,035
9
9
14,365
11
9
– Alliance Revenue
2,108
41
41
815
46
44
Product Revenue2
43,143
10
11
15,180
12
11
Collaboration Revenue
93
(14)
(15)
11
(81)
(82)
Total Revenue
43,236
10
11
15,191
12
10
Reported EPS ($)
5.10
43
42
1.64
77
70
Core3 EPS ($)
7.04
15
15
2.38
14
12

Key performance elements for 9M 2025

(Growth numbers at constant exchange rates)

● Total Revenue up 11% to $43,236m, driven by growth in all Therapy Areas, including 16% growth in Oncology and 13% growth in R&I
● Growth in Total Revenue across all major geographic regions
● Core Operating profit increased 13%
● Core EPS increased 15% to $7.04
● 16 positive Phase III readouts and 31 approvals in major regions

Pascal Soriot, Chief Executive Officer, AstraZeneca, said:

"The strong underlying momentum across our business through the first nine months of the year sets us up well to sustain growth through 2026 and has us on track to deliver our 2030 ambition.

Across our pipeline we have announced an unprecedented 16 positive Phase III trials this year, with four since our previous results including high-impact readouts for baxdrostat in hypertension and Enhertu and Datroway in breast cancer.

We are also delivering on our strategy to strengthen our operations in the United States to power our growth. This includes a historic agreement with the US government to lower the cost of medicines for American patients, and broadening our US manufacturing footprint having broken ground at our new $4.5bn Virginia manufacturing facility in October."

Guidance

AstraZeneca reiterates its Total Revenue and Core EPS guidance4 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 October 2025 to December 2025 were to remain at the average rates seen in September 2025, it is anticipated that FY 2025 Total Revenue growth and Core EPS growth would be broadly similar to the growth at CER (unchanged from the previous guidance).

View Source

Results highlights

Table 1. Milestones achieved since the prior results announcement

Phase III and other registrational data readouts

Medicine
Trial
Indication
Event
Enhertu
DESTINY-Breast05
High-risk HER2+ early breast cancer (post-neoadjuvant)
Primary endpoint met
Datroway
TROPION-Breast02
1L TNBC for patients where IO is not an option
Dual primary endpoints met
Imfinzi
MATTERHORN
Resectable gastric/GEJ cancer
Secondary endpoint met (OS)
baxdrostat
Bax24
Treatment resistant hypertension
Primary endpoint met
Fasenra
RESOLUTE
COPD
Primary endpoint not met
Saphnelo
TULIP-SC
SLE (subcutaneous)
Primary endpoint met

Regulatory approvals

Medicine
Trial
Indication
Region
Calquence
ECHO
1L MCL
JP
Calquence
ACE-LY-004
Relapsed/refractory MCL
JP
Datroway
TROPION-Breast01
HR+ HER2- mBC
CN
Enhertu
DESTINY-Breast06
CTx naïve HER2-low and -ultralow mBC
JP
Imfinzi
NIAGARA
Bladder cancer
JP
Imfinzi
AEGEAN
Resectable NSCLC
JP
Lynparza
PROpel
BRCAm mCRPC
CN
Tezspire
WAYPOINT
Chronic rhinosinusitis with nasal polyps
US, EU
Koselugo
KOMET
Adult neurofibromatosis type 1
JP, EU
Ultomiris
CHAMPION-NMOSD
NMOSD
CN

Regulatory submissions or acceptances* in major regions

Medicine
Trial
Indication
Region
Enhertu
DESTINY-PanTumour02
Previously treated HER2+ solid tumours
EU
Enhertu
DESTINY-Gastric04
2L HER2+ gastric/GEJ cancer
EU
Enhertu
DESTINY-Breast09
1L HER2+ mBC
US, JP, CN
Enhertu
DESTINY-Breast11
Neoadjuvant HER2+ Stage II or III breast cancer
US, CN
Imfinzi
MATTERHORN
Resectable early-stage gastric and GEJ cancers
EU, JP
Imfinzi
POTOMAC
High-risk non-muscle invasive bladder cancer
US, EU, JP
Truqap
CAPItello-281
PTEN-deficient metastatic hormone-sensitive prostate cancer
US, EU
Breztri
KALOS/LOGOS
Uncontrolled asthma
US, EU, JP, CN
Fasenra
NATRON
HES
US, EU, JP, CN
Saphnelo
TULIP-SC
SLE (subcutaneous)
US, EU, JP
Saphnelo
TULIP-1/2, AZALEA
SLE
CN
gefurulimab
PREVAIL
Generalised myasthenia gravis
JP

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* 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: Q3 2025

For the quarter
Reported
Change
Core
Change

ended 30 September
$m
Act
CER
$m
Act
CER

Product Revenue
15,180
12
11
15,180
12
11
∗See Tables 3, 27 and 28 for medicine details of Product Revenue, Product Sales and Alliance Revenue
Collaboration Revenue
11
(81)
(82)
11
(81)
(82)
∗See Tables 4 and 29 for details of Collaboration Revenue
Total Revenue

15,191
12
10
15,191
12
10
∗See Tables 5 and 6 for Total Revenue by Therapy Area and by region
Gross Margin (%)
82
+4pp
+4pp
82


∗Variations in Gross Margin can be expected between periods due to various factors, including fluctuations in foreign exchange rates, product seasonality and Collaboration Revenue
∗See ‘Reporting changes’ below for the definition of Gross Margin5
R&D expense
3,663
18
16
3,550
16
14
∗Core R&D: 23% of Total Revenue
+ Accelerated recruitment year-to-date in ongoing trials
+ Investments in transformative technologies such as IO bispecifics, cell therapy and radioconjugates
+ Positive data read-outs for high-value pipeline opportunities that have ungated large late-stage trials
+ Addition of R&D projects from business development
SG&A expense
5,085
(1)
(3)
3,822
6
4
∗Core SG&A: 25% of Total Revenue
Other operating income and expense6
89
>3x
>3x
96
>3x
>3x

Operating Profit
3,583
70
64
4,993
16
13

Operating Margin (%)
24
+8pp
+8pp
33
+1pp
+1pp

Net finance expense
349
27
25
305
(7)
(9)
− Reduction in Core driven by lower short-term borrowing during the quarter
+ Reported expense in Q3 2024 included a favourable fair value adjustment
Tax rate (%)
22


21
+2pp
+2pp
∗Variations in the tax rate can be expected between periods
EPS ($)
1.64
77
70
2.38
14
12

For monetary values the unit of change is percent. For Gross Margin, Operating Margin and Tax rate, the unit of change is percentage points (pp).
In the expense commentary above, the plus and minus symbols denote the directional impact of the item being discussed, e.g. a ‘+’ symbol beside an R&D expense comment indicates that the item increased R&D expenditure relative to the prior year period.

Corporate and business development

Listing harmonisation

As announced on 29 September 2025 and approved by shareholders on 3 November 2025, AstraZeneca will harmonise its share listing structure to deliver a global listing for global investors in a global company. It is expected that AstraZeneca shareholders will be able to trade their interests in AstraZeneca ordinary shares across the London Stock Exchange, Nasdaq Stockholm and the New York Stock Exchange from 2 February 2026. For further details, see the Circular containing details of the Harmonised Listing Structure.

US investment plans
In October 2025, AstraZeneca announced having broken ground on its $4.5bn manufacturing facility in Rivanna Futures, Albemarle County, Virginia. This is part of the Company’s plans to invest $50bn in US manufacturing and R&D by 2030, announced in July 2025.

The Virginia plant is expected to create approximately 3,600 direct and indirect jobs. It will produce drug substance for AstraZeneca’s weight management and metabolic portfolio, including oral GLP-1 (AZD5004), baxdrostat, oral PCSK9 (laroprovstat) and combination small molecule products, and also antibody drug conjugates for the Oncology portfolio.

Agreement with US Government

In October 2025, AstraZeneca announced a historic agreement with the US administration to lower the cost of prescription medicines for American patients. The Company voluntarily agreed to a range of measures which will enable American patients to access medicines at prices that are equalised with those available in wealthy countries.

As part of the agreement, AstraZeneca will provide Direct-to-Consumer sales to eligible patients with prescriptions for select products for chronic diseases.

AstraZeneca has also reached an agreement with the US Department of Commerce to delay Section 232 tariffs for three years, enabling the Company to fully onshore medicines manufacturing so that all of its medicines sold in America are made in America.

SixPeaks

On 22 October 2025, AstraZeneca, by exercise of an option, completed the acquisition of the remaining share capital of SixPeaks Bio AG (SixPeaks), following an initial investment of $15m made in Q2 2024. $170m was paid on closing, $30m to be paid after two years and up to a further $100m is payable on achievement of regulatory milestones. SixPeaks is investigating potential therapies for weight-management with the aim of preserving lean muscle mass.

Agreement with Merck on Koselugo

In August 2025, the contractual arrangements between AstraZeneca and Merck & Co., Inc., (Merck; known as MSD outside of the US and Canada) were updated and simplified relating to the global development and commercialisation of Koselugo, an oral, selective MEK inhibitor. Under the updated arrangements AstraZeneca will fully recognise the costs, revenues and profits of Koselugo globally. Merck received an upfront payment of $150 million and will receive deferred payments totalling up to $400m. In addition, Merck is eligible to receive up to $175m in potential approval milestones and up to $235m in sales milestone payments, plus single-digit royalties based on net sales. Prior to the updated arrangements, AstraZeneca fully recognised the revenues of Koselugo but shared equally pre-tax profits and losses of the product with Merck.

Sustainability highlights

For the third consecutive year, TIME Magazine recognised AstraZeneca as one of the World’s Best Companies with the Company ranking at 43 out of 1,000 global companies and as the top pharmaceutical company in terms of sustainability transparency.

Reporting calendar

The Company intends to publish its FY and Q4 2025 results on 10 February 2026.

Conference call

A conference call and webcast for investors and analysts will begin today, 6 November 2025, at 13:00 UK time. Details can be accessed via astrazeneca.com.

Reporting changes since FY 2024

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 1 January 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 policies’ 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 Tables 9 and 10 in the Financial Performance section of this document.

4. 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.

5. Effective 1 January 2025, the Group has updated its presentation of Gross Margin. For further details, see Note 1: ‘Basis of preparation and accounting policies’ in the Notes to the Interim Financial Statements.

6. 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.

Revenue drivers

Table 3: Product Revenue by medicine

9M 2025

% Change
Q3 2025

% Change

$m
% Total
Actual
CER
$m
% Total
Actual
CER
Tagrisso
5,352
12
10
10
1,864
12
11
10
Imfinzi
4,317
10
25
25
1,601
11
33
31
Calquence
2,551
6
10
10
916
6
13
11
Lynparza
2,401
6
8
7
837
6
7
5
Enhertu
1,976
5
37
38
714
5
40
39
Zoladex
884
2
5
6
296
2
7
6
Truqap
495
1
85
85
193
1
55
54
Imjudo
253
1
22
21
84
1
16
14
Datroway
38

n/m
n/m
24

n/m
n/m
Other Oncology
323
1
(10)
(9)
107
1
(9)
(10)
Oncology Product Revenue
18,590
43
16
16
6,636
44
19
18
Farxiga
6,345
15
11
11
2,135
14
10
8
Crestor
942
2
5
6
306
2
1
(1)
Brilinta
665
2
(33)
(33)
146
1
(55)
(56)
Lokelma
517
1
32
31
189
1
32
30
Seloken
469
1
1
3
160
1
6
6
roxadustat
229
1
(12)
(12)
77
1
(18)
(19)
Wainua
143

>3x
>3x
59

>2x
>2x
Other CVRM
418
1
(24)
(24)
144
1
(18)
(19)
CVRM Product Revenue
9,728
23
4
5
3,216
21
2

Symbicort
2,180
5
(1)

742
5
5
4
Fasenra
1,451
3
19
19
530
3
22
20
Breztri
906
2
26
26
323
2
21
20
Tezspire
770
2
64
63
287
2
50
47
Pulmicort
357
1
(31)
(30)
93
1
(33)
(35)
Saphnelo
483
1
48
47
180
1
45
44
Airsupra
115

>2x
>2x
45

>2x
>2x
Other R&I
231
1
(11)
(11)
59

(24)
(24)
R&I Product Revenue
6,493
15
13
13
2,259
15
15
14
Beyfortus
474
1
80
78
236
2
29
29
Synagis
220
1
(36)
(35)
58

(37)
(40)
FluMist
132

21
19
122
1
21
20
Other V&I


n/m
n/m


n/m
n/m
V&I Product Revenue
826
2
9
9
416
3
3
2
Ultomiris
3,453
8
22
21
1,225
8
19
17
Soliris
1,436
3
(30)
(28)
462
3
(24)
(24)
Strensiq
1,188
3
19
19
441
3
29
28
Koselugo
498
1
36
34
224
1
88
79
Other Rare Disease
177

18
18
64

31
26
Rare Disease Product Revenue
6,752
16
6
6
2,416
16
12
11
Nexium
638
1
(7)
(5)
204
1
(6)
(5)
Others
116

(27)
(26)
33

(39)
(39)
Other Medicines Product Revenue
754
2
(11)
(9)
237
2
(12)
(12)
Product Revenue
43,143
100
10
11
15,180
100
12
11

Alliance Revenue included above:

Enhertu
1,291
3
24
24
457
3
26
24
Tezspire
453
1
50
50
168
1
37
37
Beyfortus
252
1
>3x
>3x
142
1
>2x
>2x
Datroway
38

n/m
n/m
24

n/m
n/m
Other Alliance Revenue
74

(2)
(2)
24

(8)
(8)
Alliance Revenue
2,108
5
41
41
815
5
46
44

Table 4: Collaboration Revenue

9M 2025

% Change
Q3 2025

% Change

$m

Actual
CER
$m

Actual
CER
Farxiga: sales milestones
81

56
56
5

51
43
Others
12

(79)
(80)
6

(90)
(90)
Collaboration Revenue
93

(14)
(15)
11

(81)
(82)

Table 5: Total Revenue by Therapy Area

9M 2025

% Change
Q3 2025

% Change

$m
% Total
Actual
CER
$m
% Total
Actual
CER
Oncology
18,591
43
16
16
6,636
44
19
18
CVRM
9,809
23
5
5
3,221
21
2

R&I
6,493
15
13
13
2,259
15
15
14
V&I
826
2
2
2
416
3
(10)
(11)
BioPharmaceuticals
17,129
40
7
8
5,896
39
6
4
Rare Disease
6,752
16
6
6
2,416
16
12
11
Other Medicines
764
2
(9)
(8)
242
2
(10)
(10)
Total Revenue
43,236
100
10
11
15,191
100
12
10

Table 6: Total Revenue by region

9M 2025

% Change
Q3 2025

% Change

$m
% Total
Actual
CER
$m
% Total
Actual
CER
US
18,517
43
11
11
6,548
43
9
9
Emerging Markets ex. China
6,378
15
16
21
2,196
14
25
25
China
5,279
12
5
5
1,764
12
6
5
Emerging Markets
11,657
27
11
13
3,960
26
16
15
Europe
9,160
21
11
9
3,334
22
16
10
Established ROW
3,902
9
6
5
1,349
9
7
5
Total Revenue
43,236
100
10
11
15,191
100
12
10

Total Revenue by Medicine

Oncology

Tagrisso

9M 2025$m
Total
Revenue
% Change
Actual CER

∗Strong demand growth across all indications and key regions, leading combination in 1L NSCLC (FLAURA2)
US
2,222
11
11

∗Underlying demand growth more than offset Medicare Part D redesign
Emerging Markets
1,509
11
13

∗Favourable tender order timings in Q3 2025
Europe
1,030
8
5

∗Demand growth partially offset by pricing pressure in certain major markets
Established RoW
591
5
5

Total
5,352
10
10

Imfinzi

9M 2025
$m
Total
Revenue
% Change
Actual CER

∗Strong growth from new launch indications in bladder cancer (NIAGARA) and lung cancer (ADRIATIC, AEGEAN)

US
2,484
32
32

∗Demand growth across all indications, particularly new launches

Emerging Markets
463
27
33

∗Increased demand in GI (HIMALAYA, TOPAZ-1) and new launches in lung cancer

Europe
879
26
24

∗Growth from GI indications and continued momentum from lung cancer launches

Established RoW
491
(6)
(7)

∗Mandatory price reductions in Japan in Feb 2024 (25%), and Aug 2024 (11%), increased competition in BTC (TOPAZ-1)

Total
4,317
25
25

Calquence

9M 2025$m
Total
Revenue
% Change
Actual CER

∗Growth from sustained BTKi leadership in front-line CLL (ELEVATE-TN)
US
1,702
5
5

∗Growth in new starts in CLL, 1L MCL (ECHO) launch and improved affordability offsetting Medicare Part D redesign and formulary discounts to secure preferential formulary placement
Emerging Markets
164
41
48

Europe
569
16
14

∗Early launch momentum in fixed duration 1L CLL (AMPLIFY)
Established RoW
116
18
20

Total
2,551
10
10

Lynparza

9M 2025$m
Total
Revenue
% Change
Actual CER

∗Sustained global PARP inhibitor market leadership across four tumour types (ovarian, breast, prostate, pancreatic)
US
1,054
10
10

∗Share gains across ovarian, breast and prostate indications
Emerging Markets
487
2
4

∗Affected by generic launches in China in Q4 2024
Europe
667
9
7

∗Launches in breast and prostate cancers (OlympiA and PROpel)
Established RoW
193
3
3

∗Gains in 1L ovarian cancer, increasing share of pMMR endometrial cancer
Total
2,401
8
7

Enhertu

Combined sales of Enhertu, recorded by Daiichi Sankyo and AstraZeneca, amounted to $3,575m in 9M 2025 (9M 2024: $2,729m). US in-market sales, recorded by Daiichi Sankyo, amounted to $1,734m in 9M 2025 (9M 2024: $1,342m). AstraZeneca’s European revenue includes a mid-single-digit percentage royalty on Daiichi Sankyo’s sales in Japan, recorded as Alliance Revenue.

9M 2025$m
Total
Revenue
% Change
Actual CER

∗Standard of care in HER2-positive (DESTINY-Breast03) and HER2-low (DESTINY-Breast04) metastatic breast cancer, early uptake in other cancers

US
834
30
30

∗Accelerated uptake in chemotherapy naïve HER2-low and -ultralow breast cancer (DESTINY-Breast06)
Emerging Markets
590
67
75

∗Rapid adoption post-NRDL enlistment of HER2-positive and HER2-low breast cancer from 1 January 2025
Europe
489
22
20

∗Early launch uptake in chemotherapy naïve HER2-low breast cancer
Established RoW
63
34
38

Total
1,976
37
38

Other Oncology medicines

9M 2025$m
Total
Revenue
% Change
Actual CER

Zoladex
884
5
6

∗Growth across Emerging Markets
Truqap
495
85
85

∗Demand growth in second-line biomarker-altered metastatic breast cancer
Imjudo
253
22
21

∗Continued growth driven by lung (POSEIDON) and HCC (HIMALAYA)
Datroway
38
n/m
n/m

∗Continued uptake in breast cancer; initial use in lung cancer following US launch
Other Oncology
323
(10)
(9)

∗Faslodex generic erosion across markets

Other Oncology includes $23m of Total Revenue from Orpathys, partnered with HUTCHMED.

BioPharmaceuticals – CVRM

Farxiga

9M 2025$m
Total
Revenue
% Change
Actual CER

∗Growth driven by HF and CKD indications, SGLT2 class growth supported by cardiorenal guidelines
US
1,244
(3)
(3)

∗Prior year period benefitted from launch of authorised generic
Emerging Markets
2,623
18
21

∗Continued strong growth despite generic competition in some markets
Europe
2,147
13
10

∗Demand growth, impact from generic entry in the UK in Q3 2025
Established RoW
413
11
11

Total
6,426
11
12

Other CVRM medicines

9M 2025$m
Total
Revenue
% Change
Actual CER

Crestor
942
5
6

∗Continued sales growth driven by Emerging Markets
Brilinta
665
(33)
(33)

∗Decline driven by generic entry in the US and Europe in Q2 2025
Seloken
469
1
3

∗Vast majority of revenue growth driven by Emerging Markets
Lokelma
517
32
31

∗Strong growth in all major regions with continued launches in new markets
roxadustat
229
(12)
(12)

∗Decline driven by generic competition
Wainua
143
>3x
>3x

∗Majority of revenue from US, first launches in ex-US markets in Q2 2025
Other CVRM
418
(24)
(24)

BioPharmaceuticals – R&I

Symbicort

9M 2025$m
Total
Revenue
% Change
Actual CER

∗Sustained market leader in a stable ICS/LABA class, treating COPD and asthma
US
903
2
2

∗Demand for authorised generic partially offsetting brand price pressures
Emerging Markets
624
(4)
(3)

∗China affected by ICS/LABA class erosion in COPD in favour of FDC triple therapy
Europe
406
(2)
(4)

∗Continued generic erosion
Established RoW
247
3
5

Total
2,180
(1)

Fasenra

9M 2025$m
Total
Revenue
% Change
Actual CER

∗Expanded severe eosinophilic asthma market share leadership in IL-5 class, further fuelled by first wave market launches for EGPA indication
US
886
18
18

∗Sustained double-digit volume growth with expanded class leadership
Emerging Markets
81
18
22

∗Asthma launch momentum across key markets 
Europe
351
19
17

∗Sustained leadership in severe eosinophilic asthma
Established RoW
133
26
27

∗Strong growth supported by recent EGPA launch in Japan
Total
1,451
19
19

Breztri

9M 2025$m
Total
Revenue
% Change
Actual CER

∗Fastest growing medicine within the expanding FDC triple class (ICS/LABA/LAMA), treating COPD
US
462
26
26

∗Consistent share growth within expanding FDC triple class
Emerging Markets
239
20
21

∗Market share leadership in China with strong FDC triple class penetration
Europe
136
34
31

∗Sustained growth from market share gain and new launches
Established RoW
69
31
31

∗Increasing market share in Japan
Total
906
26
26

Tezspire

Combined sales of Tezspire, recorded by Amgen and AstraZeneca, amounted to $1,321m in 9M 2025 (9M 2024: $843m).

9M 2025$m
Total
Revenue
% Change
Actual CER

∗Sustained demand growth in severe asthma with launch momentum across multiple markets
US
453
50
50

∗Continued strong demand growth with increasing new patient share volumes in biologics segment
Emerging Markets
24
>3x
>3x

∗Strong continued launch uptake
Europe
207
98
93

∗Maintained new-to-brand leadership across multiple markets and new launches
Established RoW
86
55
55

∗Strong growth driven by Japan
Total
770
64
63

Other R&I medicines

9M 2025$m
Total
Revenue
% Change
Actual CER

Pulmicort
357
(31)
(30)

∗Generic competition in Emerging Markets (~80% of revenue)

Saphnelo
483
48
47

∗Strong US demand growth, ongoing launches in Europe and Established RoW

Airsupra
115
>2x
>2x

∗Strong US launch momentum and volume uptake

Other R&I
231
(11)
(11)

BioPharmaceuticals – V&I

Beyfortus Total Revenue reflects the sum of Product Sales from AstraZeneca’s sales of manufactured Beyfortus product to Sanofi and Alliance Revenue from AstraZeneca’s share of gross profits and royalties on sales of Beyfortus in major markets outside the US.

9M 2025$m
Total
Revenue
% Change
Actual CER

Beyfortus
474
49
47

∗Increased capacity and strong demand
Synagis
220
(36)
(35)

∗Competition from Beyfortus
FluMist
132
21
19

Other V&I
0
n/m
n/m

Rare Disease

Ultomiris

Ultomiris Total Revenue includes sales of Voydeya, which is approved as an add on treatment to Ultomiris and Soliris for the ~20-30% of PNH patients who experience clinically significant EVH.

9M 2025$m
Total
Revenue
% Change
Actual CER

∗Growth due to patient demand, both naïve to branded medicines and conversion from Soliris in all indications (gMG, NMOSD, aHUS and PNH)

US
1,961
20
20

∗Demand growth across indications, including within the competitive gMG and PNH landscapes, minimal impact from Medicare Part D redesign

Emerging Markets
177
92
>2x

∗Expansion into new markets and growth in patient demand

Europe
769
18
16

∗Strong demand growth following recent launches; competition in gMG and PNH

Established RoW
546
17
16

∗Continued conversion and strong demand following new launches

Total
3,453
22
21

Soliris

9M 2025$m
Total
Revenue
% Change
Actual CER

∗Decline driven by conversion of patients to Ultomiris in all indications (gMG, NMOSD, aHUS, PNH), competition, and biosimilar pressure in Europe
US
844
(28)
(28)

∗Competition in gMG and PNH, biosimilars launched in April 2025
Emerging Markets
327
(11)
(2)


Europe
159
(54)
(55)

∗Biosimilar competition in PNH and aHUS
Established RoW
106
(35)
(34)

● Driven by conversion to Ultomiris
Total
1,436
(30)
(28)

Strensiq

9M 2025$m
Total
Revenue
% Change
Actual CER

∗Growth driven by continued patient demand and geographic expansion
US
953
17
17

∗Demand growth, offset by Medicare Part D redesign
Emerging Markets
61
58
61

Europe
89
22
19

Established RoW
85
23
21

Total
1,188
19
19

Other Rare Disease medicines

9M 2025$m
Total
Revenue
% Change
Actual CER

Koselugo
498
36
34

∗Growth driven by continued patient demand and geographic expansion. Q3 2025 benefitted from favourable timing of tender orders in Emerging Markets
Other Rare Disease
177
18
18

∗Other Rare Disease medicines include Kanuma and Beyonttra (JP only)

Other Medicines

9M 2025$m
Total
Revenue
% Change
Actual CER

Nexium
638
(7)
(5)

∗Growth in Emerging Markets, generic erosion elsewhere

Others
126
(20)
(20)

∗Generic erosion

R&D progress

This section covers R&D events and milestones that occurred between 29 July 2025 and 5 November 2025. A comprehensive view of AstraZeneca’s pipeline of medicines in human trials can be found in the latest Clinical Trials Appendix, available on AstraZeneca’s investor relations webpage. The Clinical Trials Appendix includes tables with details of the ongoing clinical trials for AstraZeneca medicines and new molecular entities in the pipeline.

Oncology

AstraZeneca presented new data across its diverse portfolio of cancer medicines at two major medical congresses since the prior results announcement: the IASLC 2025 World Conference on Lung Cancer (WCLC) and the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025 (ESMO) (Free ESMO Whitepaper). Across the two meetings, more than 160 abstracts were presented featuring 20 approved and potential new medicines including 35 oral presentations.

Calquence

Approval
JP
ECHO
August 2025
New disclosure
∗For mantle cell lymphoma in previously untreated diseases: in combination with bendamustine hydrochloride and rituximab (genetical recombination).
Approval
JP
ACE-LY-004
August 2025
New disclosure
∗For mantle cell lymphoma in relapsed or refractory diseases.

Datroway

Approval
CN
TROPION-Breast01
August 2025
New disclosure
∗For the treatment of adult patients with unresectable or metastatic HR-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine therapy and at least one line of chemotherapy in the advanced setting.
Data presentation
ESMO
TROPION-Breast02
October 2025
∗Positive results from the TROPION-Breast02 Phase III trial showed Datroway demonstrated a 5.0-month improvement in median OS (HR 0.79; 95% CI 0.64-0.98; p=0.0291) and reduced the risk of disease progression or death by 43% (HR 0.57; 95% CI 0.47-0.69; p<0.0001) compared to chemotherapy as 1st-line treatment for patients with locally recurrent inoperable or metastatic TNBC for whom immunotherapy was not an option.

Enhertu

Approval
JP
DESTINY-Breast06
August 2025
∗For the treatment of adult patients with HR-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) unresectable or recurrent breast cancer.
Priority Review
US
DESTINY-Breast09
September 2025
∗In combination with pertuzumab for the 1st-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer.
Data presentation
ESMO
DESTINY-Breast11
October 2025
∗Positive results from the DESTINY-Breast11 Phase III trial showed Enhertu followed by THP resulted in a pCR rate of 67.3% compared with 56.3% for ddAC-THP, representing a pCR rate improvement of 11.2%, in patients with high-risk, locally advanced HER2-positive early-stage breast cancer.
Data presentationESMO
DESTINY-Breast05
October 2025
∗Positive results from the DESTINY-Breast05 Phase III trial showed Enhertu significantly reduced the risk of invasive disease recurrence or death by 53% compared with T-DM1 as a post-neoadjuvant treatment (HR 0.47, 95% CI 0.34-0.66, p<0.0001) in patients with HER2-positive early breast cancer with residual invasive disease in the breast and/or axillary lymph nodes after neoadjuvant treatment. At three years, 92.4% of patients in the Enhertu arm were alive and free of invasive disease, compared with 83.7% of those in the T-DM1 arm.

Imfinzi

Approval
JP
NIAGARA
September 2025
New disclosure
∗Neoadjuvant and adjuvant therapy in bladder cancer.
Approval
JP
AEGEAN
September 2025
New disclosure
∗Neoadjuvant and adjuvant treatment in non-small cell lung cancer.
Data presentation
ESMO
MATTERHORN
October 2025
∗Positive results from the final OS analysis of the MATTERHORN Phase III trial showed perioperative treatment with Imfinzi in combination with standard-of-care FLOT chemotherapy reduced the risk of death by 22% compared with chemotherapy alone (HR 0.78; 95% CI 0.63-0.96; p=0.021) in patients with resectable, early-stage and locally advanced and GEJ cancers.
Data presentation
ESMO
POTOMAC
October 2025
∗Positive results from the POTOMAC Phase III trial showed adding one year of treatment with Imfinzi to BCG induction and maintenance therapy demonstrated a 32% reduction in the risk of high-risk disease recurrence or death versus the comparator arm (HR 0.68; 95% CI 0.50-0.93; p=0.0154) in patients with BCG-naïve, high-risk non-muscle invasive bladder cancer.

Lynparza

Approval
CN
PROpel
July 2025
New disclosure
∗In combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with g/sBRCAm mCRPC.

Tagrisso

Data presentation
WCLC

FLAURA2
September 2025
∗Positive results from the final OS analysis of the FLAURA2 Phase III trial showed Tagrisso with the addition of pemetrexed and platinum-based chemotherapy demonstrated a median OS of nearly four years (47.5 months) compared to approximately three years (37.6 months) for Tagrisso monotherapy in the 1st-line treatment of patients with locally advanced or metastatic EGFRm NSCLC.

BioPharmaceuticals – CVRM
AstraZeneca presented 32 abstracts and 13 posters alongside two hot-line oral presentations at the European Society of Cardiology (ESC) in Madrid, Spain.

baxdrostat

Data presentation
ESC
BaxHTN
August 2025
∗Positive results from the BaxHTN Phase III trial showed that baxdrostat met the primary and all secondary endpoints, delivering meaningful and sustained blood pressure reductions in patients with hard-to-control hypertension. At week 12, the absolute reduction from baseline in mean seated SBP was 15.7 mmHg (95% CI, -17.6 to -13.7) and placebo-adjusted reduction was 9.8 mmHg (95% CI, -12.6 to -7.0; p<0.001) for the 2mg dose. Results were consistent across both uncontrolled and treatment-resistant subgroups.
Phase III readout
Bax24
October 2025
∗Positive high-level results from the Bax24 Phase III trial showed baxdrostat demonstrated a statistically significant and highly clinically meaningful reduction in ambulatory 24-hour average systolic blood pressure compared with placebo at 12 weeks. Efficacy was observed throughout the 24-hour period, including early morning, when patients with hypertension are at a higher risk of cardiovascular events.

BioPharmaceuticals – R&I

Airsupra

Approval
US

BATURA
October 2025

∗US Prescribing Information now includes clinically meaningful evidence in reducing severe exacerbations from the BATURA study in patients with mild asthma.

Fasenra

Phase III readout

RESOLUTE
September 2025

∗ The RESOLUTE Phase III trial despite showing numerical improvement, did not achieve statistical significance in the primary endpoint in patients with chronic obstructive pulmonary disease.

Saphnelo

Phase III readout

TULIP-SC
September 2025

∗Positive high-level results from a pre-specified interim analysis of the Phase III TULIP-SC trial in patients with systemic lupus erythematosus showed that the subcutaneous administration of Saphnelo demonstrated a statistically significant and clinically meaningful reduction in disease activity compared to placebo. The TULIP-SC interim results were presented at the American College of Rheumatology annual meeting in October 2025.
CHMP opinion
EU
TULIP-SC
October 2025
∗Recommended for approval as a self-administered once-weekly pre-filled pen for adult patients with systemic lupus erythematosus on top of standard therapy.

Tezspire

Approval
EU
WAYPOINT
October 2025
∗As an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe CRSwNP who have not adequately responded to standard therapy (systemic corticosteroids and/or surgery).
Approval
US
WAYPOINT
October 2025
∗As an add-on maintenance treatment of adult and paediatric patients aged 12 years and older with inadequately controlled CRSwNP.

Rare Disease

Alexion, AstraZeneca Rare Disease, delivered 18 presentations, including four oral presentations, from its leading rare neurology portfolio at the American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting and the Myasthenia Gravis Foundation of America (MGFA) Scientific Session in San Francisco, California.

Koselugo

Approval
Japan

KOMET
August 2025
∗For the treatment of adult patients with symptomatic, inoperable plexiform neurofibromas in neurofibromatosis type 1.
Approval
EU
KOMET
October 2025
∗For the treatment of adult patients with symptomatic, inoperable plexiform neurofibromas in neurofibromatosis type 1.

Approval
Japan
SPRINKLE
September 2025
∗Granule formulation for paediatric patients one year of age and older with neurofibromatosis type 1 who have symptomatic, inoperable plexiform neurofibromas.

Approval
US
SPRINKLE
September 2025
∗Granule formulation for paediatric patients one year of age and older with neurofibromatosis type 1 who have symptomatic, inoperable plexiform neurofibromas.

Ultomiris

Approval
China

CHAMPION-NMOSD
August 2025

∗For the treatment of adult patients with neuromyelitis optica spectrum disorder who are anti-aquaporin-4 antibody positive.

gefurulimab

Data presentation
AANEM/MGFA
PREVAIL
October 2025
∗Positive results from the PREVAIL Phase III trial demonstrated an improvement from baseline in MG-ADL total score at week 26 compared to placebo (treatment difference: -1.6 [95% CI: -2.4, -0.8], p<0.0001). A clinically meaningful improvement was observed as early as week one, and was sustained through week 26. Additionally, a clinically meaningful improvement in key secondary endpoint, QMG total score, was seen as early as week four (treatment difference: -1.8 [ 95% CI: -2.5, -1.1], p<0.0001) and was sustained through week 26 (treatment difference: -2.1 [95% CI: -3.1, -1.1], p<0.0001).

Sustainability

Sustainability highlights

For the third consecutive year, TIME Magazine recognised AstraZeneca as one of the World’s Best Companies with the Company ranking at 43 out of 1,000 global companies and as the top pharmaceutical company in terms of sustainability transparency. AstraZeneca also secured fifth place in Sustainability Magazine’s Top 250 World’s Most Sustainable Companies 2025, affirming its status as a global leader in responsible business and pharmaceutical innovation.

AstraZeneca engaged on climate action, health systems resilience and health equity at the United Nations (UN) General Assembly High-Level Meeting on non-communicable diseases (NCDs) and Climate Week NYC in September through over 100 engagements. EVP Global Operations, IT and Chief Sustainability Officer Pam Cheng represented the private sector at the UN alongside governments, NGOs and academia, focusing on the need to tackle NCDs.

Chair Michel Demaré also joined a group of 25 global health leaders, including former heads of state and ministers, calling for action on this topic through an Open Letter in POLITICO, with a focus on the human, social and financial impacts of chronic disease and targeted solutions.

Sustainability impact

Climate and nature

– The Company focused on sustainable respiratory care at the European Respiratory Society (ERS), hosting a sustainability symposium, key engagements and running a sustainable booth with a living lung installation.

– The Company won a 2025 Freezer Challenge Award for the fourth time from My Green Lab and the International Institute for Sustainable Laboratories, recognised as the Top Organization in the biotech and pharmaceutical sector for energy savings and best-in-class cold storage management.

Health equity

– At EXPO 2025, the Company advanced priorities to transform lung health in Japan and Asia-Pacific through best practice sharing on screening and integrated disease management. The Company convened national and international government and clinical experts in lung cancer and COPD to further collaboration for high-risk patients and reduce mortality in Japan.

– AstraZeneca’s Young Health Programme (YHP) received the ACE Award for Workforce Innovation and Global Impact at the Healthcare Businesswomen’s Association’s (HBA) annual conference, recognising how the programme supports employee engagement, advances health equity and strengthens health systems through youth empowerment. YHP was also recognised with the Third Sector Award for Large Corporate Partnership of the Year with Plan International UK.

– The Company expanded its Healthy Heart Africa (HHA) programme in the Côte d’Ivoire, in partnership with the Ministry of Health, to include chronic kidney disease (CKD) care in addition to hypertension. The programme also expanded in Rwanda, where it will develop a protocol for CKD care in primary health, with training to be cascaded to healthcare providers, in collaboration with PATH.

Health systems resilience

– The Partnership for Health System Sustainability and Resilience (PHSSR) published its summary report on Acting Early on NCDs which captures highlights from research conducted in eight countries on health systems’ capability to act early on cancers, chronic respiratory diseases and CVRM. AstraZeneca engaged on its findings with the World Economic Forum Sustainable Development Impact Meetings in New York.

Operating and financial review

Reporting currency

All narrative on growth and results in this section is based on actual exchange rates, and financial figures are in US$ millions ($m), unless stated otherwise.

Reporting period

The performance shown in this announcement covers the nine-month period to 30 September 2025 (‘the period’ or ‘9M 2025’) compared to the nine-month period to 30 September 2024 (‘9M 2024’), or the three-month period to 30 September 2025 (‘the quarter’ or ‘Q3 2025’) compared to the three-month period to 30 September 2024 (‘Q3 2024’), unless stated otherwise.

Core financial measures

Core financial measures, EBITDA, Net debt, Gross Margin, Operating Margin and CER are non-GAAP financial measures because they cannot be derived directly from the Group’s Condensed consolidated interim financial statements.

Management believes that these non-GAAP financial measures, when provided in combination with Reported results, provide investors and analysts with helpful supplementary information to understand better the financial performance and position of the Group on a comparable basis from period to period.

These non-GAAP financial measures are not a substitute for, or superior to, financial measures prepared in accordance with GAAP.

Core financial measures (cont.)

Core financial measures are adjusted to exclude certain significant items:

– Charges and provisions related to our global restructuring programmes, which includes charges that relate to the impact of restructuring programmes on our capitalised manufacturing assets and IT assets

– Amortisation and impairment of intangible assets, including impairment reversals but excluding any charges relating to IT assets

– Other specified items, principally comprising acquisition-related costs and credits, which include the imputed finance charges and fair value movements relating to contingent consideration on business combinations, imputed finance charges and remeasurement adjustments on certain Other payables arising from intangible asset acquisitions, remeasurement adjustments relating to certain Other payables and debt items assumed from the Alexion acquisition and legal settlements

– The tax effects of the adjustments above are excluded from the Core Tax charge

Details on the nature of Core financial measures are provided on page 70 of the Annual Report and Form 20-F Information 2024.

Reference should be made to the Reconciliation of Reported to Core financial measures table included in the Financial Performance section in this announcement.

Definitions

Gross Margin is defined as Gross Profit as a percentage of Total Revenue.

EBITDA is defined as Reported Profit before tax after adding back Net finance expense, results from Joint ventures and associates and charges for Depreciation, amortisation and impairment. Reference should be made to the Reconciliation of Reported Profit before tax to EBITDA included in the Financial Performance section in this announcement.

Operating margin is defined as Operating profit as a percentage of Total Revenue.

Net debt is defined as Interest-bearing loans and borrowings and Lease liabilities, net of Cash and cash equivalents, Other investments, and Net derivative financial instruments. Reference should be made to Note 3 ‘Net debt’, included in the Notes to the interim financial statements in this announcement.

The Company strongly encourages investors and analysts not to rely on any single financial measure, but to review AstraZeneca’s financial statements, including the Notes thereto, and other available Company reports, carefully and in their entirety.

Due to rounding, the sum of a number of dollar values and percentages in this announcement may not agree to totals.

Financial performance

Table 7: Reported Profit and Loss

9M 2025
9M 2024
% Change
Q3 2025
Q3 2024
% Change

$m
$m
Actual
CER
$m
$m
Actual
CER
– Product Sales
41,035
37,576
9
9
14,365
12,947
11
9
– Alliance Revenue
2,108
1,498
41
41
815
559
46
44
Product Revenue
43,143
39,074
10
11
15,180
13,506
12
11
Collaboration Revenue
93
108
(14)
(15)
11
59
(81)
(82)
Total Revenue
43,236
39,182
10
11
15,191
13,565
12
10
Cost of sales
(7,515)
(7,482)

2
(2,801)
(3,081)
(9)
(10)
Gross profit
35,721
31,700
13
13
12,390
10,484
18
16
Distribution expense
(426)
(412)
3
4
(148)
(145)
2

R&D expense
(10,370)
(8,906)
16
16
(3,663)
(3,115)
18
16
SG&A expense
(14,441)
(14,567)
(1)
(1)
(5,085)
(5,143)
(1)
(3)
Other operating income & expense
281
152
85
87
89
25
>3x
>3x
Operating profit
10,765
7,967
35
35
3,583
2,106
70
64
Net finance expense
(985)
(919)
7
7
(349)
(274)
27
25
Joint ventures and associates
(7)
(23)
(68)
(70)
10
(4)
n/m
n/m
Profit before tax
9,773
7,025
39
38
3,244
1,828
77
70
Taxation
(1,869)
(1,484)
26
25
(709)
(395)
79
72
Tax rate
19%
21%

22%
22%

Profit after tax
7,904
5,541
43
42
2,535
1,433
77
70
Earnings per share
$5.10
$3.57
43
42
$1.64
$0.92
77
70

Table 8: Reconciliation of Reported Profit before tax to EBITDA

9M 2025
9M 2024
% Change
Q3 2025
Q3 2024
% Change

$m
$m
Actual
CER
$m
$m
Actual
CER
Reported Profit before tax
9,773
7,025
39
38
3,244
1,828
77
70
Net finance expense
985
919
7
7
349
274
27
25
Joint ventures and associates
7
23
(68)
(70)
(10)
4
n/m
n/m
Depreciation, amortisation and impairment
4,222
4,351
(3)
(4)
1,549
1,817
(15)
(16)
EBITDA
14,987
12,318
22
21
5,132
3,923
31
28

Table 9: Reconciliation of Reported to Core financial measures: 9M 2025

For the nine months ended 30 September

Reported
Restructuring
Intangible Asset Amortisation & Impairments
Other
Core
% Change

$m
$m
$m
$m
$m
Actual
CER
Gross profit
35,721
(61)
24
12
35,696
10
10
– Gross Margin
83%

83%


Distribution expense
(426)



(426)
3
4
R&D expense
(10,370)
134
141
4
(10,091)
17
16
– R&D % of Total Revenue
24%

23%
-1pp
-1pp
SG&A expense
(14,441)
113
3,038
209
(11,081)
3
3
– SG&A % of Total Revenue
33%

26%
+2pp
+2pp
Total operating expense
(25,237)
247
3,179
213
(21,598)
9
9
Other operating income & expense
281
(6)

7
282
88
91
Operating profit
10,765
180
3,203
232
14,380
13
13
– Operating Margin
25%

33%
+1pp
+1pp
Net finance expense
(985)


162
(823)
(4)
(4)
Taxation
(1,869)
(49)
(611)
(98)
(2,627)
11
11
EPS
$5.10
$0.08
$1.68
$0.18
$7.04
15
15

Table 10: Reconciliation of Reported to Core financial measures: Q3 2025

For the quarter ended 30 September

Reported
Restructuring
Intangible Asset Amortisation & Impairments
Other
Core
% Change

$m
$m
$m
$m
$m
Actual
CER
Gross profit
12,390
9
7
11
12,417
12
10
– Gross Margin
82%

82%


Distribution expense
(148)



(148)
2

R&D expense
(3,663)
33
79
1
(3,550)
16
14
– R&D % of Total Revenue
24%

23%
-1pp
-1pp
SG&A expense
(5,085)
37
1,095
131
(3,822)
6
4
– SG&A % of Total Revenue
33%

25%
+1pp
+1pp
Total operating expense
(8,896)
70
1,174
132
(7,520)
10
9
Other operating income & expense
89


7
96
>3x
>3x
Operating profit
3,583
79
1,181
150
4,993
16
13
– Operating Margin
24%

33%
+1pp
+1pp
Net finance expense
(349)


44
(305)
(7)
(9)
Taxation
(709)
(19)
(225)
(49)
(1,002)
33
30
EPS
$1.64
$0.03
$0.62
$0.09
$2.38
14
12

Profit and Loss drivers

Gross profit

The stable Gross Margin (Reported and Core) in 9M 2025 was a result of:

– Positive effects from geographic mix

– Negative effects from product mix. The rising contribution of Product Sales with profit sharing arrangements (Lynparza, Enhertu, Tezspire, Koselugo) has a negative impact on Gross Margin because AstraZeneca records Product Sales in certain markets and pays away a share of the gross profits to its collaboration partners. The profit share paid to partners is recorded in AstraZeneca’s Cost of sales line

– Pricing adjustments, for example to sales reimbursed by the Medicare Part D programme in the US, diluted the Gross Margin

Variations in Gross Margin performance between periods can continue to be expected due to product seasonality, foreign exchange fluctuations, and other effects.

R&D expense

The change in R&D expense (Reported and Core) in the period was impacted by:

– Positive data read-outs for high-value pipeline opportunities that have ungated late-stage trials

– Investment in platforms, new technology and capabilities to enhance R&D capabilities

– Addition of R&D projects following completion of previously announced business development activity

SG&A expense

– The change in SG&A expense (Reported and Core) in the period was driven primarily by market development activities for launches and to support continued growth in existing brands

Other operating income and expense

– Other operating income in 9M 2025 consisted primarily of royalties and an upfront fee on a divestment

Net finance expense

Core Net finance expense decreased 4% (4% at CER) in 9M 2025, mainly driven by an adjustment of interest on tax, due to a reduction of tax liabilities relating to prior periods, recognised in the first quarter, and also a reduction in short-term borrowings.

Core Net finance expense decreased 7% (9% at CER) in Q3 2025, mainly driven by a reduction in short-term borrowings.

Taxation

The effective Reported and Core tax rates for the nine months to 30 September 2025 were 19% (9M 2024: 21% and 20% respectively).

The cash tax paid for the nine months ended 30 September 2025 was $2,193m (9M 2024: $1,978m), representing 22% of Reported Profit before tax (9M 2024: 28%).

Cash Flow

Table 11: Cash Flow summary: 9M 2025

For the nine months ended 30 September

2025
$m
2024
$m
Change$m
Reported Operating profit
10,765
7,967
2,798
Depreciation, amortisation and impairment
4,222
4,351
(129)
Movement in working capital and short-term provisions
64
(543)
607
Gains on disposal of intangible assets
(118)
(34)
(84)
Fair value movements on contingent consideration arising from business combinations
(29)
251
(280)
Non-cash and other movements
591
15
576
Interest paid
(1,069)
(1,075)
6
Taxation paid
(2,193)
(1,978)
(215)
Net cash inflow from operating activities
12,233
8,954
3,279
Net cash inflow before financing activities
6,871
2,155
4,716
Net cash (outflow) from financing activities
(4,262)
(3,325)
(937)

Net cash flow

The change in Net cash inflow from operating activities of $3,279m is primarily driven by the increased operating profit in 2025.

The change in Net cash inflow before financing activities of $4,716m is primarily driven by the reduction in cash outflow relating to the Acquisitions of subsidiaries, net of cash acquired of $2,771m, which in 2024 related to the acquisition of Gracell Biotechnologies Inc. and the acquisition of Fusion Pharmaceuticals Inc.

The change in Net cash outflow from financing activities of $937m is primarily driven by the issue of new long-term loans of $6,492m in 2024, with no issuance in 2025, and offset by the repayment of loans of $4,647m in 2024, with no repayment in 2025.

Capital expenditure

Capital expenditure on tangible assets and Software-related intangible assets amounted to $2,091m in 9M 2025 (9M 2024: $1,415m). The increase of capital expenditure in 2025 was driven by investment in several major manufacturing projects and continued investment in technology upgrades.

Net debt

Net debt decreased by $605m in the nine months to 30 September 2025 to $23,965m. Details of the committed undrawn bank facilities are disclosed within the going concern section of Note 1. Details of the Company’s solicited credit ratings and further details on Net debt are disclosed in Note 3.

Net debt

Table 12: Net debt summary

At 30 Sep2025
$m
At 31 Dec 2024
$m
At 30 Sep 2024
$m
Cash and cash equivalents
8,143
5,488
4,797
Other investments
39
166
133
Cash and investments
8,182
5,654
4,930
Overdrafts and short-term borrowings
(622)
(330)
(769)
Commercial paper
(1,091)

(472)
Lease liabilities
(1,758)
(1,452)
(1,422)
Current instalments of loans
(4,461)
(2,007)
(12)
Non-current instalments of loans
(24,700)
(26,506)
(28,887)
Interest-bearing loans and borrowings (Gross debt)
(32,632)
(30,295)
(31,562)
Net derivatives
485
71
284
Net debt
(23,965)
(24,570)
(26,348)

Summarised financial information for guarantee of securities of subsidiaries

AstraZeneca Finance LLC ("AstraZeneca Finance") is the issuer of 1.2% Notes due 2026, 4.8% Notes due 2027, 4.875% Notes due 2028, 1.75% Notes due 2028, 4.85% Notes due 2029, 4.9% Notes due 2030, 4.9% Notes due 2031, 2.25% Notes due 2031, 4.875% Notes due 2033 and 5% Notes due 2034 (the "AstraZeneca Finance USD Notes"). Each series of AstraZeneca Finance USD Notes has been fully and unconditionally guaranteed by AstraZeneca PLC. AstraZeneca Finance is 100% owned by AstraZeneca PLC and each of the guarantees issued by AstraZeneca PLC is full and unconditional and joint and several.

The AstraZeneca Finance USD Notes are senior unsecured obligations of AstraZeneca Finance and rank equally with all of AstraZeneca Finance’s existing and future senior unsecured and unsubordinated indebtedness. The guarantee by AstraZeneca PLC of the AstraZeneca Finance USD Notes is the senior unsecured obligation of AstraZeneca PLC and ranks equally with all of AstraZeneca PLC’s existing and future senior unsecured and unsubordinated indebtedness. Each guarantee by AstraZeneca PLC is effectively subordinated to any secured

indebtedness of AstraZeneca PLC to the extent of the value of the assets securing such indebtedness. The AstraZeneca Finance USD Notes are structurally subordinated to indebtedness and other liabilities of the subsidiaries of AstraZeneca PLC, none of which guarantee the AstraZeneca Finance USD Notes.

AstraZeneca PLC manages substantially all of its operations through divisions, branches and/or investments in subsidiaries and affiliates. Accordingly, the ability of AstraZeneca PLC to service its debt and guarantee obligations is also dependent upon the earnings of its subsidiaries, affiliates, branches and divisions, whether by dividends, distributions, loans or otherwise. Please refer to the Consolidated financial statements of AstraZeneca PLC in our Annual Report on Form 20-F as filed with the SEC and information contained herein for further financial information regarding AstraZeneca PLC and its consolidated subsidiaries. For further details, terms and conditions of the AstraZeneca Finance USD Notes please refer to AstraZeneca PLC’s reports on Form 6-K furnished to the SEC on 22 February 2024, 3 March 2023 and 28 May 2021.

Pursuant to Rule 13-01 and Rule 3-10 of Regulation S-X under the Securities Act of 1933, as amended (the "Securities Act"), we present below the summary financial information for AstraZeneca PLC, as Guarantor, excluding its consolidated subsidiaries, and AstraZeneca Finance, as the issuer, excluding its consolidated subsidiaries. The following summary financial information of AstraZeneca PLC and AstraZeneca Finance is presented on a combined basis and transactions between the combining entities have been eliminated. Financial information for non-guarantor entities has been excluded. Intercompany balances and transactions between the obligor group and the non-obligor subsidiaries are presented on separate lines.

Obligor group summarised statements

Table 13: Obligor group summarised Statement of comprehensive income: 9M 2025

For the nine months ended 30 September

2025
$m
2024
$m
Total Revenue


Gross profit


Operating loss


Loss for the period
(957)
(894)
Transactions with subsidiaries that are not issuers or guarantors
6,509
1,342

Table 14: Obligor group summarised Statement of financial position

At 30 Sep 2025
$m
At 30 Sep 2024
$m
Current assets
13
10
Non-current assets
141
84
Current liabilities
(5,976)
(801)
Non-current liabilities
(24,704)
(28,906)
Amounts due from subsidiaries that are not issuers or guarantors
21,519
16,705
Amounts due to subsidiaries that are not issuers or guarantors

Capital allocation

The Group’s capital allocation priorities include: investing in the business and pipeline; maintaining a strong, investment-grade credit rating; potential value-enhancing business development opportunities; and supporting the progressive dividend policy.

In approving the declaration of dividends, the Board considers both the liquidity of the Company and the level of reserves legally available for distribution.

In FY 2025, the Company intends to increase the annual dividend per share declared to $3.20 per share. Dividends are paid to shareholders from AstraZeneca PLC, a Group holding company with no direct operations. The ability of AstraZeneca PLC to make shareholder distributions is dependent on the creation of profits for distribution and the receipt of funds from subsidiary companies.

The consolidated Group reserves set out in the Condensed consolidated statement of financial position do not reflect the profit available for distribution to the shareholders of AstraZeneca PLC.

In FY 2024, capital expenditure on tangible assets and Software-related intangible assets amounted to $2,218m. In FY 2025 the Group expects to increase expenditure on tangible assets and Software-related intangible assets by approximately 50%, driven by manufacturing expansion projects and investments in systems and technology.

Foreign exchange

The Company’s transactional currency exposures on working capital balances, which typically extend for up to three months, are hedged where practicable using forward foreign exchange contracts against the individual companies’ reporting currency.Foreign exchange gains and losses on forward contracts transacted for transactional hedging are taken to profit or to Other comprehensive income if the contract is in a designated cashflow hedge.

In addition, the Company’s external dividend payments, paid principally in pound sterling and Swedish krona, are fully hedged from the time of their announcement to the payment date.

Table 15: Currency sensitivities

Currency
Primary Relevance
Exchange rate vs USD (average rate in period)
Annual impact of 5% weakening vs USD1 ($m)

FY 20242
YTD 20253
Change
(%)
September 20254
Change
(%)
TotalRevenue
Core Operating Profit
EUR
Total Revenue
0.92
0.89
3
0.85
8
(461)
(232)
CNY
Total Revenue
7.21
7.22

7.12
1
(313)
(171)
JPY
Total Revenue
151.46
148.10
2
147.87
2
(179)
(121)
GBP
Operating expense
0.78
0.76
3
0.74
6
(68)
124
SEK
Operating expense
10.57
9.94
6
9.37
13
(9)
69
Other

(557)
(289)

1. Assumes the average exchange rate vs USD in FY 2025 is 5% lower than the average rate in FY 2024. The impact data are estimates, based on best prevailing assumptions around currency profiles.
2. Based on average daily spot rates 1 January 2024 to 31 December 2024.
3. Based on average daily spot rates 1 January 2025 to 30 September 2025.
4. Based on average daily spot rates 1 September 2025 to 30 September 2025.

Interim financial statements

Table 16: Condensed consolidated statement of comprehensive income: 9M 2025

For the nine months ended 30 September
2025
$m
2024
$m
– Product Sales
41,035
37,576
– Alliance Revenue
2,108
1,498
Product Revenue
43,143
39,074
Collaboration Revenue
93
108
Total Revenue
43,236
39,182
Cost of sales
(7,515)
(7,482)
Gross profit
35,721
31,700
Distribution expense
(426)
(412)
Research and development expense
(10,370)
(8,906)
Selling, general and administrative expense
(14,441)
(14,567)
Other operating income and expense
281
152
Operating profit
10,765
7,967
Finance income
225
394
Finance expense
(1,210)
(1,313)
Share of after tax losses in associates and joint ventures
(7)
(23)
Profit before tax
9,773
7,025
Taxation
(1,869)
(1,484)
Profit for the period
7,904
5,541

Other comprehensive income

Items that will not be reclassified to profit or loss:

Remeasurement of the defined benefit pension liability
116
136
Net (losses)/gains on equity investments measured at fair value through other comprehensive income
(21)
264
Fair value movements related to own credit risk on bonds designated as fair value through profit or loss

12
Tax on items that will not be reclassified to profit or loss
(13)
(50)

82
362
Items that may be reclassified subsequently to profit or loss:

Foreign exchange arising on consolidation
2,266
543
Foreign exchange arising on designated liabilities in net investment hedges
15
(84)
Fair value movements on cash flow hedges
256
(42)
Fair value movements on cash flow hedges transferred to profit and loss
(318)
1
Fair value movements on derivatives designated in net investment hedges
(7)
13
Gains of hedging
8
2
Tax on items that may be reclassified subsequently to profit or loss
(50)
16

2,170
449
Other comprehensive income, net of tax
2,252
811

Total comprehensive income for the period
10,156
6,352

Profit attributable to:

Owners of the Parent
7,899
5,535
Non-controlling interests
5
6

7,904
5,541

Total comprehensive income attributable to:

Owners of the Parent
10,149
6,346
Non-controlling interests
7
6

10,156
6,352
Earnings per share

Basic earnings per $0.25 Ordinary Share
$5.10
$3.57
Diluted earnings per $0.25 Ordinary Share
$5.06
$3.54
Weighted average number of Ordinary Shares in issue (millions)
1,550
1,550
Diluted weighted average number of Ordinary Shares in issue (millions)
1,561
1,562

Table 17: Condensed consolidated statement of comprehensive income: Q3 2025

For the quarter ended 30 September

2025
$m
2024
$m
– Product Sales
14,365
12,947
– Alliance Revenue
815
559
Product Revenue
15,180
13,506
Collaboration Revenue
11
59
Total Revenue
15,191
13,565
Cost of sales
(2,801)
(3,081)
Gross profit
12,390
10,484
Distribution expense
(148)
(145)
Research and development expense
(3,663)
(3,115)
Selling, general and administrative expense
(5,085)
(5,143)
Other operating income and expense
89
25
Operating profit
3,583
2,106
Finance income
85
183
Finance expense
(434)
(457)
Share of after tax losses in associates and joint ventures
10
(4)
Profit before tax
3,244
1,828
Taxation
(709)
(395)
Profit for the period
2,535
1,433

Other comprehensive income

Items that will not be reclassified to profit or loss:

Remeasurement of the defined benefit pension liability
146
35
Net gains on equity investments measured at fair value through other comprehensive income
104
175
Fair value movements related to own credit risk on bonds designated as fair value through profit or loss


Tax on items that will not be reclassified to profit or loss
(10)
(23)

240
187
Items that may be reclassified subsequently to profit or loss:

Foreign exchange arising on consolidation
(198)
1,097
Foreign exchange arising on designated liabilities in net investment hedges
5
12
Fair value movements on cash flow hedges
(17)
96
Fair value movements on cash flow hedges transferred to profit and loss
(3)
(101)
Fair value movements on derivatives designated in net investment hedges
13
(32)
Costs of hedging
(2)
(12)
Tax on items that may be reclassified subsequently to profit or loss
2
(22)

(200)
1,038
Other comprehensive income, net of tax
40
1,225

Total comprehensive income for the period
2,575
2,658

Profit attributable to:

Owners of the Parent
2,533
1,429
Non-controlling interests
2
4

2,535
1,433

Total comprehensive income attributable to:

Owners of the Parent
2,575
2,654
Non-controlling interests

4

2,575
2,658
Earnings per share

Basic earnings per $0.25 Ordinary Share
$1.64
$0.92
Diluted earnings per $0.25 Ordinary Share
$1.62
$0.91
Weighted average number of Ordinary Shares in issue (millions)
1,551
1,550
Diluted weighted average number of Ordinary Shares in issue (millions)
1,561
1,562

Table 18: Condensed consolidated statement of financial position

At30 Sep 2025
At31 Dec 2024
At30 Sep 2024
Assets
$m
$m
$m
Non-current assets

Property, plant and equipment
12,083
10,252
10,135
Right-of-use assets
1,700
1,395
1,378
Goodwill
21,219
21,025
21,139
Intangible assets
38,191
37,177
39,394
Investments in associates and joint ventures
296
268
290
Other investments
1,990
1,632
1,855
Derivative financial instruments
502
182
319
Other receivables
1,159
930
915
Income tax receivable
1,247


Deferred tax assets
6,129
5,347
5,342

84,516
78,208
80,767
Current assets

Inventories
6,593
5,288
5,662
Trade and other receivables
14,338
12,972
11,879
Other investments
39
166
133
Derivative financial instruments
12
54
16
Income tax receivable
815
1,859
1,668
Cash and cash equivalents
8,143
5,488
4,797

29,940
25,827
24,155
Total assets
114,456
104,035
104,922

Liabilities

Current liabilities

Interest-bearing loans and borrowings
(6,174)
(2,337)
(1,253)
Lease liabilities
(379)
(339)
(317)
Trade and other payables
(25,028)
(22,465)
(21,684)
Derivative financial instruments
(29)
(50)
(17)
Provisions
(1,176)
(1,269)
(1,187)
Income tax payable
(1,268)
(1,406)
(1,468)

(34,054)
(27,866)
(25,926)
Non-current liabilities

Interest-bearing loans and borrowings
(24,700)
(26,506)
(28,887)
Lease liabilities
(1,379)
(1,113)
(1,105)
Derivative financial instruments

(115)
(34)
Deferred tax liabilities
(3,604)
(3,305)
(3,568)
Retirement benefit obligations
(1,271)
(1,330)
(1,361)
Provisions
(929)
(921)
(1,063)
Income tax payable
(535)
(238)
(174)
Other payables
(2,013)
(1,770)
(1,999)

(34,431)
(35,298)
(38,191)
Total liabilities
(68,485)
(63,164)
(64,117)

Net assets
45,971
40,871
40,805

Equity

Share capital
388
388
388
Share premium account
35,243
35,226
35,203
Other reserves
2,044
2,012
1,990
Retained earnings
8,213
3,160
3,138
Capital and reserves attributable to equity holders of the Parent
45,888
40,786
40,719
Non-controlling interests
83
85
86
Total equity
45,971
40,871
40,805

Table 19: Condensed consolidated statement of changes in equity

Share capital
Share premium account
Other reserves
Retained earnings
Total attributable to owners of the parent
Non-controlling interests
Total equity

$m
$m
$m
$m
$m
$m
$m
At 1 Jan 2024
388
35,188
2,065
1,502
39,143
23
39,166
Profit for the period



5,535
5,535
6
5,541
Other comprehensive income



811
811

811
Transfer to other reserves


1
(1)



Transactions with owners

Dividends



(4,602)
(4,602)

(4,602)
Dividends paid to non-controlling interests





(4)
(4)
Issue of Ordinary Shares

15


15

15
Changes in non-controlling interests





61
61
Movement in shares held by Employee Benefit Trusts


(76)

(76)

(76)
Share-based payments charge for the period



487
487

487
Settlement of share plan awards



(594)
(594)

(594)
Net movement

15
(75)
1,636
1,576
63
1,639
At 30 September 2024
388
35,203
1,990
3,138
40,719
86
40,805

At 1 Jan 2025
388
35,226
2,012
3,160
40,786
85
40,871
Profit for the period



7,899
7,899
5
7,904
Other comprehensive (expense)/income


(61)
2,311
2,250
2
2,252
Transfer to other reserves


48
(48)



Transactions with owners

Dividends



(4,846)
(4,846)

(4,846)
Dividends paid to non-controlling interests





(2)
(2)
Issue of Ordinary Shares

17


17

17
Changes in non-controlling interests



8
8
(7)
1
Movement in shares held by Employee Benefit Trusts


45

45

45
Share-based payments charge for the period



529
529

529
Settlement of share plan awards



(800)
(800)

(800)
Net movement

17
32
5,053
5,102
(2)
5,100
At 30 September 2025
388
35,243
2,044
8,213
45,888
83
45,971

Transfer to other reserves includes $70m in respect of the opening balance on the Cash flow hedge reserve. The cash flow hedge reserve was previously disclosed within Retained earnings but from 2025 is disclosed within Other reserves.

Table 20: Condensed consolidated statement of cash flows: 9M 2025

For the nine months ended 30 September

2025
$m
2024
$m
Cash flows from operating activities

Profit before tax
9,773
7,025
Finance income and expense
985
919
Share of after tax losses of associates and joint ventures
7
23
Depreciation, amortisation and impairment
4,222
4,351
Movement in working capital and short-term provisions
64
(543)
Gains on disposal of intangible assets
(118)
(34)
Fair value movements on contingent consideration arising from business combinations
(29)
251
Non-cash and other movements
591
15
Cash generated from operations
15,495
12,007
Interest paid
(1,069)
(1,075)
Tax paid
(2,193)
(1,978)
Net cash inflow from operating activities
12,233
8,954

Cash flows from investing activities

Acquisition of subsidiaries, net of cash acquired
(60)
(2,771)
Payment of contingent consideration from business combinations
(897)
(737)
Purchase of property, plant and equipment
(1,774)
(1,216)
Disposal of property, plant and equipment
10
53
Purchase of intangible assets
(2,844)
(2,415)
Disposal of intangible assets
96
107
Purchase of non-current asset investments
(218)
(96)
Disposal of non-current asset investments

73
Movement in short-term investments, fixed deposits and other investing instruments
122
67
Payments to associates and joint ventures
(10)
(158)
Disposal of investments in associates and joint ventures

13
Interest received
213
281
Net cash outflow from investing activities
(5,362)
(6,799)
Net cash inflow before financing activities
6,871
2,155

Cash flows from financing activities

Proceeds from issue of share capital
17
15
Own shares purchased by Employee Benefit Trust
(508)
(81)
Payments to acquire non-controlling interests
(14)

Issue of loans and borrowings
9
6,492
Repayment of loans and borrowings
(20)
(4,647)
Dividends paid
(4,968)
(4,626)
Hedge contracts relating to dividend payments
113
16
Repayment of obligations under leases
(273)
(233)
Movement in short-term borrowings
1,382
572
Payment of Acerta Pharma share purchase liability

(833)
Net cash outflow from financing activities
(4,262)
(3,325)

Net increase/(decrease) in Cash and cash equivalents in the period
2,609
(1,170)
Cash and cash equivalents at the beginning of the period
5,429
5,637
Exchange rate effects
42
(32)
Cash and cash equivalents at the end of the period
8,080
4,435

Cash and cash equivalents consist of:

Cash and cash equivalents
8,143
4,797
Overdrafts
(63)
(362)

8,080
4,435

Notes to the Interim financial statements

Note 1: Basis of preparation and accounting policies

These unaudited Interim financial statements for the nine months ended 30 September 2025 have been prepared in accordance with International Accounting Standard 34, ‘Interim Financial Reporting’ (IAS 34), as issued by the International Accounting Standards Board (IASB), IAS 34 as adopted by the European Union, UK-adopted IAS 34 and the Disclosure Guidance and Transparency Rules sourcebook of the United Kingdom’s Financial Conduct Authority and with the requirements of the Companies Act 2006 as applicable to companies reporting under those standards.

The unaudited Interim financial statements for the nine months ended 30 September 2025 were approved by the Board of Directors for publication on 6 November 2025.

This results announcement does not constitute statutory accounts of the Group within the meaning of sections 434(3) and 435(3) of the Companies Act 2006. The annual financial statements of the Group for the year ended 31 December 2024 were prepared in accordance with UK-adopted international accounting standards and with the requirements of the Companies Act 2006. The annual financial statements also comply fully with IFRS Accounting Standards as issued by the IASB and International Accounting Standards as adopted by the European Union. Except for the estimation of the interim income tax charge, the Interim financial statements have been prepared applying the accounting policies that were applied in the preparation of the Group’s published consolidated financial statements for the year ended 31 December 2024.

The comparative figures for the financial year ended 31 December 2024 are not the Group’s statutory accounts for that financial year. Those accounts have been reported on by the Group’s auditors and have been delivered to the Registrar of Companies; their report was (i) unqualified, (ii) did not include a reference to any matters to which the auditors drew attention by way of emphasis without qualifying their report, and (iii) did not contain a statement under section 498(2) or (3) of the Companies Act 2006.

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.

There are no changes to the Revenue accounting policy regarding the types of transactions recorded in each revenue category. The comparative period has been retrospectively adjusted to reflect the additional subtotal, resulting in total Product Revenue being reported for the nine months ended 30 September 2024 of $39,074m.

Going concern

The Group has considerable financial resources available. As at 30 September 2025, the Group has $13.0bn in financial resources (cash and cash equivalent balances of $8.1bn and undrawn committed bank facilities of $4.9bn that are available until April 2030), with $6.6bn of borrowings due within one year. These facilities contain no financial covenants.

The Group has assessed the prospects of the Group over a period longer than the required 12 months from the date of Board approval of these consolidated financial statements, with no deterioration noted requiring a further extension of this review. The Group’s revenues are largely derived from sales of medicines covered by patents, which provide a relatively high level of resilience and predictability to cash inflows, although government price interventions in response to budgetary constraints are expected to continue to adversely affect revenues in some of our significant markets. The Group, however, anticipates new revenue streams from both recently launched medicines and those in development, and the Group has a wide diversity of customers and suppliers across different geographic areas.

Consequently, the Directors believe that, overall, the Group is well placed to manage its business risks successfully. Accordingly, they continue to adopt the going concern basis in preparing the Interim financial statements.

Legal proceedings

The information contained in Note 5 updates the disclosures concerning legal proceedings and contingent liabilities in the Group’s Annual Report and Form 20-F Information 2024.

Note 2: Intangible assets

The acquisition of EsoBiotec completed on 19 May 2025. The transaction is recorded as an asset acquisition based upon the concentration test permitted under IFRS 3 ‘Business Combinations’, with consideration and net assets acquired of $403m, which included intangible assets acquired of $426m, current payables of $29m, $4m of cash and cash equivalents and current receivables of $2m. Contingent consideration of up to $575m could be paid on achievement of regulatory milestones, those liabilities will be recorded when the relevant regulatory milestone is achieved.

Intangible asset additions of $536m in the quarter relate to the total of net upfront payment made, the present value of non-contingent future payments and a sales-related payment due to Merck in connection with the restructuring of arrangements relating to Koselugo, recorded as an asset acquisition. A regulatory milestone of $50m, and sales-related payment of $35m additionally fell due and were capitalised in the quarter. Further contingent payments of up to $300m could be paid on achievement of regulatory milestones or on achievement of sales-related thresholds. Those liabilities

will be recorded when milestones are triggered, or performance conditions have been satisfied. Sales-related payments are accrued and capitalised when considered probable with reference to the latest Group sales forecasts for approved indications at the present value of expected future cash flows.

Note 3: Net debt

Table 21: Net debt

At 1 Jan 2025
Cash flow
Acquisitions
Non-cash
and other
Exchange
movements
At 30 Sep 2025

$m
$m
$m
$m
$m
$m
Non-current instalments of loans
(26,506)


2,433
(627)
(24,700)
Non-current instalments of leases
(1,113)


(217)
(49)
(1,379)
Total long-term debt
(27,619)


2,216
(676)
(26,079)
Current instalments of loans
(2,007)
11

(2,465)

(4,461)
Current instalments of leases
(339)
326
(1)
(346)
(19)
(379)
Commercial paper

(1,091)



(1,091)
Collateral received from derivative counterparties
(181)
(232)



(413)
Other short-term borrowings excluding overdrafts
(90)
(59)


3
(146)
Overdrafts
(59)
(3)


(1)
(63)
Total current debt
(2,676)
(1,048)
(1)
(2,811)
(17)
(6,553)
Gross borrowings
(30,295)
(1,048)
(1)
(595)
(693)
(32,632)
Net derivative financial instruments
71
(385)

799

485
Net borrowings
(30,224)
(1,433)
(1)
204
(693)
(32,147)
Cash and cash equivalents
5,488
2,492
120

43
8,143
Other investments – current
166
(122)


(5)
39
Cash and investments
5,654
2,370
120

38
8,182
Net debt
(24,570)
937
119
204
(655)
(23,965)

The table above provides an analysis of Net debt and a reconciliation of Net cash flow to the movement in Net debt. The Group monitors Net debt as part of its capital management policy as described in Note 28 of the Annual Report and Form 20-F Information 2024. Net debt is a non-GAAP financial measure.

Net debt decreased by $605m in the nine months to 30 September 2025 to $23,965m.

Details of the committed undrawn bank facilities are disclosed within the going concern section of Note 1. Non-cash movements in the period include fair value adjustments under IFRS 9 ‘Financial Instruments’.

The Group has agreements with some bank counterparties whereby the parties agree to post cash collateral on financial derivatives, for the benefit of the other, equivalent to the market valuation of the derivative positions above a predetermined threshold. The carrying value of such cash collateral held by the Group at 30 September 2025 was $413m (31 December 2024: $181m) and the carrying value of such cash collateral posted by the Group at 30 September 2025 was $25m (31 December 2024: $129m).

The equivalent GAAP measure to Net debt is ‘liabilities arising from financing activities’, which excludes the amounts for cash and overdrafts, other investments and non-financing derivatives shown.

During the nine months ended 30 September 2025, Moody’s upgraded the Group’s solicited long term credit rating to A1 from A2, which occurred during Q1 2025. The short-term rating remained at P-1. There were no changes to Standard and Poor’s credit ratings (long term: A+; short term: A-1).

Note 4: Financial Instruments

As detailed in the Group’s most recent annual financial statements, the principal financial instruments consist of derivative financial instruments, other investments, trade and other receivables, cash and cash equivalents, trade and other payables, lease liabilities and interest-bearing loans and borrowings.

The Group has certain equity investments that are categorised as Level 3 in the fair value hierarchy that are held at $539m (31 December 2024: $353m) and for which a fair value loss of $47m has been recognised in the nine months ended 30 September 2025 (9M 2024: $nil). In the absence of specific market data, these unlisted investments are held at fair value based on the cost of investment and adjusted as necessary for impairments and revaluations on new funding rounds, which are seen to approximate the fair value. All other fair value gains and/or losses that are presented in Net gains/(losses) on equity investments measured at fair value through other comprehensive income, in the Condensed consolidated statement of comprehensive income for the nine months ended 30 September 2025 are Level 1 fair value measurements, valued based on quoted prices in active markets.

Financial instruments measured at fair value include $2,004m of other investments, $6,732m held in money-market funds and $485m of derivatives as at 30 September 2025. With the exception of derivatives being Level 2 fair valued, and certain equity instruments of $539m categorised as Level 3, the aforementioned balances are Level 1 fair valued. Financial instruments measured at amortised cost include $25m of cash collateral pledged to counterparties. The total fair value of Interest-bearing loans and borrowings as at 30 September 2025, which have a carrying value of $32,632m in the Condensed consolidated statement of financial position, was $32,275m.

Contingent consideration arising from business combinations is fair valued using decision-tree analysis, with key inputs including the probability of success, consideration of potential delays and the expected levels of future revenues.

The contingent consideration balance relating to BMS’s share of the global diabetes alliance of $523m (31 December 2024: $1,309m) would increase/decrease by $52m with an increase/decrease in sales of 10%, as compared with the current estimates.

Table 22: Contingent consideration

2025
2024

Diabetes alliance
$m
Other
$m
Total
$m
Total
$m
At 1 January
1,309
442
1,751
2,137
Additions through business combinations



198
Settlements
(787)
(110)
(897)
(737)
Revaluations
(30)
1
(29)
252
Discount unwind
31
15
46
85
At 30 September
523
348
871
1,935

Note 5: Legal proceedings and contingent liabilities

AstraZeneca is involved in various legal proceedings considered typical to its business, including litigation and investigations, including Government investigations, relating to product liability, commercial disputes, infringement of intellectual property (IP) rights, the validity of certain patents, anti-trust law and sales and marketing practices.

The matters discussed below constitute the more significant developments since publication of the disclosures concerning legal proceedings in the Company’s Annual Report and Form 20-F Information 2024 and the Interim Financial Statements for the six months ended 30 June 2025 (the Disclosures). Information about the nature and facts of the cases is disclosed in accordance with IAS 37 ‘Provisions, Contingent Liabilities and Contingent Assets’.

As discussed in the Disclosures, the majority of claims involve highly complex issues. Often these issues are subject to substantial uncertainties and, therefore, the probability of a loss, if any, being sustained and/or an estimate of the amount of any loss is difficult to ascertain.

In cases that have been settled or adjudicated, or where quantifiable fines and penalties have been assessed and which are not subject to appeal, or where a loss is probable and we are able to make a reasonable estimate of the loss, AstraZeneca records the loss absorbed or makes a provision for its best estimate of the expected loss. The position could change over time and the estimates that the Company made, and upon which the Company have relied in calculating these provisions are inherently imprecise. There can, therefore, be no assurance that any losses that result from the outcome of any legal proceedings will not exceed the amount of the provisions that have been booked in the accounts. The major factors causing this uncertainty are described more fully in the Disclosures and herein.

AstraZeneca has full confidence in, and will vigorously defend and enforce, its IP.

Matters disclosed in respect of the third quarter of 2025 and to 6 November 2025

Table 23: Patent litigation

Legal proceedings brought against AstraZeneca

Factor Bioscience patent proceedings, US
Considered to be a contingent liability
∗In September 2025, Factor Bioscience Inc. (Factor) filed a complaint against AstraZeneca, and others in the U.S. District Court for the District of Delaware, alleging infringement of several Factor patents related to technology for producing gene-edited cells using synthetic messenger ribonucleic acid (mRNA) molecules encoding transcription activator-like effector nuclease (TALEN) gene-editing proteins.
∗The complaint alleges that certain drug research, design and development activities by AstraZeneca and others infringe Factor’s patents.
Forxiga patent proceedings, UK
Matter concluded
∗In the UK, one of AstraZeneca’s patents relating to Forxiga was challenged by Generics (UK) Limited, Teva Pharmaceutical Industries Limited, and Glenmark Pharmaceuticals Europe Limited.
∗Trial regarding patent validity occurred in March 2025. In April 2025, the UK Patents Court held the patent invalid. AstraZeneca appealed the decision. In July 2025, the UK Court of Appeal dismissed AstraZeneca’s appeal and upheld the lower court’s invalidity decision. AstraZeneca’s application for permission to appeal to the UK Supreme Court was denied.
∗In March 2025 and onward, AstraZeneca obtained injunctions against generic manufacturers’ at-risk sales of dapagliflozin products in the UK. All injunctions have since been lifted.
∗This matter has concluded.

Legal proceedings brought by AstraZeneca

Lynparza patent proceedings, Canada
Considered to be a contingent asset
∗In July 2025, AstraZeneca was served with a Notice of Allegation from Cipla Ltd. challenging a patent relating to Lynparza.
∗AstraZeneca commenced an action in response in August 2025. Trial is scheduled to begin in April 2027.
∗In August 2025, AstraZeneca was served with a Notice of Allegation from Natco Pharma (Canada) Inc. challenging a patent relating to Lynparza.
∗AstraZeneca commenced an action in response in October 2025. No trial date has been set.
Soliris patent proceedings, UK
Considered to be a contingent asset
∗In May 2024, AstraZeneca initiated patent infringement proceedings against Amgen Ltd. and Samsung Bioepis UK Limited (Samsung) in the UK High Court of Justice alleging that their respective biosimilar eculizumab products infringe an AstraZeneca patent; on the same day, Samsung initiated a revocation action for the same patent.
∗Trial was held in March 2025. In May 2025, the UK court issued a decision finding AstraZeneca’s patent invalid and not infringed.
∗In August 2025, AstraZeneca appealed.
Tagrisso patent proceedings, Russia
Considered to be a contingent asset
∗In August 2023, AstraZeneca filed lawsuits in the Arbitration Court of the Moscow region (Court) against the Russian Ministry of Health (MOH) and Axelpharm LLC (Axelpharm) for improper use of AstraZeneca’s information in the authorisation of a generic version of Tagrisso. The suit against the MOH was dismissed in July 2024, after two appeals. The case against Axelpharm was dismissed in September 2024, and AstraZeneca has appealed.
∗In November 2023, Axelpharm sought a compulsory licence under a patent related to Tagrisso; the action remains pending. The Axelpharm patent on which the compulsory licensing action was based was held invalid by the Russian Patent and Trademark Office (PTO) in August 2024 following a challenge by AstraZeneca. The PTO’s decision was upheld in June 2025, following an appeal by Axelpharm. In August 2025, Axelpharm filed a further appeal before the Presidium of the Intellectual Property Court and that appeal will be heard in November 2025.
∗In July 2024, AstraZeneca filed a patent infringement claim against Axelpharm in relation to a generic version of Tagrisso. The action was stayed by the Court pending resolution of the compulsory licensing action.
∗In August 2024, after AstraZeneca filed a complaint, the Federal Anti-Monopoly Service of Russia (FAS) initiated a case against Axelpharm and OncoTarget LLC (OncoTarget). In November 2024, the FAS found Axelpharm to have committed unfair competition, but not OncoTarget. Axelpharm’s appeal against the FAS’s finding was upheld in June 2025. AstraZeneca appealed against the ruling in June 2025 and a hearing has been scheduled before the Ninth Arbitration Appellate Court in December 2025.

Table 24: Commercial litigation

Legal proceedings brought against AstraZeneca

340B Antitrust litigation, US
Considered to be a contingent liability
∗In September 2021, AstraZeneca was served with a class-action antitrust complaint filed in the US District Court for the Western District of New York (District Court) by Mosaic Health alleging a conspiracy to restrict access to 340B discounts in the diabetes market through contract pharmacies.
∗In September 2022, the District Court granted AstraZeneca’s motion to dismiss the complaint. In February 2024, the District Court denied Plaintiffs’ request to file an amended complaint and entered an order closing the matter. In March 2024, Plaintiffs filed an appeal.
∗In August 2025, the US Court of Appeals for the Second Circuit reversed the District Court’s decision.
∗AstraZeneca and the other defendants have filed a motion for reconsideration.
Seroquel XR Antitrust Litigation, US
Matter concluded
∗In 2019, AstraZeneca was named in several related complaints now proceeding in US District Court in Delaware (District Court), including several putative class action lawsuits that were purportedly brought on behalf of classes of direct purchasers or end payors of Seroquel XR, that allege AstraZeneca and generic drug manufacturers violated US antitrust laws when settling patent litigation related to Seroquel XR.
∗In July 2022, the District Court dismissed claims relating to one of the generic manufacturers while allowing claims relating to the second generic manufacturer to proceed.
∗In September 2024, AstraZeneca reached a settlement agreement with one of the plaintiff classes which the court approved.
∗In May 2025, AstraZeneca resolved the matter with all remaining plaintiffs for a total payment of $97m. In September of 2025, the Court approved the class-related portion of the settlement.
∗The matter is now concluded.

Table 25: Government investigations and proceedings

Legal proceedings brought against AstraZeneca

Shenzhen Bay Customs Office, China
Considered to be a contingent liability

∗In relation to the alleged unpaid importation taxes, in October 2025, AstraZeneca received a final appraisal notice, which supersedes the previously-disclosed appraisal notices, from the Shenzhen Bay Customs Office stating that the total amount of unpaid tax, inclusive of the previously-disclosed amounts, is RMB 24 million (approximately $3.5m).
∗To the best of AstraZeneca’s knowledge, the importation taxes referred to in the appraisal notice relate to Enhertu, Imfinzi and Imjudo.
∗AstraZeneca has since prepaid the full amount as voluntary compensation to the State.
∗A fine of between one and five times the amount of these paid importation taxes may also be levied if AstraZeneca is found liable.

Legal proceedings brought by AstraZeneca

340B State litigation, US
Considered to be a contingent asset
∗AstraZeneca has filed lawsuits against Arkansas, Colorado, Hawaii, Kansas, Louisiana, Maine, Maryland, Minnesota, Mississippi, Missouri, Nebraska, North Dakota, Oklahoma, South Dakota, Tennessee, Utah, and West Virginia challenging the constitutionality of each state’s 340B statute.
∗In Arkansas, AstraZeneca moved for summary judgment in August 2025, and the Court denied the intervenor’s motion to dismiss in September 2025 finding AstraZeneca’s claims were distinct from the claims in the prior PhRMA litigation. Trial is scheduled for February 2026.
∗In Colorado, AstraZeneca filed a complaint in August 2025 and a motion for a preliminary injunction in October 2025.
∗In Hawaii, AstraZeneca filed a complaint in August 2025 and a motion for a preliminary injunction in September 2025.
∗In Louisiana, the Louisiana Department of Justice sent AstraZeneca a Civil Investigative Demand in September 2025 for alleged non-compliance with Louisiana’s 340B Statute.
∗In Maine, AstraZeneca filed a complaint in September 2025.
∗In North Dakota, AstraZeneca filed a complaint in August 2025.
∗In Oklahoma, AstraZeneca filed a complaint and a motion for a preliminary injunction in October 2025. Later in October, the court granted AstraZeneca’s motion for a preliminary injunction.
∗In South Dakota, AstraZeneca filed a complaint in August 2025.
∗In Tennessee, AstraZeneca filed a complaint in August 2025.
Inflation Reduction Act Litigation, US
Considered to be a contingent asset
∗In August 2023, AstraZeneca filed a lawsuit in the US District Court for the District of Delaware (District Court) against the US Department of Health and Human Services (HHS) challenging aspects of the drug price negotiation provisions of the Inflation Reduction Act and the implementing guidance and regulations. In March 2024, the District Court granted HHS’ motions and dismissed AstraZeneca’s lawsuit.
∗In May 2025, the US Court of Appeals for the Third Circuit affirmed the District Court’s dismissal of AstraZeneca’s challenge.
∗In September 2025, AstraZeneca sought review by the US Supreme Court.

Other

Additional government inquiries

As is true for most, if not all, major prescription pharmaceutical companies, AstraZeneca is currently involved in multiple inquiries into drug marketing and pricing practices. In addition to the investigations described above, various law enforcement offices have, from time to time, requested information from the Group. There have been no material developments in those matters.

Note 6: Subsequent events

On 22 October 2025, AstraZeneca, by exercise of an option, completed the acquisition of the remaining share capital of SixPeaks Bio AG (SixPeaks), following an initial investment of $15m made in Q2 2024. $170m was paid on closing, $30m to be paid after two years and up to a further $100m is payable on achievement of regulatory milestones, which will be accrued for at its present value. These payments will be recognised in equity as SixPeaks has been consolidated as a subsidiary due to AstraZeneca’s control since the initial equity investment in Q2 2024.

Note 7: Analysis of Revenue and Other operating income and expense

Table 26: Product Sales year-on-year analysis: 9M 2025

For the nine months
World
US
Emerging Markets
Europe
Established RoW
ended 30 September

Change

Change

Change

Change

Change

$m
Act %
CER %
$m
Act %
$m
Act %
CER %
$m
Act %
CER %
$m
Act %
CER %
Tagrisso
5,352
10
10
2,222
11
1,509
11
13
1,030
8
5
591
5
5
Imfinzi
4,317
25
25
2,484
32
463
27
33
879
26
24
491
(6)
(7)
Calquence
2,551
10
10
1,702
5
164
41
48
569
16
14
116
18
20
Lynparza
2,401
8
7
1,054
10
487
2
4
667
9
7
193
3
3
Enhertu
685
73
76


476
84
90
146
59
56
63
34
38
Zoladex
852
4
6
13
17
661
6
9
112
1
(1)
66
(10)
(9)
Truqap
495
85
85
413
59
16
n/m
n/m
45
n/m
n/m
21
n/m
n/m
Imjudo
253
22
21
165
23
17
56
60
36
37
35
35
(5)
(6)
Other Oncology
322
(10)
(9)
6
(60)
215
(7)
(5)
15
(13)
(15)
86
(7)
(9)
Oncology
17,228
15
15
8,059
17
4,008
16
19
3,499
17
14
1,662
3
2
Farxiga
6,341
11
11
1,244
(3)
2,623
18
21
2,147
13
10
327
3
3
Crestor
941
5
6
36
9
808
11
12
1
(98)
(98)
96
(5)
(6)
Brilinta
665
(33)
(33)
326
(40)
203
(13)
(12)
129
(36)
(37)
7
(46)
(44)
Lokelma
517
32
31
226
25
99
47
49
91
37
34
101
30
28
Seloken
468
1
3

n/m
451

3
14
44
41
3
(5)
(2)
Roxadustat
227
(12)
(11)


227
(12)
(11)






Wainua
143
n/m
n/m
137
n/m
4


2





Other CVRM
418
(24)
(24)
44
(69)
208
12
13
119
(31)
(31)
47
(9)
(10)
CVRM
9,720
4
5
2,013
(9)
4,623
12
14
2,503
5
3
581
3
2
Symbicort
2,180
(1)

903
2
624
(4)
(3)
406
(2)
(4)
247
3
5
Fasenra
1,451
19
19
886
18
81
18
22
351
19
17
133
26
27
Breztri
906
26
26
462
26
239
20
21
136
34
31
69
31
31
Tezspire
317
89
87


24
n/m
n/m
207
98
93
86
55
55
Pulmicort
357
(31)
(30)
4
(74)
280
(34)
(33)
46
(10)
(11)
27
3
5
Saphnelo
483
48
47
421
43
10
98
99
34
97
92
18
61
58
Airsupra
115
n/m
n/m
113
n/m
2
n/m
n/m






Other R&I
211
(13)
(13)
67

95
(26)
(25)
44
3
1
5
(5)
(3)
R&I
6,020
11
11
2,856
18
1,355
(9)
(7)
1,224
19
17
585
18
19
Beyfortus
222
18
19
137
(8)



83
n/m
n/m
2
n/m
n/m
Synagis
220
(36)
(35)
(2)
9
160
(5)
(1)
37
(54)
(54)
25
(75)
(75)
FluMist
132
21
19
20
(23)
1
n/m
n/m
82
34
30
29
34
35
Other V&I

n/m
n/m



n/m
n/m

n/m
n/m

n/m
n/m
V&I
574
(16)
(15)
155
(23)
161
(4)

202
7
5
56
(54)
(54)
Ultomiris
3,453
22
21
1,961
20
177
92
n/m
769
18
16
546
17
16
Soliris
1,436
(30)
(28)
844
(28)
327
(11)
(2)
159
(54)
(55)
106
(35)
(34)
Strensiq
1,188
19
19
953
17
61
58
61
89
22
19
85
23
21
Koselugo
498
36
34
157

188
75
70
115
56
53
38
36
35
Other Rare Disease
177
18
18
83
15
37
54
57
50
6
4
7
13
12
Rare Disease
6,752
6
6
3,998
4
790
26
32
1,182
(1)
(3)
782
7
6
Nexium
626
(7)
(5)
53
(30)
476
4
6
31
(22)
(24)
66
(31)
(31)
Other
115
(26)
(25)
(4)
n/m
88
(17)
(16)
27
(23)
(22)
4
37
28
Other Medicines
741
(10)
(9)
49
(43)
564

2
58
(23)
(23)
70
(29)
(29)
Total Medicines
41,035
9
9
17,130
10
11,501
10
13
8,668
10
8
3,736
3
3

The table provides an analysis of year-on-year Product Sales, with Actual and CER growth rates reflecting year-on-year growth.

Table 27: Product Sales year-on-year analysis: Q3 2025

For the quarter
World
US
Emerging Markets
Europe
Established RoW
ended 30 September

Change

Change

Change

Change

Change

$m
Act %
CER %
$m
Act %
$m
Act %
CER %
$m
Act %
CER %
$m
Act %
CER %
Tagrisso
1,864
11
10
784
10
501
12
12
372
13
7
207
11
8
Imfinzi
1,601
33
31
912
34
169
41
44
342
45
37
178
6
3
Calquence
916
13
11
612
7
61
49
45
200
19
12
43
29
30
Lynparza
837
7
5
365
5
164
6
4
242
13
7
66
7
5
Enhertu
257
73
75


184
89
94
52
50
44
21
30
32
Zoladex
285
7
6
4
21
219
6
7
40
20
13
22
(8)
(9)
Truqap
193
55
54
159
33
7
n/m
n/m
18
n/m
n/m
9
n/m
n/m
Imjudo
84
16
14
55
18
6
52
45
13
29
21
10
(13)
(16)
Other Oncology
106
(9)
(10)
2
(52)
69
(7)
(7)
5
(6)
(11)
30
(9)
(12)
Oncology
6,143
18
17
2,893
16
1,380
21
21
1,284
24
17
586
9
7
Farxiga
2,134
10
8
441
7
893
19
18
698
4
(2)
102
(4)
(5)
Crestor
305
1
(1)
12
5
262
4
3

n/m
n/m
31
2
(1)
Brilinta
146
(55)
(56)
55
(71)
66

(1)
23
(66)
(68)
2
(59)
(62)
Lokelma
189
32
30
82
25
36
42
41
35
39
31
36
37
32
Seloken
160
6
6

n/m
153
5
5
6
62
47
1
3
5
Roxadustat
77
(17)
(18)


77
(17)
(18)






Wainua
59
n/m
n/m
55
n/m
3


1





Other CVRM
144
(18)
(19)
17
(56)
69
8
8
43
(15)
(18)
15
(32)
(34)
CVRM
3,214
2

662
(10)
1,559
12
11
806
(2)
(8)
187
(2)
(4)
Symbicort
742
5
4
305
5
224
10
10
135
4
(2)
78
(5)
(4)
Fasenra
530
22
20
330
21
28
5
7
122
20
13
50
41
39
Breztri
323
21
20
167
17
83
22
20
49
33
25
24
24
23
Tezspire
119
75
66


8
n/m
n/m
79
82
70
32
47
43
Pulmicort
93
(33)
(35)

n/m
72
(34)
(36)
12
(15)
(19)
9
(6)
(6)
Saphnelo
180
45
44
156
42
4
8
5
13
83
72
7
94
83
Airsupra
45
n/m
n/m
43
n/m
2
n/m
n/m






Other R&I
53
(26)
(26)
12
(12)
24
(43)
(42)
15
15
9
2
(8)
(8)
R&I
2,085
14
12
1,013
19
445
(3)
(3)
425
23
16
202
16
15
Beyfortus
94
(30)
(29)
35
(63)



59
53
53



Synagis
58
(37)
(40)
(1)
n/m
39
6
4
11
(14)
(24)
9
(80)
(80)
FluMist
122
21
20
20
(12)
1
n/m
n/m
82
46
42
19
(12)
(11)
Other V&I

n/m
n/m

n/m




n/m
n/m



V&I
274
(23)
(24)
54
(63)
40
7
7
152
41
37
28
(57)
(57)
Ultomiris
1,225
19
17
690
16
64
n/m
n/m
271
14
8
200
18
15
Soliris
462
(24)
(24)
276
(24)
102
(8)
(5)
47
(46)
(49)
37
(24)
(24)
Strensiq
441
29
28
369
29
11
45
38
32
26
18
29
21
17
Koselugo
224
88
79
51
(7)
113
n/m
n/m
44
53
44
16
55
52
Other Rare Disease
64
31
26
29
14
17
n/m
n/m
16
(5)
(10)
2
20
16
Rare Disease
2,416
12
11
1,415
7
307
76
73
410
4
(2)
284
12
9
Nexium
200
(5)
(5)
16
(45)
143
2
3
14
1
(3)
27
(4)
(6)
Other
33
(39)
(38)
(7)
n/m
29
(26)
(26)
9
7
13
2
n/m
n/m
Other Medicines
233
(12)
(12)
9
(73)
172
(4)
(3)
23
4
3
29

(4)
Total Medicines
14,365
11
9
6,046
8
3,903
15
15
3,100
14
7
1,316
5
3

The table provides an analysis of year-on-year Product Sales, with Actual and CER growth rates reflecting year-on-year growth.

Table 28: Alliance Revenue: 9M 2025

For the nine months ended 30 September
2025
$m
2024
$m
Enhertu
1,291
1,045
Tezspire
453
303
Beyfortus
252
75
Datroway
38

Other Alliance Revenue
74
75
Total
2,108
1,498

Table 29: Collaboration Revenue: 9M 2025

For the nine months ended 30 September
2025
$m
2024
$m
Farxiga: sales milestones
81
52
Beyfortus: sales milestones

56
Other Collaboration Revenue
12

Total
93
108

Table 30: Other operating income and expense: 9M 2025

For the nine months ended 30 September
2025
$m
2024
$m
Total
281
152

(Press release, AstraZeneca, NOV 6, 2025, View Source [SID1234659552])

Evaxion announces business update and third quarter 2025 financial results

On November 6, 2025 Evaxion A/S (NASDAQ: EVAX) ("Evaxion"), a clinical-stage TechBio company specializing in developing AI-Immunology powered vaccines, reported business update and announces third quarter 2025 financial results.

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Business highlights (since last quarterly update)
Evaxion has seen tremendous progress in recent months with several massive achievements. We maintain a high activity level and continue to execute our plans. Highlights include:

Evaxion’s Board of Directors has appointed Dr Helen Tayton-Martin as new CEO, effective November 24, 2025. Dr Tayton-Martin brings more than 30 years of experience, including biotech M&A, business development and operations.
Unprecedented data from the phase 2 trial with personalized cancer vaccine EVX-01 in advanced melanoma patients presented on stage at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, one of the most prestigious medical oncology conferences in the world.
We continue to enhance and expand our AI-Immunology platform, most recently with the addition of an automated vaccine design module replacing previous manual vaccine design processes.
EVX-B3, the bacterial vaccine candidate now out-licensed to MSD (tradename of Merck & Co., Inc., Rahway, NJ, USA), was discovered with AI-Immunology, making it the first AI-designed vaccine candidate ever to be licensed by a pharmaceutical company. We have received $7.5 million in option exercise fee and will be eligible for future payments of up to $592 million.
Evaxion’s cash runway has been extended to the second half of 2027 from previously first half of 2027 following the payment from MSD and cash raised from capital market activities in September and October totaling $7.2 million.

"We are really pleased with our achievements in recent months which have validated both our technology and strategy as well as significantly strengthened our position for future value creation. The impressive EVX-01 data shows our capabilities in cancer vaccines and the out-licensing of EVX-B3 confirms them in infectious disease vaccines. This is very important as we maintain a number of partnership discussions across disease areas and our AI-Immunology platform," says Birgitte Rønø, CSO and interim CEO of Evaxion.

Conference call and webcast
Evaxion’s Executive Management will host a conference call and webcast at 8.30 ET/14.30 CET today, presenting the business update and financial results as well as taking questions. This event is free, open to the public and encouraged.

To join the conference call, listen to the presentation and ask verbal questions, please register in advance via this link to receive the dial-in telephone numbers and a unique PIN code. The call can be accessed 15 minutes prior to the start of the live event.

To join the webcast, please click on this link. The webcast recording will be available on our website shortly after the event.

Research & Development (R&D) update
Evaxion has a R&D pipeline of innovative vaccine candidates for both cancer and infectious diseases.

Our lead asset is the personalized cancer vaccine EVX-01. Developed with AI-Immunology, it is designed to target multiple neoantigens; cancer unique proteins arising from mutations. We have now completed the initially planned two-years of treatment in the phase 2 trial with EVX-01 in patients with advanced melanoma (skin cancer) with very encouraging results.

The two-year data demonstrated an Objective Response Rate (ORR) of 75% as 12 out of 16 patients had objective clinical responses, with four patients obtaining a complete response. The ORR is even higher than the 69% observed after one year of treatment. Additionally, a durable clinical benefit was observed as 92% of patients were still responding at two years follow-up and no relapses were observed.

54% of patients had a deepened response during treatment, improving from stable disease or partial response to partial or complete response. Tumor reduction (target lesions) was observed in 15 out of the 16 patients enrolled in the trial.

In the trial, EVX-01 induced an immune response in all patients, with 81% of the targeted neoantigens generating potent specific T-cell responses. This high immunogenicity rate stands out as highly encouraging compared to historical observations and compares very favorably to what is seen with other approaches. These results also underline and validate the precision of the AI-Immunology platform in accurately identifying neoantigens, which leads to detectable signals in patients.

Data also confirmed EVX-01 to be a well-tolerated treatment. All in all, the data clearly supports further clinical development of EVX-01, for which we are actively looking for a partner. The phase 2 trial goes on with a one-year extension for a subset of patients to further strengthen EVX-01’s already encouraging data package.

The data was presented in an oral presentation at the ESMO (Free ESMO Whitepaper) conference, a strong testament to the interest in EVX-01 and the field of personalized cancer vaccines in general. We were present throughout the conference to interact and discuss with all interested stakeholders, including potential business partners.

We have recently expanded our pipeline with EVX-04, a novel vaccine candidate targeting multiple non-conventional ERV tumor antigens, developed with AI-Immunology. We will pursue clinical development of EVX-04, currently in preclinical development, as a new therapeutic vaccine against acute myeloid leukemia (AML).

EVX-04 is designed to target non-conventional ERV (endogenous retrovirus) tumor antigens from the dark genome. These antigens are present in tumors but absent in normal tissue, making them highly attractive targets for cancer vaccines.

Leveraging our proprietary AI-Immunology platform, Evaxion has identified ERV antigens in patient tumor sequencing data. Uniquely, the platform then selects optimal fragments from these antigens based on their potential to be effective vaccine targets across a wide range of patients.

By including multiple of these fragments in EVX-04, the vaccine is designed to be effective in all patients regardless of immune and tumor ERV antigen differences. This makes EVX-04 a so-called off-the-shelf vaccine preproduced and ready for immediate administration after diagnosis.

Data generated in the EVX-02 program has actively informed the development of both EVX-04 and EVX-03. As a matter of portfolio management, the EVX-02 program is now inactivated and removed from our R&D pipeline.

Further to the advancement of our R&D pipeline, the continued development and improvement of AI-Immunology is also an important part of our R&D work. Most recently, we have developed an automated vaccine design module replacing previous manual vaccine design processes. Thus, AI-Immunology, already superior in vaccine target discovery, now also enables enhanced design applicable for both new vaccines and optimization of approved ones.

Automated design can both improve the quality of the vaccines and shorten the design time compared to manual methods from months to days, also carrying significant cost savings.
The new module offers solutions for common problems encountered with traditional manual design methods, namely ensuring that vaccine targets can be properly expressed and obtained in the correct conformations.

The new design module can be applied to new as well as existing vaccines thereby potentially enabling the development of new and improved generations of vaccines already in use.

Further to our clinical progress, we also maintain a high level of preclinical activity with a number of active preclinical programs. Following the out-licensing of EVX-B3, the further development of this vaccine candidate is now in the hands of MSD and therefore removed from our R&D pipeline.

We maintain the ambition of replenishing the pipeline with another infectious disease vaccine candidate, having already added EVX-B4 earlier this year. However, our priority will be to do this as part of a target discovery collaboration with an external partner.

Business development update
We were delighted by the out-licensing of EVX-B3, which validates Evaxion, the platform and our pipeline as well as our strategy for long-term value creation and monetization of our assets. We have received $7.5 million in option exercise fee and will be eligible for future payments of up to $592 million.

MSD also holds an option to license EVX-B2, our Gonorrhea vaccine candidate. In September 2025 it was agreed to extend the evaluation period for EVX-B2. The extension follows an expansion of the initial evaluation plan encompassing further experiments. Consequently, a decision on potential in-licensing of EVX-B2 by MSD is now expected in the first half of 2026.

Should MSD exercise the option on EVX-B2, we will receive a cash payment of $2.5 million and be eligible for future development, regulatory and sales milestone payments of up to $592 million as well as royalties on sales as for EVX-B3. The milestones are not additive per product to get to total deal value as some discount may occur if both programs progress successfully.

We remain active in several parallel partnership discussions based on external interest in both our platform and pipeline as we continue to pursue our strategy of monetizing value through multiple partnerships. As has been the case throughout 2025, turmoil in financial markets and regulatory uncertainty impacts the decision processes with some potential partners, prolonging some discussions. Having concluded the deal on EVX-B3, we maintain the ambition of entering at least one more partnership deal in the coming months, even if uncertainty of timing is increasing.

Cash runway extended
On October 30, 2025, we announced the successful completion of different capital market activities, raising a gross total of $7.2 million. As a result, we now have cash on hand to fund our operations and R&D programs into the second half of 2027, extended from first half of 2027.

The proceeds strengthened both Evaxion’s cash position and equity and followed the influx of $7.5 million paid by MSD when licensing EVX-B3.

Of the $7.2 million, $4.5 million came from sales of shares in an at-the-market (ATM) offering and $2.7 million came from exercise of investor warrants. The latter reduced the number of outstanding warrants to purchase Evaxion ADSs by 1.0 million. The total number of outstanding warrants is now 2.8 million, including employee warrants, with a weighted average exercise price of $10.94.

Third quarter 2025 financial results
The third quarter showed strong financial performance with net income of $4.6 million, driven by revenue income from MSD’s option exercise and financial income from an 89% share price premium of the European Investment Bank’s (EIB’s) debt-to-equity conversion. The third quarter net income is a significant improvement compared to a net loss of $1.9 million for the same period 2024.

Revenue of $7.5 million for the quarter ending September 30, 2025, primarily relates to MSD option exercise and also includes revenue recorded from Gates Foundation. With the out-licensing of EVX-B3 to MSD, all future development cost of the program will be carried by MSD, while the deal will provide Evaxion with future revenue income potential of up to $592 million through milestone payments.

Research and development (R&D) expenses were $3.1 million for the period ending September 30, 2025, compared to $2.6 million last year. Project costs are more back-end loaded in 2025 compared to 2024, and overall, our expenses are well managed and within targets for the year.

General and administrative expenses were $1.4 million for the third quarter 2025, compared to $2.1 million in 2024. The decrease is primarily driven by lower capital market transaction costs.

Net financial income of $1.3 million is driven by $2.7 million financial income mainly due to the 89% share price premium from the EIB debt-to-equity conversion in July 2025, and $1.4 million financial expense mainly due to remeasurement of the derivative liability from investor warrants from our January 2025 public offering.

During the third quarter of 2025 we continued strong execution of our financial strategy, resulting in improved equity, lower leverage and extended cash runway. Our cash runway has now been extended to second half of 2027, improved from earlier first half of 2027.

Cash and cash equivalents as of September 30, 2025, were $10.6 million, compared to $6.0 million as of December 31, 2024. January to October 2025, we have received proceeds from capital market activity and recorded income of total $31.8 million, providing a significant improvement in our cash position.

Total equity amounts to $16.6 million as of September 30, 2025, which is a significant improvement compared to a negative equity of $(1.7) million as of December 31, 2024.

The equity is negatively impacted by $1.5 million as of September 30, 2025, arising from the net effect of the derivative liability from investor warrants issued as part of our January 2025 public offering. According to IAS/IFRS, the investor warrants are seen as derivative instruments, as the exercise price is denominated in USD while our company’s functional currency is DKK. Part of the proceeds from capital raises are consequently recognized as derivative liabilities. Reassessments are disclosed as financial income/expense and reverted to equity when warrants are exercised or lapse. The derivative liability from investor warrants has no impact on other items in the financial statement, hence Evaxion discloses the impact as a separate equity item. With the investor warrants exercised during October 2025, the net impact is expected to be reduced to a nominal impact by year end 2025.

Evaxion’s equity and market capitalization remain well above Nasdaq’s requirements, with ample headroom expected to persist, as we continue to execute our financial strategy.

Further, we will continue to focus and maintain our strict cost control and diligently prioritize and optimize our resource allocation. This enables us to absorb the general cost increase and inflation within the same cash spend as in 2024, e.g. we expect an operational cash burn of approximately $14 million in 2025.

(Press release, Evaxion Biotech, NOV 6, 2025, View Source [SID1234659568])

PharmaMar receives a US$10 million milestone payment from Janssen for Yondelis

On November 6, 2025 PharmaMar Group (MSE: PHM) reported it has received a payment of $10 million from Janssen Products, LP, a Johnson & Johnson company, after reaching a commercial milestone for Yondelis (trabectedin) in the United States as defined in the licensing agreement.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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In August 2019, PharmaMar entered into a new licensing agreement with Johnson & Johnson, which replaced a 2001 licensing agreement, under which Johnson & Johnson retained the right to sell and distribute, on an exclusive basis, trabectedin in the USA.

Today, trabectedin is approved in more than 70 countries for the treatment of soft tissue sarcoma and in some of these countries for ovarian cancer as well.

(Press release, PharmaMar, NOV 6, 2025, View Source [SID1234659584])

DARZALEX FASPRO® is the first and only treatment approved by the U.S. FDA for patients with high-risk smoldering multiple myeloma

On November 6, 2025 Johnson & Johnson (NYSE:JNJ) reported the U.S. Food and Drug Administration (FDA) approved DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) as a single agent treatment for adult patients with high-risk smoldering multiple myeloma (HR-SMM).1 DARZALEX FASPRO is the first and only approved treatment for HR-SMM, enabling earlier intervention before the disease progresses to active multiple myeloma.

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FDA approval is based on findings from the AQUILA study (NCT03301220), which evaluated the efficacy and safety of DARZALEX FASPRO compared to active monitoring (or "Watch and Wait") in the largest Phase 3 trial in patients with HR-SMM. The AQUILA study demonstrated a significant improvement in the primary endpoint of progression-free survival (PFS), with DARZALEX FASPRO reducing the risk of disease progression to active multiple myeloma or death by 51 percent compared to active monitoring, according to the International Myeloma Working Group (IMWG) diagnostic criteria for multiple myeloma. Today’s milestone follows the May 2025 vote by the U.S. FDA Oncologic Drugs Advisory Committee (ODAC) in favor of the benefit-risk profile of DARZALEX FASPRO as a single agent treatment for patients with HR-SMM.

Smoldering multiple myeloma (SMM) is an asymptomatic malignancy that is genomically the same as active multiple myeloma and where these abnormal cells can be detected in the bone marrow.2,3,4 In 2025, it is estimated that more than 36,000 people will be diagnosed with multiple myeloma in the U.S., and approximately 15 percent of those are classified as smoldering.5,6 An estimated 50 percent of patients diagnosed with HR-SMM are likely to progress to active disease within two years of diagnosis.6 Currently, the standard of care for HR-SMM is active monitoring to track signs of biochemical progression and/or end-organ damage. Recent evidence suggests that people at high-risk of progressing to active multiple myeloma could benefit from earlier therapeutic intervention.6

"Until now, patients diagnosed with smoldering multiple myeloma only have the option to watch and wait for any active signs of progression to active disease," said Peter Voorhees, M.D., Atrium Health/Levine Cancer Institute, Charlotte, N.C.* "Results from AQUILA demonstrated DARZALEX FASPRO significantly delayed disease progression, underscoring the role of early disease intervention for patients with high-risk smoldering multiple myeloma."

The Phase 3 AQUILA study showed after a median follow-up of 65.2 months, 63.1 percent of patients who received DARZALEX FASPRO had not progressed to active myeloma at 5 years (60 months) versus 40.7 percent in the active monitoring group (hazard ratio [HR], 0.49; 95 percent confidence interval [CI], 0.36-0.67; P<0.001). Today, most physicians use the Mayo 2018 criteria (20/2/20) to assess risk status in patients with smoldering myeloma. In a post hoc analysis of AQUILA, 41 percent of patients met the Mayo 2018 HR-SMM classification. Among these patients, median PFS was not reached in the DARZALEX FASPRO arm and was 22.1 months in the active monitoring arm (HR, 0.36; 95 percent CI, 0.23-0.58).1

Beyond the primary endpoint of PFS, patients in AQUILA who received DARZALEX FASPRO saw a higher response rate of 63.4 percent compared to 2.0 percent with active monitoring (P<0.001). The median time to patients receiving first-line multiple myeloma treatment was delayed for patients receiving DARZALEX FASPRO compared to active monitoring, with median time to first treatment NR vs 50.2 months for the active monitoring group (HR, 0.46; 95 percent CI, 0.33-0.62).1

"DARZALEX FASPRO is a foundational therapy in multiple myeloma and illustrates our commitment to improve outcomes for patients at every stage of their disease," said Jordan Schecter, M.D., Vice President, Research & Development, Multiple Myeloma, Oncology, Johnson & Johnson Innovative Medicine. "Data from the AQUILA study reinforce the significant impact DARZALEX FASPRO continues to have for patients. With today’s approval, patients with HR-SMM will now be able to receive this treatment before they progress to active multiple myeloma, giving us the opportunity to shift the treatment paradigm and bring hope to people who are impacted by this disease."

Adverse reactions observed in the pivotal AQUILA study were generally consistent with previous DARZALEX FASPRO studies. The most common adverse reactions (≥20%) in patients with HR-SMM who received DARZALEX FASPRO monotherapy are upper respiratory tract infection, musculoskeletal pain, fatigue, diarrhea, rash, sleep disorder, sensory neuropathy, and injection site reactions.1

Results from AQUILA were first presented at the 2024 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and simultaneously published in The New England Journal of Medicine. A subgroup analysis from the AQUILA study, evaluating the efficacy and safety of DARZALEX FASPRO monotherapy in patients with HR-SMM using IMWG 2020 and IMWG 2020 plus cytogenetic risk models, will be presented at the 2025 ASH (Free ASH Whitepaper) Annual Meeting in Orlando from December 6-9.

About the AQUILA Study

AQUILA (NCT03301220) is a randomized, multicenter Phase 3 study comparing treatment with DARZALEX FASPRO to active monitoring in patients with SMM. Patients received single agent DARZALEX FASPRO as a fixed-duration treatment for up to 36 months. The primary endpoint is progression-free survival (PFS), defined as progression to active multiple myeloma (MM) as assessed by an independent review committee, according to IMWG diagnostic criteria for MM (SLiM-CRAB), or death. Major secondary endpoints included overall response rate, PFS on first-line MM treatment (PFS2), and overall survival. Forty-one percent of patients had 2 or more of the following criteria for high-risk smoldering multiple myeloma: serum monoclonal protein level >2 g/dL, involved-to-uninvolved serum-free light chain ratio >20, and bone marrow plasma cells >20%. DARZALEX FASPRO is only indicated for patients with high-risk smoldering multiple myeloma and is not indicated for other risk categories.

About Multiple Myeloma

Multiple myeloma is a blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.7 In multiple myeloma, these malignant plasma cells proliferate and replace normal cells in the bone marrow.8 Multiple myeloma is the second most common blood cancer worldwide and remains an incurable disease.9 In 2025, it is estimated that more than 36,000 people will be diagnosed with multiple myeloma in the U.S. and more than 12,000 will die from the disease.5 People with multiple myeloma have a 5-year survival rate of 59.8 percent.10 While some people diagnosed with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels, kidney problems or infections.2,10

About Smoldering Multiple Myeloma

Smoldering multiple myeloma (SMM) is an asymptomatic precursor disease state of multiple myeloma where abnormal cells can be detected in the bone marrow.11 People living with SMM do not show signs or symptoms typically associated with active myeloma, such as bone pain, bone fractures, kidney problems, or anemia. However, as abnormal plasma cells are present, organ damage may begin and progress asymptomatically.4,6 Approximately fifteen percent of all cases are classified as SMM, and half of those diagnosed with high-risk SMM are estimated to progress to active multiple myeloma within two years.6

About DARZALEX FASPRO and DARZALEX

DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) received U.S. FDA approval in May 2020 and is approved for ten indications in multiple myeloma, four of which are for frontline treatment in newly diagnosed patients who are transplant eligible or ineligible.1 It is the only subcutaneous CD38-directed antibody approved to treat patients with multiple myeloma. DARZALEX FASPRO is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE drug delivery technology.

DARZALEX (daratumumab) received U.S. FDA approval in November 2015 and is approved in eight indications, three of which are in the frontline setting, including newly diagnosed patients who are transplant-eligible and ineligible.12 DARZALEX is the first CD38-directed antibody approved to treat multiple myeloma.12 DARZALEX-based regimens have been used in the treatment of more than 618,000 patients worldwide and more than 68,000 patients in the U.S. alone.

In August 2012, Janssen Biotech, Inc. and Genmab A/S entered a worldwide agreement, which granted Janssen an exclusive license to develop, manufacture and commercialize daratumumab

For more information, visit www.DARZALEX.com.

DARZALEX FASPRO INDICATIONS AND IMPORTANT SAFETY INFORMATION

INDICATIONS

DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) is indicated for the treatment of adult patients with multiple myeloma:

In combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation in newly diagnosed patients who are eligible for autologous stem cell transplant
In combination with bortezomib, melphalan, and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant
In combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy
In combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant
In combination with pomalidomide and dexamethasone in patients who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor (PI)
In combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy
In combination with bortezomib and dexamethasone in patients who have received at least one prior therapy
As monotherapy in patients who have received at least three prior lines of therapy including a PI and an immunomodulatory agent or who are double refractory to a PI and an immunomodulatory agent
DARZALEX FASPRO as monotherapy is indicated for the treatment of adult patients with high-risk smoldering multiple myeloma.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

DARZALEX FASPRO is contraindicated in patients with a history of severe hypersensitivity to daratumumab, hyaluronidase, or any of the components of the formulation.

WARNINGS AND PRECAUTIONS

Hypersensitivity and Other Administration Reactions

Both systemic administration-related reactions, including severe or life-threatening reactions, and local injection-site reactions can occur with DARZALEX FASPRO. Fatal reactions have been reported with daratumumab-containing products, including DARZALEX FASPRO.

Systemic Reactions

In a pooled safety population of 1446 patients with multiple myeloma (N=1235) or light chain (AL) amyloidosis (N=193) who received DARZALEX FASPRO as monotherapy or in combination, 7% of patients experienced a systemic administration-related reaction (Grade 2: 3%, Grade 3: 0.8%, Grade 4: 0.1%). In patients with high-risk smoldering multiple myeloma (N=193), systemic administration-related reactions occurred in 17% of patients in AQUILA (Grade 2: 7%, Grade 3: 1%).

In all patients (N=1639), systemic administration-related reactions occurred in 7% of patients with the first injection, 0.5% with the second injection, and cumulatively 1% with subsequent injections. The median time to onset was 3.2 hours (range: 4 minutes to 3.5 days). Of the 283 systemic administration-related reactions that occurred in 135 patients, 240 (85%) occurred on the day of DARZALEX FASPRO administration. Delayed systemic administration-related reactions have occurred in 1% of the patients.

Severe reactions included hypoxia, dyspnea, hypertension, tachycardia, and ocular adverse reactions, including choroidal effusion, acute myopia, and acute angle closure glaucoma. Other signs and symptoms of systemic administration-related reactions may include respiratory symptoms, such as bronchospasm, nasal congestion, cough, throat irritation, allergic rhinitis, and wheezing, as well as anaphylactic reaction, pyrexia, chest pain, pruritus, chills, vomiting, nausea, hypotension, and blurred vision.

Pre-medicate patients with histamine-1 receptor antagonist, acetaminophen, and corticosteroids. Monitor patients for systemic administration-related reactions, especially following the first and second injections. For anaphylactic reaction or life-threatening (Grade 4) administration-related reactions, immediately and permanently discontinue DARZALEX FASPRO. Consider administering corticosteroids and other medications after the administration of DARZALEX FASPRO depending on dosing regimen and medical history to minimize the risk of delayed (defined as occurring the day after administration) systemic administration-related reactions.

Ocular adverse reactions, including acute myopia and narrowing of the anterior chamber angle due to ciliochoroidal effusions with potential for increased intraocular pressure or glaucoma, have occurred with daratumumab-containing products. If ocular symptoms occur, interrupt DARZALEX FASPRO and seek immediate ophthalmologic evaluation prior to restarting DARZALEX FASPRO.

Local Reactions

In this pooled safety population of 1446 patients with multiple myeloma (N=1253) or light chain amyloidosis (N=193), injection-site reactions occurred in 8% of patients, including Grade 2 reactions in 1.1%. The most frequent (>1%) injection-site reaction were injection site erythema and injection site rash. In patients with high-risk smoldering multiple myeloma (N=193), injection-site reactions occurred in 28% of patients, including Grade 2 reactions in 3%. These local reactions occurred a median of 6 minutes (range: 0 minutes to 6.5 days) after starting administration of DARZALEX FASPRO. Monitor for local reactions and consider symptomatic management.

Infections

DARZALEX FASPRO can cause serious, life-threatening, or fatal infections. In patients who received DARZALEX FASPRO in a pooled safety population including patients with smoldering multiple myeloma and light chain (AL) amyloidosis (N=1639), serious infections, including opportunistic infections, occurred in 24% of patients, Grade 3 or 4 infections occurred in 22%, and fatal infections occurred in 2.5%. The most common type of serious infection reported was pneumonia (8.5%).

Monitor patients for signs and symptoms of infection prior to and during treatment with DARZALEX FASPRO and treat appropriately. Administer prophylactic antimicrobials according to guidelines.

Neutropenia

Daratumumab may increase neutropenia induced by background therapy. Monitor complete blood cell counts periodically during treatment according to manufacturer’s prescribing information for background therapies. Monitor patients with neutropenia for signs of infection. Consider withholding DARZALEX FASPRO until recovery of neutrophils. In lower body weight patients receiving DARZALEX FASPRO, higher rates of Grade 3-4 neutropenia were observed.

Thrombocytopenia

Daratumumab may increase thrombocytopenia induced by background therapy. Monitor complete blood cell counts periodically during treatment according to manufacturer’s prescribing information for background therapies. Consider withholding DARZALEX FASPRO until recovery of platelets.

Embryo-Fetal Toxicity

Based on the mechanism of action, DARZALEX FASPRO can cause fetal harm when administered to a pregnant woman. DARZALEX FASPRO may cause depletion of fetal immune cells and decreased bone density. Advise pregnant women of the potential risk to a fetus. Advise females with reproductive potential to use effective contraception during treatment with DARZALEX FASPRO and for 3 months after the last dose.

The combination of DARZALEX FASPRO with lenalidomide, thalidomide, or pomalidomide is contraindicated in pregnant women because lenalidomide, thalidomide, and pomalidomide may cause birth defects and death of the unborn child. Refer to the lenalidomide, thalidomide, or pomalidomide prescribing information on use during pregnancy.

Interference With Serological Testing

Daratumumab binds to CD38 on red blood cells (RBCs) and results in a positive indirect antiglobulin test (indirect Coombs test). Daratumumab-mediated positive indirect antiglobulin test may persist for up to 6 months after the last daratumumab administration. Daratumumab bound to RBCs masks detection of antibodies to minor antigens in the patient’s serum. The determination of a patient’s ABO and Rh blood type are not impacted.

Notify blood transfusion centers of this interference with serological testing and inform blood banks that a patient has received DARZALEX FASPRO. Type and screen patients prior to starting DARZALEX FASPRO.

Interference With Determination of Complete Response

Daratumumab is a human immunoglobulin G (IgG) kappa monoclonal antibody that can be detected on both the serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for the clinical monitoring of endogenous M-protein. This interference can impact the determination of complete response and of disease progression in some DARZALEX FASPRO-treated patients with IgG kappa myeloma protein.

ADVERSE REACTIONS

In multiple myeloma, the most common adverse reaction (≥20%) with DARZALEX FASPRO monotherapy is upper respiratory tract infection. The most common adverse reactions with combination therapy (≥20% for any combination) include fatigue, nausea, diarrhea, dyspnea, insomnia, headache, rash, pyrexia, cough, muscle spasms, back pain, vomiting, hypertension, musculoskeletal pain, upper respiratory tract infection, peripheral neuropathy, peripheral sensory neuropathy, constipation, pneumonia, edema, peripheral edema, and anemia.

The most common adverse reactions (≥20%) in patients with high-risk smoldering multiple myeloma who received DARZALEX FASPRO monotherapy are upper respiratory tract infection, musculoskeletal pain, fatigue, diarrhea, rash, sleep disorder, sensory neuropathy, and injection site reactions.

The most common hematology laboratory abnormalities (≥40%) with DARZALEX FASPRO are decreased leukocytes, decreased lymphocytes, decreased neutrophils, decreased platelets, and decreased hemoglobin.

Please click here to read the full Prescribing Information for DARZALEX FASPRO.

DARZALEX INDICATIONS AND IMPORTANT SAFETY INFORMATION

INDICATIONS

DARZALEX (daratumumab) is indicated for the treatment of adult patients with multiple myeloma:

In combination with bortezomib, melphalan, and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant
In combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy
In combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant
In combination with pomalidomide and dexamethasone in patients who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor
In combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy
In combination with bortezomib and dexamethasone in patients who have received at least one prior therapy
As monotherapy in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent
CONTRAINDICATIONS

DARZALEX is contraindicated in patients with a history of severe hypersensitivity (eg, anaphylactic reactions) to daratumumab or any of the components of the formulation.

WARNINGS AND PRECAUTIONS

Infusion-Related Reactions

DARZALEX can cause severe and/or serious infusion-related reactions including anaphylactic reactions. These reactions can be life threatening, and fatal outcomes have been reported. In clinical trials (monotherapy and combination: N=2066), infusion-related reactions occurred in 37% of patients with the Week 1 (16 mg/kg) infusion, 2% with the Week 2 infusion, and cumulatively 6% with subsequent infusions. Less than 1% of patients had a Grade 3/4 infusion-related reaction at Week 2 or subsequent infusions. The median time to onset was 1.5 hours (range: 0 to 73 hours). Nearly all reactions occurred during infusion or within 4 hours of completing DARZALEX. Severe reactions have occurred, including bronchospasm, hypoxia, dyspnea, hypertension, tachycardia, headache, laryngeal edema, pulmonary edema, and ocular adverse reactions, including choroidal effusion, acute myopia, and acute angle closure glaucoma. Signs and symptoms may include respiratory symptoms, such as nasal congestion, cough, throat irritation, as well as chills, vomiting, and nausea. Less common signs and symptoms were wheezing, allergic rhinitis, pyrexia, chest discomfort, pruritus, hypotension and blurred vision.

When DARZALEX dosing was interrupted in the setting of ASCT (CASSIOPEIA) for a median of 3.75 months (range: 2.4 to 6.9 months), upon re-initiation of DARZALEX, the incidence of infusion-related reactions was 11% for the first infusion following ASCT. Infusion-related reactions occurring at re-initiation of DARZALEX following ASCT were consistent in terms of symptoms and severity (Grade 3 or 4: <1%) with those reported in previous studies at Week 2 or subsequent infusions. In EQUULEUS, patients receiving combination treatment (n=97) were administered the first 16 mg/kg dose at Week 1 split over two days, ie, 8 mg/kg on Day 1 and Day 2, respectively. The incidence of any grade infusion-related reactions was 42%, with 36% of patients experiencing infusion-related reactions on Day 1 of Week 1, 4% on Day 2 of Week 1, and 8% with subsequent infusions.

Pre-medicate patients with antihistamines, antipyretics, and corticosteroids. Frequently monitor patients during the entire infusion. Interrupt DARZALEX infusion for reactions of any severity and institute medical management as needed. Permanently discontinue DARZALEX therapy if an anaphylactic reaction or life-threatening (Grade 4) reaction occurs and institute appropriate emergency care. For patients with Grade 1, 2, or 3 reactions, reduce the infusion rate when re-starting the infusion.

To reduce the risk of delayed infusion-related reactions, administer oral corticosteroids to all patients following DARZALEX infusions. Patients with a history of chronic obstructive pulmonary disease may require additional post-infusion medications to manage respiratory complications. Consider prescribing short- and long-acting bronchodilators and inhaled corticosteroids for patients with chronic obstructive pulmonary disease.

Ocular adverse reactions, including acute myopia and narrowing of the anterior chamber angle due to ciliochoroidal effusions with potential for increased intraocular pressure or glaucoma, have occurred with DARZALEX infusion. If ocular symptoms occur, interrupt DARZALEX infusion and seek immediate ophthalmologic evaluation prior to restarting DARZALEX.

Interference With Serological Testing

Daratumumab binds to CD38 on red blood cells (RBCs) and results in a positive indirect antiglobulin test (indirect Coombs test). Daratumumab-mediated positive indirect antiglobulin test may persist for up to 6 months after the last daratumumab infusion. Daratumumab bound to RBCs masks detection of antibodies to minor antigens in the patient’s serum. The determination of a patient’s ABO and Rh blood type is not impacted. Notify blood transfusion centers of this interference with serological testing and inform blood banks that a patient has received DARZALEX. Type and screen patients prior to starting DARZALEX.

Neutropenia and Thrombocytopenia

DARZALEX may increase neutropenia and thrombocytopenia induced by background therapy. Monitor complete blood cell counts periodically during treatment according to manufacturer’s prescribing information for background therapies. Monitor patients with neutropenia for signs of infection. Consider withholding DARZALEX until recovery of neutrophils or for recovery of platelets.

Interference With Determination of Complete Response

Daratumumab is a human immunoglobulin G (IgG) kappa monoclonal antibody that can be detected on both the serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for the clinical monitoring of endogenous M-protein. This interference can impact the determination of complete response and of disease progression in some patients with IgG kappa myeloma protein.

Embryo-Fetal Toxicity

Based on the mechanism of action, DARZALEX can cause fetal harm when administered to a pregnant woman. DARZALEX may cause depletion of fetal immune cells and decreased bone density. Advise pregnant women of the potential risk to a fetus. Advise females with reproductive potential to use effective contraception during treatment with DARZALEX and for 3 months after the last dose.

The combination of DARZALEX with lenalidomide, pomalidomide, or thalidomide is contraindicated in pregnant women because lenalidomide, pomalidomide, and thalidomide may cause birth defects and death of the unborn child. Refer to the lenalidomide, pomalidomide, or thalidomide prescribing information on use during pregnancy.

ADVERSE REACTIONS

The most frequently reported adverse reactions (incidence ≥20%) were: upper respiratory infection, neutropenia, infusion related reactions, thrombocytopenia, diarrhea, constipation, anemia, peripheral sensory neuropathy, fatigue, peripheral edema, nausea, cough, pyrexia, dyspnea, and asthenia. The most common hematologic laboratory abnormalities (≥40%) with DARZALEX are: neutropenia, lymphopenia, thrombocytopenia, leukopenia, and anemia.

Please click here to read the full Prescribing Information for DARZALEX.

(Press release, Johnson & Johnson, NOV 6, 2025, View Source [SID1234659612])