Nasdaq Nordic · interim-report
Kvartalsrapport Q2 2024
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Omsättning
- Strong underlying growth supports FY 2024 guidance upgrade, with both Total Revenue and Core EPS now | expected to increase by a mid teens percentage at CER[1]
- expected to increase by a mid teens percentage at CER[1] | Revenue and EPS summary
- H1 2024 % Change Q2 2024% Change $m Actual CER $m Actual CER | - Product Sales 24,629 15 18 12,452 14 18 - Alliance Revenue 939 50 50 482 42 42 - CollaborationRevenue 49 (78) (78) 4 (98) (98) | Total Revenue 25,617 15 18 12,938 13 17
- - Product Sales 24,629 15 18 12,452 14 18 - Alliance Revenue 939 50 50 482 42 42 - CollaborationRevenue 49 (78) (78) 4 (98) (98) | Total Revenue 25,617 15 18 12,938 13 17 | Reported EPS $2.65 13 23 $1.24 6 15
- ‒ Total Revenue up 18% to $25,617m, driven by an 18% increase in Product Sales and continued growth inAlliance Revenue from partnered medicines
- ‒ Total Revenue growth from Oncology was 22%, CVRM 22%, R&I 22%, and Rare Disease 15%
- ‒ Core Product Sales Gross Margin[3] of 82%
- ‒ Core EPS increased 5% to $4.03. The increase in Core EPS was lower than Total Revenue growth principallydue to gains recognised in the prior year, specifically a $241m gain on the disposal of Pulmicort Flexhaler USrights (Q1 2023), and a $712m gain relating to updates to contractual arrangements for Beyfortus (Q2 2023)
EBITDA
- Core financial measures, EBITDA, Net debt, Product Sales Gross Margin, Operating Margin and CER are non-GAAP financial measures because they cannot be derived directly from the Group's Condensed consolidatedfinancial statements. Management believes that these non-GAAP financial measures, when provided incombination with Reported results, provide investors and analysts with helpful supplementary information tounderstand better the financial performance and position of the Group on a comparable ba
- EBITDA is defined as Reported Profit before tax after adding back Net finance expense, results from Jointventures 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 thisannouncement.
- Table 10: Reconciliation of Reported Profit before tax to EBITDA
- Reported Profit before tax 5,197 4,350 19 29 2,397 2,088 15 24 Net finance expense 645 654 (1) (4) 343 367 (7) (7)Joint ventures and associates 19 1 n/m n/m 6 1 n/m n/mDepreciation, amortisation andimpairment 2,534 2,778 (9) (9) 1,279 1,276 - 1 | EBITDA 8,395 7,783 8 13 4,025 3,732 8 14
Rörelseresultat
- ‒ Other operating income is expected to decrease substantially (FY 2023 included a $241m gain on the disposalof Pulmicort Flexhaler US rights, and a $712m one-time gain relating to updates to contractual arrangementsfor Beyfortus)
- Operating margin is defined as Operating profit as a percentage of Total Revenue.
- SG&A expense (9,424) (9,045) 4 6 (4,929) (4,986) (1) 1 | Other operating income &expense 127 1,163 (89) (89) 60 784 (92) (92) | Operating profit 5,861 5,005 17 25 2,746 2,456 12 20
- Other operating income &expense 127 1,163 (89) (89) 60 784 (92) (92) | Operating profit 5,861 5,005 17 25 2,746 2,456 12 20 | Net finance expense (645) (654) (1) (4) (343) (367) (7) (7)
- Other operatingincome & expense 127 (2) - - 125 (89) (89) | Operating profit 5,861 349 1,942 259 8,411 2 7 Operating Margin 23% 33% -4pp -3pp | Net financeexpense (645) - - 115 (530) 6 3
- Other operatingincome & expense 60 - - - 60 (92) (92) | Operating profit 2,746 154 987 214 4,101 (4) 1 Operating Margin 21% 32% -6pp -5pp | Net financeexpense (343) - - 58 (285) 10 10
- ‒ The change in SG&A expense (Reported and Core) in the period was driven primarily by market developmentactivities for launches and to support continued growth in existing brands | Other operating income and expense
- ‒ In the prior year period, Other operating income and expense included a $241m gain on the disposal of the USrights to Pulmicort Flexhaler and a $712m gain relating to updates to contractual arrangements for Beyfortus | Net finance expense
Periodens resultat
- Taxation (1,089) (726) | Profit for the period 4,108 3,624 | Other comprehensive income:
- Taxation (469) (268) | Profit for the period 1,928 1,820 | Other comprehensive income:
- At 1 Jan 2023 387 35,155 2,069 (574) 37,037 21 37,058 | Profit for the period - - - 3,621 3,621 3 3,624 Other comprehensive income - - - 31 31 - 31 | Transfer to other reserves - - 7 (7) - - -
- At 1 Jan 2024 388 35,188 2,065 1,502 39,143 23 39,166 | Profit for the period - - - 4,106 4,106 2 4,108 | Other comprehensive expense - - - (414) (414) - (414)
Resultat per aktie
- Strong underlying growth supports FY 2024 guidance upgrade, with both Total Revenue and Core EPS now | expected to increase by a mid teens percentage at CER[1]
- expected to increase by a mid teens percentage at CER[1] | Revenue and EPS summary
- Total Revenue 25,617 15 18 12,938 13 17 | Reported EPS $2.65 13 23 $1.24 6 15 | Core[2] EPS $4.03 (1) 5 $1.98 (8) (3)
- Reported EPS $2.65 13 23 $1.24 6 15 | Core[2] EPS $4.03 (1) 5 $1.98 (8) (3)
- ‒ Core EPS increased 5% to $4.03. The increase in Core EPS was lower than Total Revenue growth principallydue to gains recognised in the prior year, specifically a $241m gain on the disposal of Pulmicort Flexhaler USrights (Q1 2023), and a $712m gain relating to updates to contractual arrangements for Beyfortus (Q2 2023)
- ‒ Guidance for FY 2024 increased, with Total Revenue and Core EPS anticipated to grow by a mid teenspercentage at CER (previously a low double-digit to low teens percentage). An increase in CollaborationRevenue is not assumed in the upgraded guidance | Pascal Soriot, Chief Executive Officer, AstraZeneca, said:
- "Building on our strong growth in the first half of the year and continued underlying demand for our medicines weare upgrading our FY 2024 guidance for both Total Revenue and Core EPS.
- Due to strong underlying growth in Product Sales and Alliance Revenue, the Company raises its Total Revenueand Core EPS guidance for FY 2024 at CER, based on the average foreign exchange rates through 2023.
Kassaflöde
- ‒ An Interim dividend of $1 per share (77.6 pence, 10.79 SEK) has been declared. | Table 13: Cash Flow summary
- 175 (42) | Items that may be reclassified subsequently to profit or loss:Foreign exchange arising on consolidation (554) 105 Foreign exchange arising on designated liabilities in net investment hedges (96) (101)Fair value movements on cash flow hedges (138) 89 Fair value movements on cash flow hedges transferred to profit and loss 102 (71)Fair value movements on derivatives designated in net investment hedges 45 40 Gains/(costs) of hedging 14 (1)Tax on items that may be reclassified subsequently to profit | (589) 73
- 35 (104) | Items that may be reclassified subsequently to profit or loss:Foreign exchange arising on consolidation (39) (209)Foreign exchange arising on designated liabilities in net investment hedges 2 (94)Fair value movements on cash flow hedges (52) 33 Fair value movements on cash flow hedges transferred to profit and loss 32 4 Fair value movements on derivatives designated in net investment hedges 23 24 Costs of hedging (1) (1)Tax on items that may be reclassified subsequently to profit or loss 3 - | (32) (243)
- The table below provides an analysis of Net debt and a reconciliation of Net Cash flow to the movement in Netdebt. The Group monitors Net debt as part of its capital management policy as described in Note 28 of the AnnualReport and Form 20-F Information 2023. Net debt is a non-GAAP financial measure. | Table 23: Net debt
Likvida medel
- At 30 Jun 2024 At 31 Dec 2023 At 30 Jun 2023 $m $m $m | Cash and cash equivalents 6,916 5,840 5,664 Other investments 160 122 148 | Cash and investments 7,076 5,962 5,812
- Cash flows from financing activitiesProceeds from issue of share capital 11 8 Issue of loans and borrowings 4,976 3,816 Repayment of loans and borrowings (2,643) (3,408)Dividends paid (3,050) (3,069)Hedge contracts relating to dividend payments (8) 27 Repayment of obligations under leases (150) (129)Movement in short-term borrowings 2,503 72 Payment of Acerta Pharma share purchase liability (833) (867)Net cash inflow/(outflow) from financing activities 806 (3,550) | Net increase/(decrease) in Cash and cash equivalents in the period 1,092 (465)Cash and cash equivalents at the beginning of the period 5,637 5,983
- Exchange rate effects (52) (47) | Cash and cash equivalents at the end of the period 6,677 5,471 | Cash and cash equivalents consist of:Cash and cash equivalents 6,916 5,664 Overdrafts (239) (193)
- Cash and cash equivalents at the end of the period 6,677 5,471 | Cash and cash equivalents consist of:Cash and cash equivalents 6,916 5,664 Overdrafts (239) (193) | 6,677 5,471
- The acquisition of Icosavax, Inc. completed on 19 February 2024. The transaction is recorded as an assetacquisition based on the concentration test permitted under IFRS 3 'Business Combinations', with consideration of$841m principally relating to $639m of intangible assets, $141m of cash and cash equivalents and $51m ofmarketable securities. Contingent consideration of up to $300m could be paid on achievement of regulatory andsales milestones; these potential liabilities would be recorded when t | Note 3: Net debt
- At 1 Jan2024 CashflowAcquisitions Non-cash& other Exchangemovements At 30 Jun2024 $m $m $m $m $m $m | Gross borrowings (28,622) (4,754) (30) (301) 174 (33,533)Net derivative financial instruments 150 65 - (82) - 133 Net borrowings (28,472) (4,689) (30) (383) 174 (33,400)Cash and cash equivalents 5,840 885 242 - (51) 6,916 Other investments - current 122 (42) 87 - (7) 160 | Cash and investments 5,962 843 329 - (58) 7,076
- As detailed in the Group's most recent annual financial statements, the principal financial instruments consist ofderivative financial instruments, other investments, trade and other receivables, cash and cash equivalents, tradeand other payables, lease liabilities and interest-bearing loans and borrowings.
- Fair values $mIntangible assets 1,038 Cash and cash equivalents 212 Net deferred tax liability (260)Other immaterial balances (89) | Total net assets acquired 901
Nettoskuld
- * See commentary above on Gross Margin,R&D, SG&A and Other operating incomeand expense | Net financeexpense $343m -7% Actual -7% CER $285m 10%Actual 10% CER + Higher level of Net debt | Tax rate 20% +7ppActual +7pp CER 19% +2pp Actual +2pp CER * Variations in the tax rate can be expectedbetween periods
- Core financial measures, EBITDA, Net debt, Product Sales Gross Margin, Operating Margin and CER are non-GAAP financial measures because they cannot be derived directly from the Group's Condensed consolidatedfinancial statements. Management believes that these non-GAAP financial measures, when provided incombination with Reported results, provide investors and analysts with helpful supplementary information tounderstand better the financial performance and position of the Group on a comparable ba
- Net debt is defined as Interest-bearing loans and borrowings and Lease liabilities, net of Cash and cashequivalents, Other investments, and Net derivative financial instruments. Reference should be made to Note 3 'Netdebt' included in the Notes to the Interim financial statements in this announcement.
- Non-cash and other movements (550) (594) 44 Interest paid (583) (483) (100)Taxation paid (1,337) (1,061) (276) | Net cash inflow from operating activities 5,571 4,851 720 | Net cash inflow before financing activities 286 3,085 (2,799)
- Net cash inflow from operating activities 5,571 4,851 720 | Net cash inflow before financing activities 286 3,085 (2,799) | Net cash inflow/(outflow) from financing activities 806 (3,550) 4,356 The change in Net cash inflow before financing activities in the half year to 30 June 2024 is primarily driven by themovement in Acquisitions of subsidiaries, net of cash acquired and initial investment, of $2,771m, and relates tothe acquisition of Gracell Biotechnologies, Inc. for $774m and acquisition of Fusion Pharmaceuticals Inc., for$1,997m as compared to the acquisition of Neogene Therapeutics, Inc. for $189m in H1 2023.
- Net cash inflow before financing activities 286 3,085 (2,799) | Net cash inflow/(outflow) from financing activities 806 (3,550) 4,356 The change in Net cash inflow before financing activities in the half year to 30 June 2024 is primarily driven by themovement in Acquisitions of subsidiaries, net of cash acquired and initial investment, of $2,771m, and relates tothe acquisition of Gracell Biotechnologies, Inc. for $774m and acquisition of Fusion Pharmaceuticals Inc., for$1,997m as compared to the acquisition of Neogene Therapeutics, Inc. for $189m in H1 2023.
- The increase in Net cash inflow/(outflow) from financing activities of $4,356m is primarily driven by the increase inIssue of loans and borrowings of $1,160m, by the decrease in Repayment of loans and borrowings of $765m andthe increase in Movement in short-term borrowings of $2,431m mainly due to the Commercial paper issued duringthe half year for $2,453m. | Capital expenditure
- Capital expenditure amounted to $799m in H1 2024 (H1 2023: $517m). Capital expenditure is expected toincrease substantially in 2024, driven by investment in several major manufacturing projects and continuedinvestment in technology upgrades. | Table 14: Net debt summary
Antal anställda
- ‒ A survey of more than 600 employees in 16 countries where the Young Health Programme (YHP) is activeshowed that more than 95% of employees feel proud to be associated with the YHP. With its expansion into thePhilippines, the programme is now active in 41 countries globally. In recognition of the impact of the YHP,AstraZeneca was the only corporate partner invited to speak at UNICEF's Annual Meeting attended byUNICEF's 33 CEOs and their Board Chairs in high-income countries
- US proceedings | In December 2022, AstraZeneca was served with a lawsuit filed by seven former employees in the US DistrictCourt for the District of Delaware (District Court) asserting claims of discrimination on grounds of age and religion,related to AstraZeneca's vaccination requirement. In March 2023, AstraZeneca filed a partial motion to dismisscertain religious discrimination claims and a motion to strike the class and collective claims. In September 2023,Plaintiffs moved for conditional certification of th | Pay Equity Litigation
- US proceedings | AstraZeneca is defending a putative class and collective action in the US District Court for the Northern District ofIllinois (District Court) brought by three named plaintiffs, who are former AstraZeneca employees. The caseinvolves claims under the federal and Illinois Equal Pay Acts, with the plaintiffs alleging they were paid less thanmale employees who performed substantially similar and/or equal work. In May 2024, the District Courtconditionally certified a collective under the federal Equa | University of Sheffield Contract Dispute
- Turkey proceedings | In Turkey, in July 2020, the Turkish Ministry of Health (Ministry of Health) initiated an investigation regardingpayments to healthcare providers by Alexion and former employees and consultants. The investigation arose fromAlexion's disclosure of a $21.5m civil settlement with the US Securities & Exchange Commission (SEC) in July2020 fully resolving the SEC's investigation into possible violations of the US Foreign Corrupt Practices Act. InSeptember 2021, the Ministry of Health completed its dra | Legal proceedings brought by AstraZeneca considered to be contingent assets
Bruttomarginal
- ‒ Core Product Sales Gross Margin[3] of 82%
- OperatingMargin 21% StableActual +1pp CER 32% -6pp Actual -5pp CER | * See commentary above on Gross Margin,R&D, SG&A and Other operating incomeand expense | Net financeexpense $343m -7% Actual -7% CER $285m 10%Actual 10% CER + Higher level of Net debt
- Core financial measures, EBITDA, Net debt, Product Sales Gross Margin, Operating Margin and CER are non-GAAP financial measures because they cannot be derived directly from the Group's Condensed consolidatedfinancial statements. Management believes that these non-GAAP financial measures, when provided incombination with Reported results, provide investors and analysts with helpful supplementary information tounderstand better the financial performance and position of the Group on a comparable ba
- Product Sales Gross Margin is calculated by dividing the difference between Product Sales and Cost of Sales bythe Product Sales. The calculation of Reported and Core Product Sales Gross Margin excludes the impact ofAlliance Revenue and Collaboration Revenue and any associated costs, thereby reflecting the underlyingperformance of Product Sales.
- ‒ The calculation of Reported and Core Product Sales Gross Margin excludes the impact of Alliance Revenueand Collaboration Revenue
- ‒ The change in Product Sales Gross Margin (Reported and Core) in H1 2024 was impacted by:
- ‒ Positive effects from product mix. The increased contribution from Rare Disease and Oncology medicineshad a positive impact on the Product Sales Gross Margin
- ‒ Dilutive effects from product mix. The rising contribution of Product Sales with profit sharing arrangements(Lynparza, Enhertu, Tezspire, Koselugo) has a negative impact on Product Sales Gross Margin becauseAstraZeneca records Product Sales in certain markets and pays away a share of the gross profits to itscollaboration partners. The growth in Beyfortus also has a dilutive impact on Product Sales Gross Margin,as AstraZeneca is responsible for manufacturing, and Sanofi is responsible for distr
Fulltext
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AstraZeneca25 July 2024 H1 and Q2 2024 results
Strong underlying growth supports FY 2024 guidance upgrade, with both Total Revenue and Core EPS now
expected to increase by a mid teens percentage at CER[1]
Revenue and EPS summary
H1 2024 % Change Q2 2024% Change $m Actual CER $m Actual CER
- Product Sales 24,629 15 18 12,452 14 18 - Alliance Revenue 939 50 50 482 42 42 - CollaborationRevenue 49 (78) (78) 4 (98) (98)
Total Revenue 25,617 15 18 12,938 13 17
Reported EPS $2.65 13 23 $1.24 6 15
Core[2] EPS $4.03 (1) 5 $1.98 (8) (3)
Financial performance for H1 2024 (Growth numbers at constant exchange rates)
‒ Total Revenue up 18% to $25,617m, driven by an 18% increase in Product Sales and continued growth inAlliance Revenue from partnered medicines
‒ Total Revenue growth from Oncology was 22%, CVRM 22%, R&I 22%, and Rare Disease 15%
‒ Core Product Sales Gross Margin[3] of 82%
‒ Core Operating Margin of 33%
‒ Core Tax Rate of 20%
‒ Core EPS increased 5% to $4.03. The increase in Core EPS was lower than Total Revenue growth principallydue to gains recognised in the prior year, specifically a $241m gain on the disposal of Pulmicort Flexhaler USrights (Q1 2023), and a $712m gain relating to updates to contractual arrangements for Beyfortus (Q2 2023)
‒ Interim dividend increased 7c to $1.00 (77.6 pence, 10.79 SEK) has been declared
‒ Guidance for FY 2024 increased, with Total Revenue and Core EPS anticipated to grow by a mid teenspercentage at CER (previously a low double-digit to low teens percentage). An increase in CollaborationRevenue is not assumed in the upgraded guidance
Pascal Soriot, Chief Executive Officer, AstraZeneca, said:
"Building on our strong growth in the first half of the year and continued underlying demand for our medicines weare upgrading our FY 2024 guidance for both Total Revenue and Core EPS.
At our Investor Day in May we set out a new revenue ambition to deliver $80 billion of Total Revenue by 2030. Thisis a clear reflection of the substantial growth potential we see from both our approved medicines and those in ourlate-stage pipeline. Already this year we have announced five positive, potentially practice-changing Phase IIIstudies that are anticipated to meaningfully contribute to our growth.
In the year to date we have continued to make encouraging progress with several disruptive technologies,including antibody drug conjugates, bispecifics, cell and gene therapies, radioconjugates, and weight managementmedicines, all of which have the potential to drive our growth beyond 2030."
Key milestones achieved since the prior results announcement
‒ Positive read-outs for Imfinzi in combination with chemotherapy in muscle-invasive bladder cancer (NIAGARA),Calquence in untreated mantle cell lymphoma (ECHO), Enhertu in HR-positive, HER2-low metastatic breastcancer (DESTINY-Breast06)
‒ US approvals for Imfinzi in combination with chemotherapy followed by Imfinzi monotherapy for primaryadvanced or recurrent endometrial cancer that is mismatch repair deficient (DUO-E). EU approvals for Truqap
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in combination with Faslodex for biomarker-positive estrogen receptor-positive, HER2-negative advancedbreast cancer (CAPItello-291), Tagrisso with the addition of chemotherapy for 1st ‑ line EGFRm NSCLC(FLAURA2). Japan and China approvals for Tagrisso with the addition of chemotherapy for the 1st-- ‑ lineEGFRm NSCLC (FLAURA2)
Guidance
Due to strong underlying growth in Product Sales and Alliance Revenue, the Company raises its Total Revenueand Core EPS guidance for FY 2024 at CER, based on the average foreign exchange rates through 2023.
Total Revenue is expected to increase by a mid teens percentage(previously a low double-digit to low teens percentage)
Core EPS is expected to increase by a mid teens percentage(previously a low double-digit to low teens percentage) ‒ An increase in Collaboration Revenue is not assumed in the upgraded guidance (previously assumed asubstantial increase)
‒ Other operating income is expected to decrease substantially (FY 2023 included a $241m gain on the disposalof Pulmicort Flexhaler US rights, and a $712m one-time gain relating to updates to contractual arrangementsfor Beyfortus)
‒ The Core Tax rate is expected to be between 18-22% The Company is unable to provide guidance on a Reported basis because it cannot reliably forecast materialelements 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 statementssection regarding forward-looking statements at the end of this announcement.
Currency impact
If foreign exchange rates for July 2024 to December 2024 were to remain at the average rates seen in June 2024,it is anticipated that FY 2024 Total Revenue would incur a low single-digit percentage adverse impact compared tothe performance at CER, and Core EPS would incur a mid single-digit percentage adverse impact. The Company'sforeign exchange rate sensitivity analysis is provided in Table 17.
Table 1: Key elements of Total Revenue performance in Q2 2024
% Change
Revenue type $m Actual % CER % Product Sales 12,452 14 18
Alliance Revenue 482 42 42 * $344m Enhertu (Q2 2023:$255m)
* $104m Tezspire (Q2 2023:$62m)
Collaboration Revenue 4 (98) (98) * Q2 2023 included $180m forCOVID-19 mAbs
Total Revenue 12,938 13 17
Therapy areas $m Actual % CER %
Oncology 5,331 15 19 * Tagrisso up 8% (12% at CER)due to strong global demand,Calquence up 21% (22% atCER) with sustained leadershipin 1L CLL. Enhertu TotalRevenue up 46% (49% at CER)
CVRM 3,160 18 22 * Farxiga up 29% (32% at CER),Lokelma up 36% (41% at CER)
R&I 1,905 23 26 * Breztri up 44% (47% at CER).Saphnelo up 65%, Tezspire up97% (>2x at CER), Symbicortup 20% (25% CER)
V&I 119 (57) (53) * The drop in V&I revenue wasprimarily driven by lowerCollaboration Revenue fromCOVID-19 mAbs
* Beyfortus revenue was $35m(Q2 2023: $2m), which morethan offset a $6m decline inSynagis
Rare Disease 2,147 10 14 * Ultomiris up 33% (36% atCER), partially offset by declinein Soliris of 14% (8% at CER)
* Strensiq up 13% (14% at CER)and Koselugo up 43% (45% at
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CER)
Other Medicines 276 (11) (5)Total Revenue 12,938 13 17
Regions $m Actual % CER %
US 5,571 17 17 Emerging Markets 3,386 9 18
- China 1,630 13 18
- Ex-China EmergingMarkets 1,756 5 18
Europe 2,732 24 24 Established RoW 1,249 (5) 6 Total Revenue 12,938 13 17
Key partnered medicines
‒ Combined sales of Enhertu, recorded by Daiichi Sankyo Company Limited (Daiichi Sankyo) and AstraZeneca,amounted $1,772m in H1 2024 (H1 2023: $1,169m).
‒ Combined sales of Tezspire, recorded by Amgen and AstraZeneca, amounted to $507m in H1 2024 (H1 2023:$257m).‒
Table 2: Key elements of financial performance in Q2 2024
Metric Reported Reportedchange Core Corechange Comments[4]
TotalRevenue $12,938m 13%Actual 17% CER $12,938m 13%Actual 17% CER
* See Table 1 and the Total Revenuesection of this document for further details
ProductSales GrossMargin 82% StableActual Stable CER 83% StableActual Stable CER
* Variations in Product Sales Gross Margincan be expected between periods due toproduct seasonality (e.g. FluMist andBeyfortus in H2), foreign exchangefluctuations and other effects
R&D expense $3,008m 13%Actual 13% CER $2,872m 12%Actual 13% CER
+ Increased investment in the pipeline
* Core R&D-to-Total Revenue ratio of 22%(Q2 2023: 22%)
SG&Aexpense $4,929m -1% Actual 1% CER $3,735m 13%Actual 16% CER
+ Market development for recent launchesand pre-launch activities
* Core SG&A-to-Total Revenue ratio of29%(Q2 2023: 29%)
Otheroperatingincome and
expense[5]
$60m -92%Actual -92% CER $60m -92%Actual -92% CER
‒ The prior year quarter included a $712mgain relating to updates to contractualarrangements for Beyfortus
OperatingMargin 21% StableActual +1pp CER 32% -6pp Actual -5pp CER
* See commentary above on Gross Margin,R&D, SG&A and Other operating incomeand expense
Net financeexpense $343m -7% Actual -7% CER $285m 10%Actual 10% CER + Higher level of Net debt
Tax rate 20% +7ppActual +7pp CER 19% +2pp Actual +2pp CER * Variations in the tax rate can be expectedbetween periods
EPS $1.24 6% Actual 15% CER $1.98 -8%Actual -3% CER
* Further details of differences betweenReported and Core are shown in Table 12
Table 3: Pipeline highlights since prior results announcement
Event Medicine Indication / Trial Event
Regulatoryapprovals andother regulatoryactions
Imfinzi Primary advanced orrecurrent endometrialcancer with mismatchrepair deficiency (DUO-E)
Regulatory approval (US),CHMP positive opinion (EU)
Imfinzi + Lynparza Primary advanced orrecurrent endometrialcancer with mismatch
CHMP positive opinion (EU)
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repair proficiency (DUO-E)Tagrisso EGFRm NSCLC (1st-line)(FLAURA2) Regulatory approval (EU, JP,CN)Truqap Biomarker-positive ER-positive HER2-negativelocally advanced ormetastatic breast cancer(CAPItello-291)
Regulatory approval (EU)
Regulatorysubmissionsor acceptances*
Tagrisso EGFRm NSCLC (StageIII unresectable) (LAURA) sNDA acceptance and PriorityReview (US)
Dato-DXd
Non-squamous NSCLC(2nd- and 3rd-line)(TROPION-Lung01)
Regulatory submission (EU)
sipavibart Prevention of COVID-19(SUPERNOVA) Regulatory submission (EU)
Major Phase IIIdata readouts andotherdevelopments
Calquence Mantle cell lymphoma(1st ‑ line) (ECHO) Primary endpoint met
Dato-DXd Locally advanced ormetastatic NSCLC(TROPION-Lung01)
Dual primary endpoint OS notmet in the intention to treatpopulationEnhertu HER2-low breast cancer(2nd-line) (DESTINY-Breast-06)
Primary endpoint met
Imfinzi Muscle-invasive bladdercancer (NIAGARA) Primary endpoint met
Imfinzi Adjuvant use in early-stage PD-L1 ≥25% NSCLC (Adjuvant BR.31)
Primary endpoint not met
Truqap Locally advanced ormetastatic TNBC(CAPItello-290)
Primary endpoint not met
sipavibart Prevention of COVID-19(SUPERNOVA) Primary endpoint met
*US, EU and China regulatory submission denotes filing acceptance
Upcoming pipeline catalysts
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.
Corporate and business development
In May 2024, AstraZeneca announced its intention to build a $1.5 billion manufacturing facility in Singapore forantibody drug conjugates (ADCs), enhancing global supply of its ADC portfolio. ADCs are next-generationtreatments that deliver highly potent cancer-killing agents directly to cancer cells through a targeted antibody. Theplanned greenfield facility, supported by the Singapore Economic Development Board, will be AstraZeneca's firstend-to-end ADC production site, fully incorporating all steps of the manufacturing process at a commercial scale.Manufacturing of ADCs is a multi-step process that comprises antibody production, synthesis of chemotherapydrug and linker, conjugation of drug-linker to the antibody, and filling of the completed ADC substance.
In May 2024, AstraZeneca completed an additional $140m equity investment in Cellectis, a clinical-stagebiotechnology company. The equity investment and a research collaboration agreement, announced in November2023, will leverage the Cellectis proprietary gene editing technologies and manufacturing capabilities, to design upto 10 novel cell and gene therapy products for areas of high unmet need, including oncology, immunology and rarediseases. In Q4 2023, Cellectis received an initial payment of $105m from AstraZeneca, which comprised a $25mupfront cash payment under the terms of a research collaboration agreement and an $80m equity investment.Now that the additional $140m equity investment has closed, AstraZeneca holds a total equity stake of c.44% inCellectis and AstraZeneca continues to treat its investment in Cellectis as an associate.
In June 2024, AstraZeneca completed the acquisition of Fusion Pharmaceuticals Inc., a clinical-stagebiopharmaceutical company developing next-generation radioconjugates. The acquisition marks a major stepforward in AstraZeneca delivering on its ambition to transform cancer treatment and outcomes for patients byreplacing traditional regimens like chemotherapy and radiotherapy with more targeted treatments. The acquisitioncomplements AstraZeneca's leading oncology portfolio with the addition of the Fusion pipeline of radioconjugates,including FPI-2265, a potential new treatment for patients with mCRPC, and brings new expertise and pioneeringR&D, manufacturing and supply chain capabilities in actinium-based radioconjugates to AstraZeneca. See Note 5for further information.
In July 2024, AstraZeneca completed the acquisition of Amolyt Pharma, a clinical-stage biotechnology companyfocused on developing novel treatments for rare endocrine diseases. The acquisition bolsters the Alexion,AstraZeneca Rare Disease late-stage pipeline and expands on its bone metabolism franchise with the notable
===== SIDA 5 =====
addition of eneboparatide (AZP-3601), a Phase III investigational therapeutic peptide with a novel mechanism ofaction designed to meet key therapeutic goals for hypoparathyroidism. In patients with hypoparathyroidism, adeficiency in parathyroid hormone production results in significant dysregulation of calcium and phosphate, whichcan lead to life-altering symptoms and complications, including chronic kidney disease. See Note 7 for furtherinformation.
Sustainability highlights
At the 77th World Health Assembly in Geneva, Switzerland in May, AstraZeneca convened Ministers of Health,industry, civil society and patient groups. Areas of focus for engagement, led by Ruud Dobber, EVPBioPharmaceuticals, included the need to increase early action to prevent, diagnose and treat disease and toaccelerate collaboration to build resilient, equitable and net zero health systems.
Conference call
A conference call and webcast for investors and analysts will begin today, 25 July 2024, at 11:45 UK time. Detailscan be accessed via astrazeneca.com.
Reporting calendar
The Company intends to publish its 9M and Q3 2024 results on 12 November 2024. Conclusion of audit tender
Following a rigorous process, the audit tender for the Group's external audit provider has now concluded. TheAudit Committee has recommended, and the Board has endorsed, the appointment of KPMG as the Group'sexternal auditor for the financial year ending 31 December 2026. A resolution will be put to shareholders at the2026 Annual General Meeting (AGM) to approve this appointment. It is intended that PwC, who have been theGroup's auditor since the year ended 31 December 2017, will continue as the Group's auditors for the years ended31 December 2024 and 2025 and will cease to hold office at the conclusion of the Company's 2026 AGM.
Operating and financial review
All narrative on growth and results in this section is based on actual exchange rates, and financial figures are inUS$ millions ($m), unless stated otherwise. Unless stated otherwise, the performance shown in thisannouncement covers the six month period to 30 June 2024 ('the half year' or 'H1 2024') compared to the sixmonth period to 30 June 2023 ('H1 2023').
Core financial measures, EBITDA, Net debt, Product Sales Gross Margin, Operating Margin and CER are non-GAAP financial measures because they cannot be derived directly from the Group's Condensed consolidatedfinancial statements. Management believes that these non-GAAP financial measures, when provided incombination with Reported results, provide investors and analysts with helpful supplementary information tounderstand better the financial performance and position of the Group on a comparable basis from period toperiod. These non-GAAP financial measures are not a substitute for, or superior to, financial measures prepared inaccordance with GAAP.
Core financial measures are adjusted to exclude certain significant items:
‒ Charges and provisions related to restructuring programmes, which includes charges that relate to the impactof restructuring programmes on capitalised IT assets
‒ Amortisation and impairment of intangible assets, including impairment reversals but excluding any chargesrelating to IT assets
‒ Other specified items, principally the imputed finance charges and fair value movements relating to contingentconsideration on business combinations, imputed finance charges and remeasurement adjustments on certainOther payables arising from intangible asset acquisitions, legal settlements and remeasurement adjustmentsrelating to Other payables assumed from the Alexion acquisition
‒ 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 61 of the Annual Report and Form 20-FInformation 2023.
Reference should be made to the Reconciliation of Reported to Core financial measures table included in thefinancial performance section in this announcement.
Product Sales Gross Margin is calculated by dividing the difference between Product Sales and Cost of Sales bythe Product Sales. The calculation of Reported and Core Product Sales Gross Margin excludes the impact ofAlliance Revenue and Collaboration Revenue and any associated costs, thereby reflecting the underlyingperformance of Product Sales.
EBITDA is defined as Reported Profit before tax after adding back Net finance expense, results from Jointventures and associates and charges for Depreciation, amortisation and impairment. Reference should be made
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to the Reconciliation of Reported Profit before tax to EBITDA included in the financial performance section in thisannouncement.
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 cashequivalents, Other investments, and Net derivative financial instruments. Reference should be made to Note 3 'Netdebt' 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 toreview 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 tototals.
Total Revenue
Table 4: Total Revenue by therapy area and medicine[6]
H1 2024 Q2 2024
% Change % Change
Total Revenue $m % Total Actual CER $m % Total Actual CER
Oncology 10,440 41 19 22 5,331 41 15 19
- Tagrisso 3,203 13 10 13 1,608 12 8 12 - Imfinzi 2,259 9 20 25 1,147 9 13 18 - Calquence 1,508 6 27 28 790 6 21 22 - Lynparza 1,450 6 6 9 744 6 4 7 - Enhertu 932 4 61 62 472 4 46 49 - Zoladex 567 2 19 26 282 2 17 25 - Imjudo 136 1 35 38 74 1 17 19 - Truqap 142 1 n/m n/m 92 1 n/m n/m - Orpathys 25 - 14 18 13 - (5) (1)- Other Oncology 216 1 (21) (15) 109 1 (17) (11)
BioPharmaceuticals: CVRM 6,220 24 19 22 3,160 24 18 22
- Farxiga 3,836 15 35 38 1,945 15 29 32 - Brilinta 665 3 - 2 342 3 3 5 - Crestor 590 2 1 6 293 2 4 11 - Lokelma 249 1 26 30 136 1 36 41 - Seloken/Toprol-XL 315 1 (8) (1) 150 1 (8) - - roxadustat 167 1 22 27 90 1 20 25 - Andexxa 105 - 18 21 59 - 29 35 - Wainua 21 - n/m n/m 16 - n/m n/m - Other CVRM 272 1 (30) (28) 130 1 (26) (24)
BioPharmaceuticals: R&I 3,791 15 19 22 1,905 15 23 26
- Symbicort 1,491 6 16 19 722 6 20 25 - Fasenra 781 3 5 6 423 3 4 5 - Breztri 454 2 48 51 235 2 44 47 - Pulmicort 379 1 10 14 155 1 25 30 - Tezspire 280 1 >2x >2x 160 1 97 >2x - Saphnelo 203 1 77 77 112 1 65 65 - Airsupra 21 - n/m n/m 14 - n/m n/m - Other R&I 181 1 (26) (25) 83 1 (21) (19)
BioPharmaceuticals: V&I 350 1 (45) (42) 119 1 (57) (53)
- Beyfortus 80 - >10x >10x 35 - >10x >10x - Synagis 253 1 (11) (6) 81 1 (6) 8 - COVID-19 mAbs 3 - (99) (99) 1 - (99) (99)- FluMist 8 - (34) (36) 2 - (84) (84)- Other V&I 6 - (79) (80) - - n/m n/m
Rare Disease 4,243 17 11 15 2,147 17 10 14
- Ultomiris 1,804 7 32 35 946 7 33 36 - Soliris 1,439 6 (13) (8) 700 5 (14) (8)- Strensiq 653 3 16 18 340 3 13 14 - Koselugo 247 1 55 64 114 1 43 45 - Kanuma 100 - 17 20 47 - 3 8
Other Medicines 573 2 (9) (2) 276 2 (11) (5)
- Nexium 469 2 (6) 2 227 2 (10) (3)- Others 104 - (21) (18) 49 - (16) (12)Total 25,617 100 15 18 12,938 100 13 17
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Table 5: Alliance Revenue
H1 2024 Q2 2024
% Change % Change
$m % Total Actual CER $m % Total Actual CER
Enhertu 683 73 44 44 344 71 35 36 Tezspire 180 19 72 72 104 22 67 67 Beyfortus 26 3 n/m n/m 7 1 n/m n/m Other Alliance Revenue 50 5 4 4 27 6 17 17
Total 939 100 50 50 482 100 42 42
Table 6: Collaboration Revenue
H1 2024 Q2 2024
% Change % Change
$m % Total Actual CER $m % Total Actual CER
Farxiga: sales milestones 49 100 96 96 4 100 >5x >5x COVID-19 mAbs: licence fees - - n/m n/m - - n/m n/m Other Collaboration Revenue - - (98) (98) - - n/m n/m
Total 49 100 (78) (78) 4 100 (98) (98)
Table 7: Total Revenue by therapy area
H1 2024 Q2 2024
% Change % Change
$m % Total Actual CER $m % Total Actual CER
Oncology 10,440 41 19 22 5,331 41 15 19 Biopharmaceuticals 10,362 40 14 17 5,184 40 15 19
CVRM 6,220 24 19 22 3,160 24 18 22 R&I 3,791 15 19 22 1,905 15 23 26 V&I 350 1 (45) (42) 119 1 (57) (53)
Rare Disease 4,243 17 11 15 2,147 17 10 14 Other Medicines 573 2 (9) (2) 276 2 (11) (5)
Total 25,617 100 15 18 12,938 100 13 17
Table 8: Total Revenue by region
H1 2024 Q2 2024
% Change % Change
$m % Total Actual CER $m % Total Actual CER
US 10,695 42 18 18 5,571 43 17 17
Emerging Markets 7,119 28 13 22 3,386 26 9 18
China 3,378 13 11 15 1,630 13 13 18 Emerging Markets ex. China 3,740 15 16 29 1,756 14 5 18
Europe 5,365 21 23 22 2,732 21 24 24 Established ROW 2,438 10 (5) 4 1,249 10 (5) 6
Total 25,617 100 15 18 12,938 100 13 17
Oncology
Oncology Total Revenue of $10,440m in H1 2024 increased by 19% (22% at CER), representing 41% of overallTotal Revenue (H1 2023: 39%).
Tagrisso
H1 2024, $m Worldwide US Emerging Markets Europe Established RoW
Total Revenue 3,203 1,282 919 628 374Actual change 10% 16% 8% 16% (11%)CER change 13% 16% 16% 15% (2%)
===== SIDA 8 =====
Region Drivers and commentary
Worldwide * Strong global demand for Tagrisso in adjuvant (ADAURA) and 1st-line settings(FLAURA, FLAURA2)
US * Continued adjuvant and 1st-line demand growth
Emerging Markets * Encouraging demand growth across markets despite local competition in China
Europe * Continued demand growth in 1st-line and adjuvant settings
Established RoW * Continued growth across indications, impacted by 10.5% mandatory price reduction inJapan effective from June 2023
Imfinzi
H1 2024, $m Worldwide US Emerging Markets Europe Established RoW
Total Revenue 2,259 1,202 245 459 353Actual change 20% 17% 35% 38% 7%CER change 25% 17% 58% 36% 19% Region Drivers and commentary
Worldwide * Continued growth driven by BTC (TOPAZ-1), HCC (HIMALAYA), and increased patientshare in Stage IV NSCLC (POSEIDON) and extensive-stage SCLC (CASPIAN)
US * Continued demand growth driven primarily by HCC and extensive-stage SCLC, havingachieved peak market share and stabilisation in BTC
Emerging Markets * New patient share growth across all indications
* China growth driven largely by increasing demand in BTC
Europe * Growth driven by share gains in extensive-stage SCLC and new launches in HCC,BTC and NSCLC
Established RoW * Increased demand in GI indications, offset by a 25% mandatory price reduction inJapan effective from 1 February 2024
Calquence
H1 2024, $m Worldwide US Emerging Markets Europe Established RoWTotal Revenue 1,508 1,048 75 320 65Actual change 27% 21% 82% 42% 30%CER change 28% 21% >2x 41% 34% Region Drivers and commentary
Worldwide * Sustained leadership in front-line CLL (ELEVATE-TN) and increased global penetration
US * Growth driven by leading share of new patient starts in front-line CLL, and improvedaffordability
Europe * Continued strong growth in front-line
Lynparza
H1 2024, $m Worldwide US Emerging Markets Europe Established RoW
Total Revenue 1,450 607 320 398 125Actual change 6% 5% 15% 9% (14%)
CER change 9% 5% 26% 8% (6%)
Region Drivers and commentary
Worldwide * Lynparza remains the leading medicine in the PARP inhibitor class globally across fourtumour types (ovarian, breast, prostate, pancreatic), as measured by total prescriptionvolume
* No Collaboration Revenue for Lynparza was recognised in either H1 2024 or H1 2023,hence the Product Sales numbers are identical to the Total Revenue numbers shownabove
US * Continued leadership within PARP inhibitor class despite competition, offset bynegative class pressure and maturity
Emerging Markets * Volume growth in China from increased share in newly diagnosed BRCA-mutatedovarian cancer (SOLO-1) and inclusion of HRD-positive ovarian cancer (PAOLA-1) onNRDL with no price reduction
Europe * Demand growth driven by recent launches in mCRPC (PROpel) and early breastcancer (OlympiA)
Established RoW * Demand growth from 1st-line ovarian cancer, offset by price reduction in Japaneffective from November 2023
Enhertu
===== SIDA 9 =====
H1 2024, $m Worldwide US Emerging Markets Europe Established RoWTotal Revenue 932 414 224 263 31Actual change 61% 22% >2x >2x >3xCER change 62% 22% >2x >2x >3x Region Drivers and commentary
Worldwide * Combined sales of Enhertu, recorded by Daiichi Sankyo and AstraZeneca, amountedto $1,772m in H1 2024 (H1 2023: $1,169m)
US * US in-market sales, recorded by Daiichi Sankyo, amounted to $865m in H1 2024 (H12023: $712m)
* Continued demand across all indications with encouraging early launch followingtumour-agnostic approval in April 2024 (DESTINY-PanTumor02, DESTINY-Lung01,DESTINY ‑ CRC02)
Emerging Markets * Sustained demand growth, with quarterly phasing impacted by launch-related inventorybuild in China in Q1 2024 and subsequent destocking
Europe * Continued demand growth due to increasing adoption in HER2-positive (DESTINY-Breast03) and HER2-low (DESTINY-Breast04) metastatic breast cancer
Established RoW * AstraZeneca's Alliance Revenue includes a mid single-digit percentage royalty onDaiichi Sankyo's sales in Japan
Other Oncology medicines
H1 2024 Change
Total Revenue $m Actual CER Drivers and commentary
Zoladex 567 19% 26% * Strong underlying growth in China and Emerging Markets andmoderate growth in Europe offset by drop in Japan
Imjudo 136 35% 38% * Continued growth across markets slightly offset by US inventorydestocking in H1 2024
Truqap 142 n/m n/m * Strong demand growth with strong uptake in biomarker alteredsubgroup of HR-positive HER2-negative metastatic breastcancer (CAPItello-291)
Orpathys 25 14% 18% * Demand in China for the treatment of patients with NSCLC withMET exon 14 skipping alterations
Other Oncology 216 (21%) (15%) * Decline in Faslodex Total Revenue due to VBP implementationin China in March 2024 in addition to ongoing generic erosion inEurope
BioPharmaceuticals
BioPharmaceuticals Total Revenue increased by 14% (17% at CER) in H1 2024 to $10,362m, representing 40% ofoverall Total Revenue (H1 2023: 41%).
BioPharmaceuticals - CVRM
CVRM Total Revenue increased by 19% (22% at CER) to $6,220m in H1 2024 and represented 24% of overallTotal Revenue (H1 2023: 24%).
Farxiga
H1 2024, $m Worldwide US Emerging Markets Europe Established RoW
Total Revenue 3,836 869 1,474 1,233 260Actual change 35% 37% 37% 45% (5%)CER change 38% 37% 44% 44% 3% Region Drivers and commentary
Worldwide * Farxiga volume is growing faster than the overall SGLT2 market in all major regions,driven by continued demand in heart failure and CKD
* SGLT2 class growth underpinned by updated cardiorenal guidelines
US * Growth driven by underlying demand in HFrEF and CKD
* Launch of an authorised generic in the first quarter of 2024
Emerging Markets * Increased reimbursement supporting solid growth despite entry of generic competitionin some markets
* Strong momentum in Latin America
Europe * Continued strong class growth and market share gains fuelled by HFpEF approval in2023 and guidelines updates
Established RoW * Performance impacted by generic competition in Canada
===== SIDA 10 =====
* In Japan, AstraZeneca sells to collaborator Ono Pharmaceutical Co., Ltd, whichrecords in-market sales
Other CVRM medicines
H1 2024 Change
Total Revenue $m Actual CER Drivers and commentary
Brilinta 665 - 2% * Continued sales growth in Emerging Markets, decline in Est.RoW driven by generic competition in Canada
Crestor 590 1% 6% * Continued sales growth in Emerging Markets
Seloken 315 (8%) (1%) * Stable following VBP implementation in China in 2022
Lokelma 249 26% 30% * Strong growth in all major regions. Continued launches in newmarkets
roxadustat 167 22% 27% * Increased demand in both the dialysis and non-dialysis-dependent populations. NRDL listing renewed
Andexxa 105 18% 21% * Growth in all major regions
Wainua 21 n/m n/m * Encouraging launch uptake following ATTRv-PN approval in theUS in December 2023
Other CVRM 272 (30%) (28%)
BioPharmaceuticals - R&I
Total Revenue of $3,791m from R&I medicines increased 19% (22% at CER) and represented 15% of overall TotalRevenue (H1 2023: 14%). This reflected growth in Fasenra, Tezspire, Breztri, Saphnelo and Airsupra, following itsrecent launch.
Fasenra
H1 2024, $m Worldwide US Emerging Markets Europe Established RoW
Total Revenue 781 478 41 192 70Actual change 5% 2% 45% 9% (2%)CER change 6% 2% 53% 8% 6% Region Drivers and commentary
Worldwide * Continued asthma market share leadership in IL-5 class across major markets
US * Maintained share of a growing severe asthma biologics market
Emerging Markets * Continued strong demand growth driven by launch acceleration across key markets
Europe * Expanded leadership in severe eosinophilic asthma
Established RoW * In Japan, maintained class leadership in a broadly stable market
Breztri
H1 2024, $m Worldwide US Emerging Markets Europe Established RoWTotal Revenue 454 225 131 65 33Actual change 48% 37% 61% 80% 33%CER change 51% 37% 69% 79% 44% Region Drivers and commentary
Worldwide * Fastest growing medicine within the expanding FDC triple class, across major markets
US * Consistent share growth within the expanding FDC triple class
Emerging Markets * Maintained market share leadership in China with strong triple FDC class penetration
* Further expansion with launches in additional geographies
Europe * Sustained growth across markets driven by new launches
Established RoW * Increased market share in Japan
Tezspire
H1 2024, $m Worldwide US Emerging Markets Europe Established RoWTotal Revenue 280 180 5 61 34Actual change >2x 72% >10x >3x >2xCER change >2x 72% >10x >3x >2x Region Drivers and commentary
Worldwide * Combined sales of Tezspire, recorded by Amgen and AstraZeneca, amounted to$507m in H1 2024 (H1 2023: $257m)
===== SIDA 11 =====
US * Continued growth in total prescriptions, and maintained new-to-brand market sharewith majority of patients new-to-biologics
Europe * Achieved new-to-brand leadership across multiple markets, new launches continue toprogress
Established RoW * Japan maintained new-to-brand leadership
Symbicort
H1 2024, $m Worldwide US Emerging Markets Europe Established RoWTotal Revenue 1,491 598 450 286 157Actual change 16% 38% 11% - (4%)CER change 19% 38% 21% (1%) (2%) Region Drivers and commentary
Worldwide * Symbicort remained the global market leader within a stable ICS/LABA class
US * Continued strong demand for the authorised generic and favourable channel mix
Emerging Markets * Strong demand growth
Europe * Continued price and volume erosion from generics and a slowing overall marketpartially offset by growth in some markets within mild asthma
Established RoW * Continued generic erosion in Japan
Other R&I medicines
H1 2024 Change
Total Revenue $m Actual CER Drivers and commentary
Pulmicort 379 10% 14% * >80% of revenues from Emerging Markets
Saphnelo 203 77% 77% * Demand acceleration in the US, and additional growth driven byongoing launches in Europe and Established RoW
Airsupra 21 n/m n/m * Strong US launch momentum and volume uptake. Revenue inthe period reflects introductory discounts as early accesscontinues to build
Other R&I 181 (26%) (25%) * Generic competition
BioPharmaceuticals - V&I
Total Revenue from V&I medicines reduced by 45% (42% at CER) to $350m (H1 2023: $632m) and represented1% of overall Total Revenue (H1 2023: 3%). Collaboration Revenue was $nil in the period (H1 2023: $190m).
V&I medicines
H1 2024 Change
Total Revenue $m Actual CER Drivers and commentary
Beyfortus 80 >10x >10x * Product Sales recognises AstraZeneca's sales of manufacturedBeyfortus product to Sanofi
* Alliance Revenue recognises AstraZeneca's 50% share ofgross profits on sales of Beyfortus in major markets outside theUS, and 25% of brand revenues in rest of world markets
* AstraZeneca has no participation in US profits or losses
Synagis 253 (11%) (6%) * Decline has been more than offset by Beyfortus growth
COVID-19 mAbs 3 (99%) (99%) * Decline in Evusheld sales and Collaboration Revenue (TotalRevenue H1 2023: $306m)
FluMist 8 (34%) (36%)
Other V&I 6 (79%) (80%) * Decline in Vaxzevria sales (H1 2023: $28m)
Rare Disease
Total Revenue from Rare Disease medicines increased by 11% (15% at CER) in H1 2024 to $4,243m,
representing 17% of overall Total Revenue (H1 2023: 17%).
Ultomiris
H1 2024, $m Worldwide US Emerging Markets Europe Established RoWTotal Revenue 1,804 1,032 66 411 295
===== SIDA 12 =====
Actual change 32% 27% >2x 32% 42%CER change 35% 27% >2x 31% 58% Region Drivers and commentary
Worldwide * Growth due to increased use in neurology, geographic expansion, further patientdemand and conversion from Soliris
* The reported revenues for Ultomiris include sales of Voydeya, which is approved as anadd ‑ on treatment to Ultomiris and Soliris for the 10-20% of PNH patients whoexperience clinically significant EVH.
* Voydeya is a strategic launch in this small subset of PNH patients. Voydeya ensuresthese patients can remain on the standard of care, Ultomiris
US * Patient growth in gMG and newly launched NMOSD, continued conversion from Soliris
Emerging Markets * Continued growth following launches in new markets
Europe * Strong demand growth following recent launches, particularly from neurologyindications, accelerated conversion from Soliris in key markets, partially offset by pricereductions to secure reimbursement for new indications
Established RoW * Continued conversion from Soliris and strong demand following new launches
Soliris
H1 2024, $m Worldwide US Emerging Markets Europe Established RoW
Total Revenue 1,439 808 255 260 116Actual change (13%) (9%) 19% (29%) (33%)CER change (8%) (9%) 54% (30%) (30%) Region Drivers and commentary
US * Decline driven by successful conversion of Soliris patients to Ultomiris
Emerging Markets * Growth driven by patient demand following launches in new markets
Europe * Decline driven by biosimilar erosion in PNH and aHUS and successful conversion fromSoliris to Ultomiris
Established RoW * Decline driven by successful conversion from Soliris to Ultomiris
Strensiq
H1 2024, $m Worldwide US Emerging Markets Europe Established RoWTotal Revenue 653 529 31 48 45Actual change 16% 17% 30% 14% 4%CER change 18% 17% 47% 12% 15% Region Drivers and commentary
Worldwide * Growth driven by strong patient demand
Other Rare Disease medicines
H1 2024 Change
Total Revenue $m Actual CER Drivers and commentary
Koselugo 247 55% 64% * Driven by patient demand and expansion in new markets
Kanuma 100 17% 20% * Continued global demand
Other medicines (outside the main therapy areas)
H1 2024 Change
Total Revenue $m Actual CER Drivers and commentary
Nexium 469 (6%) 2% * Growth in Emerging Markets offset declines elsewhere
Others 104 (21%) (18%) * Continued impact of generic competition
Financial performance
Table 9: Reported Profit and Loss
H1 2024H1 2023 % Change Q2 2024Q2 2023 % Change
===== SIDA 13 =====
$m $m Actual CER $m $m Actual CER
Total Revenue 25,617 22,295 15 18 12,938 11,416 13 17
- Product Sales 24,629 21,448 15 18 12,452 10,882 14 18
- Alliance Revenue 939 627 50 50 482 341 42 42
- Collaboration Revenue 49 220 (78) (78) 4 193 (98) (98)
Cost of sales (4,401) (3,865) 14 17 (2,183) (1,960) 11 17
Gross profit 21,216 18,430 15 18 10,755 9,456 14 17
Distribution expense (267) (265) 1 3 (132) (131) 1 4
R&D expense (5,791) (5,278) 10 10 (3,008) (2,667) 13 13
SG&A expense (9,424) (9,045) 4 6 (4,929) (4,986) (1) 1
Other operating income &expense 127 1,163 (89) (89) 60 784 (92) (92)
Operating profit 5,861 5,005 17 25 2,746 2,456 12 20
Net finance expense (645) (654) (1) (4) (343) (367) (7) (7)
Joint ventures and associates (19) (1) n/m n/m (6) (1) n/m n/m
Profit before tax 5,197 4,350 19 29 2,397 2,088 15 24
Taxation (1,089) (726) 50 62 (469) (268) 75 90
Tax rate 21% 17% 20% 13%
Profit after tax 4,108 3,624 13 23 1,928 1,820 6 15
Earnings per share $2.65 $2.34 13 23 $1.24 $1.17 6 15
Table 10: Reconciliation of Reported Profit before tax to EBITDA
H1 2024H1 2023 % Change Q2 2024Q2 2023 % Change
$m $m Actual CER $m $m Actual CER
Reported Profit before tax 5,197 4,350 19 29 2,397 2,088 15 24 Net finance expense 645 654 (1) (4) 343 367 (7) (7)Joint ventures and associates 19 1 n/m n/m 6 1 n/m n/mDepreciation, amortisation andimpairment 2,534 2,778 (9) (9) 1,279 1,276 - 1
EBITDA 8,395 7,783 8 13 4,025 3,732 8 14
Table 11: Reconciliation of Reported to Core financial measures: H1 2024[7]
H1 2024 Reported Restructuring
IntangibleAssetAmortisation &Impairments
Other Core Core% Change
$m $m $m $m $m Actual CER
Gross profit 21,216 36 19 - 21,271 14 17 Product SalesGross Margin 82% 82% -1pp -1pp
Distributionexpense (267) - - - (267) 1 3
R&D expense (5,791) 177 39 5 (5,570) 14 15 % of TotalRevenue 23% 22% - +1pp
SG&A expense (9,424) 138 1,884 254 (7,148) 13 15 % of TotalRevenue 37% 28% +1pp +1pp
Total operatingexpense (15,482) 315 1,923 259 (12,985) 13 15
Other operatingincome & expense 127 (2) - - 125 (89) (89)
Operating profit 5,861 349 1,942 259 8,411 2 7 Operating Margin 23% 33% -4pp -3pp
Net financeexpense (645) - - 115 (530) 6 3
Taxation (1,089) (80) (368) (71) (1,608) 13 19
EPS $2.65 $0.17 $1.01 $0.20 $4.03 (1) 5
Table 12: Reconciliation of Reported to Core financial measures: Q2 20247
Q2 2024 Reported Restructuring IntangibleAsset Other Core Core% Change
===== SIDA 14 =====
Amortisation &Impairments
$m $m $m $m $m Actual CER
Gross profit 10,755 16 9 - 10,780 13 17 Product SalesGross Margin 82% 83% - -
Distributionexpense (132) - - - (132) 1 4
R&D expense (3,008) 97 35 4 (2,872) 12 13 % of TotalRevenue 23% 22% - +1pp
SG&A expense (4,929) 41 943 210 (3,735) 13 16 % of TotalRevenue 38% 29% - -
Total operatingexpense (8,069) 138 978 214 (6,739) 12 14
Other operatingincome & expense 60 - - - 60 (92) (92)
Operating profit 2,746 154 987 214 4,101 (4) 1 Operating Margin 21% 32% -6pp -5pp
Net financeexpense (343) - - 58 (285) 10 10
Taxation (469) (35) (185) (52) (741) 7 13
EPS $1.24 $0.08 $0.51 $0.15 $1.98 (8) (3)
Profit and Loss drivers
Gross profit
‒ The calculation of Reported and Core Product Sales Gross Margin excludes the impact of Alliance Revenueand Collaboration Revenue
‒ The change in Product Sales Gross Margin (Reported and Core) in H1 2024 was impacted by:
‒ Positive effects from product mix. The increased contribution from Rare Disease and Oncology medicineshad a positive impact on the Product Sales Gross Margin
‒ Dilutive effects from product mix. The rising contribution of Product Sales with profit sharing arrangements(Lynparza, Enhertu, Tezspire, Koselugo) has a negative impact on Product Sales Gross Margin becauseAstraZeneca records Product Sales in certain markets and pays away a share of the gross profits to itscollaboration partners. The growth in Beyfortus also has a dilutive impact on Product Sales Gross Margin,as AstraZeneca is responsible for manufacturing, and Sanofi is responsible for distribution. AstraZenecarecords its sales to Sanofi as Product Sales, and those sales generate a lower Product Sales Gross Marginthan the Company average
‒ Dilutive effects from geographic mix. In Emerging Markets, the Product Sales Gross Margin tends to bebelow the Company average
‒ Variations in Product Sales Gross Margin performance between periods can continue to be expected due toproduct 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 several high priority medicines 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 activityincluding Icosavax, Gracell and Fusion
‒ The change in Reported R&D expense was also impacted by intangible asset impairments in the prior period
SG&A expense
‒ The change in SG&A expense (Reported and Core) in the period was driven primarily by market developmentactivities for launches and to support continued growth in existing brands
Other operating income and expense
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‒ In the prior year period, Other operating income and expense included a $241m gain on the disposal of the USrights to Pulmicort Flexhaler and a $712m gain relating to updates to contractual arrangements for Beyfortus
Net finance expense
‒ Core Net finance expense increased 6% (3% increase at CER) principally due to the higher level of gross debtpartially offset by the higher level of cash and short-term investments.
Taxation
‒ The effective Reported Tax rate for the six months to 30 June 2024 was 21% (H1 2023: 17%) and the effectiveCore Tax rate was 20% (H1 2023: 18%)
‒ The cash tax paid for the six months to 30 June 2024 was $1,337m (H1 2023: $1,061m), representing 26% ofReported Profit before tax (H1 2023: 24%)
Dividend
‒ An Interim dividend of $1 per share (77.6 pence, 10.79 SEK) has been declared.
Table 13: Cash Flow summary
H1 2024 H1 2023 Change $m $m $m
Reported Operating profit 5,861 5,005 856 Depreciation, amortisation and impairment 2,534 2,778 (244)Movement in working capital and short-term provisions (584) (747) 163 Gains on disposal of intangible assets (21) (249) 228 Fair value movements on contingent consideration arising frombusiness combinations 251 202 49
Non-cash and other movements (550) (594) 44 Interest paid (583) (483) (100)Taxation paid (1,337) (1,061) (276)
Net cash inflow from operating activities 5,571 4,851 720
Net cash inflow before financing activities 286 3,085 (2,799)
Net cash inflow/(outflow) from financing activities 806 (3,550) 4,356 The change in Net cash inflow before financing activities in the half year to 30 June 2024 is primarily driven by themovement in Acquisitions of subsidiaries, net of cash acquired and initial investment, of $2,771m, and relates tothe acquisition of Gracell Biotechnologies, Inc. for $774m and acquisition of Fusion Pharmaceuticals Inc., for$1,997m as compared to the acquisition of Neogene Therapeutics, Inc. for $189m in H1 2023.
The increase in Net cash inflow/(outflow) from financing activities of $4,356m is primarily driven by the increase inIssue of loans and borrowings of $1,160m, by the decrease in Repayment of loans and borrowings of $765m andthe increase in Movement in short-term borrowings of $2,431m mainly due to the Commercial paper issued duringthe half year for $2,453m.
Capital expenditure
Capital expenditure amounted to $799m in H1 2024 (H1 2023: $517m). Capital expenditure is expected toincrease substantially in 2024, driven by investment in several major manufacturing projects and continuedinvestment in technology upgrades.
Table 14: Net debt summary
At 30 Jun 2024 At 31 Dec 2023 At 30 Jun 2023 $m $m $m
Cash and cash equivalents 6,916 5,840 5,664 Other investments 160 122 148
Cash and investments 7,076 5,962 5,812
Overdrafts and short-term borrowings (596) (515) (421)
Commercial paper (2,453) - -
Lease liabilities (1,241) (1,128) (953)Current instalments of loans (2,018) (4,614) (4,135)Non-current instalments of loans (27,225) (22,365) (24,329)
Interest-bearing loans and borrowings (Gross debt) (33,533) (28,622) (29,838)
Net derivatives 133 150 56 Net debt (26,324) (22,510) (23,970)
Net debt increased by $3,814m in the six months to 30 June 2024 to $26,324m. Details of the committed undrawnbank facilities are disclosed within the going concern section of Note 1. Details of the Company's solicited credit
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ratings and further details on Net debt are disclosed in Note 3.
Capital allocation
The Board's aim is to continue to strike a balance between the interests of the business, financial creditors and theCompany's shareholders. The Company's capital allocation priorities include: investing in the business andpipeline; maintaining a strong, investment-grade credit rating; potential value-enhancing business developmentopportunities; and supporting the progressive dividend policy.
In approving the declaration of dividends, the Board considers both the liquidity of the company and the level ofreserves legally available for distribution. Dividends are paid to shareholders from AstraZeneca PLC, a Groupholding company with no direct operations. The ability of AstraZeneca PLC to make shareholder distributions isdependent on the creation of profits for distribution and the receipt of funds from subsidiary companies. Theconsolidated Group reserves set out in the Condensed consolidated statement of financial position do not reflectthe profit available for distribution to the shareholders of AstraZeneca PLC.
Summarised financial information for guarantee of securities of subsidiaries
AstraZeneca Finance LLC ("AstraZeneca Finance") is the issuer of 0.7% Notes due 2024, 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 due2030, 4.9% Notes due 2031, 2.25% Notes due 2031, 4.875% Notes due 2033 and 5% Notes due 2034 (the"AstraZeneca Finance Notes"). Each series of AstraZeneca Finance Notes has been fully and unconditionallyguaranteed by AstraZeneca PLC. AstraZeneca Finance is 100% owned by AstraZeneca PLC and each of theguarantees issued by AstraZeneca PLC is full and unconditional and joint and several.
The AstraZeneca Finance Notes are senior unsecured obligations of AstraZeneca Finance and rank equally withall of AstraZeneca Finance's existing and future senior unsecured and unsubordinated indebtedness. Theguarantee by AstraZeneca PLC of the AstraZeneca Finance Notes is the senior unsecured obligation ofAstraZeneca PLC and ranks equally with all of AstraZeneca PLC's existing and future senior unsecured andunsubordinated indebtedness. Each guarantee by AstraZeneca PLC is effectively subordinated to any securedindebtedness of AstraZeneca PLC to the extent of the value of the assets securing such indebtedness. TheAstraZeneca Finance Notes are structurally subordinated to indebtedness and other liabilities of the subsidiaries ofAstraZeneca PLC, none of which guarantee the AstraZeneca Finance Notes.
AstraZeneca PLC manages substantially all of its operations through divisions, branches and/or investments insubsidiaries and affiliates. Accordingly, the ability of AstraZeneca PLC to service its debt and guarantee obligationsis 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 asfiled with the SEC and information contained herein for further financial information regarding AstraZeneca PLCand its consolidated subsidiaries. For further details, terms and conditions of the AstraZeneca Finance Notesplease refer to AstraZeneca PLC's reports on Form 6-K furnished to the SEC on 22 February 2024, 3 March 2023and 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 consolidatedsubsidiaries. The following summary financial information of AstraZeneca PLC and AstraZeneca Finance ispresented on a combined basis and transactions between the combining entities have been eliminated. Financialinformation for non-guarantor entities has been excluded. Intercompany balances and transactions between theobligor group and the non-obligor subsidiaries are presented on separate lines.
Table 15: Obligor group summarised Statement of comprehensive income
H1 2024 H1 2023 $m $m
Total Revenue - -
Gross profit - - Operating loss - (2)Loss for the period (545) (480)Transactions with subsidiaries that are not issuers or guarantors 964 9,487
Table 16: Obligor group summarised Statement of financial position
At 30 Jun 2024 At 30 Jun 2023 $m $m
Current assets 13 7 Non-current assets - -
Current liabilities (4,795) (4,091)Non-current liabilities (27,133) (24,165)Amounts due from subsidiaries that are not issuers or guarantors 20,730 15,761 Amounts due to subsidiaries that are not issuers or guarantors - (290)
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Foreign exchange
The Company's transactional currency exposures on working capital balances, which typically extend for up tothree months, are hedged where practicable using forward foreign exchange contracts against the individualcompanies' reporting currency. Foreign exchange gains and losses on forward contracts transacted fortransactional hedging are taken to profit or to Other comprehensive income if the contract is in a designatedcashflow hedge. In addition, the Company's external dividend payments, paid principally in pound sterling andSwedish krona, are fully hedged from announcement to payment date.
Table 17: Currency sensitivities
The Company provides the following information on currency-sensitivity:
Averagerates vs. USD
Annual impact($m) of 5%strengthening(FY 2024 averagerate vs. FY 2023
average) [8]
Currency PrimaryRelevance FY
2023[9] YTD
2024[10] Change (%)
June
2024[11] Change (%)
TotalRevenue
CoreOperatingProfitEUR Total Revenue 0.92 0.93 (0) 0.93 (0) 397 179
CNY Total Revenue 7.09 7.23 (2) 7.27 (3) 322 182 JPY Total Revenue 140.60 152.26 (8) 158.03 (11) 177 119
Other[12] 453 227
GBP Operatingexpense 0.80 0.79 2 0.79 2 60 (126)
SEK Operatingexpense 10.61 10.54 1 10.49 1 9 (63)
Related-party transactions
There have been no significant related-party transactions in the period.
Principal risks and uncertainties
The Principal Risks and uncertainties facing the Group are set out on pages 54 to 57 of the Annual Report andForm 20-F Information 2023, and summarised below. They are not expected to change in respect of the secondsix months of the financial year and remain appropriate for the Group. In summary, the principal risks anduncertainties listed in the Annual Report and 20-F Information 2023 are:
1. Product pipeline: failure or delay in the delivery of AstraZeneca's pipeline or launch of new medicines;failure to meet regulatory or ethical requirements for medicine development or approval
2. Commercialisation risks: pricing, affordability, access and competitive pressures; failures or delays inthe quality or execution of the Group's commercial strategies
3. Supply-chain and business-execution risks: failure to maintain supply of compliant, quality medicines;failure in information technology or cybersecurity; failure to attract, develop, engage and retain adiverse, talented and capable workforce
4. Legal, regulatory and compliance risks: safety and efficacy of marketed medicines is questioned;adverse outcome of litigation and / or governmental investigations; IP risks related to our products
5. Economic and financial risks: failure to achieve strategic plans or meet targets or expectations;geopolitical and / or macroeconomic volatility disrupts the operation of our global business
Sustainability
AstraZeneca released its first Sustainability Impact Publication as a complement to its ninth annual Sustainability
Report. This publication spotlights the diverse ways in which the Company is contributing to the health of people,
society and the planet.
Access to healthcare
‒ At the 77th World Health Assembly (WHA) in Geneva, Switzerland in May, AstraZeneca convened Ministers ofHealth, industry, civil society and patient groups. Areas of focus for engagement, led by Ruud Dobber, EVP
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BioPharmaceuticals, included the need to increase early action to prevent, diagnose and treat disease and toaccelerate collaboration to build resilient, equitable and net zero health systems
‒ At the WHA, AstraZeneca launched the expansion of its flagship Healthy Heart Africa programme to includechronic kidney disease as well as cardiovascular disease, recognising the growing burden of non-communicable diseases (NCDs) in Africa. As of May 2024, HHA has conducted more than 57 millionscreenings for high blood pressure and identified more than 11.3 million elevated readings, with 4.5 millionpatients diagnosed with hypertension since launch
‒ Also at the WHA, the Lung Ambition Alliance, of which the Company is a founding member, launchedthe Saving Lives from Lung Cancer platform and a calculator tool developed by AstraZeneca to supportpolicymakers and the lung cancer community in identifying high-risk populations for early intervention‒ The Partnership for Health System Sustainability and Resilience (PHSSR) held its third Summit during the AbuDhabi Global Healthcare Week in May, bringing together more than 200 healthcare leaders from the MiddleEast, Africa and beyond including three Ministers of Health and 29 speakers, to drive forward the dialogue oninvesting in strengthening health systems. PHSSR also hosted local events in Taiwan, Portugal and theNetherlands during the quarter. In addition, insights from the PHSSR Asia-Pacific report were shared with adelegation from Korea at WHA
‒ A survey of more than 600 employees in 16 countries where the Young Health Programme (YHP) is activeshowed that more than 95% of employees feel proud to be associated with the YHP. With its expansion into thePhilippines, the programme is now active in 41 countries globally. In recognition of the impact of the YHP,AstraZeneca was the only corporate partner invited to speak at UNICEF's Annual Meeting attended byUNICEF's 33 CEOs and their Board Chairs in high-income countries
‒ In June, the Company expanded its partnership with Direct Relief, approving the humanitarian organisation asa global medicine donation partner, enabling medicine donation to support global humanitarian relief efforts
Environmental protection
‒ AstraZeneca received multiple recognitions for its sustainability leadership this quarter, including retaining itsEcoVadis Gold Medal ranking for the second consecutive year. This reflects its place in the top three percent ofcompanies evaluated on environment, labour and human rights, ethics and sustainable procurement. TheCompany was also recognised in the 2024 FT Europe Climate Leaders list, where it was the toppharmaceutical company for the second year in a row
‒ AstraZeneca is collaborating with the World Business Council for Sustainable Development and its peers todevelop a Roadmap to Nature Positive for the pharmaceutical sector, announced in May. The Roadmap willoffer sector-specific guidance to accelerate toward nature positive, in alignment with the Taskforce for Nature-related Financial Disclosures, Science-based Targets Network and the EU's Corporate Sustainability ReportingDirective
‒ Pam Cheng, Executive Vice President of Global Operations and IT and Chief Sustainability Officer, joined aGlobal Health Leaders panel at the inaugural Climate and Health Day of the US Climate Action Summit.Leaders from government, industry, philanthropy and finance discussed the critical need to drive coordinatedaction on the climate and health nexus
Ethics and transparency
‒ AstraZeneca shared a new Diversity in Clinical Trials Standard internally for use across all therapy areas inR&D. This outlines the Company's mandatory principles on diversity for all AstraZeneca-sponsored clinicaltrials, in line with regulatory requirements, and reflects the Company's unwavering commitment to ensuring itsclinical trials are representative of diverse populations
‒ Approximately 6,500 colleagues across 10 regions and 16 business units took the time to respond toAstraZeneca's second employee Ethics Survey. An analysis of 2023 results showed employee feedbackcontinues to be positive, with 97% of respondents confirming they know how to raise an ethical concern and87% confirming that it is easy to do the right thing in their day-to-day work
‒ The Company released new guidance on the selection, design, installation and maintenance of solarPhotovoltaic (PV) power systems, which highlights the importance of conducting due diligence on human rightsrisks associated with new solar PV projects
Research and development
This section covers R&D events and milestones that have occurred since the prior results announcement on25 April 2024, up to and including events on 24 July 2024.
A comprehensive view of AstraZeneca's pipeline of medicines in human trials can be found in the latest ClinicalTrials Appendix, available on www.astrazeneca.com/investor-relations. The Clinical Trials Appendix includes tableswith details of the ongoing clinical trials for AstraZeneca medicines and new molecular entities in the pipeline.
Oncology
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AstraZeneca presented new data across its diverse portfolio of cancer medicines at two major medical congressessince the prior results announcement: the American Society of Clinical Oncology (ASCO) in May and June 2024and European Hematology Association (EHA) in June 2024. At ASCO, AstraZeneca presented more than 100abstracts featuring 25 approved and potential new medicines across the Company's diverse oncology portfolio andpipeline, including two late-breaking plenary presentations, a special late-breaking abstract session presentationand 15 oral presentations. At EHA, AstraZeneca presented 17 abstracts including one oral presentation and 10posters across one approved and four investigational products.
Tagrisso
Event Commentary
Presentation:ASCO LAURA Primary analysis of the Phase III LAURA trial, presented at ASCO, showedTagrisso reduced the risk of disease progression or death by 84% comparedto placebo (HR 0.16, 95% CI 0.10-0.24, p<0.001) as assessed by BICR.Median PFS was 39.1 months in patients treated with Tagrisso versus 5.6months for placebo.
sNDAacceptanceand PriorityReview
US For the treatment of adult patients with unresectable, Stage III EGFRmNSCLC after chemoradiotherapy. (LAURA, June 2024)
Approvals Japan, China Tagrisso with the addition of pemetrexed and platinum-based chemotherapyfor the 1st-line treatment of adult patients with locally advanced or metastaticEGFRm NSCLC whose tumours have exon 19 deletions or exon 21 (L858R)mutations. (FLAURA2, June 2024)Approval Europe Tagrisso with the addition of pemetrexed and platinum-based chemotherapyfor the 1st-line treatment of adult patients with advanced EGFRm NSCLCwhose tumours have exon 19 deletions or exon 21 (L858R) mutations.(FLAURA2, July 2024)
Imfinzi and Imjudo
Event Commentary
Presentation:ASCO ADRIATIC Planned interim analysis of the Phase III ADRIATIC trial, presented at ASCO,demonstrated Imfinzi reduced the risk of death by 27% versus placebo (OSHR 0.73, 95% CI 0.57-0.93, p=0.0104) with an estimated 57% of patientstreated with Imfinzi alive at three years compared to 48% on placebo. (June2024)
Approval US Imfinzi in combination with carboplatin and paclitaxel followed by Imfinzimonotherapy for treatment for adult patients with primary advanced orrecurrent endometrial cancer that is mismatch repair deficient. (DUO-E, June2024)
Phase III datareadout NIAGARA Met primary endpoint, with Imfinzi in combination with chemotherapydemonstrating a statistically significant and clinically meaningful improvementin the primary endpoint of event-free survival and the key secondary endpointof OS versus neoadjuvant chemotherapy for patients with muscle-invasivebladder cancer. (June 2024)
Trial update BR.31 BR.31 Phase III trial for Imfinzi in early-stage (IB-IIIA) NSCLC after completetumour resection in patients whose tumours express PD-L1 on 25% or moretumour cells did not achieve statistical significance for the primary endpoint ofdisease-free survival versus placebo. (June 2024)
CHMP positiveopinion Europe Imfinzi plus chemotherapy as 1st-line treatment followed by Lynparza andImfinzi for patients with mismatch repair proficient disease. Imfinzi pluschemotherapy followed by Imfinzi alone for patients with mismatch repairdeficient disease. (DUO ‑ E, July 2024)
Lynparza
Event Commentary
CHMP positiveopinion Europe Imfinzi plus chemotherapy as 1st-line treatment followed by Lynparza andImfinzi for patients with mismatch repair proficient disease. (DUO-E, July2024)
Enhertu
Event Commentary
Phase IIIreadout andpresentation:ASCO
DESTINY-Breast06 Met primary endpoint, demonstrating Enhertu resulted in a statisticallysignificant and clinically meaningful improvement in PFS in HR-positive,HER2-low metastatic breast cancer following one or more lines of endocrinetherapy. (April 2024)
Primary analysis of the Phase III DESTINY-Breast06 trial, presented atASCO, demonstrated Enhertu resulted in a statistically significant andclinically meaningful improvement in PFS compared to standard-of-carechemotherapy in patients with HR-positive, HER2-low metastatic breast
===== SIDA 20 =====
cancer (HR 0.62, 95% CI 0.51-0.74, p<0.0001). Enhertu also demonstrated astatistically significant and clinically meaningful improvement in the overall trialpopulation (patients with HR-positive, HER2-low and HER2-ultralow disease)(HR 0.63, 95% CI 0.53-0.75, p<0.0001). (June 2024)
Calquence
Event Commentary
Phase IIIreadout andpresentation:EHA
ECHO Met primary endpoint with Calquence combination regimen demonstrating astatistically significant and clinically meaningful improvement in PFS in 1st-line mantle cell lymphoma. (May 2024)
Interim analysis of the Phase III ECHO trial, presented at EHA, demonstratedCalquence in combination with standard-of-care chemoimmunotherapy,bendamustine and rituximab, resulted in a statistically significant and clinicallymeaningful 27% reduction in risk of progression or death versus standard ofcare in previously untreated adult patients with mantle cell lymphoma (HR0.73, 95% CI 0.57-0.94, p=0.016). The secondary endpoint of OS showed afavourable trend for the Calquence combination compared tochemoimmunotherapy (HR 0.86; 95% CI 0.65-1.13; p=0.2743, not statisticallysignificant, follow-up continues). (June 2024)
Truqap
Event Commentary
Phase III trialupdate CAPItello-290 CAPItello-290 Phase III trial for Truqap in combination with paclitaxel inpatients with locally advanced or metastatic TNBC did not meet the dualprimary endpoints of improvement in OS vs paclitaxel in combination withplacebo in either the overall trial population or in a subgroup of patients withtumours harbouring specific biomarker alterations (PIK3CA, AKT1 or PTEN).(June 2024)
Approval Europe In combination with Faslodex for the treatment of adult patients with estrogenreceptor-positive, HER2-negative locally advanced or metastatic breastcancer with one or more PIK3CA, AKT1, or PTEN-alterations followingrecurrence or progression on or after an endocrine-based regimen.(CAPItello-291, June 2024)
Datopotamab deruxtecan (Dato-DXd)
Event Commentary
Phase IIII trialupdate TROPION-Lung01
Dual primary endpoint of improvement in overall survival for Dato-DXd versusdocetaxel not met. Numerical improvement in overall survival compared todocetaxel in the overall trial population of patients with locally advanced ormetastatic NSCLC. In the prespecified subgroup of patients with non-squamous NSCLC, Dato-DXd showed a clinically meaningful improvement inOS compared to docetaxel. (May 2024)
BioPharmaceuticals - CVRM
Farxiga
Event Commentary
Approval US Improvement of glycaemic control in paediatric patients with type-2 diabetesaged 10 years and older (T2NOW, June 2024)
AZD0780 (oral PCSK9)
Event Commentary
Presentation:EuropeanAtherosclerosisSociety
Positive Phase I data demonstrating a statistically significant reduction of 52%in LDL-C levels on top of rosuvastatin treatment, with 78% total reductionfrom baseline, in treatment-naive participants with hypercholesterolaemia.(May 2024)
BioPharmaceuticals - R&I
Tezspire
Event Commentary
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Presentation:AmericanThoracicSociety
COURSE Results from the COURSE Phase II trial demonstrated that treatment withTezspire led to a 17% numerical reduction in the annual rate of moderate orsevere COPD exacerbations compared to placebo at week 52. In patientswith blood eosinophil counts of 150 cell/µl or more, treatment with Tezspireled to a nominally significant reduction of 37% in the rate of moderate orsevere exacerbations compared to placebo. (May 2024)
Phase IIIreadout DIRECTION Met the primary endpoint, demonstrating a statistically significant reduction inannual asthma exacerbation rate (AAER) over 52 weeks compared toplacebo in patients in China with a history of uncontrolled asthma. (July 2024)
BioPharmaceuticals - V&I
sipavibart (COVID-19 mAb)
Event Commentary
Phase IIIreadout SUPERNOVA Positive high-level results from the SUPERNOVA Phase III trial showedsipavibart demonstrated a statistically significant reduction in the incidence ofsymptomatic COVID-19 in an immunocompromised patient population. Thetrial was conducted during an evolving variant landscape in which COVID-19cases captured over the course of the trial were caused by several differentSARS-CoV-2 variants. (May 2024)
Rare Disease
AstraZeneca presented new clinical data from the industry's largest and broadest amyloidosis pipeline at theInternational Symposium on Amyloidosis (ISA) in May 2024. Clinical data was presented on ALXN2220 andanselamimab, which are being evaluated in Phase III clinical trials for ATTR and light chain (AL) amyloidosis,respectively.
Interim financial statements
Table 18: Condensed consolidated statement of comprehensive income: H1 2024
For the half year ended 30 June 2024 2023 $m $m
Total Revenue 25,617 22,295 Product Sales 24,629 21,448 Alliance Revenue 939 627 Collaboration Revenue 49 220
Cost of sales (4,401) (3,865)
Gross profit 21,216 18,430
Distribution expense (267) (265)Research and development expense (5,791) (5,278)Selling, general and administrative expense (9,424) (9,045)Other operating income and expense 127 1,163
Operating profit 5,861 5,005
Finance income 211 141 Finance expense (856) (795)Share of after tax losses in associates and joint ventures (19) (1)
Profit before tax 5,197 4,350
Taxation (1,089) (726)
Profit for the period 4,108 3,624
Other comprehensive income:
Items that will not be reclassified to profit or loss:
Remeasurement of the defined benefit pension liability 101 7 Net gains/(losses) on equity investments measured at fair value through othercomprehensive income 89 (48)
Fair value movements related to own credit risk on bonds designated as fair valuethrough profit or loss 12 4
Tax on items that will not be reclassified to profit or loss (27) (5)
175 (42)
Items that may be reclassified subsequently to profit or loss:Foreign exchange arising on consolidation (554) 105 Foreign exchange arising on designated liabilities in net investment hedges (96) (101)Fair value movements on cash flow hedges (138) 89 Fair value movements on cash flow hedges transferred to profit and loss 102 (71)Fair value movements on derivatives designated in net investment hedges 45 40 Gains/(costs) of hedging 14 (1)Tax on items that may be reclassified subsequently to profit or loss 38 12
(589) 73
Other comprehensive (expense)/income, net of tax (414) 31
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Total comprehensive income for the period 3,694 3,655
Profit attributable to:Owners of the Parent 4,106 3,621 Non-controlling interests 2 3
4,108 3,624
Total comprehensive income attributable to:
Owners of the Parent 3,692 3,652 Non-controlling interests 2 3 3,694 3,655
Basic earnings per $0.25 Ordinary Share $2.65 $2.34 Diluted earnings per $0.25 Ordinary Share $2.63 $2.32 Weighted average number of Ordinary Shares in issue (millions) 1,549 1,549
Diluted weighted average number of Ordinary Shares in issue (millions) 1,560 1,560
Table 19: Condensed consolidated statement of comprehensive income: Q2 2024
For the quarter ended 30 June Unreviewed[13] Unreviewed
2024 2023 $m $m
Total Revenue 12,938 11,416 Product Sales 12,452 10,882 Alliance Revenue 482 341 Collaboration Revenue 4 193
Cost of sales (2,183) (1,960)
Gross profit 10,755 9,456
Distribution expense (132) (131)Research and development expense (3,008) (2,667)Selling, general and administrative expense (4,929) (4,986)Other operating income and expense 60 784
Operating profit 2,746 2,456
Finance income 100 64 Finance expense (443) (431)Share of after tax losses in associates and joint ventures (6) (1)Profit before tax 2,397 2,088
Taxation (469) (268)
Profit for the period 1,928 1,820
Other comprehensive income:
Items that will not be reclassified to profit or loss:
Remeasurement of the defined benefit pension liability (43) 17 Net gains/(losses) on equity investments measured at fair value through othercomprehensive income 54 (94)
Fair value movements related to own credit risk on bonds designated as fairvalue through profit or loss 12 2
Tax on items that will not be reclassified to profit or loss 12 (29)
35 (104)
Items that may be reclassified subsequently to profit or loss:Foreign exchange arising on consolidation (39) (209)Foreign exchange arising on designated liabilities in net investment hedges 2 (94)Fair value movements on cash flow hedges (52) 33 Fair value movements on cash flow hedges transferred to profit and loss 32 4 Fair value movements on derivatives designated in net investment hedges 23 24 Costs of hedging (1) (1)Tax on items that may be reclassified subsequently to profit or loss 3 -
(32) (243)
Other comprehensive income/(expense), net of tax 3 (347)
Total comprehensive income for the period 1,931 1,473
Profit attributable to:
Owners of the Parent 1,927 1,818 Non-controlling interests 1 2
1,928 1,820
Total comprehensive income attributable to:
Owners of the Parent 1,930 1,471 Non-controlling interests 1 2
1,931 1,473
Basic earnings per $0.25 Ordinary Share $1.24 $1.17 Diluted earnings per $0.25 Ordinary Share $1.24 $1.17 Weighted average number of Ordinary Shares in issue (millions) 1,550 1,550
Diluted weighted average number of Ordinary Shares in issue (millions) 1,560 1,560
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Table 20: Condensed consolidated statement of financial position
Reviewed[14]
At 30 Jun2024
AuditedAt 31 Dec2023
ReviewedAt 30 Jun2023
$m $m $m AssetsNon-current assetsProperty, plant and equipment 9,630 9,402 8,675Right-of-use assets 1,203 1,100 949Goodwill 21,060 20,048 19,960Intangible assets 39,426 38,089 38,326Investments in associates and joint ventures 264 147 72Other investments 1,607 1,530 1,071Derivative financial instruments 217 228 163Other receivables 806 803 752Deferred tax assets 4,734 4,718 3,736
78,947 76,065 73,704
Current assetsInventories 5,667 5,424 5,051Trade and other receivables 11,047 12,126 11,092Other investments 160 122 148Derivative financial instruments 28 116 44Income tax receivable 1,575 1,426 840Cash and cash equivalents 6,916 5,840 5,664 25,393 25,054 22,839
Total assets 104,340 101,119 96,543Liabilities Current liabilitiesInterest-bearing loans and borrowings (5,067) (5,129) (4,556)Lease liabilities (292) (271) (231)Trade and other payables (20,463) (22,374) (19,738)Derivative financial instruments (51) (156) (83)Provisions (1,168) (1,028) (567)Income tax payable (1,525) (1,584) (1,200) (28,566) (30,542) (26,375)
Non-current liabilitiesInterest-bearing loans and borrowings (27,225) (22,365) (24,329)Lease liabilities (949) (857) (722)Derivative financial instruments (61) (38) (68)Deferred tax liabilities (3,333) (2,844) (2,800)Retirement benefit obligations (1,326) (1,520) (1,078)Provisions (1,074) (1,127) (1,357)Other payables (2,208) (2,660) (2,398)
(36,176) (31,411) (32,752)
Total liabilities (64,742) (61,953) (59,127)
Net assets 39,598 39,166 37,416
EquityCapital and reserves attributable to equity holders of the ParentShare capital 388 388 387Share premium account 35,199 35,188 35,163Other reserves 2,078 2,065 2,076Retained earnings 1,847 1,502 (234) 39,512 39,143 37,392 Non-controlling interests 86 23 24 Total equity 39,598 39,166 37,416
Table 21: Condensed consolidated statement of changes in equity
Sharecapital
Sharepremiumaccount
Otherreserves Retainedearnings
Totalattributableto owners ofthe parent
Non-controllinginterests
Totalequity
$m $m $m $m $m $m $m
At 1 Jan 2023 387 35,155 2,069 (574) 37,037 21 37,058
Profit for the period - - - 3,621 3,621 3 3,624 Other comprehensive income - - - 31 31 - 31
Transfer to other reserves - - 7 (7) - - -
Transactions with ownersDividends - - - (3,047) (3,047) - (3,047)
Issue of Ordinary Shares - 8 - - 8 - 8
===== SIDA 24 =====
Share-based payments chargefor the period - - - 274 274 - 274
Settlement of share planawards - - - (532) (532) - (532)
Net movement - 8 7 340 355 3 358
At 30 Jun 2023 387 35,163 2,076 (234) 37,392 24 37,416
At 1 Jan 2024 388 35,188 2,065 1,502 39,143 23 39,166
Profit for the period - - - 4,106 4,106 2 4,108
Other comprehensive expense - - - (414) (414) - (414)
Transfer to other reserves - - 13 (13) - - -
Transactions with ownersDividends - - - (3,052) (3,052) - (3,052)
Issue of Ordinary Shares - 11 - - 11 - 11
Changes in non-controllinginterests - - - - - 61 61
Share-based payments chargefor the period - - - 307 307 - 307
Settlement of share plan awards - - - (589) (589) - (589)
Net movement - 11 13 345 369 63 432
At 30 Jun 2024 388 35,199 2,078 1,847 39,512 86 39,598
Table 22: Condensed consolidated statement of cash flows: H1 2024
For the half year ended 30 June 2024 2023 $m $m
Cash flows from operating activitiesProfit before tax 5,197 4,350 Finance income and expense 645 654 Share of after tax losses of associates and joint ventures 19 1 Depreciation, amortisation and impairment 2,534 2,778 Movement in working capital and short-term provisions (584) (747)Gains on disposal of intangible assets (21) (249)Fair value movements on contingent consideration arising from businesscombinations 251 202
Non-cash and other movements (550) (594)Cash generated from operations 7,491 6,395
Interest paid (583) (483)Tax paid (1,337) (1,061)
Net cash inflow from operating activities 5,571 4,851
Cash flows from investing activities Acquisition of subsidiaries, net of cash acquired (2,771) (189)Payments upon vesting of employee share awards attributable to businesscombinations - (23)
Payment of contingent consideration from business combinations (474) (398)Purchase of property, plant and equipment (799) (517)Disposal of property, plant and equipment 53 126 Purchase of intangible assets (1,474) (1,436)Disposal of intangible assets 75 288 Movement in profit-participation liability - 175 Purchase of non-current asset investments (67) (26)Disposal of non-current asset investments 51 10 Movement in short-term investments, fixed deposits and other investinginstruments 42 90
Payments to associates and joint ventures (140) - Disposal of investments in associates and joint ventures 13 - Interest received 206 134
Net cash outflow from investing activities (5,285) (1,766)Net cash inflow before financing activities 286 3,085
Cash flows from financing activitiesProceeds from issue of share capital 11 8 Issue of loans and borrowings 4,976 3,816 Repayment of loans and borrowings (2,643) (3,408)Dividends paid (3,050) (3,069)Hedge contracts relating to dividend payments (8) 27 Repayment of obligations under leases (150) (129)Movement in short-term borrowings 2,503 72 Payment of Acerta Pharma share purchase liability (833) (867)Net cash inflow/(outflow) from financing activities 806 (3,550)
Net increase/(decrease) in Cash and cash equivalents in the period 1,092 (465)Cash and cash equivalents at the beginning of the period 5,637 5,983
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Exchange rate effects (52) (47)
Cash and cash equivalents at the end of the period 6,677 5,471
Cash and cash equivalents consist of:Cash and cash equivalents 6,916 5,664 Overdrafts (239) (193)
6,677 5,471
Responsibility statement of the directors in respect of the half-yearly financial report
We confirm that to the best of our knowledge:
‒ the condensed consolidated Interim Financial Statements have been prepared in accordance with IAS 34'Interim Financial Reporting' as issued by the International Accounting Standards Board (IASB), IAS 34 asadopted by the European Union and UK-adopted IAS 34;
‒ the half-yearly management report gives a true and fair view of the assets, liabilities, financial position andprofit or loss of the company;
‒ the half-yearly management report includes a fair review of the information required by:
a) DTR 4.2.7R of the Disclosure and Transparency Rules, being an indication of important events that haveoccurred during the first six months of the financial year and their impact on the condensed consolidatedInterim Financial Statements; and a description of the principal risks and uncertainties for the remaining sixmonths of the year; and
b) DTR 4.2.8R of the Disclosure and Transparency Rules, being related party transactions that have takenplace in the first six months of the current financial year and that have materially affected the financialposition or performance of the enterprise during that period; and any changes in the related partytransactions described in the last annual report that could do so.
The Board
The Board of Directors that served during all or part of the six month period to 30 June 2024 and their respectiveresponsibilities can be found on the Leadership team section of astrazeneca.com. Approved by the Board and signed on its behalf by
Pascal SoriotChief Executive Officer
25 July 2024
Independent review report to AstraZeneca PLC
Report on the Interim financial statements
Our conclusion
We have reviewed AstraZeneca PLC's Interim financial statements (the "Interim financial statements") in the half-yearly financial report of AstraZeneca PLC for the six month period ended 30 June 2024 (the "period").
Based on our review, nothing has come to our attention that causes us to believe that the Interim financialstatements are not prepared, in all material respects, in accordance with International Accounting Standard 34,'Interim Financial Reporting' (IAS 34), as issued by the International Accounting Standards Board (IASB), IAS 34as adopted by the European Union, UK-adopted IAS 34, and the Disclosure Guidance and Transparency Rulessourcebook of the United Kingdom's Financial Conduct Authority.
The Interim financial statements comprise:
‒ the Condensed consolidated statement of financial position as at 30 June 2024;‒ the Condensed consolidated statement of comprehensive income: H1 2024 for the period then ended;‒ the Condensed consolidated statement of changes in equity for the period then ended; ‒ the Condensed consolidated statement of cash flows: H1 2024 for the period then ended; and‒ the explanatory notes to the Interim financial statements.
The Interim financial statements included in the half-yearly financial report of AstraZeneca PLC have beenprepared in accordance with International Accounting Standard 34, 'Interim Financial Reporting' (IAS 34), asissued 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'sFinancial Conduct Authority.
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Basis for conclusion
We conducted our review in accordance with International Standard on Review Engagements (UK) 2410, 'Reviewof Interim Financial Information Performed by the Independent Auditor of the Entity' issued by the FinancialReporting Council for use in the United Kingdom ("ISRE (UK) 2410"). A review of interim financial informationconsists of making enquiries, primarily of persons responsible for financial and accounting matters, and applyinganalytical and other review procedures.
A review is substantially less in scope than an audit conducted in accordance with International Standards onAuditing (UK) and, consequently, does not enable us to obtain assurance that we would become aware of allsignificant matters that might be identified in an audit. Accordingly, we do not express an audit opinion.
We have read the other information contained in the half-yearly financial report and considered whether it containsany apparent misstatements or material inconsistencies with the information in the Interim financial statements.
Conclusions relating to going concern
Based on our review procedures, which are less extensive than those performed in an audit as described in theBasis for conclusion section of this report, nothing has come to our attention to suggest that the directors haveinappropriately adopted the going concern basis of accounting or that the directors have identified materialuncertainties relating to going concern that are not appropriately disclosed. This conclusion is based on the reviewprocedures performed in accordance with ISRE (UK) 2410. However, future events or conditions may cause thegroup to cease to continue as a going concern.
Independent review report to AstraZeneca PLC (continued)
Responsibilities for the Interim financial statements and the review
Our responsibilities and those of the directors
The half-yearly financial report, including the Interim financial statements, is the responsibility of, and has beenapproved by the directors. The directors are responsible for preparing the half-yearly financial report in accordancewith the Disclosure Guidance and Transparency Rules sourcebook of the United Kingdom's Financial ConductAuthority. In preparing the half-yearly financial report, including the Interim financial statements, the directors areresponsible for assessing the group's ability to continue as a going concern, disclosing, as applicable, mattersrelated to going concern and using the going concern basis of accounting unless the directors either intend toliquidate the group or to cease operations, or have no realistic alternative but to do so.
Our responsibility is to express a conclusion on the Interim financial statements in the half-yearly financial reportbased on our review. Our conclusion, including our Conclusions relating to going concern, is based on proceduresthat are less extensive than audit procedures, as described in the Basis for conclusion paragraph of this report.This report, including the conclusion, has been prepared for and only for the company for the purpose ofcomplying with the Disclosure Guidance and Transparency Rules sourcebook of the United Kingdom's FinancialConduct Authority and for no other purpose. We do not, in giving this conclusion, accept or assume responsibilityfor any other purpose or to any other person to whom this report is shown or into whose hands it may come savewhere expressly agreed by our prior consent in writing. PricewaterhouseCoopers LLPChartered AccountantsLondon
25 July 2024
Notes to the Interim financial statements
Note 1: Basis of preparation and accounting policies
These unaudited condensed consolidated Interim financial statements for the six months ended 30 June 2024have been prepared in accordance with International Accounting Standard 34, 'Interim Financial Reporting' (IAS34), as issued by the International Accounting Standards Board (IASB), IAS 34 as adopted by the EuropeanUnion, UK-adopted IAS 34 and the Disclosure Guidance and Transparency Rules sourcebook of the UnitedKingdom's Financial Conduct Authority and with the requirements of the Companies Act 2006 as applicable tocompanies reporting under those standards.
The unaudited Interim financial statements for the six months ended 30 June 2024 were approved by the Board ofDirectors for publication on 25 July 2024.
This results announcement does not constitute statutory accounts of the Group within the meaning of sections434(3) and 435(3) of the Companies Act 2006. The annual financial statements of the Group for the year ended 31December 2023 were prepared in accordance with UK-adopted international accounting standards and with therequirements of the Companies Act 2006. The annual financial statements also comply fully with IFRS AccountingStandards as issued by the IASB and International Accounting Standards as adopted by the European Union.
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Except for the estimation of the interim income tax charge, the Interim financial statements have been preparedapplying the accounting policies that were applied in the preparation of the Group's published consolidatedfinancial statements for the year ended 31 December 2023.
The comparative figures for the financial year ended 31 December 2023 are not the Group's statutory accounts forthat financial year. Those accounts have been reported on by the Group's auditors and have been delivered to theRegistrar of Companies; their report was (i) unqualified, (ii) did not include a reference to any matters to which theauditors drew attention by way of emphasis without qualifying their report, and (iii) did not contain a statementunder section 498(2) or (3) of the Companies Act 2006.
Going concern
The Group has considerable financial resources available. As at 30 June 2024, the Group has $11.8bn in financialresources (cash and cash equivalent balances of $6.9bn and undrawn committed bank facilities of $4.9bn, with$5.4bn of borrowings due within one year). These facilities contain no financial covenants and were undrawn at 30June 2024. The $4.9bn facilities are available until April 2029. Additionally, there are a further $2.0bn undrawncommitted bank facilities available until February 2025.
The Group's revenues are largely derived from sales of medicines covered by patents, which provide a relativelyhigh level of resilience and predictability to cash inflows, although government price interventions in response tobudgetary 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 indevelopment, 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 riskssuccessfully. Accordingly, they continue to adopt the going concern basis in preparing the Interim financialstatements.
Legal proceedings
The information contained in Note 6 updates the disclosures concerning legal proceedings and contingentliabilities in the Group's Annual Report and Form 20-F Information 2023. Employee Benefit TrustFollowing an amendment to the Employee Benefit Trust (EBT) Deed on 10th June 2024, AstraZeneca obtainedcontrol and commenced consolidation of the EBT. Going forward, cash paid on purchases of AstraZenecaOrdinary shares or American Depository Receipts will be presented within Financing activities in the Cash flowstatement.
Note 2: Intangible assets
In accordance with IAS 36 'Impairment of Assets', reviews for triggers of impairment or impairment reversals at anindividual asset or cash generating unit level were conducted, and impairment tests carried out where triggerswere identified. As a result, total impairment charge of $26m has been recorded against intangible assets duringthe six months ended 30 June 2024 (H1 2023: $320m net charge). In H1 2023, net impairment charges includedthe $244m impairment of the ALXN1840 intangible asset, following the decision to discontinue this developmentprogramme in Wilson's disease.
The acquisition of Icosavax, Inc. completed on 19 February 2024. The transaction is recorded as an assetacquisition based on the concentration test permitted under IFRS 3 'Business Combinations', with consideration of$841m principally relating to $639m of intangible assets, $141m of cash and cash equivalents and $51m ofmarketable securities. Contingent consideration of up to $300m could be paid on achievement of regulatory andsales milestones; these potential liabilities would be recorded when the relevant recognition event for a regulatoryor sales milestone is achieved.
Note 3: Net debt
The table below provides an analysis of Net debt and a reconciliation of Net Cash flow to the movement in Netdebt. The Group monitors Net debt as part of its capital management policy as described in Note 28 of the AnnualReport and Form 20-F Information 2023. Net debt is a non-GAAP financial measure.
Table 23: Net debt
At 1 Jan2024 CashflowAcquisitions Non-cash& other Exchangemovements At 30 Jun2024 $m $m $m $m $m $m
Non-current instalments of loans (22,365) (4,973) (3) (2) 118 (27,225)Non-current instalments of leases (857) - (12) (97) 17 (949)
Total long-term debt (23,222) (4,973) (15) (99) 135 (28,174)Current instalments of loans (4,614) 2,583 (9) (5) 27 (2,018)Current instalments of leases (271) 174 (6) (197) 8 (292)Commercial paper - (2,453) - - - (2,453)Collateral received from derivativecounterparties (215) 13 - - - (202)Other short-term borrowings excludingoverdrafts (97) (63) - - 5 (155)
Overdrafts (203) (35) - - (1) (239)Total current debt (5,400) 219 (15) (202) 39 (5,359)
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At 1 Jan2024 CashflowAcquisitions Non-cash& other Exchangemovements At 30 Jun2024 $m $m $m $m $m $m
Gross borrowings (28,622) (4,754) (30) (301) 174 (33,533)Net derivative financial instruments 150 65 - (82) - 133 Net borrowings (28,472) (4,689) (30) (383) 174 (33,400)Cash and cash equivalents 5,840 885 242 - (51) 6,916 Other investments - current 122 (42) 87 - (7) 160
Cash and investments 5,962 843 329 - (58) 7,076
Net debt (22,510) (3,846) 299 (383) 116 (26,324) Net debt increased by $3,814m in the half year to $26,324m. Details of the committed undrawn bank facilities aredisclosed within the going concern section of Note 1. Non-cash movements in the period include fair valueadjustments under IFRS 9 'Financial Instruments'.
In February 2024, AstraZeneca issued the following:
- $1,250m of fixed-rate notes with a coupon of 4.8% maturing in February 2027- $1,250m of fixed-rate notes with a coupon of 4.85% maturing in February 2029- $1,000m of fixed-rate notes with a coupon of 4.9% maturing in February 2031- $1,500m of fixed-rate notes with a coupon of 5% maturing in February 2034AstraZeneca repaid two bonds of carrying value $2,569m in Q2 2024 included in the cash outflow fromRepayment of loans and borrowings of $2,643m. AstraZeneca also issued Commercial paper during the half yearand the balance as at 30 June 2024 is $2,453m (H1 2023: $nil).
The Group has agreements with some bank counterparties whereby the parties agree to post cash collateral onfinancial derivatives, for the benefit of the other, equivalent to the market valuation of the derivative positionsabove a predetermined threshold. The carrying value of such cash collateral held by the Group at 30 June 2024was $202m (31 December 2023: $215m) and the carrying value of such cash collateral posted by the Group at 30June 2024 was $97m (31 December 2023: $102m).
The equivalent GAAP measure to Net debt is 'liabilities arising from financing activities', which excludes theamounts for cash and overdrafts, other investments and non-financing derivatives shown above and includes theAcerta Pharma share purchase liability of $nil (31 December 2023: $833m).
During the six months ended 30 June 2024, there have been no changes to the Company's solicited long termcredit ratings. Moody's credit ratings were long term: A2; short term: P-1. Standard and Poor's credit ratings werelong 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 ofderivative financial instruments, other investments, trade and other receivables, cash and cash equivalents, tradeand 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 heldat $337m (31 December 2023: $313m) and for which a fair value gain of $1m has been recognised in the sixmonths ended 30 June 2024 (H1 2023: $1m). In the absence of specific market data, these unlisted investmentsare held at fair value based on the cost of investment and adjusted as necessary for impairments and revaluationson new funding rounds, which are seen to approximate the fair value. All other fair value gains and/or losses thatare presented in Net gains/(losses) on equity investments measured at fair value through other comprehensiveincome, in the Condensed consolidated statement of comprehensive income for the six months ended 30 June2024, are Level 1 fair value measurements, valued based on quoted prices in active markets.
Financial instruments measured at fair value include $1,670m of other investments, $5,463m held in money-market funds and $133m of derivatives as at 30 June 2024. With the exception of derivatives being Level 2 fairvalued, and certain equity instruments of $350m categorised as Level 3, the aforementioned balances are Level 1fair valued. Financial instruments measured at amortised cost include $97m of cash collateral pledged tocounterparties. The total fair value of interest-bearing loans and borrowings at 30 June 2024, which have acarrying value of $33,533m in the Condensed consolidated statement of financial position, was $32,231m.
Table 24: Financial instruments - contingent consideration
2024 2023
Diabetesalliance Other Total Total
$m $m $m $m
At 1 January 1,945 192 2,137 2,222
Additions through business combinations - 198 198 60 Settlements (473) (1) (474) (398)Revaluations 220 31 251 202 Discount unwind 50 7 57 66
At 30 June 1,742 427 2,169 2,152
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Contingent consideration arising from business combinations is fair valued using decision-tree analysis, with keyinputs including the probability of success, consideration of potential delays and the expected levels of futurerevenues.
The contingent consideration balance relating to BMS's share of the global diabetes alliance of $1,742m(31 December 2023: $1,945m) would increase/decrease by $174m with an increase/decrease in sales of 10%, ascompared with the current estimates.
Note 5: Business combinations
Gracell
On 22 February 2024, AstraZeneca completed the acquisition of Gracell Biotechnologies Inc. (Gracell), a globalclinical-stage biopharmaceutical company developing innovative cell therapies for the treatment of cancer andautoimmune diseases. Gracell will operate as a wholly owned subsidiary of AstraZeneca, with operations in Chinaand the US.
The acquisition enriches AstraZeneca's growing pipeline of cell therapies with AZD0120 (formerly GC012F), anovel, clinical-stage T-cell (CAR-T: therapeutic chimeric antigen receptor) therapy. AZD0120 is a potential newtreatment for multiple myeloma, as well as other haematologic malignancies and autoimmune diseases, includingSystemic Lupus Erythematosus (SLE).
The transaction is recorded as a business combination using the acquisition method of accounting in accordancewith IFRS 3 'Business Combinations'. Consequently, the assets acquired, and liabilities assumed are recorded atfair value. Due to the proximity of the acquisition to the reporting date, the purchase price allocation exercise underIFRS 3 is in process, with the following items disclosed on a provisional basis.
Fair values $mIntangible assets 1,038 Cash and cash equivalents 212 Net deferred tax liability (260)Other immaterial balances (89)
Total net assets acquired 901
Goodwill 136
Consideration 1,037 The total consideration fair value of $1,037m includes cash consideration of $983m and future regulatorymilestone-based consideration of $54m. Intangible assets recognised relate to products in development,principally AZD0120, and were fair valued using the multi-period excess earnings method, which uses severalestimates regarding the amount and timing of future cash flows. The key assumptions in the cash flows are PTRS,peak year sales and revenue erosion profiles.
The net deferred tax liability of $260m principally arises from the deferred tax impact of the uplift in fair value ofintangible assets.
Goodwill of $136m has been recognised, which principally comprises the premium attributable to the coretechnological capabilities and knowledge base of the company. Goodwill is not expected to be deductible for taxpurposes.
Gracell's results have been consolidated into the Group's results from 22 February 2024.
Fusion
On 4 June 2024, AstraZeneca completed the acquisition of Fusion Pharmaceuticals Inc., (Fusion) a clinical-stagebiopharmaceutical company developing next-generation radioconjugates. The acquisition marks a major stepforward in AstraZeneca delivering on its ambition to transform cancer treatment and outcomes for patients byreplacing traditional regimens like chemotherapy and radiotherapy with more targeted treatments. As a result ofthe acquisition, Fusion became a wholly owned subsidiary of AstraZeneca, with operations in Canada and the US.
This acquisition complements AstraZeneca's leading oncology portfolio with the addition of the Fusion pipeline ofradioconjugates, including their most advanced programme, FPI-2265, a potential new treatment for patients withmetastatic castration-resistant prostate cancer (mCRPC), and brings new expertise and pioneering R&D,manufacturing and supply chain capabilities in actinium-based radioconjugates to AstraZeneca.
The transaction is recorded as a business combination using the acquisition method of accounting in accordancewith IFRS 3 'Business Combinations'. Consequently, the assets acquired, and liabilities assumed are recorded atfair value. Due to the proximity of the acquisition to the reporting date, the purchase price allocation exercise underIFRS 3 is in process, with the following items disclosed on a provisional basis.
Fair values $m
===== SIDA 30 =====
Intangible assets 1,326 Cash and cash equivalents 30 Current investments 87 Net deferred tax liability (246)Other immaterial balances 51 Total net assets acquired 1,248 Goodwill 947 Consideration 2,195
The total consideration fair value of $2,195m includes cash consideration of $2,051m and future regulatorymilestone-based consideration of $144m. Intangible assets relating to products in development comprise the FPI-2265 ($848m), FPI-2059 ($165m) and AZD2068 ($313m) programmes. These were fair valued using the multi-period excess earnings method, which uses several estimates regarding the amount and timing of future cashflows. The key assumptions in the cash flows are PTRS, peak year sales and revenue erosion profiles.
The net deferred tax liability of $246m principally arises from the deferred tax impact of the uplift in fair value ofintangible assets.
Goodwill recognised comprises a number of not individually quantifiable elements. These include the premiumattributable to a pre-existing well positioned business in the innovation intensive biopharmaceuticals market with ahighly skilled workforce, unidentified potential products that future research and development may yield, and thecore capabilities and knowledge base of the company including radioisotope supply and manufacturing expertise.Goodwill is not expected to be deductible for tax purposes.
Immediately prior to the acquisition, AstraZeneca held an approximately 1% shareholding in Fusion considered tohave a fair value of $24m.
Fusion's results have been consolidated into the Group's results from 4 June 2024.
Note 6: Legal proceedings and contingent liabilities
AstraZeneca is involved in various legal proceedings considered typical to its business, including litigation andinvestigations, including Government investigations, relating to product liability, commercial disputes, infringementof 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 disclosuresconcerning legal proceedings in the Company's Annual Report and Form 20-F Information 2023 (the Disclosures).Information about the nature and facts of the cases is disclosed in accordance with IAS 37.
As discussed in the Disclosures, the majority of claims involve highly complex issues. Often these issues aresubject to substantial uncertainties and, therefore, the probability of a loss, if any, being sustained and/or anestimate 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 andwhich are not subject to appeal, or where a loss is probable and we are able to make a reasonable estimate of theloss, AstraZeneca records the loss absorbed or makes a provision for its best estimate of the expected loss. Theposition could change over time and the estimates that the Company made, and upon which the Company haverelied in calculating these provisions are inherently imprecise. There can, therefore, be no assurance that anylosses that result from the outcome of any legal proceedings will not exceed the amount of the provisions thathave been booked in the accounts. The major factors causing this uncertainty are described more fully in theDisclosures and herein.
AstraZeneca has full confidence in, and will vigorously defend and enforce, its IP.
Matters disclosed in respect of the second quarter of 2024 and to 25 July 2024
Patent litigation
Legal proceedings brought against AstraZeneca considered to be contingent liabilities
Enhertu
US patent proceedings
In October 2020, Seagen Inc. (Seagen) filed a complaint against Daiichi Sankyo Company, Limited (DaiichiSankyo) in the US District Court for the Eastern District of Texas (District Court) alleging that Enhertu infringes aSeagen patent. AstraZeneca co-commercialises Enhertu with Daiichi Sankyo, Inc. in the US. After trial in April2022, the jury found that the patent was infringed and awarded Seagen $41.82m in past damages. In July 2022,the District Court entered final judgment and declined to enhance damages on the basis of wilfulness. In October2023, the District Court entered an amended final judgment that requires Daiichi Sankyo to pay Seagen a royaltyof 8% on US sales of Enhertu from 1 April 2022 through to 4 November 2024, in addition to the past damagespreviously awarded by the District Court. AstraZeneca and Daiichi Sankyo have appealed the District Court'sdecision.
In December 2020 and January 2021, AstraZeneca and Daiichi Sankyo, Inc. filed post-grant review (PGR)petitions with the US Patent and Trademark Office (USPTO) alleging, among other things, that the Seagen patent
===== SIDA 31 =====
is invalid for lack of written description and enablement. The USPTO initially declined to institute the PGRs, but, inApril 2022, the USPTO granted the rehearing requests and instituted both PGR petitions. Seagen subsequentlydisclaimed all patent claims at issue in one of the PGR proceedings. In July 2022, the USPTO reversed itsinstitution decision and declined to institute the other PGR petition. AstraZeneca and Daiichi Sankyo, Inc.requested reconsideration of the decision not to institute review of the patent. In February 2023, the USPTOreinstituted the PGR proceeding. In February 2024, the USPTO issued a decision that the claims wereunpatentable. Seagen has appealed this decision.
Tagrisso
US patent proceedings
In September 2021, Puma Biotechnology, Inc. (Puma) and Wyeth LLC (Wyeth) filed a patent infringement lawsuitin the US District Court for the District of Delaware (District Court) against AstraZeneca relating to Tagrisso. InMarch 2024, the District Court dismissed Puma. The trial, with Wyeth as the plaintiff, took place in May 2024. Thejury found Wyeth's patents infringed and awarded Wyeth $107.5m in past damages. The jury also found that theinfringement was not wilful. A bench trial on AstraZeneca's indefiniteness and equitable defenses took place inJune 2024. The parties await the court's decision on the bench trial issues and consideration of post-trial motions.
Legal proceedings brought by AstraZeneca considered to be contingent assets
Calquence
US patent proceedings
In February 2022, in response to Paragraph IV notices from multiple ANDA filers, AstraZeneca filed patentinfringement lawsuits in the US District Court for the District of Delaware (District Court). In its complaint,AstraZeneca alleged that a generic version of Calquence capsules, if approved and marketed, would infringepatents that are owned or licensed by AstraZeneca. In 2024, AstraZeneca entered into settlement agreements withall five generic manufacturers, resolving the Calquence capsule ANDA litigation proceedings.
In April 2024, AstraZeneca received a Paragraph IV notice from an ANDA filer relating to patents listed in the FDAOrange Book with reference to Calquence tablets. In May 2024, in response to the Paragraph IV notice,AstraZeneca filed a patent infringement lawsuit against Cipla Limited and Cipla USA, Inc. in the District Court,alleging that a generic version of Calquence tablets, if approved and marketed, would infringe patents that areowned or licensed by AstraZeneca.
Lokelma
US patent proceedings
In August 2022, in response to Paragraph IV notices, AstraZeneca initiated ANDA litigation against multiple genericfilers in the US District Court for the District of Delaware (District Court). AstraZeneca alleged that a genericversion of Lokelma, if approved and marketed, would infringe patents that are owned or licensed by AstraZeneca.
AstraZeneca entered into separate settlement agreements with two generic manufacturers which resulted indismissal of the corresponding litigations. Additional proceedings with the remaining generic manufacturers areongoing in the District Court. Trial is scheduled for March 2025.
Lynparza
US patent proceedings
In December 2022, AstraZeneca received a Paragraph IV notice from Natco Pharma Limited (Natco) relating toLynparza patents. In February 2023, in response to the Paragraph IV notice, AstraZeneca, MSD InternationalBusiness GmbH, and the University of Sheffield initiated ANDA litigation against Natco in the US District Court forthe District of New Jersey (District Court). In the complaint, AstraZeneca alleged that Natco's generic version ofLynparza, if approved and marketed, would infringe AstraZeneca's patents. No trial date has been scheduled.
In December 2023, AstraZeneca received a Paragraph IV notice from Sandoz Inc. (Sandoz) relating to Lynparzapatents. In February 2024, in response to the Paragraph IV notice, AstraZeneca, MSD International BusinessGmbH, and the University of Sheffield initiated ANDA litigation against Sandoz in the District Court. In thecomplaint, AstraZeneca alleged that Sandoz's generic version of Lynparza, if approved and marketed, wouldinfringe AstraZeneca's patents. No trial date has been scheduled.
In May 2024, AstraZeneca filed additional ANDA actions against Natco and Sandoz asserting recently issuedpatents covering Lynparza. These actions have been consolidated with the earlier filed ANDA actions and no trialdate has been scheduled.
In May 2024, AstraZeneca received a Paragraph IV notice from Cipla USA, Inc. and Cipla Limited (collectively,Cipla) relating to Lynparza patents. In June 2024, in response to the Paragraph IV notice, AstraZeneca, MSDInternational Business GmbH, and the University of Sheffield initiated ANDA litigation against Cipla in the DistrictCourt. In the complaint, AstraZeneca alleged that Cipla's generic version of Lynparza, if approved and marketed,would infringe AstraZeneca's patents. No trial date has been scheduled.
Soliris
US patent proceedings
In January 2024, Alexion initiated patent infringement litigation against Samsung Bioepis Co. Ltd. (Samsung) in theUS District Court for the District of Delaware alleging that Samsung's biosimilar eculizumab product will infringe sixSoliris-related patents. No trial date has been scheduled. Five of the six asserted patents are also the subject ofinter partes review (IPR) proceedings before the US Patent and Trademark Office. Alexion filed a motion for apreliminary injunction seeking to enjoin Samsung from launching its biosimilar eculizumab product upon FDA
===== SIDA 32 =====
approval. The court denied Alexion's motion and Alexion has appealed that decision. On 22 July 2024, Samsungannounced FDA approval of Samsung's biosimilar. European patent proceedings
In March 2024, Alexion filed motions for provisional measures against Amgen Pharmaceuticals Inc (Amgen) andSamsung Bioepis Co. Ltd. (Samsung) and their respective affiliates at the Hamburg Local Division of the UnifiedPatent Court on the basis that Amgen's and Samsung's biosimilar eculizumab products infringe an Alexion patent.In June 2024 the UPC denied the requested provisional measures. Alexion has appealed this decision. In parallel,Samsung has filed opposition to the patent at the European Patent Office. UK patent proceedings
In May 2024, Alexion initiated patent infringement proceedings against Amgen Ltd and Samsung Bioepis UK Ltd(Samsung UK) in the UK High Court of Justice alleging that their respective biosimilar eculizumab productsinfringe an Alexion patent; on the same day, Samsung UK initiated a revocation action for the same patent. Trialhas been scheduled for March 2025.
Tagrisso
Russia patent proceedings
In Russia, in August 2023, AstraZeneca filed lawsuits in the Arbitration Court of the Moscow Region (Court)against the Ministry of Health of the Russian Federation and Axelpharm LLC (Axelpharm) related to Axelpharm'simproper use of AstraZeneca's information to obtain authorisation to market a generic version of Tagrisso. InDecember 2023, the Court dismissed the lawsuit against the Ministry of Health of the Russian Federation. Theappellate court affirmed the dismissal in March 2024. AstraZeneca filed a further appeal, which remains pending.The lawsuit against Axelpharm remains pending.
In Russia, in November 2023, Axelpharm filed a compulsory licensing action against AstraZeneca in the Courtrelated to a patent that covers Tagrisso. The compulsory licensing action remains pending. AstraZeneca has alsochallenged before the Russian Patent and Trademark Office ("PTO") the validity of the Axelpharm patent on whichthe compulsory licensing action is predicated; that challenge remains pending before the Russian PTO.
In July 2024, AstraZeneca filed a patent infringement lawsuit and an unfair competition claim with the Federal Anti-Monopoly Service of Russia against AxelPharm and others related to the securing of state contracts in Russia forits generic version of osimertinib.
Commercial litigation
Legal proceedings brought against AstraZeneca considered to be contingent liabilities
Anti-Terrorism Act Civil Lawsuit
US proceedings
In the US, in October 2017, AstraZeneca and certain other pharmaceutical and/or medical device companies werenamed as defendants in a complaint filed in the US District Court for the District of Columbia (District Court) by USnationals (or their estates, survivors, or heirs) who were killed or wounded in Iraq between 2005 and 2013. Theplaintiffs allege that the defendants violated the US Anti-Terrorism Act and various state laws by sellingpharmaceuticals and medical supplies to the Iraqi Ministry of Health. In July 2020, the District Court grantedAstraZeneca's and the other defendants' motion to dismiss the lawsuit, which the DC Circuit Court of Appeals (theAppellate Court) reversed in January 2022. In June 2024, the United States Supreme Court issued an ordervacating the 2022 decision and granted AstraZeneca's and the other defendants' request for a remand to theAppellate Court for reconsideration under new case law.
Employment Litigation
US proceedings
In December 2022, AstraZeneca was served with a lawsuit filed by seven former employees in the US DistrictCourt for the District of Delaware (District Court) asserting claims of discrimination on grounds of age and religion,related to AstraZeneca's vaccination requirement. In March 2023, AstraZeneca filed a partial motion to dismisscertain religious discrimination claims and a motion to strike the class and collective claims. In September 2023,Plaintiffs moved for conditional certification of the collective action. In June 2024, the District Court grantedAstraZeneca's partial motion to dismiss, granted AstraZeneca's motion to strike, and denied without prejudicePlaintiff's motion for conditional certification.
Pay Equity Litigation
US proceedings
AstraZeneca is defending a putative class and collective action in the US District Court for the Northern District ofIllinois (District Court) brought by three named plaintiffs, who are former AstraZeneca employees. The caseinvolves claims under the federal and Illinois Equal Pay Acts, with the plaintiffs alleging they were paid less thanmale employees who performed substantially similar and/or equal work. In May 2024, the District Courtconditionally certified a collective under the federal Equal Pay Act and authorised the sending of notice to potentialcollective action members. The notice was distributed in June 2024.
University of Sheffield Contract Dispute
UK proceedings
In June 2024, AstraZeneca was served with a lawsuit filed by the University of Sheffield (Sheffield). In itscomplaint, Sheffield alleges that AstraZeneca made misrepresentations to induce Sheffield to amend a patentlicense relating to Lynparza. AstraZeneca is considering its response.
Viela Bio, Inc. Shareholder Litigation
===== SIDA 33 =====
US proceedings
In February 2023, AstraZeneca was served with a lawsuit filed in Delaware state court against AstraZeneca andcertain officers (collectively, Defendants), on behalf of a putative class of Viela Bio, Inc. (Viela) shareholders. Thecomplaint alleged that the Defendants breached their fiduciary duty to Viela shareholders in the course of Viela's2021 merger with Horizon Therapeutics, plc. In July 2024, the Court granted with prejudice AstraZeneca's motionto dismiss.
Legal proceedings brought by AstraZeneca considered to be contingent assets
PARP Inhibitor Royalty Dispute
UK proceedings
In October 2012, Tesaro, Inc. (now wholly owned by GlaxoSmithKline plc, (GSK)) entered into two worldwide,royalty-bearing patent license agreements with AstraZeneca related to GSK's product niraparib. In May 2021,AstraZeneca filed a lawsuit against GSK in the Commercial Court of England and Wales alleging that GSK hadfailed to pay all of the royalties due on niraparib sales under the license agreements. In April 2023, after trial, thetrial court issued a decision in AstraZeneca's favour. In February 2024, the Court of Appeal reversed the decision.In March 2024, AstraZeneca filed a request for permission to appeal with the Supreme Court of the UnitedKingdom. In May 2024, the Supreme Court denied permission to appeal. The case will return to the trial court forfurther proceedings.
Government investigations/proceedings
Legal proceedings brought against AstraZeneca considered to be contingent liabilities
Boston US Attorney Investigation
US Proceedings
In June 2024, AstraZeneca was served with a subpoena issued by the US Attorney's Office in Boston, seekingdocuments and information relating to payments by AstraZeneca to healthcare providers. AstraZeneca iscooperating with this enquiry.
Turkish Ministry of Health Matter
Turkey proceedings
In Turkey, in July 2020, the Turkish Ministry of Health (Ministry of Health) initiated an investigation regardingpayments to healthcare providers by Alexion and former employees and consultants. The investigation arose fromAlexion's disclosure of a $21.5m civil settlement with the US Securities & Exchange Commission (SEC) in July2020 fully resolving the SEC's investigation into possible violations of the US Foreign Corrupt Practices Act. InSeptember 2021, the Ministry of Health completed its draft investigation report, and referred the matter to theAnkara Public Prosecutor's Office with a recommendation for further proceedings against certain formeremployees. In June 2024, the Ankara Public Prosecutor's Office closed its investigation without further action.
Legal proceedings brought by AstraZeneca considered to be contingent assets
Inflation Reduction Act Litigation
US proceedings
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 negotiationprovisions of the Inflation Reduction Act and the implementing guidance and regulations. In March 2024, theDistrict Court granted HHS' motions and dismissed AstraZeneca's lawsuit. AstraZeneca has appealed the DistrictCourt's decision.
340B State Litigation
US proceedings
AstraZeneca has filed lawsuits against Arkansas, Kansas, Louisiana, Maryland, Minnesota, Mississippi, and WestVirginia challenging the constitutionality of each state's 340B statute. In the Arkansas matter, trial is scheduled forApril 2025. In the Louisiana matter, AstraZeneca and the state have filed motions for summary judgment and ahearing was held in June 2024. The remaining matters are in their preliminary stages.
Other
Additional government inquiries
As is true for most, if not all, major prescription pharmaceutical companies, AstraZeneca is currently involved inmultiple 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 beenno material developments in those matters.
Matters disclosed in respect of the first quarter of 2024 and to 25 April 2024
Patent litigation
Legal proceedings brought against AstraZeneca considered to be contingent liabilities
===== SIDA 34 =====
Forxiga
UK patent proceedings
In the UK, one of AstraZeneca's patents relating to Forxiga is being challenged by Generics (UK) Limited, TevaPharmaceutical Industries Limited, and Glenmark Pharmaceuticals Europe Limited. Trial is scheduled for March2025.
Tagrisso
US patent proceedings
In September 2021, Puma Biotechnology, Inc. (Puma) and Wyeth LLC (Wyeth) filed a patent infringement lawsuitin the US District Court for the District of Delaware (District Court) against AstraZeneca relating to Tagrisso. InMarch 2024, the District Court dismissed Puma. A trial, with Wyeth as the plaintiff, has been scheduled for May2024.
Legal proceedings brought by AstraZeneca considered to be contingent assets
Calquence
US patent proceedings
In February 2022, in response to Paragraph IV notices from multiple ANDA filers, AstraZeneca filed patentinfringement lawsuits in the US District Court for the District of Delaware (District Court). In its complaint,AstraZeneca alleged that a generic version of Calquence capsules, if approved and marketed, would infringepatents that are owned or licensed by AstraZeneca. Trial is scheduled for March 2025.
In March and April 2024, AstraZeneca entered into settlement agreements with generic manufacturers, SandozInc., and Natco Pharma Limited with Natco Pharma Inc., resulting in dismissal of the corresponding Calquencecapsule ANDA litigation proceedings. Additional Calquence capsule ANDA litigation proceedings with theremaining three generic manufacturers are ongoing in the District Court.
In April 2024, AstraZeneca received a Paragraph IV notice from an ANDA filer relating to patents listed in the FDAOrange Book with reference to Calquence tablets. AstraZeneca is considering its response.
Lokelma
US patent proceedings
In August 2022, in response to Paragraph IV notices, AstraZeneca initiated ANDA litigation against multiple genericfilers in the US District Court for the District of Delaware (District Court). Trial is scheduled for March 2025.
AstraZeneca entered into a settlement agreement with a generic manufacturer, Alkem Laboratories, which resultedin dismissal of the corresponding litigation. Additional proceedings with the remaining generic manufacturers areongoing in the District Court.
Soliris
US patent proceedings
In January 2024, Alexion initiated patent infringement litigation against Samsung Bioepis Co. Ltd. (Samsung) in theUS District Court for the District of Delaware alleging that Samsung's biosimilar eculizumab product, for whichSamsung is currently seeking FDA approval, will infringe six Soliris-related patents. No trial date has beenscheduled. Five of the six asserted patents are also the subject of inter partes review proceedings before the USPatent and Trademark Office. In February 2024, Alexion filed a motion for a preliminary injunction seeking to enjoinSamsung from launching its biosimilar eculizumab product upon FDA approval. A hearing on Alexion's preliminaryinjunction motion is scheduled for May 2024. European patent proceedings
In March 2024, Alexion filed motions for preliminary injunctions against Amgen and Samsung at the HamburgLocal Division of the Unified Patent Court on the basis that Amgen's and Samsung's biosimilar eculizumabproducts infringe Alexion's eculizumab molecule patent that is expected to grant in Q2 2024. No hearing date forthe preliminary injunction motions has been set.
Tagrisso
Russia patent proceedings
In Russia, in August 2023, AstraZeneca filed lawsuits in the Arbitration Court of the Moscow Region (Court)against the Ministry of Health of the Russian Federation and Axelpharm LLC (Axelpharm) related to Axelpharm'simproper use of AstraZeneca's information to obtain authorisation to market a generic version of Tagrisso. InDecember 2023, the Court dismissed the lawsuit against the Ministry of Health of the Russian Federation. InJanuary 2024, AstraZeneca filed an appeal, and the appellate court affirmed the dismissal in March 2024. Thelawsuit against Axelpharm remains pending.
In Russia, in November 2023, Axelpharm filed a compulsory licensing action against AstraZeneca in the Courtrelated to a patent that covers Tagrisso. The compulsory licensing action remains pending.
Product liability litigation
Legal proceedings brought against AstraZeneca for which a provision has been taken
Nexium and Losec/Prilosec
US proceedings
===== SIDA 35 =====
AstraZeneca has been defending lawsuits brought in federal and state courts involving claims that plaintiffs havebeen diagnosed with various injuries following treatment with proton pump inhibitors (PPIs), including Nexium andPrilosec. Most of the lawsuits alleged kidney injury. In August 2017, the pending federal court cases wereconsolidated into a multidistrict litigation (MDL) proceeding in the US District Court for the District of New Jerseyfor pre-trial purposes. Cases alleging kidney injury were also filed in Delaware and New Jersey state courts.
In addition, AstraZeneca has been defending lawsuits involving allegations of gastric cancer following treatmentwith PPIs, including one such claim in the US District Court for the Middle District of Louisiana (Louisiana DistrictCourt).
In October 2023, AstraZeneca resolved all pending claims in the MDL, as well as all pending claims in Delawareand New Jersey state courts, for $425m, for which a provision has been taken. The only remaining case is the onepending in the Louisiana District Court, which is scheduled for trial in January 2025. Canada proceedings
In Canada, in July and August 2017, AstraZeneca was served with three putative class action lawsuits. Two of thelawsuits have been dismissed, one in 2019 and one in 2021. The third lawsuit seeks authorisation to representindividual residents in Canada who allegedly suffered kidney injuries from the use of proton pump inhibitors,including Nexium and Losec.
Legal proceedings brought against AstraZeneca considered to be contingent liabilities
Onglyza and Kombiglyze
US proceedings
In the US, AstraZeneca has been defending various lawsuits in both California state court and in a consolidatedfederal proceeding alleging heart failure, cardiac injuries, and/or death from treatment with Onglyza or Kombiglyze.In the California state court proceeding, the trial court granted summary judgment for AstraZeneca, which theCalifornia appellate court affirmed. The California Supreme Court has declined further review, and the Californiamatter has concluded. The consolidated federal cases were dismissed in August 2022 by the US District Court forthe Eastern District of Kentucky. That dismissal was affirmed by the US Court of Appeals for the Sixth Circuit inFebruary 2024.
Vaxzevria
UK proceedings
AstraZeneca is defending lawsuits in the UK involving multiple claimants alleging injuries following vaccination withAstraZeneca's COVID-19 vaccine. Most of the lawsuits involve claims of thrombosis with thrombocytopeniasyndrome. No trial dates have been scheduled.
Commercial litigation
Legal proceedings brought against AstraZeneca considered to be contingent liabilities
340B Antitrust Litigation
US proceedings
In September 2021, AstraZeneca was served with a class-action antitrust complaint filed in the US District Courtfor the Western District of New York (District Court) by Mosaic Health alleging a conspiracy to restrict access to340B discounts in the diabetes market through contract pharmacies. In September 2022, the District Court grantedAstraZeneca's motion to dismiss the Complaint. In February 2024, the District Court denied Plaintiffs' request tofile an amended complaint and entered an order closing the matter. In March 2024, Plaintiffs filed an appeal.
Definiens
Germany proceedings
In Germany, in July 2020, AstraZeneca received a notice of arbitration filed with the German Institution ofArbitration from the sellers of Definiens AG (the Sellers) regarding the 2014 Share Purchase Agreement (SPA)between AstraZeneca and the Sellers. The Sellers claim that they are owed approximately $140m in earn-outsunder the SPA. In December 2023, after an arbitration hearing, the arbitration panel made a final award of$46.43m in favour of the Sellers. In March 2024, AstraZeneca filed an application with the Bavarian SupremeCourt to set aside the arbitration award.
Legal proceedings brought by AstraZeneca considered to be contingent assets
PARP Inhibitor Royalty Dispute
UK proceedings
In October 2012, Tesaro, Inc. (now wholly owned by GlaxoSmithKline plc, (GSK)) entered into two worldwide,royalty-bearing patent license agreements with AstraZeneca related to GSK's product niraparib. In May 2021,AstraZeneca filed a lawsuit against GSK in the Commercial Court of England and Wales alleging that GSK hadfailed to pay all of the royalties due on niraparib sales under the license agreements. In April 2023, after trial, thetrial court issued a decision in AstraZeneca's favour. In February 2024, Court of Appeal reversed. In March 2024,AstraZeneca filed a request for permission to appeal with the Supreme Court of the United Kingdom.
Government investigations/proceedings
Legal proceedings brought against AstraZeneca considered to be contingent liabilities
===== SIDA 36 =====
340B Qui Tam
US proceedings
In July 2023, AstraZeneca was served with an unsealed civil lawsuit brought by a qui tam relator on behalf of theUnited States, several states, and the District of Columbia in the US District Court for the Central District ofCalifornia (District Court). The complaint alleges that AstraZeneca violated the US False Claims Act and state lawanalogues. In March 2024, the District Court granted AstraZeneca's motion to dismiss the First AmendedComplaint without leave to amend. In April 2024, the relator filed an appeal.
Legal proceedings brought by AstraZeneca considered to be contingent assets
Inflation Reduction Act Litigation
US proceedings
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 negotiationprovisions of the Inflation Reduction Act and the implementing guidance and regulations. In March 2024, theDistrict Court granted HHS' motions and dismissed AstraZeneca's lawsuit.
Arkansas 340B Litigation
US proceedings
In March 2024, AstraZeneca filed a lawsuit against the State of Arkansas alleging that the Arkansas's 340B statuteis preempted by federal law and unconstitutional.
Other
Additional government inquiries
As is true for most, if not all, major prescription pharmaceutical companies, AstraZeneca is currently involved inmultiple 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 beenno material developments in those matters.
Note 7: Subsequent events
On 15 July 2024, AstraZeneca completed the acquisition of Amolyt Pharma, a clinical-stage biotechnologycompany focused on developing novel treatments for rare endocrine diseases. AstraZeneca acquired alloutstanding equity of Amolyt for a total consideration of up to $1.05 billion, on a cash and debt free basis. Thisincludes an initial payment of $800m on deal closing, subject to customary closing adjustments, and a further up to$250m in contingent milestones-based consideration. Due to the timing of the transaction post period end, theaccounting and other disclosures will be finalised in the second half of 2024.
Note 8
Table 25: H1 2024 - Product Sales year-on-year analysis[15]
The CER information in respect of H1 2024 included in the Interim financial statements has not been reviewed byPricewaterhouseCoopers LLP.
World US Emerging Markets Europe Established RoW
$m Act %
chg
CER %
chg $m % chg $m Act %
chg
CER %
chg $m Act %
chg
CER %
chg $m Act %
chg
CER %
chg
Oncology 9,737 17 21 4,387 20 2,300 18 28 1,967 25 23 1,083 (2) 8
Tagrisso 3,203 10 13 1,282 16 919 8 16 628 16 15 374 (11) (2)
Imfinzi 2,259 20 25 1,202 17 245 35 58 459 38 36 353 7 19
Calquence 1,508 27 28 1,048 21 75 82 n/m 320 42 41 65 30 34
Lynparza 1,450 6 9 607 5 320 15 26 398 9 8 125 (14) (6)
Enhertu 249 n/m n/m - - 161 n/m n/m 57 n/m n/m 31 n/m n/m
Zoladex 549 19 27 8 20 415 22 31 77 16 14 49 2 12
Imjudo 136 35 38 88 30 7 n/m n/m 16 n/m n/m 25 (5) 6
Truqap 142 n/m n/m 141 n/m - - - - - - 1 n/m n/m
Orpathys 25 14 19 - - 25 14 19 - - - - - -
Others 216 (21) (15) 11 6 133 (21) (15) 12 (36) (36) 60 (21) (12)
BioPharmaceuticals: CVRM 6,164 18 22 1,483 16 2,749 17 24 1,559 33 32 373 (8) 2
Farxiga 3,785 35 38 867 37 1,474 37 44 1,233 45 44 211 (15) (5)
Brilinta 665 - 2 354 (1) 166 4 14 136 - (1) 9 (26) (19)
Crestor 589 1 6 22 (18) 475 4 9 22 (30) (29) 70 3 13
Seloken/Toprol-XL 315 (8) (1) - n/m 307 (8) (1) 6 4 7 2 (39) (37)
Lokelma 249 26 30 115 10 42 75 83 41 62 61 51 16 31
roxadustat 163 22 27 - - 163 22 27 - - - - n/m n/m
Andexxa 105 18 21 42 14 2 n/m n/m 40 38 36 21 (9) 4
Wainua 21 n/m n/m 21 n/m - - - - - - - - -
Others 272 (30) (28) 62 (50) 120 (27) (22) 81 (10) (10) 9 (7) (5)
BioPharmaceuticals: R&I 3,601 17 20 1,567 21 1,032 16 23 680 17 16 322 7 12
Symbicort 1,491 16 19 598 38 450 11 21 286 - (1) 157 (4) (2)
Fasenra 781 5 6 478 2 41 45 53 192 9 8 70 (2) 6
===== SIDA 37 =====
Pulmicort 379 10 14 8 (53) 317 16 22 37 1 (1) 17 (13) (9)
Breztri 454 48 51 225 37 131 61 69 65 80 79 33 33 44
Tezspire 100 n/m n/m - - 5 n/m n/m 61 n/m n/m 34 n/m n/m
Saphnelo 203 77 77 184 71 2 n/m n/m 10 n/m n/m 7 86 91
Airsupra 21 n/m n/m 21 n/m - - - - - - - - -
Others 172 (27) (26) 53 (47) 86 (18) (14) 29 3 2 4 (12) (10)
BioPharmaceuticals: V&I 324 (27) (24) 55 n/m 131 (12) (7) 81 (28) (30) 57 (68) (65)
Synagis 253 (11) (6) (1) n/m 131 4 10 67 (27) (29) 56 (15) (6)
Beyfortus 54 n/m n/m 53 n/m - - - - (81) (61) 1 n/m n/m
FluMist 8 n/m n/m 3 n/m - - - 5 n/m 97 - n/m n/m
COVID-19 mAbs 3 (98) (98) - - - n/m n/m 3 (58) (59) - n/m n/m
Others 6 (79) (80) - - - n/m n/m 6 (41) (43) - n/m n/m
Rare Disease 4,243 11 15 2,517 10 454 40 70 794 3 2 478 9 20
Ultomiris 1,804 32 35 1,032 27 66 n/m n/m 411 32 31 295 42 58
Soliris 1,439 (13) (8) 808 (9) 255 19 54 260 (29) (30) 116 (33) (30)
Strensiq 653 16 18 529 17 31 30 47 48 14 12 45 4 15
Koselugo 247 55 64 101 13 83 n/m n/m 45 95 92 18 n/m n/m
Kanuma 100 17 20 47 18 19 7 20 30 24 25 4 11 20
Other medicines 560 (9) (2) 52 (24) 385 (1) 8 53 10 10 70 (35) (29)
Nexium 459 (7) 1 47 (22) 318 4 15 26 3 2 68 (34) (28)
Others 101 (17) (14) 5 (40) 67 (22) (18) 27 18 19 2 (53) (49)
Total Product Sales 24,629 15 18 10,061 17 7,051 16 26 5,134 21 19 2,383 (6) 3
Table 26: Q2 2024 - Product Sales year-on-year analysis (Unreviewed)[16]
The Q2 2024 information in respect of the three months ended 30 June 2024 included in the Interim financialstatements has not been reviewed by PricewaterhouseCoopers LLP.
World US Emerging Markets Europe Established RoW
$m Act %
chg
CER %
chg $m % chg $m Act %
chg
CER %
chg $m Act %
chg
CER %
chg $m Act %
chg
CER %
chg
Oncology 4,976 14 18 2,302 17 1,098 11 22 1,015 24 24 561 (9) 2
Tagrisso 1,608 8 12 658 13 432 6 15 327 15 15 191 (12) (1)
Imfinzi 1,147 13 18 620 15 117 16 39 227 33 33 183 (9) 3
Calquence 790 21 22 554 14 36 51 72 167 42 43 33 20 23
Lynparza 744 4 7 319 3 153 8 18 206 10 11 66 (15) (6)
Enhertu 127 89 99 - - 77 60 72 31 n/m n/m 19 n/m n/m
Zoladex 273 17 25 5 29 201 17 28 42 23 21 25 6 17
Imjudo 74 17 19 49 37 4 n/m n/m 8 64 55 13 (38) (30)
Truqap 92 n/m n/m 91 n/m - - - - - - 1 n/m n/m
Orpathys 12 (7) (3) - - 12 (7) (3) - - - - - -
Others 109 (17) (11) 6 24 66 (16) (10) 7 (11) (10) 30 (26) (16)
BioPharmaceuticals: CVRM 3,153 18 22 735 11 1,384 17 24 843 38 38 191 (14) (3)
Farxiga 1,940 29 32 394 16 763 32 39 680 49 49 103 (23) (14)
Brilinta 342 3 5 191 7 78 (1) 6 69 1 1 4 (38) (23)
Crestor 292 4 11 12 (2) 234 8 14 10 (34) (32) 36 3 15
Seloken/Toprol-XL 150 (8) - - n/m 146 (8) - 3 46 53 1 (40) (38)
Lokelma 136 36 41 64 29 21 68 78 23 63 64 28 16 33
roxadustat 88 20 26 - - 88 20 26 - - - - - -
Andexxa 59 29 35 22 34 1 n/m n/m 22 51 51 14 (6) 8
Wainua 16 n/m n/m 16 n/m - - - - - - - - -
Others 130 (26) (24) 36 (45) 53 (19) (14) 36 (9) (8) 5 (14) (12)
BioPharmaceuticals: R&I 1,797 21 24 830 23 444 23 34 350 21 21 173 8 14
Symbicort 722 20 25 299 49 197 12 25 143 4 5 83 (4) (1)
Fasenra 423 4 5 268 - 19 33 46 99 11 11 37 3 11
Pulmicort 155 25 30 3 (53) 126 40 47 17 6 2 9 (18) (13)
Breztri 235 44 47 120 43 61 42 49 35 68 69 19 26 37
Tezspire 57 n/m n/m - - 3 n/m n/m 35 n/m n/m 19 n/m n/m
Saphnelo 112 65 65 101 59 1 28 n/m 6 n/m n/m 4 90 86
Airsupra 14 n/m n/m 14 n/m - - - - - - - - -
Others 79 (24) (22) 25 (52) 37 7 12 15 2 3 2 (6) (4)
BioPharmaceuticals: V&I 112 28 42 28 n/m 41 (10) 4 7 (55) (53) 36 36 55
Synagis 81 (6) 8 (1) n/m 41 (16) (2) 6 (42) (42) 35 27 46
Beyfortus 28 n/m n/m 27 n/m - - - - n/m (91) 1 n/m n/m
FluMist 2 n/m n/m 2 n/m - - - - (26) (21) - - -
COVID-19 mAbs 1 n/m n/m - - - n/m n/m 1 (65) (64) - (99) (99)
Others - n/m n/m - - - - - - n/m n/m - - -
Rare Disease 2,147 10 14 1,311 10 203 35 67 392 3 3 241 7 18
Ultomiris 946 33 36 550 27 35 n/m n/m 209 38 38 152 38 56
Soliris 700 (14) (8) 398 (11) 129 30 74 118 (36) (36) 55 (36) (33)
Strensiq 340 13 14 283 14 10 7 15 24 13 13 23 4 17
Koselugo 114 43 45 55 13 24 73 80 26 n/m n/m 9 63 85
Kanuma 47 3 8 25 21 5 (54) (49) 15 28 33 2 11 41
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Other medicines 267 (11) (5) 28 (13) 179 (3) 5 24 (7) (7) 36 (38) (32)
Nexium 219 (12) (5) 25 (17) 146 (2) 7 13 (5) (5) 35 (37) (32)
Others 48 (9) (6) 3 39 33 (8) (4) 11 (9) (9) 1 (54) (49)
Total Product Sales 12,452 14 18 5,234 16 3,349 15 25 2,631 23 23 1,238 (5) 5
Table 27: Alliance Revenue
H1 2024 H1 2023 $m $m
Enhertu 683 475 Tezspire 180 105 Beyfortus 26 - Other Alliance Revenue 50 47
Total 939 627
Table 28: Collaboration Revenue
H1 2024 H1 2023 $m $m Farxiga: sales milestones 49 25 COVID-19 mAbs licence fees - 180 Other Collaboration Revenue - 15
Total 49 220
Table 29: Other operating income and expense
H1 2024 H1 2023 $m $m
brazikumab licence termination funding - 75 Divestment of US rights to Pulmicort Flexhaler - 241 Update to the contractual relationships for Beyfortus (nirsevimab) - 712 Other 127 135
Total 127 1,163
Other shareholder information
Financial calendar
Announcement of 9M and Q3 2024 results: 12 November 2024Announcement of FY and Q4 2024 results: 6 February 2025 Dividends are normally paid as follows:
First interim: announced with half year results and paid in SeptemberSecond interim: announced with full year results and paid in March
The record date for the first interim dividend for 2024, payable on 9 September 2024, will be 9 August 2024. Theex-dividend date will be 8 August 2024. Conclusion of audit tender
Following a rigorous process, the audit tender for the Group's external audit provider has now concluded. TheAudit Committee has recommended, and the Board has endorsed, the appointment of KPMG as the Group'sexternal auditor for the financial year ending 31 December 2026. A resolution will be put to shareholders at the2026 Annual General Meeting (AGM) to approve this appointment. It is intended that PwC, who have been theGroup's auditor since the year ended 31 December 2017, will continue as the Group's auditors for the years ended31 December 2024 and 2025 and will cease to hold office at the conclusion of the Company's 2026 AGM.
Contacts
For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here.
Addresses for correspondence
Registered office Registrar andtransfer office Swedish CentralSecurities Depository
US depositaryDeutsche Bank TrustCompany Americas
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1 Francis Crick AvenueCambridge BiomedicalCampusCambridgeCB2 0AA
Equiniti LimitedAspect HouseSpencer RoadLancingWest SussexBN99 6DA
Euroclear Sweden AB POBox 191SE-101 23 Stockholm
American Stock Transfer6201 15th AvenueBrooklynNY 11219
United Kingdom United Kingdom Sweden United States+44 (0) 20 3749 5000 0800 389 1580 +46 (0) 8 402 9000 +1 (888) 697 8018
+44 (0) 121 415 7033 +1 (718) 921 8137
db@astfinancial.com
Trademarks
Trademarks of the AstraZeneca group of companies appear throughout this document in italics. Medicalpublications also appear throughout the document in italics. AstraZeneca, the AstraZeneca logotype and theAstraZeneca symbol are all trademarks of the AstraZeneca group of companies. Trademarks of companies otherthan AstraZeneca that appear in this document include: Beyfortus, a trademark of Sanofi Pasteur Inc.; Enhertu, atrademark of Daiichi Sankyo; Seloken, owned by AstraZeneca or Taiyo Pharma Co., Ltd (depending ongeography); Synagis, owned by AstraZeneca or Sobi aka Swedish Orphan Biovitrum AB (publ). (depending ongeography); and Tezspire, a trademark of Amgen, Inc.
Information on or accessible through AstraZeneca's websites, including astrazeneca.com, does not form part ofand is not incorporated into this announcement.
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on thediscovery, development, and commercialisation of prescription medicines in Oncology, Rare Disease, andBioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based inCambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions ofpatients worldwide. Please visit astrazeneca.com and follow the Company on Social Media @AstraZeneca.
Cautionary statements regarding forward-looking statements
In order, among other things, to utilise the 'safe harbour' provisions of the US Private Securities Litigation ReformAct of 1995, AstraZeneca (hereafter 'the Group') provides the following cautionary statement:
This document contains certain forward-looking statements with respect to the operations, performance andfinancial condition of the Group, including, among other things, statements about expected revenues, margins,earnings per share or other financial or other measures. Although the Group believes its expectations are basedon reasonable assumptions, any forward-looking statements, by their very nature, involve risks and uncertaintiesand may be influenced by factors that could cause actual outcomes and results to be materially different fromthose predicted. The forward-looking statements reflect knowledge and information available at the date ofpreparation of this document and the Group undertakes no obligation to update these forward-looking statements.The Group identifies the forward-looking statements by using the words 'anticipates', 'believes', 'expects', 'intends'and similar expressions in such statements. Important factors that could cause actual results to differ materiallyfrom those contained in forward-looking statements, certain of which are beyond the Group's control, include,among other things:
‒ the risk of failure or delay in delivery of pipeline or launch of new medicines‒ the risk of failure to meet regulatory or ethical requirements for medicine development or approval‒ the risk of failures or delays in the quality or execution of the Group's commercial strategies‒ the risk of pricing, affordability, access and competitive pressures‒ the risk of failure to maintain supply of compliant, quality medicines‒ the risk of illegal trade in the Group's medicines‒ the impact of reliance on third-party goods and services‒ the risk of failure in information technology or cybersecurity‒ the risk of failure of critical processes‒ the risk of failure to collect and manage data in line with legal and regulatory requirements and strategicobjectives‒ the risk of failure to attract, develop, engage and retain a diverse, talented and capable workforce‒ the risk of failure to meet regulatory or ethical expectations on environmental impact, including climate change‒ the risk of the safety and efficacy of marketed medicines being questioned‒ the risk of adverse outcome of litigation and/or governmental investigations‒ intellectual property-related risks to the Group's products‒ the risk of failure to achieve strategic plans or meet targets or expectations‒ the risk of failure in financial control or the occurrence of fraud‒ the risk of unexpected deterioration in the Group's financial position‒ the impact that global and/or geopolitical events may have or continue to have on these risks, on the Group'sability to continue to mitigate these risks, and on the Group's operations, financial results or financial condition
Glossary
1L, 2L, etc First line, second line, etcADC Antibody drug conjugate
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aHUS Atypical haemolytic uraemic syndromeAKT Protein kinase BAL amyloidosis Light chain amyloidosisANDA Abbreviated New Drug Application (US)ASO Antisense oligonucleotideATTR-CM Transthyretin-mediated amyloid cardiomyopathyATTRv / -PN / -CM Hereditary transthyretin-mediated amyloid / polyneuropathy / cardiomyopathyBCMA B-cell maturation antigenBRCA / m Breast cancer gene / mutationBTC Biliary tract cancerBTK Bruton tyrosine kinaseC5 Complement component 5CAR-T Chimeric antigen receptor T-cellcCRT Concurrent chemoradiotherapyCD19 A gene expressed in B-cellsCER Constant exchange ratesCHMP Committee for Medicinal Products for Human Use (EU)CI Confidence intervalCKD Chronic kidney diseaseCLL Chronic lymphocytic leukaemiaCOPD Chronic obstructive pulmonary diseaseCOP28 28th annual United Nations (UN) climate meetingCRC Colorectal cancerCRL Compete Response LetterCRPC Castration-resistant prostate cancerCSPC Castration-sensitive prostate cancerCTLA-4 Cytotoxic T-lymphocyte-associated antigen 4CVRM Cardiovascular, Renal and MetabolismDDR DNA damage responseDNA Deoxyribonucleic acidEBITDA Earnings before interest, tax, depreciation and amortisationEGFR / m Epidermal growth factor receptor / gene mutationEGPA Eosinophilic granulomatosis with polyangiitisEPS Earnings per shareER Estrogen receptor ERBB2 v-erb-b2 avian erythroblastic leukaemia viral oncogene homologue 2EVH Extravascular haemolysisFDA Food and Drug Agency (US)FDC Fixed dose combinationg Germline, e.g. gBRCAmGAAP Generally Accepted Accounting PrinciplesGEJ Gastro oesophageal junctionGI GastrointestinalGLP1 / -RA Glucagon-like peptide-1 / receptor agonistgMG Generalised myasthenia gravisHCC Hepatocellular carcinomaHER2 / +/- / low / m Human epidermal growth factor receptor 2 / positive / negative / low level expression /mutantHF/ pEF / rEF Heart failure / with preserved ejection fraction / with reduced ejection fractionhMPV Human metapneumovirusHR Hazard ratioHR / + / - Hormone receptor / positive / negativeHRD Homologous recombination deficiencyHRR / m Homologous recombination repair gene / mutationi.m. Intramuscular injectioni.v. Intravenous injectionIAS / B International AccountingStandards / BoardICS Inhaled corticosteroidIFRS International Financial Reporting StandardsIgAN Immunoglobulin A neuropathyIHC ImmunohistochemistryIL-5, IL-33, etc Interleukin-5, Interleukin-33, etcIP Intellectual PropertyIVIg Intravenous immune globulinLABA Long-acting beta-agonistLAMA Long-acting muscarinic-agonistLS-SCLC Limited stage small cell lung cancerLRTD Lower respiratory tract diseasem Metastatic, e.g. mBTC , mCRPC, mCSPCmAb Monoclonal antibodyMDL Multidistrict litigationMET Mesenchymal epithelial transitionNF1-PN Neurofibromatosis type 1 with plexiform neurofibromasn/m Not meaningfulNMOSD Neuromyelitis optica spectrum disorderNRDL National reimbursement drug listNSCLC Non-small cell lung cancerOECD Organisation for EconomicCo-operation and DevelopmentOOI Other operating incomeORR Overall response rateOS Overall survival
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PARP / i / -1sel Poly ADP ribose polymerase / inhibitor /-1 selectivepCR Pathologic complete responsePCSK9 Proprotein convertase subtilisin/kexin type 9PD Progressive diseasePD-1 Programmed cell death protein 1PD-L1 Programmed cell death ligand 1PDUFA Prescription Drug User Fee ActPHSSR Partnership for Health System Sustainability and ResiliencePFS Progression free survivalPIK3CA Phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alphaPMDI Pressure metered dose inhalerPNH / -EVH Paroxysmal nocturnal haemoglobinuria / with extravascular haemolysisPPI Proton pump inhibitorsPSR Platinum sensitive relapsePTEN Phosphatase and tensin homologueQ3W, Q4W, etc Every three weeks, every four weeks, etcR&D Research and developmentR&I Respiratory & ImmunologyRSV Respiratory syncytial virussBLA Supplemental biologics license application (US)SCLC Small cell lung cancers.c. Subcutaneous injectionSEA Severe eosinophilic asthmaSEC Securities Exchange Commission (US)SG&A Sales, general and administrationSGLT2 Sodium-glucose cotransporter 2SLL Small lymphocytic lymphomaSMI Sustainable Markets InitiativesNDA Supplemental new drug applicationSPA Share Purchase AgreementT2D Type-2 diabetesTACE Transarterial chemoembolizationTHP A treatment regimen: docetaxel, trastuzumab and pertuzumabTNBC Triple negative breast cancerTNF Tumour necrosis factorTOP1 Topoisomerase ITROP2 Trophoblast cell surface antigen 2USPTO US Patent and Trademark OfficeV&I Vaccines & Immune TherapiesVBP Volume-based procurementVLP Virus like particle
- End of document -
[1] Constant exchange rates. The differences between Actual Change and CER Change are due to foreign exchange movementsbetween periods in 2024 vs. 2023. CER financial measures are not accounted for according to generally accepted accountingprinciples (GAAP) because they remove the effects of currency movements from Reported results.
[2] Core financial measures are adjusted to exclude certain items. The differences between Reported and Core measures are primarilydue to costs relating to the amortisation of intangibles, impairments, legal settlements and restructuring charges. A full reconciliationbetween Reported EPS and Core EPS is provided in Table 11 and Table 12 in the Financial performance section of this document.
[3] The calculations for Reported and Core Product Sales Gross Margin exclude the impact of Alliance Revenue and CollaborationRevenue.
[4] In Table 2, the plus and minus symbols denote the directional impact of the item being discussed, e.g. a '+' symbol next to acomment related to the R&D expense indicates that the item resulted in an increase in the R&D spend relative to the prior year.
[5] Income from disposals of assets and businesses, where the Group does not retain a significant ongoing economic interest, continueto be recorded in Other operating income and expense in the Company's financial statements.
[6] The presentation of Table 4 has been updated to show Total Revenue by medicine, by including Alliance Revenue and CollaborationRevenue within each revenue figure. Previously, this table showed Product Sales for each medicine and therapy area, and theCompany's total Alliance Revenue and Collaboration Revenue were shown as separate lines at the bottom of the table.
[7] The presentation of this table has been updated by removing the "Acquisition of Alexion" column due to immateriality of items in thiscategory
[8] Based on best prevailing assumptions around currency profiles.
[9] Based on average daily spot rates 1 Jan 2023 to 31 Dec 2023.
[10] Based on average daily spot rates 1 Jan 2024 to 30 Jun 2024.
[11] Based on average daily spot rates 1 Jun 2024 to 30 Jun 2024.
[12] Other currencies include AUD, BRL, CAD, KRW and RUB.
[13] The Q2 2024 and Q2 2023 information in respect of the three months ended 30 June 2024 and 30 June 2023 respectively includedin the Interim financial statements have not been reviewed by PricewaterhouseCoopers LLP
[14] The Condensed consolidated statement of financial position as at 30 June 2024 and 30 June 2023 have been reviewed byPricewaterhouseCoopers LLP. The Condensed consolidated statement of financial position as at 31 December 2023 has beenaudited by PricewaterhouseCoopers LLP.
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[15] The table provides an analysis of year-on-year Product Sales, with Actual and CER growth rates reflecting year-on-year growth.Due to rounding, the sum of a number of dollar values and percentages may not agree to totals.
[16] The table provides an analysis of year-on-year Product Sales, with Actual and CER growth rates reflecting year-on-year growth.Due to rounding, the sum of a number of dollar values and percentages may not agree to totals.