FULLTEXT DEL 1 AV 1
Kvartalsrapport Q2 2023
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AstraZeneca
28 July 2023
H1 and Q2 2023 results
Strong revenue and EPS growth, reflecting momentum of recent launches and robust commercial execution
Revenue and EPS summary
H1 2023 Q2 2023
% Change % Change
$m Actual CER1 $m Actual CER
- Product Sales 21,448 (1) 3 10,882 2 5
- Alliance Revenue2 627 >2x >2x 341 >2x >2x
- Collaboration RevenueError!
Bookmark not defined.
220 (16) (15) 193 n/m n/m
Total Revenue 22,295 1 4 11,416 6 9
Total Revenue ex COVID-19 21,961 12 16 11,237 14 17
Reported3 EPS4 $2.34 >4x >6x $1.17 >5x >9x
Core5 EPS $4.07 13 21 $2.15 25 38
Financial performance (H1 2023 figures unless otherwise stated, growth numbers at CER)
‒ Total Revenue $22,295m, up 4% despite a decline of $2,181m from COVID-19 medicines6
‒ Excluding COVID-19 medicines, Total Revenue increased 16% and Product Sales increased 15%
‒ Total Revenue from Oncology medicines increased 22%, CVRM7 20%, R&I8 10%, and Rare Disease 12%
‒ Core Product Sales Gross Margin9 of 83%, up three percentage points, reflecting the decline in sales of lower
margin COVID-19 medicines, the cost of production in prior periods, and ongoing mix shift to more speciality
medicines
‒ In Q2 2023, Core Other operating income and expense inclu ded the previously-announced gain resulting
from an update to the contractual relationships for Beyfortus (nirsevimab), totalling $712m
‒ Core EPS increased 21% to $4.07. Interim dividend maintained at $0.93 (71.8 pence, 9.64 SEK)
‒ Reiterating guidance for FY 2023 Total Revenue and Core EPS
Pascal Soriot, Chief Executive Officer, AstraZeneca, said:
"Each of our non-COVID-19 therapy areas saw double -digit revenue growth, with eight medicines delivering
more than $1bn of revenue in the first half, demonstrating the strength of our business. Several medicines grew
rapidly including Ultomiris, Imfinzi/Imjudo and Farxiga, with revenues up 64%, 57% and 40% respectively.
1 Constant exchange rates. The differences between Actual Change and CER Change are due to foreign exchange movements between
periods in 2023 vs 2022. CER financial measures are not accounted for according to generally accepted accounting principles ( GAAP)
because they remove the effects of currency movements from Reported results.
2 Effective 1 January 2023, the Group has updated the presentation of Total Revenue. For further details of the presentation of Alliance
Revenue and Collaboration Revenue, see the Basis of preparation and accounting policies section of the Notes to the Interim Financial
Statements section.
3 Reported financial measures are the financial results presented in accordance with UK-adopted International Accounting Standards and
International Financial Reporting Standards (IFRSs) as issued by the International Accounting Standards Board (IASB) and International
Accounting Standards as adopted by the European Union.
4 Earnings per share.
5 Core financial measures are adjusted to exclude certain items. The differences between Reported and Core measures are primarily due
to costs relating to the acquisition of Alexion, amortisation of intangibles, impairments, legal settlements and restructuring charges. A full
reconciliation between Reported EPS and Core EPS is provided in Table 13 and Table 14 in the Financial performance section of this
document.
6 The COVID-19 medicines are Vaxzevria, Evusheld, and AZD3152 – the COVID-19 antibody currently in development.
7 Cardiovascular, Renal and Metabolism.
8 Respiratory & Immunology.
9 The calculation of Reported and Core Product Sales Gross Margin (previously termed as Gross Margin) excludes the impact of Alliance
Revenue and Collaboration Revenue.
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Our pipeline momentum continues with eight positive pivotal tri als for our Oncology medicines so far this year,
and we are encouraged by the positive data from TROPION -Lung01, the first pivotal trial of datopotamab
deruxtecan. We look forward to sharing the data with the medical community at an upcoming medical congress
and are proceeding to file the data with the US Food and Drug Administration.
And finally, as part of our flagship sustainability programme, Ambition Zero Carbon, we announced a $ 400m
investment in AZ Forest, raising our commitment to plant 200 million trees by 2030. "
Key milestones achieved since the prior results announcement
‒ Key positive read-outs: datopotamab deruxtecan in lung cancer (TROPION -Lung01), Tagrisso in NSCLC10
(FLAURA2), Lynparza + Imfinzi in endometrial cancer (DUO -E), Imfinzi in gastric and gastroesophageal
cancers (MATTERHORN)
‒ Key regulatory approvals: US approvals for Lynparza in BRCA-mutated prostate cancer (PROpel), Farxiga
in HF11 regardless of ejection fraction (DELIVER), and Beyfortus for the prevention of RSV 12; EU approvals
for Ultomiris in NMOSD 13; China approval for Enhertu in HER2 14-low metastatic breast cancer, Soliris in
gMG15 and Koselugo in neurofibromatosis
‒ Other milestones: capivasertib in combination with Faslodex granted priority review in the US for advanced
HR16-positive breast cancer
Guidance
The Company reiterates guidance for FY 2023 at CER, based on the average foreign exchange rates through
2022.
Total Revenue is expected to increase by a low-to-mid single-digit percentage.
Excluding COVID-19 medicines, Total Revenue is expected to increase by a low double-digit percentage.
Core EPS is expected to increase by a high single-digit to low double-digit percentage.
‒ Total Revenue from COVID -19 medicines ( Vaxzevria17 and COVID-19 mAbs18) is expected to decline
significantly in FY 2023
‒ Total Revenue from China is expected to return to growth and increase by a low-to-mid single -digit
(previously low single-digit) percentage in FY 2023
‒ Alliance Revenue and Collaboration Revenue are both expected to increase 19, driven by continued growth
of our partnered medicines and success-based milestones
‒ Core Operating expenses are expected to increase by a low -to-mid single -digit percentage, driven by
investment in recent launches and the ungating of new trials following pipeline success
‒ 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 material
elements of the Reported results, including any fair value adjustments arising on acquisition -related liabilities,
intangible asset impairment charges and legal settlement provisions. Please refer to the cautionary statements
section regarding forward-looking statements at the end of this announcement.
10 Non-small cell lung cancer.
11 Heart failure.
12 Respiratory syncytial virus.
13 Neuromyelitis optica spectrum disorder.
14 Human epidermal growth factor receptor 2.
15 Generalised myasthenia gravis.
16 Hormone receptor.
17 Vaxzevria is AstraZeneca's trademark for the Company's supply of the AstraZeneca COVID -19 Vaccine. In the financial tables in this
report, 'Vaxzevria Total Revenue' includes royalties from sub-licensees that produce and supply the AstraZeneca COVID -19 Vaccine
under their own trademarks, recorded in Alliance Revenue.
18 Monoclonal antibodies. The COVID-19 mAbs are Evusheld and AZD3152.
19 For Alliance Revenue and Collaboration Revenue, the comparable amounts for FY 2022 are $749m and $604m respectively.
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Currency impact
If foreign exchange rates for July to December 2023 were to remain at the average rates seen in June 2023, it
is anticipated that FY 2023 Total Revenue would incur a low single-digit adverse impact versus the performance
at CER, and Core EPS would incur a low -to-mid single -digit advers e impact (previously a low single -digit
adverse impact).
.
The Company's foreign exchange rate sensitivity analysis is provided in Table 19.
Table 1: Key elements of Total Revenue performance in Q2 2023
% Change
Revenue type $m Actual CER
Product Sales 10,882 2 5 Double-digit growth at CER in Oncology, CVRM,
R&I and Rare Disease
Alliance Revenue
341 >2x >2x $255m for Enhertu (Q2 2022: $100m)
$62m for Tezspire (Q2 2022: $13m)
See Table 6 for further details
Collaboration Revenue
193 n/m n/m $180m for COVID-19 mAbs licence payment from
Serum Institute of India Pvt. Ltd. (SII)
See Table 7 for further details
Total Revenue 11,416 6 9 Excluding COVID-19 medicines, Q2 2023 Total
Revenue increased by 14% (17% at CER)
Therapy areas
$m Actual % CER %
Oncology
4,646 22 25 Strong performance across key medicines and
regions
No sales or regulatory milestones from Lynparza
in the quarter (Q2 2022: $nil)
CVRM
2,682 14 18 Farxiga up 37% (41% CER), Lokelma up 51%
(55% at CER), roxadustat up 42% (51% CER),
Brilinta declined 5% (3% at CER)
R&I
1,547 11 14 Fasenra up 15% (16% CER), Breztri up 75%
(79% CER). Saphnelo and Tezspire continue to
grow rapidly during their launch phase
V&I20
278 (72) (71) COVID-19 mAbs: $180m from Collaboration
Revenue, -$1m Product Sales (Q2 2022: $445m)
Vaxzevria: $nil (Q2 2022: $455m)
Rare Disease
1,953 8 10 Ultomiris up 64% (66% at CER), partially offset by
decline in Soliris of 21% (19% at CER)
Strensiq up 24% (25% at CER) reflecting strong
patient demand and geographic expansion
Other Medicines 311 (27) (23) Nexium generic competition in Japan
Total Revenue 11,416 6 9
Regions inc. COVID-19 $m Actual % CER %
US 4,782 10 10
Emerging Markets 3,115 12 19
- China 1,441 - 7
- Ex-China Emerging Markets 1,674 23 32
Europe 2,211 6 6
Established RoW 1,308 (16) (9)
Total Revenue inc. COVID-19 11,416 6 9
Regions ex. COVID-19 $m Actual % CER %
US 4,782 17 17
Emerging Markets 2,938 13 21
- China 1,441 1 7 Fourth consecutive quarter of growth at CER
- Ex-China Emerging Markets 1,497 28 39
20 Vaccines & Immune Therapies.
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Europe 2,208 18 18
Established RoW 1,309 1 8
Total Revenue ex. COVID-19 11,237 14 17
Table 2: Key elements of financial performance in Q2 2023
Metric
Reported Reported
change
Core Core
change
Comments21
Total
Revenue $11,416m 6% Actual
9% CER $11,416m 6% Actual
9% CER
Excluding COVID-19 medicines, Q2 2023
Total Revenue increased by 14% (17% at
CER)
See Table 1 and the Total Revenue section
of this document for further details
Product
Sales Gross
Margin
82% +10pp Actual
+12pp CER 82%
Stable at
Actual
+2pp CER
+ Increasing mix of sales from Oncology and
Rare Disease medicines
+ Decreasing mix of Vaxzevria sales
‒ Increasing mix of products with profit-sharing
arrangements, where AstraZeneca books
Product Sales and records an expense in
COGS22 for the profit share due to its partner
Variations in Product Sales Gross Margin
can be expected between periods due to
product seasonality, foreign exchange
fluctuations, cost inflation and other effects
R&D
expense $2,667m 5% Actual
7% CER $2,568m 6% Actual
8% CER
+ Increased investment in the pipeline
Core R&D-to-Total Revenue ratio of 22%
(Q2 2022: 23%)
Year-on-year comparisons can be impacted
by differences in cost phasing driven by study
starts and execution
SG&A
expense $4,986m 6% Actual
8% CER $3,296m 5% Actual
8% CER
+ Market development for recent launches and
pre-launch activities
+ Reported SG&A impacted by increased
charges for legal provisions, including a
$510m charge to provisions relating to a
legal settlement in Q2 2023 (see Note 6)
Core SG&A-to-Total Revenue ratio of 29%
(Q2 2022: 29%)
Year-on-year comparisons can be impacted
by differences in cost phasing
Other
operating
income and
expense23
$784m >6x Actual
>6x CER $784m >6x Actual
>6x CER
+ Reported and Core Other operating income
includes a gain of $712m from an update to
the contractual relationships for Beyfortus
(nirsevimab)
Operating
Margin 22% +17pp Actual
+19pp CER 38% +6pp Actual
+8pp CER
See Product Sales Gross Margin, expenses
and Other operating income commentary
above
Other operating income contributed seven
percentage points to Operating margin in Q2
2023
21 In Table 2 , the plus and minus symbols denote the directional impact of the item being discussed, e.g. a ‘+’ symbol next to an R&D
expense comment indicates that the item increased the R&D expense relative to the prior year.
22 Cost of goods sold.
23 Income from disposals of assets and businesses, where the Group does not retain a significant ongoing economic interest, continue to
be recorded in Other operating income and expense in the Company’s financial statements.
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Net finance
expense $367m 25% Actual
17% CER $262m 17% Actual
4% CER
+ Higher rates on floating debt and bond
issuances, partially offset by higher interest
received on cash balances
+ Reported also impacted by the discount
unwind on acquisition-related liabilities
Tax rate 13% n/m 17% +2pp Actual
+2pp CER
Variations in the tax rate can be expected
between periods
EPS $1.17 >5x Actual
>9x CER $2.15 25% Actual
38% CER
Further details of differences between
Reported and Core are shown in Table 14
Table 3: Pipeline highlights since prior results announcement
Event Medicine Indication / Trial Event
Regulatory
approvals and
other
regulatory
actions
Lynparza Prostate cancer (1st-line) (PROpel) Regulatory approval (US)
Enhertu HER2-low breast cancer (3rd-line)
(DESTINY-Breast04) Regulatory approval (CN)
Farxiga HFpEF24 (DELIVER) Regulatory approval (US)
Xigduo Type-2 diabetes (XR formulation) Regulatory approval (CN)
Beyfortus RSV (MELODY/MEDLEY) Regulatory approval (US)
Ultomiris NMOSD Regulatory approval (EU, JP)
Koselugo NF1-PN25 (paediatric) (SPRINT) Regulatory approval (CN)
Soliris gMG Regulatory approval (CN)
Soliris gMG (refractory, children and
adolescents) Regulatory approval (EU)
Regulatory
submissions
or acceptances
Enhertu HER2-positive breast cancer (3rd-
line) (DESTINY-Breast02) Regulatory submission (US)
capivasertib HR+/HER2-negative breast cancer
(2nd-line) (CAPItello-291)
Regulatory submission (US, EU,
JP), Priority Review (US)
Fasenra Uncontrolled asthma (MIRACLE) Regulatory submission (CN)
Beyfortus RSV (MELODY/MEDLEY) Regulatory submission and Priority
Review (CN)
danicopan PNH26 with EVH27 Regulatory submission (US, JP)
Major Phase III
data readouts
and other
developments
Tagrisso EGFRm28 NSCLC (1st-line)
(FLAURA2) Primary endpoint met
Lynparza + Imfinzi Endometrial cancer (1st-line)
(DUO-E) Dual primary endpoint met
Lynparza +
cediranib
Platinum-resistant or -refractory
ovarian cancer (GY005) Primary endpoint not met
Imfinzi
Resectable, early-stage and locally
advanced gastric and
gastroesophageal junction cancers
(MATTERHORN)
Key secondary endpoint met
(pCR29)
datopotamab
deruxtecan
NSCLC (2nd- and 3rd-line)
(TROPION-Lung01) Dual primary endpoint met (PFS30)
Upcoming pipeline catalysts
24 Heart failure with preserved ejection fraction.
25 Neurofibromatosis type 1 plexiform neurofibromas.
26 Paroxysmal nocturnal haemoglobinuria.
27 Extravascular haemolysis.
28 Epidermal growth factor receptor mutation.
29 Pathologic complete response.
30 Progression free survival.
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For a table of anticipated timings of key trial readouts, please refer to page 2 of the Clinical Trials Appendix,
available on www.astrazeneca.com/investor-relations.html.
Other pipeline updates
The clinical development programme for brazikumab in inflammatory bowel diseases was discontinued following
a review of brazikumab's development timeline.
A Phase III trial for Fasenra in bullous pemphigoid was discontinued for futility (efficacy).
Table 4: Phase III trials started since 1 January 2023
Medicine Trial name Indication
datopotamab
deruxtecan
AVANZAR NSCLC (1st-line)
TROPION-Lung07 Non-squamous NSCLC (1st-line)
camizestrant CAMBRIA-1 HR-positive/HER2-negative adjuvant breast cancer
Tezspire CROSSING Eosinophilic oesophagitis
AZD3152 SUPERNOVA COVID-19 prophylaxis
Ultomiris ARTEMIS Cardiac surgery-associated acute kidney injury
Breztri LITHOS Mild to moderate asthma
pMDI31 portfolio HFO1234ze Mucociliary clearance in healthy volunteers
pMDI portfolio HFO1234ze Well-controlled or partially-controlled asthma
Corporate and business development
As announced in April 2023, the contractual relationship between AstraZeneca and Swedish Orphan Biovitrum
AB (Sobi) relating to future sales of Beyfortus (nirsevimab) in the US has been replaced by a royalty relationship
between Sanofi and Sobi. As a result, a non-current other payable representing AstraZeneca's future obligations
to Sobi was eliminated from AstraZeneca 's Statement of Financial Position in the quarter , and AstraZeneca
recorded a gain of $712m in Core Other operating income.
In June 2023, AstraZeneca entered into an exclusive option and license agreement with Quell Therapeutics to
develop multiple engineered T-regulator cell therapies that have the potential to be curative in Type -1 diabetes
and inflammatory bowel disease indications.
In July 2023, AstraZeneca and Ionis Pharmaceuticals Inc. expanded their existing collaboration on eplontersen
to also include Latin America. AstraZeneca will pay Ionis $20m for the right to commercialise eplontersen in this
region.
In July 2023, AstraZeneca and Vaxess Technologies Inc. commenced a collaboration for the evaluation of a
novel RNA-based pandemic influenza prototype vaccine in patch format. The collaboration is a part of a broader
development programme based on AstraZeneca 's February 2023 agreement with the US Government's
Department of Defense via the MCDC Consortium , with funding from the Biomedical Advanced Research and
Development Authority, to develop an RNA-based pandemic influenza vaccine.
In July 2023, Alexion, AstraZeneca Rare Disease (Alexion) and Pfizer Inc. (Pfi zer) entered into an agreement
for Alexion to purchase and licence the assets of Pfizer 's early-stage rare disease gene therapy portfolio for a
total consideration of up to $1bn, plus tiered royalties on sales. Alexion plans to close the transaction in Q3
2023, subject to the satisfaction of closing conditions.
Sustainability summary
In July 2023, AstraZeneca announced a $400m investment in AstraZeneca's AZ Forest programme, raising its
commitment to plant 200 million trees by 2030. Global projects involve local communities and ecological experts
to deliver reforestation at scale, as well as to support biodiversity and to sustain livelihoods.
Management changes
31 Pressure metered dose inhaler.
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Sharon Barr , currently Senior Vice President, Head of Research and Product Development of Alexion, will
succeed Mene Pangalos as Executive Vice President, BioPharmaceuticals R&D. Mene is retiring and will step
down from his role early next year, after almost fourteen years with the company and an illustrious 35 -year
career. Sharon will report to Chief Executive Officer, Pascal Soriot and become a member of AstraZeneca 's
Senior Executive Team as of 1 August.
Conference call
A conference call and webcast for investor s and analysts will begin today, 28 July 2023, at 11:45 UK time.
Details can be accessed via astrazeneca.com.
Reporting calendar
The Company intends to publish its nine month and third quarter results on Thursday 9 November 2023.
Operating and financial review
All narrative on growth and results in this section is based on actual foreign exchange rates, and financial figures
are in US$ millions ($m), unless stated otherwise. Unless stated othe rwise, t he performance shown in this
announcement covers the six-month period to 30 June 2023 ('the half' or 'H1 2023') compared to the six-month
period to 30 June 2022 ('H1 2022'), or the three -month period to 30 June 2023 ( 'the quarter ' or 'Q2 2023 ')
compared to the three-month period to 30 June 2022 (Q2 2022).
Core financial measures, EBITDA, Net debt, Product Sales Gross Margin (previously termed as Gross Margin),
Operating Margin and CER are non-GAAP financial measures because they cannot be derived directly from the
Group's Interim Financial Statements. Management believes that these non-GAAP financial measures, when
provided in combination with Reported results, provide investors and analysts with helpful supplementary
information to understand better the financial performance and position of the Group on a comparable basis
from period to period. These non -GAAP financial measures are not a substitute for, or superior to, financial
measures prepared in accordance with GAAP.
Core financial measures are adjusted to exclude certain significant items, such as:
‒ Amortisation and impairment of intangible assets, including impairment reversals but excluding any charges
relating to IT assets
‒ Charges and provisions related to restructuring programmes, which includes charges that relate to the impact
of restructuring programmes on capitalised IT assets
‒ Alexion acquisition -related items, primarily fair value adjustments on acquired inventories and fair value
impact of replacement employee share awards
‒ Other specified items, principally the imputed finance charge s and fair value movements relating to
contingent consideration on business combinations , imputed finance charges and reme asurement
adjustments on certain Other payables arising from intangible asset acquisitions , legal settlements and
remeasurement adjustments relating to certain 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 63 of the Annual Report and Form 20-F
Information 2022.
Reference should be made to the Reconciliation of Reported to Core financial measures table included in the
financial performance section in this announcement.
Product Sales Gross Margin (previously termed Gross Ma rgin) is the percentage by which Product Sales
exceeds the Cost of Sales, calculated by dividing the difference between the two by the sales figure. The
calculation of Reported and Core Product Sales Gross Margin excludes the impact of Alliance Revenue and
Collaboration Revenue and any associated costs, thereby reflecting the underlying performance of Product
Sales.
EBITDA is defined as Reported Profit before tax after adding back Net finance expense, results from Joint
ventures and associates and charges for Depreciation, amortisation and impairment. Reference should be made
to the Reconciliation of Reported Profit before tax to EBITDA included in the financial performance section in
this announcement.
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Operating margin is defined as Operating profit as a percentage of Total Revenue.
Net debt is defined as Interest -bearing loans and borrowings and Lease liabilities, net of Cash and cash
equivalents, Other investments, and Net derivative financial instruments. Reference should be made to Note 3
'Net debt' included in the Notes to the Interim Financial Statements in this announcement.
The Company strongly encourages investors and analysts not to rely on any single financial measure, but to
review AstraZeneca's financial statements, including the Notes thereto, and other available Company reports,
carefully and in their entirety.
Due to rounding, the sum of a number of dollar values and percentages in this announcement may not agree to
totals.
Total Revenue
Table 5: Therapy area and medicine performance - Product Sales and Total Revenue
H1 2023 Q2 2023
% Change % Change
Product Sales $m % Total Actual CER $m % Total Actual CER
Oncology 8,302 37 17 21 4,382 38 18 22
- Tagrisso 2,915 13 8 12 1,491 13 7 10
- Imfinzi 32 1,976 9 53 57 1,076 9 55 58
- Lynparza 1,368 6 6 10 717 6 7 9
- Calquence 1,185 5 31 33 653 6 34 34
- Enhertu 104 - >3x >3x 67 1 >3x >3x
- Orpathys 22 - (7) - 13 - 22 30
- Zoladex 459 2 (4) 4 233 2 (1) 5
- Faslodex 153 1 (14) (7) 78 1 (8) (3)
- Others 120 1 (37) (33) 54 - (42) (39)
BioPharmaceuticals: CVRM 5,205 23 14 19 2,675 23 14 18
- Farxiga 2,804 13 33 39 1,505 13 36 41
- Brilinta 665 3 (1) 1 331 3 (5) (3)
- Lokelma 198 1 53 59 100 1 51 55
- roxadustat 134 1 48 59 73 1 46 56
- Andexxa 89 - 28 33 45 - 23 26
- Crestor 585 3 7 14 280 2 - 5
- Seloken/Toprol-XL 343 2 (27) (20) 164 1 (26) (21)
- Onglyza 127 1 (8) (4) 65 1 (9) (6)
- Bydureon 89 - (37) (37) 43 - (41) (41)
- Others 171 1 (13) (10) 69 1 (30) (28)
BioPharmaceuticals: R&I 3,066 14 6 10 1,483 13 7 10
- Symbicort 1,288 6 - 4 600 5 (2) 1
- Fasenra 744 3 12 14 406 4 15 16
- Breztri 307 1 71 76 163 1 75 79
- Saphnelo 115 1 >3x >3x 68 1 >2x >2x
- Tezspire 30 - n/m n/m 19 - n/m n/m
- Pulmicort 346 2 4 11 124 1 7 13
- Bevespi 29 - (1) (1) 15 - (1) (3)
- Daliresp/Daxas 30 - (72) (72) 17 - (71) (70)
- Others 177 1 (30) (26) 71 1 (34) (32)
BioPharmaceuticals: V&I 443 2 (84) (83) 88 1 (91) (90)
- COVID-19 mAbs33 126 1 (86) (85) (1) - n/m n/m
- Vaxzevria 28 - (98) (98) - - n/m n/m
- Beyfortus 2 - n/m n/m 2 - n/m n/m
- Synagis 284 1 1 8 87 1 8 16
- FluMist 3 - n/m n/m - - n/m n/m
32 Product Sales shown in the Imfinzi line include Product Sales from Imjudo
33 COVID-19 monoclonal antibodies. In H1 2023, all COVID-19 mAbs Product Sales were generated from sales of Evusheld
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Rare Disease 3,819 17 9 12 1,953 17 8 10
- Soliris 1,648 7 (18) (16) 814 7 (21) (19)
- Ultomiris 1,364 6 60 64 713 6 64 66
- Strensiq 562 3 25 26 300 3 24 25
- Koselugo 159 1 57 57 80 1 28 30
- Kanuma 86 - 16 17 46 - 28 30
Other Medicines 613 3 (27) (22) 301 3 (28) (24)
- Nexium 492 2 (27) (22) 248 2 (28) (23)
- Others 121 1 (28) (25) 53 - (29) (27)
Product Sales 21,448 96 (1) 3 10,882 95 2 5
Alliance Revenue 627 3 >2x >2x 341 3 >2x >2x
Collaboration Revenue 220 1 (16) (15) 193 2 n/m n/m
Total Revenue 22,295 100 1 4 11,416 100 6 9
Table 6: Alliance Revenue
H1 2023 Q2 2023
% Change % Change
$m % Total Actual CER $m % Total Actual CER
Enhertu 475 76 >2x >2x 255 75 >2x >2x
Tezspire 105 17 >6x >6x 62 18 >4x >4x
Vaxzevria: royalties - - n/m n/m - - n/m n/m
Other royalty income 41 7 19 18 22 6 15 13
Other Alliance Revenue 6 1 57 62 2 1 (21) (17)
Total 627 100 >2x >2x 341 100 >2x >2x
Table 7: Collaboration Revenue
H1 2023 Q2 2023
% Change % Change
$m % Total Actual CER $m % Total Actual CER
COVID-19 mAbs: licence fees 180 82 n/m n/m 180 93 n/m n/m
Farxiga: sales milestones 25 11 n/m n/m 1 1 n/m n/m
Other Collaboration Revenue 15 7 (3) (1) 12 6 >4x >4x
Total 220 100 (16) (15) 193 100 n/m n/m
Table 8: Total Revenue by therapy area
H1 2023 Q2 2023
% Change % Change
$m % Total Actual CER $m % Total Actual CER
Oncology 8,794 39 18 22 4,646 41 22 25
BioPharmaceuticals
9,051 41 (13) (9) 4,506 39 (5) (2)
- CVRM
5,239 24 14 20 2,682 23 14 18
- R&I 3,180 14 7 10 1,547 14 11 14
- V&I
632 3 (77) (76) 278 2 (72) (71)
Rare Disease
3,819 17 9 12 1,953 17 8 10
Other Medicines
631 3 (27) (22) 311 3 (27) (23)
Total
22,295 100 1 4 11,416 100 6 9
Table 9: Total Revenue by region
H1 2023 Q2 2023
% Change % Change
$m % Total Actual CER $m % Total Actual CER
US 9,081 41 7 7 4,782 42 10 10
Emerging Markets 6,277 28 2 9 3,115 27 12 19
- China 3,043 14 - 7 1,441 13 - 7
- Ex-China 3,234 15 4 11 1,674 15 23 32
Europe 4,373 20 - 3 2,211 19 6 6
Established RoW 2,564 11 (19) (11) 1,308 11 (16) (9)
===== SIDA 10 =====
10
Total 22,295 100 1 4 11,416 100 6 9
Table 10: Total Revenue by region - excluding COVID-19 medicines
H1 2023 Q2 2023
% Change % Change
$m % Total Actual CER $m % Total Actual CER
US 9,081 41 16 16 4,782 43 17 17
Emerging Markets 6,074 28 14 22 2,938 26 13 21
- China 3,043 14 1 9 1,441 13 1 7
- Ex-China 3,031 14 30 38 1,497 13 28 39
Europe 4,356 20 10 13 2,208 20 18 18
Established RoW 2,450 11 (2) 8 1,309 12 1 8
Total 21,961 100 12 16 11,237 100 14 17
Oncology
Oncology Total Revenue of $8,794m in H1 2023 increased by 18% (22% at CER), representing 39% of overall
Total Revenue (H1 2022: 34%). There was no Lynparza Collaboration Revenue in H1 2023 (H1 2022: $175m),
and Enhertu Alliance Revenue was $475m (H1 2022: $175m). Product Sales increased by 17% (21% at CER)
in H1 2023 to $8,302m, reflecting new launches and increased patient access across key brands; partially offset
by declines in legacy medicines.
Tagrisso
Total Revenue Worldwide US Emerging Markets Europe Established RoW
H1 2023 $m 2,915 1,102 851 541 421
Actual change 8% 16% 6% 6% (4%)
CER change 12% 16% 13% 9% 6%
Region Drivers and commentary
Worldwide Increased global demand use of Tagrisso in adjuvant and 1st-line settings
US Growth driven by increasing demand in 1st-line and adjuvant settings
Emerging Markets Growing demand in adjuvant and 1st-line settings in China, partially offset by impact of first
full quarter of NRDL34 renewal price effective March 2023 and competition
Europe Established standard of care in 1st-line and adjuvant settings across EU535, with increased
adjuvant treatment rates in region
Established RoW Further use in 1st-line setting and launch acceleration in adjuvant setting offset by mandatory
price reduction in Japan effective June 2023
Imfinzi and Imjudo
Total Revenue Worldwide US Emerging Markets Europe Established RoW
H1 2023 $m 1,976 1,098 183 339 356
Actual change 53% 60% 37% 27% 74%
CER change 57% 60% 47% 30% 92%
Region Drivers and commentary
Worldwide Includes $100m of Total Revenue in the half from Imjudo, which launched in Q4 2022
following approvals in the US for patients with unresectable liver cancer (HIMALAYA) and
Stage IV NSCLC (POSEIDON)
34 National reimbursement drug list.
35 France, Germany, Italy, Spain, UK.
===== SIDA 11 =====
11
Strong growth across all regions, driven by recent launches (BTC36, HCC37, Stage IV
NSCLC) and established indications (Stage III NSCLC, SCLC38)
US Continued demand growth driven primarily by BTC and HCC launches (Q3 2022 and Q4
2022 respectively)
Emerging Markets Growth across markets driven by BTC launches and recovery of diagnosis and treatment
rates following the COVID-19 pandemic
Europe Strong demand growth in SCLC, gaining share from competitors and expanded
reimbursement for new launch indications
Established RoW Strong demand growth driven by BTC and HCC
Lynparza
Total Revenue Worldwide US Emerging Markets Europe Established RoW
H1 2023 $m 1,368 580 278 365 145
Actual change (7%) - 15% (28%) 5%
CER change (4%) - 23% (25%) 15%
Product Sales Worldwide US Emerging Markets Europe Established RoW
H1 2023 $m 1,368 580 278 365 145
Actual change 6% - 15% 11% 5%
CER change 10% - 23% 14% 15%
Region Drivers and commentary
Worldwide Lynparza remains the leading medicine in the PARP39 inhibitor class globally across four
tumour types, as measured by total prescription volume
No regulatory milestones received in H1 2023
US Continued share growth within PARP inhibitor class, offset by reduced overall class use in
2nd-line ovarian cancer and flattening of HRD40 testing rates in ovarian cancer
Emerging Markets Increased demand in China offset by price reduction associated with NRDL re-enlistment
that took effect in Q1 2023 for ovarian cancer indications (PSR41 and BRCAm42 1st-line
maintenance) and new NRDL enlistment in prostate cancer (PROfound)
Europe Growth driven by increased uptake in 1st-line HRD-positive ovarian cancer, gBRCAm43
HER2-negative early breast cancer and mCRPC, partially offset by reduced use in 2nd-line
ovarian cancer
Total Revenue in the prior year period included a $175m milestone in Collaboration Revenue
Established RoW Growth driven by increased uptake in 1st-line HRD-positive ovarian cancer
Enhertu
Total Revenue Worldwide US Emerging Markets Europe Established RoW
H1 2023 $m 580 339 108 125 8
Actual change >2x >2x >4x >2x >3x
CER change >2x >2x >4x >2x >3x
Region Drivers and commentary
Worldwide Combined sales of Enhertu, recorded by Daiichi Sankyo Company Limited (Daiichi Sankyo)
and AstraZeneca, amounted to $1,169m in H1 2023 (H1 2022: $436m)
36 Biliary tract cancer.
37 Hepatocellular carcinoma.
38 Small cell lung cancer.
39 Poly ADP ribose polymerase.
40 Homologous recombination deficiency.
41 Platinum sensitive relapse.
42 Breast cancer gene mutation.
43 Germline (hereditary) breast cancer gene mutation.
===== SIDA 12 =====
12
AstraZeneca's Total Revenue of $580m in the half includes $475m of Alliance Revenue from
its share of gross profit and royalties in territories where Daiichi Sankyo records product
sales
US US in-market sales, recorded by Daiichi Sankyo, amounted to $712m in the half (H1
2022: $274m)
Rapid adoption as new standard of care across all launched indications including HER2-low
mBC44 with continued demand from metastatic breast cancer indications as well as
additional use in gastric and lung cancer
Emerging Markets Strong uptake driven by new approvals and launches
Europe Continued growth driven by increased adoption of HER2-positive and HER2-low metastatic
breast indications
Established RoW In Japan, AstraZeneca receives a mid-single-digit percentage royalty on sales made by
Daiichi Sankyo
Calquence
Total Revenue Worldwide US Emerging Markets Europe Established RoW
H1 2023 $m 1,185 869 41 225 50
Actual change 31% 18% >2x 85% 64%
CER change 33% 18% >2x 92% 75%
Region Drivers and commentary
Worldwide Increased penetration globally; leading BTKi45 in key markets
US Leadership maintained in growing BTKi class, sustained leading share in front line, offset by
impact from competition in relapsed refractory setting
EU Solid growth continued amidst growing competitive pressure
Increasing new patient starts following expanded access in key markets
Orpathys
Total Revenue of $22m (H1 2022: $24m) was driven by its inclusion in the updated NRDL in China from March
2023, for the treatment of patients with NSCLC with MET46 exon 14 skipping alterations.
Other Oncology medicines
H1 2023 Change
Total Revenue $m Actual CER
Zoladex 475 (3%) 5% Increased demand in Emerging Markets
Faslodex 153 (14%) (7%) Generic competition
Other Oncology 120 (37%) (33%) Includes Iressa, Arimidex, Casodex and other older medicines
BioPharmaceuticals
BioPharmaceuticals Total Revenue decreased by 13% (9% at CER) in H1 2023 to $9,051m, representing 41%
of overall Total Revenue ( H1 2022: 4 7%). Strong g rowth from Farxiga and newer R&I medicines offset
decreases in revenues from COVID-19 medicines and some older products.
BioPharmaceuticals - CVRM
CVRM Total Revenue increased by 14% (20% at CER) to $5,239m in H1 2023, driven by the strong Farxiga
performance, and represented 24% of overall Total Revenue (H1 2022: 21%).
Farxiga
Total Revenue Worldwide US Emerging Markets Europe Established RoW
44 Metastatic breast cancer.
45 Bruton tyrosine kinase inhibitor.
46 Mesenchymal-epithelial transition.
===== SIDA 13 =====
13
H1 2023 $m 2,834 634 1,076 850 274
Actual change 35% 35% 32% 36% 39%
CER change 40% 35% 41% 40% 52%
Region Drivers and commentary
Worldwide
Farxiga volume is growing faster than the overall SGLT247 market in all major regions, fuelled
by heart failure and CKD48 launches
Additional benefit from continued growth in the overall SGLT2 inhibitor class
US Growth driven by HFrEF49 and CKD for patients with and without T2D50 resulting in an
increasing market share
Emerging Markets Solid growth despite generic competition in some markets
Europe Benefited from the addition of cardiovascular outcomes trial data to the label and growth in
HFrEF, CKD and the HFpEF approval in February 2023
Continued strong volume growth in the quarter and expanded class leadership in several key
markets
Established RoW In Japan, AstraZeneca sells to collaborator Ono Pharmaceutical Co., Ltd, which records in-
market sales. Continued volume growth driven by HF and CKD launches
A sales milestone payment from Ono was recorded in the quarter
Brilinta
Total Revenue Worldwide US Emerging Markets Europe Established RoW
H1 2023 $m 665 357 160 136 12
Actual change (1%) 2% 10% (9%) (57%)
CER change 1% 2% 17% (7%) (53%)
Region Drivers and commentary
US Sales in the second quarter impacted by an unfavourable gross-to-net adjustment
Emerging Markets Growth in all major Emerging Markets regions following COVID-19 recovery
Europe European sales partly impacted by clawbacks
Established RoW Sales decline in the second quarter driven by generic entry in Canada
Lokelma
Total Revenue increased 53% (59% at CER) to $198m in H1 2023 with strong volume growth in all regions. In
China, Lokelma was enlisted to the NRDL in January 2022 and is now the leading potassium binder in the
country.
Roxadustat
Total Revenue increased 46% (57% at CER) to $137m , with roxadustat benefitting from increased volumes in
China following NRDL renewal in 2022.
Andexxa
Total Revenue increased 12% (16% at CER) to $89m.
Other CVRM medicines
H1 2023 Change
Total Revenue $m Actual CER
Crestor 586 7% 14% Strong sales growth in Emerging Markets, partly offset by declines
in the US and Established RoW
47 Sodium-glucose cotransporter 2.
48 Chronic kidney disease.
49 Heart failure with reduced ejection fraction.
50 Type-2 diabetes.
===== SIDA 14 =====
14
Seloken 343 (27%) (20%) Ongoing impact of China VBP51 implementation
Onglyza 127 (8%) (4%) Continued decline for DPP-IV52 class
Bydureon 89 (37%) (37%) Continued competitive pressures
Other CVRM 171 (13%) (10%)
BioPharmaceuticals - R&I
Total Revenue of $3,180m from R&I medicines in H1 2023 increased 7% (10% at CER) and represented 14%
of overall Total Revenue ( H1 2022: 13%). This reflected growth in Fasenra, Tezspire, Breztri and Saphnelo,
and stable performances from Symbicort and Pulmicort.
Fasenra
Total Revenue Worldwide US Emerging Markets Europe Established RoW
H1 2023 $m 744 468 29 176 71
Actual change 12% 12% 66% 15% (2%)
CER change 14% 12% 70% 19% 7%
Region Drivers and commentary
Worldwide Retained market share leadership in severe eosinophilic asthma in major markets
US Maintained share of a growing market, leading to strong volume growth
Emerging Markets Continues strong volume growth driven by launch acceleration across key markets
Europe Expanded leadership in severe eosinophilic asthma, with strong volume growth partially
offset by price impact in some markets
Established RoW Maintained leadership in Japan
Breztri
Total Revenue Worldwide US Emerging Markets Europe Established RoW
H1 2023 $m 307 165 81 36 25
Actual change 71% 55% 88% >2x 53%
CER change 76% 55% >2x >2x 65%
Region Drivers and commentary
Worldwide Continues to gain market share within the growing FDC53 triple class across major markets
US Consistent share growth within the FDC triple class in new-to-brand54 and total market
Emerging Markets Maintained market share leadership in China with strong triple FDC class penetration
Europe Sustained growth across markets as new launches continue to progress
Established RoW Increasing market share gains within COPD55 in Japan, and strong launch performance in
Canada
Tezspire
Total Revenue Worldwide US Emerging Markets Europe Established RoW
H1 2023 $m 135 105 - 17 13
Actual change >8x >6x n/m n/m n/m
CER change >8x >6x n/m n/m n/m
Region Drivers and commentary
51 Volume-based procurement.
52 Dipeptidyl peptidase IV.
53 Fixed dose combination.
54 ‘New-to-brand’ share represents a medicine’s share in the dynamic market.
55 Chronic obstructive pulmonary disease.
===== SIDA 15 =====
15
Worldwide Tezspire is approved in the US, EU and Japan (as well as other countries) for the treatment
of severe asthma without biomarker or phenotypic limitation
Amgen records sales in the US, and AstraZeneca records its share of US gross profits as
Alliance Revenue. AstraZeneca books Product Sales in markets outside the US
Combined sales of Tezspire by AstraZeneca and Amgen were $257m in H1 2023
US Increasing new-to-brand market share with majority of patients new to biologics
Pre-filled pen approved in February 2023
Europe Achieved and maintained new-to-brand leadership in key markets
Pre-filled pen approved in January 2023
Established RoW Japan maintained new-to-brand leadership
Saphnelo
Total Revenue Worldwide US Emerging Markets Europe Established RoW
H1 2023 $m 115 107 1 3 4
Actual change >3x >3x n/m >4x >4x
CER change >3x >3x n/m >4x >4x
Region Drivers and commentary
Worldwide Demand acceleration in the US, and additional growth driven by ongoing launches in Europe
and Japan
Symbicort
Total Revenue Worldwide US Emerging Markets Europe Established RoW
H1 2023 $m 1,288 434 405 284 165
Actual change - (10%) 32% (9%) (13%)
CER change 4% (10%) 43% (6%) (6%)
Region Drivers and commentary
Worldwide Symbicort remains the global market leader within a stable ICS56/LABA57 class
US Market share resilience, consolidating leadership in a stable ICS/LABA market
Generic entry expected in the US in H2 2023
Emerging Markets Strong underlying demand across markets. Post-COVID-19 recovery in China and channel
inventory rebuild supported by leading share performance
Europe Continued price and volume erosion from generics and a slowing overall market
Established RoW Inventory destocking in some markets and generic erosion in Japan
Other R&I medicines
H1 2023 Change
Total Revenue $m Actual CER
Pulmicort 346 4% 11% Approximately 80% of revenues from Emerging Markets
China market share has stabilised, with VBP having been in effect
for over 12 months
Strong growth in Asia, Latin America and Middle East
Bevespi 29 (1%) (1%)
Daliresp 30 (72%) (72%) Impacted by uptake of multiple generics following loss of exclusivity
in the US
Other R&I 187 (43%) (40%) Collaboration Revenue of $nil (H1 2022: $70m)
Product Sales of $177m decreased 30% (26% at CER) due to
generic competition
56 Inhaled corticosteroid.
57 Long-acting beta-agonist.
===== SIDA 16 =====
16
BioPharmaceuticals - V&I
Total Revenue from V&I medicines declined by 77% (76% at CER) to $63 2m (H1 2022 : $2,795m) and
represented 3% of overall Total Revenue (H1 2022: 13%).
COVID-19 mAbs
Total Revenue Worldwide US Emerging Markets Europe Established RoW
H1 2023 $m 306 - 185 7 114
Actual change (67%) n/m 98% (95%) (6%)
CER change (65%) n/m 98% (95%) 6%
Region Drivers and commentary
Worldwide All Product Sales in H1 2023 were derived from sales of Evusheld in the first quarter
Emerging Markets $180m license fee from SII in Q2 2023, recorded as Collaboration Revenue
Vaxzevria
Total Revenue Worldwide US Emerging Markets Europe Established RoW
H1 2023 $m 28 - 18 10 -
Actual change (98%) n/m (97%) (96%) n/m
CER change (98%) n/m (97%) (96%) n/m
Region Drivers and commentary
Worldwide Revenue in the period decreased by 98% due to the conclusion of Vaxzevria contracts
Other V&I medicines
H1 2023 Change
Total Revenue $m Actual CER
Beyfortus 2 n/m n/m The first sales to Sanofi of Beyfortus product manufactured by
AstraZeneca were booked as Product Sales in Q2 2023
AZ will also earn 50% of gross profits on sales of Beyfortus in major
markets outside the US, and 25% of revenues in rest of world
markets, which will be recorded as Alliance Revenue. AstraZeneca
has no participation in US profits or losses
Synagis 284 1% 8% Early start to RSV season in Japan
FluMist 13 n/m n/m $10m milestone received from Daiichi Sankyo in the second quarter
following FluMist approval in Japan
Rare Disease
Total Revenue from Rare Disease medicines increased by 9% (1 2% at CER) in H1 2023 to $ 3,819m,
representing 17% of overall Total Revenue (H1 2022: 16%).
Performance was driven by the continued growth and durability of the C558 franchise as well as the strength of
Strensiq patient demand.
Ultomiris
Total Revenue Worldwide US Emerging Markets Europe Established RoW
H1 2023 $m 1,364 815 30 311 208
Actual change 60% 79% - 38% 46%
CER change 64% 79% 2% 42% 62%
Region Drivers and commentary
Worldwide Growth in neurology indications, expansion into new markets and continued conversion from
Soliris
58 Complement component 5.
===== SIDA 17 =====
17
Quarter-on-quarter variability in revenue growth can be expected due to Ultomiris every
eight-week dosing schedule and lower average annual treatment cost per patient compared
to Soliris
US Growth in neurology indications as well as successful conversion from Soliris across PNH,
aHUS59 and gMG
Emerging Markets Launch in new markets
Europe Strong demand generation following new launch markets as well as accelerated conversion
in key markets
Established RoW Continued conversion from Soliris and strong demand following new launches
Soliris
Total Revenue Worldwide US Emerging Markets Europe Established RoW
H1 2023 $m 1,648 893 214 367 174
Actual change (18%) (23%) 60% (16%) (38%)
CER change (16%) (23%) 76% (14%) (33%)
Region Drivers and commentary
US Performance impacted by successful conversion of Soliris patients to Ultomiris in PNH,
aHUS and gMG, partially offset by Soliris growth in NMOSD
Emerging Markets Expansion into new markets as well as favourable timing of tender orders in some markets
Europe
Established RoW
Successful conversion from Soliris to Ultomiris, partially offset by growth in NMOSD
Strensiq
Total Revenue Worldwide US Emerging Markets Europe Established RoW
H1 2023 $m 562 453 24 42 43
Actual change 25% 28% 33% 5% 12%
CER change 26% 28% 26% 8% 23%
Region Drivers and commentary
Worldwide Strong patient demand as well as geographic expansion
Other Rare Disease medicines
H1 2023 Change
Total Revenue $m Actual CER Commentary
Koselugo 159 57% 57% Expansion in new markets
Kanuma 86 16% 17% Continued demand growth in ex-US markets
Other medicines (outside the main therapy areas)
H1 2023 Change
Total Revenue $m Actual CER Commentary
Nexium 500 (27%) (22%) Generic launches in Japan in the latter part of 2022
Others 131 (26%) (23%) Continued impact of generic competition
Financial performance
Table 11: Reported Profit and Loss
H1 2023 H1 2022 % Change Q2 2023 Q2 2022 % Change
$m $m Actual CER $m $m Actual CER
59 Atypical haemolytic uraemic syndrome.
===== SIDA 18 =====
18
Total Revenue 22,295 22,161 1 4 11,416 10,771 6 9
- Product Sales 21,448 21,610 (1) 3 10,882 10,630 2 5
- Alliance Revenue 627 290 >2x >2x 341 138 >2x >2x
- Collaboration Revenue 220 261 (16) (15) 193 3 n/m n/m
Cost of sales (3,865) (6,509) (41) (41) (1,960) (2,998) (35) (38)
Gross profit 18,430 15,652 18 24 9,456 7,773 22 28
Product Sales Gross Margin 82.0% 69.9% +12pp +13pp 82.0% 71.8% +10pp +12pp
Distribution expense (265) (254) 4 8 (131) (129) 1 4
% Total Revenue 1.2% 1.1% - - 1.1% 1.2% - -
R&D expense (5,278) (4,679) 13 16 (2,667) (2,546) 5 7
% Total Revenue 23.7% 21.1% -3pp -2pp 23.4% 23.6% - -
SG&A expense (9,045) (9,521) (5) (2) (4,986) (4,681) 6 8
% Total Revenue 40.6% 43.0% +2pp +3pp 43.7% 43.5% - -
OOI60 & expense 1,163 219 >5x >5x 784 122 >6x >6x
% Total Revenue 5.2% 1.0% +4pp +4pp 6.9% 1.1% +6pp +6pp
Operating profit 5,005 1,417 >3x >4x 2,456 539 >4x >6x
Operating Margin 22.4% 6.4% +16pp +17pp 21.5% 5.0% +17pp +19pp
Net finance expense (654) (612) 7 4 (367) (293) 25 17
Joint ventures and associates (1) (5) (71) (69) (1) 1 n/m n/m
Profit before tax 4,350 800 >5x >6x 2,088 247 >8x n/m
Taxation (726) (52) n/m n/m (268) 113 n/m n/m
Tax rate 17% 7% 13% -46%
Profit after tax 3,624 748 >4x >6x 1,820 360 >5x >9x
Earnings per share $2.34 $0.48 >4x >6x $1.17 $0.23 >5x >9x
Table 12: Reconciliation of Reported Profit before tax to EBITDA
H1 2023 H1 2022 % Change Q2 2023 Q2 2022 % Change
$m $m Actual CER $m $m Actual CER
Reported Profit before tax 4,350 800 >5x >6x 2,088 247 >8x n/m
Net finance expense 654 612 7 4 367 293 25 17
Joint ventures and associates 1 5 (71) (69) 1 (1) n/m n/m
Depreciation, amortisation and
impairment
2,778 2,666 4 7 1,276 1,357 (6) (4)
EBITDA 7,783 4,083 91 >2x 3,732 1,896 97 >2x
EBITDA for the comparative H1 2022 was negatively impacted by $2,318m unwind of inventory fair value uplift
recognised on the acquisition of Alexion . EBITDA for the comparative Q2 2022 was negatively impacted by
$1,138m unwind of inventory fair value uplift recognised on the acquisition of Alexion. This unwind had a $55m
negative impact on H1 2023 and a $19m negative impact on Q2 2023. It will continue to be minimal in future
quarters and will unwind fully over the next two quarters.
Table 13: Reconciliation of Reported to Core financial measures: H1 2023
H1 2023
Reported Restructuring
Intangible Asset
Amortisation &
Impairments
Acquisition
of Alexion Other61 Core Core
% Change
$m $m $m $m $m $m Actual CER
Gross profit 18,430 118 16 57 (3) 18,618 3 8
60 Other Operating Income.
61 Other adjustments include fair-value adjustments relating to contingent consideration on business combinations and other acquisition -
related liabilities, discount unwind on acquisition-related liabilities (see Note 4) and provision movements related to certain legal matters,
including a $510m charge to provisions relating to a legal settlement with BMS and Ono in Q2 2023 (see Note 6).
===== SIDA 19 =====
19
Product Sales
Gross Margin 82.0% 82.9% +2pp +3pp
Distribution
expense
(265) - - - - (265) 5 8
R&D expense (5,278) 69 337 3 1 (4,868) 5 9
SG&A expense (9,045) 102 1,906 4 683 (6,350) 4 8
Total operating
expense
(14,588) 171 2,243 7 684 (11,483) 5 8
Other operating
income & expense
1,163 (61) - - - 1,102 >5x >5x
Operating profit 5,005 228 2,259 64 681 8,237 12 20
Operating Margin 22.4% 36.9% +4pp +5pp
Net finance
expense
(654) - - - 152 (502) 6 1
Taxation (726) (52) (428) (15) (204) (1,425) 14 22
EPS $2.34 $0.11 $1.18 $0.03 $0.41 $4.07 13 21
Table 14: Reconciliation of Reported to Core financial measures: Q2 2023
Q2 2023
Reported Restructuring
Intangible Asset
Amortisation &
Impairments
Acquisition
of Alexion Other61 Core Core
% Change
$m $m $m $m $m $m Actual CER
Gross profit 9,456 23 8 20 (5) 9,502 6 12
Product Sales
Gross Margin
82.0% 82.4% - +2pp
Distribution
expense
(131) - - - - (131) 1 4
R&D expense (2,667) 39 57 1 2 (2,568) 6 8
SG&A expense (4,986) 61 952 2 675 (3,296) 5 8
Total operating
expense
(7,784) 100 1,009 3 677 (5,995) 5 8
Other operating
income & expense
784 - - - - 784 >6x >6x
Operating profit 2,456 123 1,017 23 672 4,291 27 39
Operating Margin 21.5% 37.6% +6pp +8pp
Net finance
expense
(367) - - - 105 (262) 17 4
Taxation (268) (28) (197) (6) (195) (694) 44 62
EPS $1.17 $0.06 $0.53 $0.01 $0.38 $2.15 25 38
Profit and Loss drivers
Gross profit
‒ The calculation of Reported and Core Product Sales Gross Margin excludes the impact of Alliance Revenue
and Collaboration Revenue. The change in Product Sales Gross Margin (Reported and Core) in the half was
impacted by:
‒ Positive effects from product mix. The increased contribution from Rare Disease and Oncology medicines
had a positive impact on the Product Sales Gross Margin. Vaxzevria sales, which are dilutive to Product
Sales Gross Margin, declined substantially
‒ Dilutive effects from product mix. The rising contribution of Product Sales with profit sharing arrangements
(Lynparza, Enhertu and Tezspire) has a negative impact on Product Sales Gross Margin because
AstraZeneca records product revenues in certain markets but pays away a share of the gross profit to its
collaboration partners
‒ Dilutive effects from geographic mix. Emerging Markets, where Product Sales Gross Margin tends to be
below the Company average, grew as a proportion of Total Revenue excluding COVID-19 medicines
===== SIDA 20 =====
20
‒ Variations in Product Sales Gross Margin performance between periods can continue to be expected due to
product seasonality, foreign exchange fluctuations, cost inflation and other effects. The full impact of cost
inflation is not seen in the Income Statement until older inventory built at lower cost has been sold; for some
product lines the lag between inflation and impact can be several quarters
R&D expense
‒ The change in R&D expense (Reported and Core) in the half was impacted by:
‒ Recent 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 productivity
‒ Reported R&D expense was also impacted by intangible asset impairments
SG&A expense
‒ The change in SG&A expense (Reported and Core) in the half was driven primarily by market development
activities for launches
‒ Reported SG&A expense was also impacted by amortisation of intangible assets related to the Alexion
acquisition and other acquisitions and collaborations
‒ Reported SG&A expense was also impacted by a $510m charge to provisions relating to a legal settlement
in Q2 2023 and the prior year period was impacted by a $775m legal settlement with Chugai Pharmaceutical
Co. Ltd
Other operating income
‒ Reported and Core Other operating income in the half included a $712m gain resulting from an update to
the contractual relationships for Beyfortus (nirsevimab), a $241m gain on the disposal of the US rights to
Pulmicort Flexhaler, and other disposal proceeds on the sale of tangible assets , and royalties on certain
medicines
Net finance expense
‒ The increase in Net finance expense (Reported and Core) in the half was primarily driven by increased
interest expense on floating rate debt and the interest on the $3.8bn of bonds issued in the period, partially
offset by increased interest income on cash balances. Reported Net finance expense also increased due to
changes in the discount unwind on acquisition related liabilities
Taxation
‒ The effective Reported Tax rate for the half was 17% (H1 2022: 7%) and the Core Tax rate was 18% (H1
2022: 18%). The Reported Tax rate was lower in H1 2022 because Reported Tax rate is influenced by the
tax rates in territories where profit is earned and Reported Profit before tax was significantly lower during H1
2022 which increases the rate impact of benefits from items such as intellectual property incentive regimes
‒ The net cash paid for the half was $1,061m (H1 2022: $1,006m), representing 24% of Reported Profit before
tax (H1 2022: 126%)
‒ On 20 June 2023, Finance (No.2) Act 2023 was substantively enacted in the UK, introducing a global
minimum effective tax rate of 15%. The legislation implements a domestic top-up tax and a multinational top-
up tax, effective for accounting periods starting on or after 31 December 2023. The Company has applied
the exception under the IAS 12 'Income Taxes' amendment for recognising and disclosing information about
deferred tax assets and liabilities related to top -up income taxes. The Company is currently assessing the
impact of these rules upon its financial statements
Dividend
‒ An interim dividend of $ 0.93 per share (71.8 pence, 9.64 SEK) has been declared. Dividend payments are
normally paid as follows:
‒ First interim dividend - announced with half-year and second-quarter results and paid in September
‒ Second interim dividend - announced with full-year and fourth-quarter results and paid in March
===== SIDA 21 =====
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Table 15: Cash Flow summary
H1 2023 H1 2022 Change
$m $m $m
Reported Operating profit 5,005 1,417 3,588
Depreciation, amortisation and impairment 2,778 2,666 112
Decrease in working capital and short-term provisions (747) 2,391 (3,138)
Gains on disposal of intangible assets (249) (81) (168)
Fair value movements on contingent consideration arising from
business combinations
202 293 (91)
Non-cash and other movements (594) (814) 220
Interest paid (483) (386) (97)
Taxation paid (1,061) (1,006) (55)
Net cash inflow from operating activities 4,851 4,480 371
Net cash inflow before financing activities 3,085 3,512 (427)
Net cash outflow from financing activities (3,550) (5,035) 1,485
In H1 2022, the Reported Operating profit of $ 1,417m included a negative impact of $ 2,318m relating to the
unwind of the inventory fair value uplift recognised on the acquisition of Alexion. This was offset by a
corresponding item (positive impact of $ 2,318m) in decrease in working capital and short-term provisions.
Overall, the unwind of the fair value uplift had no impact on Net cash inflow from operating activities. This unwind
had $55m negative impact on H1 2023 Reported operating profit and offsetting positive impact on Working
capital movements, and will continue to be minimal in future quarters. As a result of the update to the contractual
relationships between AstraZeneca, Sobi and Sanofi relating to the future sales of Beyfortus (nirsevimab) in the
US, a gain of $712m has been recorded in non -cash and other movements , with no overall net impact on the
Net cash inflow from operating activities.
The change in Net cash inflow before financing activities is primarily driven by the movement in Purchase of
intangible assets of $1,436m, including the acquisition of CinCor, in the half year to 30 June 2023.
Included within Net cash inflow before financing activities is a movement in the profit -participation liability of
$175m, resulting from the cash receipt from Sobi in Q1 2023 after achievement of a regulatory milestone. The
associated cash flow is presented within investing activities.
The decrease in Net cash outflow from financing activities of $1,485m is primarily driven by the Issue of loans and borrowings of $3,816m, offset by the increase in Repayment of loans and borrowings of $2,151m.
Capital expenditure
Capital expenditure amounted to $517m in the half to 30 June 2023 (H1 2022: $472m).
Table 16: Net debt summary
At 30
Jun 2023
At 31
Dec 2022
At 30
Jun 2022
$m $m $m
Cash and cash equivalents 5,664 6,166 4,817
Other investmentss 148 239 70
Cash and investments 5,812 6,405 4,887
Overdrafts and short-term borrowings (421) (350) (747)
Lease liabilities (953) (953) (905)
Current instalments of loans (4,135) (4,964) (1,415)
Non-current instalments of loans (24,329) (22,965) (26,461)
Interest-bearing loans and borrowings (Gross debt) (29,838) (29,232) (29,528)
Net derivatives 56 (96) (48)
Net debt (23,970) (22,923) (24,689)
Net debt increased by $1,047m in the half to 30 June 2023 to $23,970m. Details of the committed undrawn
bank facilities are disclosed within the going concern section of Note 1. Details of the Company's solicited credit
ratings and further details on Net Debt are disclosed in Note 3.
===== SIDA 22 =====
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Capital allocation
The Board's aim is to continue to strike a balance between the interests of the business, financial creditors and
the Company's shareholders. The Company's capital allocation priorities include: investing in the business and
pipeline; maintaining a strong, investment-grade credit rating; potential value-enhancing business development
opportunities; and supporting the progressive dividend policy.
In approving the declaration of dividends, the Board considers both the liquidity of the company and the level of
reserves legally available for distribution. Dividends are paid to shareholders from AstraZeneca PLC, a Group
holding company with no direct operations. The ability of AstraZeneca PLC to make shareholder distributions is
dependent on the creation of profits for distribution and the receipt of funds from subsidiary companies. The
consolidated Group reserves set out in the Condensed consolidated statement of financial position do not reflect
the profit available for distribution to the shareholders of AstraZeneca PLC.
Summarised financial information for guarantee of securities of subsidiaries
AstraZeneca Finance LLC ("AstraZeneca Finance") is the issuer of 0.700% Notes due 2024, 1.200% Notes due
2026, 4.875% Notes due 2028, 1.750% Notes due 2028, 4.900% Notes due 2030, 2.250% Notes due 2031 and
4.875% Notes due 2033 (the "AstraZeneca Finance Notes "). Each series of AstraZeneca Finance Notes has
been fully and unconditionally guaranteed by AstraZeneca PLC. AstraZeneca Finance is 100% owned by
AstraZeneca PLC and each of the guarantees 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
with all of AstraZeneca Finance's existing and future senior unsecured and unsubordinated indebtedness. The
guarantee by AstraZeneca PLC of the AstraZen eca Finance Notes is the senior unsecured obligation of
AstraZeneca PLC and ranks equally with all of AstraZeneca PLC 's existing and future senior unsecured and
unsubordinated indebtedness. Each guarantee by AstraZeneca PLC is effectively subordinated to any secured
indebtedness of AstraZeneca PLC to the extent of the value of the assets securing such indebtedness. The
AstraZeneca Finance Notes are structurally subordinated to indebtedness and other liabilities of the subsidiaries
of AstraZeneca PLC, none of which guarantee the AstraZeneca Finance Notes.
AstraZeneca PLC manages substantially all of its operations through divisions, branches and/or investments
in subsidiaries and affiliates. Accordingly, the ability of AstraZeneca PLC to service its debt an d guarantee
obligations is also dependent upon the earnings of its subsidiaries, affiliates, branches and divisions, whether
by dividends, distributions, loans or otherwise.
Please refer to the consolidated financial statements of AstraZeneca PLC in our A nnual Report on Form 20 -F
and reports on Form 6 -K with our quarterly financial results as filed or furnished with the SEC 62 for further
financial information regarding AstraZeneca PLC and its consolidated subsidiaries. For further details, terms
and condit ions of the AstraZeneca Finance Notes please refer to AstraZeneca PLC 's reports on Form 6 -K
furnished to the SEC on 3 March 2023 and 28 May 2021.
Pursuant to Rule 13 -01 and Rule 3 -10 of Regulation S -X under the Securities Act of 1933, as amended (the
"Securities Act "), we present below the summary financial information for AstraZeneca PLC, as Guarantor,
excluding its consolidated subsidiaries, and AstraZeneca Finance, as the issuer, excluding its consolidated
subsidiaries. The following summary financial i nformation of AstraZeneca PLC and AstraZeneca Finance is
presented on a combined basis and transactions between the combining entities have been eliminated.
Financial information for non -guarantor entities has been excluded. Intercompany balances and trans actions
between the obligor group and the non-obligor subsidiaries are presented on separate lines.
Table 17: Obligor group summarised Statement of comprehensive incomec
H1 2023 H1 2022
$m $m
Total Revenue - -
Gross profit - -
Operating loss (2) (2)
62 Securities Exchange Commission.
===== SIDA 23 =====
23
H1 2023 H1 2022
$m $m
Loss for the period (480) (275)
Transactions with subsidiaries that are not issuers or guarantors 9,487 331
Table 18: Obligor group summarised Statement of financial position
At 30 Jun 2023 At 30 Jun 2022
$m $m
Current assets 7 7
Non-current assets - -
Current liabilities (4,091) (1,838)
Non-current liabilities (24,165) (23,994)
Amounts due from subsidiaries that are not issuers or guarantors 15,761 7,459
Amounts due to subsidiaries that are not issuers or guarantors (290) (295)
Foreign exchange
The Company's transactional currency exposures on working-capital balances, which typically extend for up to
three months, are hedged where practicable using forward foreign exchange contracts against the individual
companies' reporting currency. Foreign exchange gains and losses on forward contracts for transactional
hedging are taken to profit or loss. In addition, the Company 's external dividend payments, paid principally in
pounds sterling and Swedish krona, are fully hedged from announcement to payment date.
Table 19: Currency sensitivities
The Company provides the following currency-sensitivity information
Average
rates vs USD
Annual impact ($m) of
5% strengthening
(FY 2023 average rate
vs FY 2022 average) 63
Currency Primary Relevance FY
202264
YTD
202365
Change
(%)
June
202366
Change67
(%)
Total
Revenue
Core
Operating
Profit
EUR Total Revenue 0.95 0.92 3 0.92 3 323 159
CNY Total Revenue 6.74 6.94 (3) 7.17 (6) 309 174
JPY Total Revenue 131.59 134.92 (2) 141.34 (7) 181 122
Other68 385 202
GBP Operating expense 0.81 0.81 (0) 0.79 2 46 (92)
SEK Operating expense 10.12 10.48 (3) 10.77 (6) 7 (55)
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 56 to 59 of the Annual Report and
Form 20-F Information 2022, and summarised below. They are not expected to change in respect of the second
six months of the financial year and remain appropriate for the Group.
In summary, the principal risks and uncertainties listed in the Annual Report and 20-F Information 2022 are:
63 Based on best prevailing assumptions around currency profiles.
64 Based on average daily spot rates 1 Jan 2022 to 31 Dec 2022.
65 Based on average daily spot rates 1 Jan 2023 to 30 Jun 2023.
66 Based on average daily spot rates 1 Jun 2023 to 30 Jun 2023.
67 Change vs the average spot rate for the previous year
68 Other currencies include AUD, BRL, CAD, KRW and RUB.
===== SIDA 24 =====
24
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 in the
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 a diverse, 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
Since the last quarterly report, AstraZeneca:
Access to healthcare
‒ Participated in the World Health Assembly in Geneva in May, including through high-level meetings on lung
health, cancer and chronic kidney disease and Chair Michel Demaré's formal participation at the World
Health Organization public session on "The role of the Health Community in Climate Action: taking stock and
moving forward" alongside the Director-General of the World Health Organization, CEO of COP28, German
Ambassador to the U.N. and other dignitaries
‒ The Partnership for Health System Sustainability and Resilience (PHSSR) continued to create research and
engagement opportunities for stakeholders in Brazil, Greece, Canada, Italy and Germany, activating
policymakers and calling for action to strengthen health systems. The PHSSR also published its 2023
PHSSR Summary Report in May, which underscores the need for both h ealth system resilience in the face
of shocks and stresses, and sustainability amid longer -term demographic, social, technological, economic
and environmental shifts. In addition, an EU PHSSR expert advisory group was convened to develop EU -
level recommendations focused on non-communicable disease prevention and early detection
‒ Healthy Heart Africa (HHA) continued to contribute to healthcare system strengthening in Africa, through
partnership between global and local stakeholders. HHA has trained more than 10,600 healthcare workers
and has conducted more than 38.5 million blood pressure screenings since its launch in 2014, achieving a
record one million screenings per month in February to June 2023 (data as at end of June 2023)
‒ Young Health Programme excee ded 10 million young people reached with information about NCD risk
factors through prevention programming and advocacy work since launch in 2010. AstraZeneca and UNICEF
were recognised with the Better Society Award for Best Partnership with an Internation al Charity for the
programme's impact
‒ A.Catalyst Network, the Company's global network of health innovation hubs, launched a new hub in Brazil
which will focus on solutions for early diagnosis, disease awareness and the interconnection of electronic
medical records in the health ecosystem, as well as reducing the emissions from the delivery of healthcare
Environmental protection
‒ Announced an innovative partnership with Vanguard Renewables to decarbonise all AstraZeneca research
and manufacturing sites in the US by the end of 2026. Food and agricultural waste will be turned into
renewable natural gas, a source of clean heat to power the Company's US sites. This partnership will deliver
emissions reductions, contribute to the circular economy and capture methane that would have otherwise
gone into atmosphere. Delivery of the renewable natural gas began in June 2023, and by 2026 as much as
650,000 million British thermal units of renewable natural gas will be produced, equivalent to the energy
required to heat more than 17,800 US homes for a year
‒ Announced an expansion of the Company's global reforestation and biodiversity programme, AZ Forest,
increasing investment to $ 400m to plant and maintain a total of 200 million trees by 2030, across six
continents. This commitment includes new or expanded projects in Brazil, India, Vietnam, Ghana and
Rwanda that will contribute to the Company's Ambition Zero Carbon programme, restore nature, promote
biodiversity and build ecological and community resilience, spanning over 100,000 hectares worldwide
===== SIDA 25 =====
25
‒ CEO Pascal Soriot signed an Open Letter to suppliers through the Sustainable Markets Initiative Health
Systems Task Force which he convenes, alongside six global pharmaceuticals leaders. This letter, endorsed
by the W orld Health Organisation, calls on suppliers to commit to the joint, minimum climate and
sustainability targets the Task Force has set, to help address the emissions across the healthcare value
chain
‒ CEO Pascal Soriot gave a keynote address on the interconnection between population and planetary health
at London Climate Week in June, highlight ing the need to decarbonise healthcare which contributes
approximately 5% of global greenhouse gas emissions. In May, Pam Cheng, EVP Global Operations & IT
and Chief Sustainability Officer, gave a keynote speech at a G7 event in Japan on the interconnection
between planetary and human health, led by the Health and Global Policy Institute and Nagasaki University
‒ Launched Activate, a new programme targeting the reduction of the environmental impact of the production
of active pharmaceutical ingredients, together with Manufact ure 2030 and five other pharmaceutical
companies in 21 countries. Initially announced at COP27, the programme is built on opportunities identified
for cross-industry collaboration and aims to make an impact across a key segment of the pharmaceutical
industry's value chain
Ethics and transparency
‒ Held an internal panel discussion on Diversity in Clinical Trials, chaired by a member of the Global Inclusion
& Diversity Council and featuring experts from across AstraZeneca. The focus was on the changes the
Company is making in its approach, and the impact the work is having on patient populations
‒ Marked "World Day for Cultural Diversity for Dialogue and Development " with an employee engagement
campaign giving colleagues the opportunity to share information about their cultures. Used the day to
highlight the importance of cultural intelligence in a global organisation and the impact it can have on
performance as well as launching a cultural intelligence toolkit to employees
‒ Marked Pride Month with posts acro ss social media channels, events held internally across the globe and
participation from the AZ Pride Employee Resources groups at Pride marches and parades across Asia,
Europe, South America and the US
Research and development
This section covers R&D ev ents and milestones that have occurred since the prior results announcement on
27 April 2023, up to and including events on 27 July 2023.
A comprehensive view of AstraZeneca's pipeline of medicines in human trials can be found in the latest Clinical
Trials Appendix, available on www.astrazeneca.com/investor-relations. The Clinical Trials Appendix includes
tables with details of the ongoing clinical trials for AstraZeneca medicines and new molecular entities in the
pipeline.
Oncology
AstraZeneca presented new practice-changing data from cancer medicines across its robust pipeline at the
2023 American Society of Clinical Oncology (ASCO) congress in June 2023. More than 130 abstracts featured
22 approved and potential new medicines across the Company 's diverse oncology portfolio and pipeline,
including 1 1 oral presentations as well as the Company 's fifth consecutive plenary presentation , featuring
Tagrisso Phase III ADAURA overall survival data.
Tagrisso
Event Commentary
Phase III trial
readout
FLAURA2 Met primary endpoint demonstrating Tagrisso in combination with chemotherapy
resulted in a statistically significant and clinically meaningful improvement in PFS
compared to Tagrisso alone for patients with locally advanced or metastatic
EGFRm NSCLC. Data to be featured as presidential plenary at t he World
Conference on Lung Cancer 2023. (May 2023)
Presentation:
ASCO
ADAURA Results from updated analysis of the ADAURA Phase III trial, presented at ASCO,
demonstrated Tagrisso reduced the risk of death by 51% compared to placebo in
both the primary analysis population (Stages II -IIIA), and in the overall trial
population (Stages IB-IIIA). (June 2023)
===== SIDA 26 =====
26
Imfinzi and Imjudo
Event Commentary
Phase III trial
readout
MATTERHORN Met key secondary endpoint demonstrating Imfinzi added to standard -of-care
FLOT69 neoadjuvant chemotherapy resulted in a statistically significant and
clinically meaningful improvement in the key secondary endpoint of pCR versus
neoadjuvant chemotherapy alone for patients with resectable, early -stage and
locally advanced gastric and gastroesophageal junction cancers. (June 2023)
Presentation:
ESMO GI70
HIMALAYA Updated results showed Imfinzi plus Imjudo demonstrated a sustained, clinically
meaningful 22% reduction in risk of death versus sorafenib in patients with
unresectable HCC who had not received prior systemic therapy and were not
eligible for localised treatment. (June 2023)
Lynparza
Event Commentary
Phase III trial
readout
DUO-E
(Lynparza and
Imfinzi)
Met primary endpoint , demonstrating that Imfinzi in combination with platinum -
based chemotherapy followed by either Imfinzi plus Lynparza or Imfinzi alone as
maintenance therapy resulted in a statistically significant and clinically meaningful
improvement in PFS compared to standard-of-care chemotherapy alone in patients
with newly diagnosed advanced or recurrent endometrial cancer. (May 2023)
Approval US Lynparza in combination with abiraterone and prednisone or prednisolone for the
treatment of adult patients with deleterious or suspected deleterious BRCAm
mCRPC71. (June 2023)
Presentation:
ASCO
DUO-O
(Lynparza and
Imfinzi)
Results from a planned interim analysis of the DUO-O Phase III trial, presented at
ASCO, showed that the combination of Lynparza, Imfinzi, chemotherapy and
bevacizumab reduced the relative risk of disease progression or death by 37%
versus chemotherapy and bevacizumab in newly diagnosed patients with advanced
high-grade epithelial ovarian cancer without tumour BRCAm. In the HRD-positive
subgroup, Lynparza, Imfinzi, chemotherapy and bevacizumab reduced the relative
risk of disease progression or death by 51% versus chemoth erapy and
bevacizumab alone. (June 2023)
Phase II/III trial
readout
GY005 Did not meet primary endpoint in the intent -to-treat population of a statistically
significant improvement in PFS with cediranib added to Lynparza or cediranib alone
versus standard of care chemotherapy in patients with recurrent platinum-resistant
or -refractory ovarian, fallopian tube, or primary peritoneal cancer. (July 2023)
Enhertu
Event Commentary
Presentation:
ASCO
DESTINY-
PanTumor02
Results from a planned interim analysis of the DESTINY-PanTumor02 Phase II trial,
presented at ASCO, demonstrated Enhertu resulted in a confirmed ORR72 of 37.1%
and DCR73 of 68.2% in previously treated patients with HER2-expressing advanced
solid tumours. (June 2023)
Phase II trial
readout
DESTINY-
PanTumor02
Primary analysis of the ongoing DESTINY -PanTumor02 Phase II trial showed
Enhertu demonstrated clinically meaningful PFS and OS across multiple HER2-
expressing advanced solid tumours , two secondary endpoints of the trial . (July
2023)
Approval China For the treatment of adult patients with unresectable or metastatic HER2-low (IHC74
1+ or IHC 2+/ISH75-) breast cancer who have received a prior systemic therapy in
the metastatic setting or developed disease recurrence during or within six months
of completing adjuvant chemotherapy. (July 2023)
69 Fluorouracil, oxaliplatin and docetaxel.
70 Gastrointestinal.
71 Metastatic castration-resistant prostate cancer.
72 Overall response rate.
73 Disease Control Rate.
74 Immunohistochemistry.
75 In situ hybridization.
===== SIDA 27 =====
27
capivasertib
Event Commentary
FDA priority
review
US Capivasertib in combination with Faslodex for the treatment of HR -positive,
HER2-negative locally advanced or metastatic breast cancer following recurrence
or progression on or after an endocrine-based regimen. (June 2023)
datopotamab deruxtecan (Dato-Dxd)
Event Commentary
Presentation:
ASCO
TROPION-
Lung02
Updated results from the TROPION-Lung02 Phase Ib trial, presented at ASCO,
demonstrated Dato -DXd plus pembrolizumab with or without platinum
chemotherapy demonstrated objective response rates of 57% and 50%,
respectively, with a disease control rate of 91% across cohorts , in patients with
advanced NSCLC. (June 2023)
Phase III trial
readout
TROPION-
Lung01
Met dual primary endpoint demonstrating statistically significant improvement for
PFS compared to docetaxel in patients with locally advanced or metastatic NSCLC
treated with at least one prior therapy. (July 2023)
BioPharmaceuticals - CVRM
Farxiga
Event Commentary
Approval
US Approved to reduce the risk of cardiovascular death, hospitalisation for heart failure
and urgent heart failure visits in adults with heart failure regardless of left ventricular
ejection fraction status. The approval was based on positive results from the
DELIVER Phase III trial. Farxiga was previously approved in the US for adults with
heart failure with reduced ejection fraction. (May 2023)
Approval China Xigduo XR ( Farxiga and metformin fixed -dose combination) approved for the
treatment of adults with type -2 diabetes as an adjunct to diet and exercise to
improve glycaemic control. (June 2023)
Andexxa
Event Commentary
Phase IV
readout
ANNEXA-I A registrational post-marketing Phase IV trial was stopped early based on achieving
pre-specified criteria of superior haemostatic efficacy versus usual care. A Phase IV
trial was required to convert from conditional to full approval in the EU and US and
the Company will now proceed with regulatory filings. (June 2023)
roxadustat
Event Commentary
Phase III data
readout
MATTERHORN
AstraZeneca's part ner, FibroGen Inc., (FibroGen) announced that the
MATTERHORN Phase III trial for the treatment of anaemia in patients with
myelodysplastic syndrome did not meet its primary efficacy endpoint. (May 2023)
Phase II/III data
readout
NCT03303066 FibroGen announced positive top-line data from a Phase III trial in patients receiving
concurrent chemotherapy treatment for non -myeloid malignancies in China .
(May 2023)
eplontersen
Event Commentary
Phase III data
readout
NEURO-
TTRansform
AstraZeneca's part ner, Ionis Pharmaceuticals, announced positive top -line
85-week data for eplontersen in patients with hereditary transthyretin -mediated
===== SIDA 28 =====
28
amyloid polyneuropathy, showing sustained improvements in measures of
neuropathy disease and a favourable safety and tolerability profile. (July 2023)
BioPharmaceuticals - R&I
Brazikumab
Event Commentary
Phase III trials
discontinued
INTREPID,
EXPEDITION
The decision to discontinue brazikumab 's inflammatory bowel disease
development programme followed a review of brazikumab's development timeline
and the context of a competitive landscape that has continued to evolve. The
timeline was impacted by delays that could not be mitigated following global events.
No safety concerns were identified for patients in these trials. (June 2023)
Fasenra
Event Commentary
Phase III trial
discontinued
FJORD Trial in bullous pemphigoid discontinued for futility (efficacy). (July 2023)
BioPharmaceuticals - V&I
AZD3152
Event Commentary
Phase I/III
safety data
SUPERNOVA Positive high -level results from the Phase I safety cohort of the ongoing
SUPERNOVA Phase I/III COVID -19 prevention trial showed that AstraZeneca 's
long-acting antibody AZD3152 was generally well -tolerated and displayed
pharmacokinetics consistent with Evusheld through day 29. These data are now
being shared with regulatory authorities and could potentially lead to availability of
AZD3152 in some countries outside of the US under early access mechanisms .
(July 2023)
Trial design
update
SUPERNOVA The primary endpoint of the SUPERNOVA has been updated to measure the
efficacy of a 300mg intramuscular dose of AZD3152. In consultation with the US
FDA, a pivotal immunobridging sub-study has been added to the trial , which will
compare neutralising antibody levels of subjects wh o receive a 1,200mg dose
delivered intravenously to neutralising antibody levels of subjects who receive
300mg IM of Evusheld. Data from the sub study are expected late in H2 2023, and
the efficacy data are expected in H1 2024.
Beyfortus
Event Commentary
Approval US Approved in the US for the prevention of respiratory syncytial virus lower respiratory
tract disease in newborns and infants born during or entering their first RSV season,
and for children up to 24 months of age who remain vulnerable to severe RSV
disease through their second RSV season. Beyfortus will be available in the US
ahead of the upcoming 2023-2024 RSV season. (July 2023)
The approval follows the unanimous vote by the Antimicrobial Drugs Advisory
Committee (AMDAC) on the favourable benefit -risk profile of Beyfortus. (June
2023)
Rare Disease
AstraZeneca presented new clinical and real -world data in multiple haematological conditions, further
demonstrating its ambition to redefine care in haematology at the European Hematology Association (EHA).
Alexion, AstraZeneca Rare Disease, showcase d pivotal data in patients with paroxysmal nocturnal
haemoglobinuria PNH experiencing symptoms of clinically significant extravascular haemolysis. Additional data
===== SIDA 29 =====
29
and analyses were presented focusing on improving understanding , and management of debilitating rare
diseases; AL76 amyloidosis and aHUS.
Soliris
Event Commentary
Approval EU Children and adolescents with refractory gMG. (June 2023)
Approval China Adults with refractory gMG. (June 2023)
Ultomiris
Event Commentary
Approval Japan Prevention of relapses in patients with NMOSD. (May 2023)
Approval EU Adults with NMOSD. (May 2023)
danicopan
Event Commentary
Presentation:
EHA
ALPHA
Phase III
Positive results showed that, first-in-class oral Factor D inhibitor, danicopan as add-
on to standard of care C5 inhibitor therapy Ultomiris or Soliris, demonstrated a
statistically significant and clinically meaningful increase in haemoglobin levels and
maintained disease control in patients with PNH who experience clinica lly
significant EVH. Primary endpoint measured the change in haemoglobin from
baseline to week 12, reported as least squares mean change from baseline and
standard error of the mean (2.94 [0.211] g/dL vs 0.50 [0.313] g/dL; p<0.0001). All
key secondary endpoints also met statistical superiority in favour of danicopan plus
Ultomiris or Soliris, compared to placebo plus C5 inhibition. (June 2023)
Koselugo
Event Commentary
Approval China Paediatric patients with neurofibromatosis type 1 and plexiform neurofibromas.
(May 2023)
Interim Financial Statements
Table 20: Condensed consolidated statement of comprehensive income: H1 2023
For the half year ended 30 June 2023 2022
$m $m
Total Revenue77 22,295 22,161
Product Sales 21,448 21,610
Alliance Revenue 627 290
Collaboration Revenue 220 261
Cost of sales (3,865) (6,509)
Gross profit 18,430 15,652
Distribution expense (265) (254)
Research and development expense (5,278) (4,679)
Selling, general and administrative expense (9,045) (9,521)
Other operating income and expense 1,163 219
Operating profit 5,005 1,417
Finance income 141 35
Finance expense (795) (647)
Share of after tax losses in associates and joint ventures (1) (5)
76 Amyloid light chain.
77 Effective 1 January 2023, the Group has updated the presentation of Total Revenue. See Note 1 for further details of the presentation of
Alliance Revenue.
===== SIDA 30 =====
30
Profit before tax 4,350 800
Taxation (726) (52)
Profit for the period 3,624 748
Other comprehensive income
Items that will not be reclassified to profit or loss
Remeasurement of the defined benefit pension liability 7 1,031
Net losses on equity investments measured at fair value through other
comprehensive income
(48) (12)
Fair value movements related to own credit risk on bonds designated as fair value
through profit or loss
4 2
Tax on items that will not be reclassified to profit or loss (5) (275)
(42) 746
Items that may be reclassified subsequently to profit or loss
Foreign exchange arising on consolidation 105 (1,326)
Foreign exchange arising on designated liabilities in net investment hedges (101) (195)
Fair value movements on cash flow hedges 89 (138)
Fair value movements on cash flow hedges transferred to profit and loss (71) 131
Fair value movements on derivatives designated in net investment hedges 40 34
Costs of hedging (1) (13)
Tax on items that may be reclassified subsequently to profit or loss 12 46
73 (1,461)
Other comprehensive income/(loss), net of tax 31 (715)
Total comprehensive income for the period 3,655 33
Profit attributable to:
Owners of the Parent 3,621 746
Non-controlling interests 3 2
3,624 748
Total comprehensive income attributable to:
Owners of the Parent 3,652 33
Non-controlling interests 3 -
3,655 33
Basic earnings per $0.25 Ordinary Share $2.34 $0.48
Diluted earnings per $0.25 Ordinary Share $2.32 $0.48
Weighted average number of Ordinary Shares in issue (millions) 1,549 1,548
Diluted weighted average number of Ordinary Shares in issue (millions) 1,560 1,561
Table 21: Condensed consolidated statement of comprehensive income: Q2 2023
For the quarter ended 30 June Unreviewed78
2023
Unreviewed
2022
$m $m
Total Revenue77 11,416 10,771
Product Sales 10,882 10,630
Alliance Revenue 341 138
Collaboration Revenue 193 3
Cost of sales (1,960) (2,998)
Gross profit 9,456 7,773
Distribution expense (131) (129)
Research and development expense (2,667) (2,546)
Selling, general and administrative expense (4,986) (4,681)
Other operating income and expense 784 122
Operating profit 2,456 539
Finance income 64 18
Finance expense (431) (311)
78 The Q2 2023 and Q2 2022 information in respect of the three months ended 30 June 2023 and 30 June 2022 respectively included in
the Interim Financial Statements have not been reviewed by PricewaterhouseCoopers LLP.
===== SIDA 31 =====
31
Share of after tax (losses)/profits in associates and joint ventures (1) 1
Profit before tax 2,088 247
Taxation (268) 113
Profit for the period 1,820 360
Other comprehensive income
Items that will not be reclassified to profit or loss
Remeasurement of the defined benefit pension liability 17 696
Net losses on equity investments measured at fair value through other
comprehensive income
(94) (30)
Fair value movements related to own credit risk on bonds designated as fair value
through profit or loss
2 2
Tax on items that will not be reclassified to profit or loss (29) (181)
(104) 487
Items that may be reclassified subsequently to profit or loss
Foreign exchange arising on consolidation (209) (1,107)
Foreign exchange arising on designated liabilities in net investment hedges (94) (163)
Fair value movements on cash flow hedges 33 (143)
Fair value movements on cash flow hedges transferred to profit and loss 4 120
Fair value movements on derivatives designated in net investment hedges 24 42
Costs of hedging (1) (13)
Tax on items that may be reclassified subsequently to profit or loss - 45
(243) (1,219)
Other comprehensive loss, net of tax (347) (732)
Total comprehensive income/(loss) for the period 1,473 (372)
Profit attributable to:
Owners of the Parent 1,818 360
Non-controlling interests 2 -
1,820 360
Total comprehensive income/(loss) attributable to:
Owners of the Parent 1,471 (372)
Non-controlling interests 2 -
1,473 (372)
Basic earnings per $0.25 Ordinary Share $1.17 $0.23
Diluted earnings per $0.25 Ordinary Share $1.17 $0.23
Weighted average number of Ordinary Shares in issue (millions) 1,550 1,549
Diluted weighted average number of Ordinary Shares in issue (millions) 1,560 1,560
Table 22: Condensed consolidated statement of financial position
Reviewed79
At 30 Jun
2023
Audited
At 31 Dec
2022
Reviewed
At 30 Jun
2022
$m $m $m
Assets
Non-current assets
Property, plant and equipment 8,675 8,507 8,722
Right-of-use assets 949 942 905
Goodwill 19,960 19,820 19,821
Intangible assets 38,326 39,307 39,900
Investments in associates and joint ventures 72 76 56
Other investments 1,071 1,066 1,124
Derivative financial instruments 163 74 113
Other receivables 752 835 881
79 The Condensed consolidated statement of financial position as at 30 June 2023 and 30 June 2022 have been reviewed by
PricewaterhouseCoopers LLP. The Condensed consolidated statement of financial position as at 31 December 2022 has been audited
by PricewaterhouseCoopers LLP.
===== SIDA 32 =====
32
Deferred tax assets 3,736 3,263 4,140
73,704 73,890 75,662
Current assets
Inventories 5,051 4,699 6,220
Trade and other receivables 11,092 10,521 8,908
Other investments 148 239 70
Derivative financial instruments 44 87 109
Intangible assets - - 89
Income tax receivable 840 731 704
Cash and cash equivalents 5,664 6,166 4,817
Assets held for sale - 150 -
22,839 22,593 20,917
Total assets 96,543 96,483 96,579
Liabilities
Current liabilities
Interest-bearing loans and borrowings (4,556) (5,314) (2,162)
Lease liabilities (231) (228) (220)
Trade and other payables (19,738) (19,040) (17,821)
Derivative financial instruments (83) (93) (90)
Provisions (567) (722) (541)
Income tax payable (1,200) (896) (981)
(26,375) (26,293) (21,815)
Non-current liabilities
Interest-bearing loans and borrowings (24,329) (22,965) (26,461)
Lease liabilities (722) (725) (685)
Derivative financial instruments (68) (164) (180)
Deferred tax liabilities (2,800) (2,944) (5,275)
Retirement benefit obligations (1,078) (1,168) (1,310)
Provisions (1,357) (896) (892)
Other payables (2,398) (4,270) (4,010)
(32,752) (33,132) (38,813)
Total liabilities (59,127) (59,425) (60,628)
Net assets 37,416 37,058 35,951
Equity
Capital and reserves attributable to equity holders of the
Parent
Share capital 387 387 387
Share premium account 35,163 35,155 35,134
Other reserves 2,076 2,069 2,068
Retained earnings (234) (574) (1,657)
37,392 37,037 35,932
Non-controlling interests 24 21 19
Total equity 37,416 37,058 35,951
Table 23: Condensed consolidated statement of changes in equity
Share
capital
Share
premium
account
Other
reserves
Retained
earnings
Total
attributable
to owners of
the parent
Non-
controlling
interests
Total
equity
$m $m $m $m $m $m $m
At 1 Jan 2022 387 35,126 2,045 1,710 39,268 19 39,287
Profit for the period - - - 746 746 2 748
Other comprehensive loss - - - (713) (713) (2) (715)
Transfer to other reserves - - 23 (23) - - -
Transactions with owners
Dividends - - - (3,046) (3,046) - (3,046)
Issue of Ordinary Shares - 8 - - 8 - 8
Share-based payments charge
for the period
- - - 346 346 - 346
===== SIDA 33 =====
33
Settlement of share plan awards - - - (677) (677) - (677)
Net movement - 8 23 (3,367) (3,336) - (3,336)
At 30 Jun 2022 387 35,134 2,068 (1,657) 35,932 19 35,951
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 owners
Dividends - - - (3,047) (3,047) - (3,047)
Issue of Ordinary Shares - 8 - - 8 - 8
Share-based payments charge
for the period
- - - 274 274 - 274
Settlement of share plan awards - - - (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
Table 24: Condensed consolidated statement of cash flows
For the half year ended 30 June 2023 2022
$m $m
Cash flows from operating activities
Profit before tax 4,350 800
Finance income and expense 654 612
Share of after tax losses of associates and joint ventures 1 5
Depreciation, amortisation and impairment 2,778 2,666
(Increase)/decrease in working capital and short-term provisions (747) 2,391
Gains on disposal of intangible assets (249) (81)
Fair value movements on contingent consideration arising from business
combinations
202 293
Non-cash and other movements (594) (814)
Cash generated from operations 6,395 5,872
Interest paid (483) (386)
Tax paid (1,061) (1,006)
Net cash inflow from operating activities 4,851 4,480
Cash flows from investing activities
Acquisition of subsidiaries, net of cash acquired (189) -
Payments upon vesting of employee share awards attributable to business
combinations
(23) (158)
Payment of contingent consideration from business combinations (398) (367)
Purchase of property, plant and equipment (517) (472)
Disposal of property, plant and equipment 126 -
Purchase of intangible assets (1,436) (434)
Disposal of intangible assets 288 442
Movement in profit-participation liability 175 -
Purchase of non-current asset investments (26) (28)
Disposal of non-current asset investments 10 35
Movement in short-term investments, fixed deposits and other investing
instruments
90 9
Payments to associates and joint ventures - (5)
Interest received 134 10
Net cash outflow from investing activities (1,766) (968)
Net cash inflow before financing activities 3,085 3,512
Cash flows from financing activities
Proceeds from issue of share capital 8 8
Issue of loans and borrowings 3,816 -
Repayment of loans and borrowings (3,408) (1,257)
Dividends paid (3,069) (2,971)
Hedge contracts relating to dividend payments 27 (77)
===== SIDA 34 =====
34
Repayment of obligations under leases (129) (134)
Movement in short-term borrowings 72 316
Payment of Acerta Pharma share purchase liability (867) (920)
Net cash outflow from financing activities (3,550) (5,035)
Net decrease in Cash and cash equivalents in the period (465) (1,523)
Cash and cash equivalents at the beginning of the period 5,983 6,038
Exchange rate effects (47) (35)
Cash and cash equivalents at the end of the period 5,471 4,480
Cash and cash equivalents consist of:
Cash and cash equivalents 5,664 4,817
Overdrafts (193) (337)
5,471 4,480
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 as
adopted by the European Union and UK-adopted IAS 34;
‒ the half-yearly management report gives a true an d fair view of the assets, liabilities, financial position and
profit 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 have
occurred during the first six months of the financial year and their impact on the condensed consolidated
Interim Financial Statements; and a description of the principal risks and uncertainties for the remaining
six months of the year; and
DTR 4.2.8R of the Disclosure and Transparency Rules, being related party transactions that have taken
place in the first six months of the current financial year and t hat have materially affected the financial
position or performance of the enterprise during that period; and any changes in the related party
transactions 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 2023 and their respective
responsibilities can be found on the Leadership team section of astrazeneca.com.
Approved by the Board and signed on its behalf by
Pascal Soriot
Chief Executive Officer
28 July 2023
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 2023 (the "period").
Based on our review, nothing has come to our attention that causes us to be lieve that the Interim financial
statements 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
34 as adopted by the European Union , UK-adopted IAS 34, and the Disclosure Guidance and Transparency
Rules sourcebook of the United Kingdom's Financial Conduct Authority.
===== SIDA 35 =====
35
The Interim financial statements comprise:
‒ the Condensed consolidated statement of financial position as at 30 June 2023;
‒ the Condensed consolidated statement of comprehensive income: H1 2023 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 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 been
prepared in accordance with Internationa l Accounting Standard 34, 'Interim Financial Reporting ' (IAS 34), as
issued by the International Accounting Standards Board (IASB), IAS 34 as adopted by the European Union ,
UK-adopted IAS 34, and the Disclosure Guidance and Transparency Rules sourcebook of the United Kingdom's
Financial Conduct Authority.
Basis for conclusion
We conducted our review in accordance with International Standard on Review Engagements (UK) 2410,
'Review of Interim Financial Information Performed by the Independent Auditor of the Entity ' issued by the
Financial Reporting Council for use in the United Kingdom ("ISRE (UK) 2410 "). A review of interim financial
information consists of making enquiries, primarily of persons responsible for financial and accounting matters,
and applying analytical and other review procedures.
A review is substantially less in scope than an audit conducted in accordance with International Standards on
Auditing (UK) and, consequently, does not enable us to obtain assurance that we would become aware of all
significant 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
contains any 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 the
Basis for conclusion section of this report, nothing has come to our attention to suggest that t he directors have
inappropriately adopted the going concern basis of accounting or that the directors have identified material
uncertainties relating to going concern that are not appropriately disclosed. This conclusion is based on the
review procedures p erformed in accordance with ISRE (UK) 2410. However, future events or conditions may
cause the group 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 been
approved by the directors. The directors are responsible for preparing the half -yearly financial report in
accordance with the Disclosure Guidance and Transparency Rules sourcebook of the United Kingdom 's
Financial Conduct Authority. In preparing the half -yearly financial report, including the Interim financial
statements, the directors are responsible for assessing the group 's ability to continue as a going concern,
disclosing, as applicable, matters related to going concern and using the going concern basis of accounting
unless the directors either int end to liquidate 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 report
based on our review. Our conclusion, including our Conclusions relating to going concern, is based on
procedures that 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 o nly for the company for the
purpose of complying with the Disclosure Guidance and Transparency Rules sourcebook of the United
Kingdom's Financial Conduct Authority and for no other purpose. We do not, in giving this conclusion, accept
===== SIDA 36 =====
36
or assume responsibility for any other purpose or to any other person to whom this report is shown or into whose
hands it may come save where expressly agreed by our prior consent in writing.
PricewaterhouseCoopers LLP
Chartered Accountants
London
28 July 2023
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 2023
have been prepared in accordance with International Accounting Standard 34, 'Interim Financial Reporting' (IAS
34), as issued by the International Accounting Standards Board (IASB), IAS 34 as adopted by the European
Union, UK-adopted IAS 34 and the Disclosure Guidance and Transparency Rules sourcebook of the United
Kingdom's Financial Conduct Authority and with the requirements of the Companies Act 2006 as applicable to
companies reporting under those standards.
The unaudited Interim Financial Statements for the six months ended 30 June 2023 were approved by the Board
of Directors for publication on 28 July 2023.
This results announcement does not constitute statutory accounts of the Group within the meaning of sections
434(3) and 435(3) of the Companies Act 2006. The annual financial statements of the Group for the year ended
31 December 2022 were prepared in accordance with UK-adopted International Accounting Standards and with
the requirements of the Companies Act 2006. The annual financial statements also comply fully with IFRSs as
issued by the IASB and International Accounting Standards as adopted by the European Union. Except for the
estimation of the interim income tax charge, the Interim Financial Statements have been prepared applying the
accounting policies that were applied in the preparation of the Group's published consolidated financial
statements for the year ended 31 December 2022.
The comparative figures for the financial year ended 31 December 2022 are not the Group's statutory accounts
for that financial year. Those accounts have been reported on by the Group's auditors and have been delivered
to the registrar of companies; their report was (i) unqualified, (ii) did not include a reference to any matters to
which the auditors drew attention by way of emphasis without qualifying their re port, and (iii) did not contain a
statement under section 498(2) or (3) of the Companies Act 2006.
Alliance and Collaboration Revenues
Effective 1 January 2023, the Group has updated the presentation of Total Revenue on the face of the Statement
of Compr ehensive Income to include Alliance Revenue as a separate element to Collaboration Revenue.
Alliance Revenue, previously reported within Collaboration Revenue, comprises income related to sales made
by collaboration partners, where AstraZeneca is entitled to a profit share, revenue share or royalties, which are
recurring in nature while the collaboration arrangement remains in place. Alliance Revenue does not include
Product Sales where AstraZeneca is leading commercialisation in a territory. Collaboration Revenue arising
from collaborative arrangements where the Group retains a significant ongoing economic interest and receives
upfront amounts and event -triggered milestones, which arise from the licensing of intellectual property, will
continue to be report ed as Collaboration Revenue. In collaboration arrangements either AstraZeneca or the
collaborator acts as principal in sales to the end customer. Where AstraZeneca acts as principal, we record
100% of sales to the end customer within Product Sales. The rev ised presentation reflects the increasing
importance of income arising from profit share arrangements where collaboration partners are responsible for
booking revenues in some or all territories.
The comparative revenue reported in H1 2023 relating to the half year to 30 June 2022 has been retrospectively
adjusted to reflect the new split of Total Revenue, resulting in Alliance Revenue being reported for the half year
30 June 2022 of $290m, however the combined total of Alliance Revenue and Collaboration Revenue is equal
to the previously reported Collaboration Revenue total for the half year 30 June 2022.
Going concern
===== SIDA 37 =====
37
The Group has considerable financial resources available. As at 30 June 2023, the Group has $ 12.6bn in
financial resources (Cash and cash equivalent balances of $5.7bn and undrawn committed bank facilities of
$6.9bn available, of which $2.0bn of the facilities are available until February 2025 and the other $4.9bn are
available until April 2026 , with $4.6bn of borrowings due within one year). These facilities contain no financial
covenants and were undrawn at 30 June 2023.
The Group's revenues are largely derived from sales of medicines covered by patents which provide a relatively
high level of resilience and predictability to cash inf lows, although government price interventions in response
to budgetary constraints are expected to continue to adversely affect revenues in some of our significant
markets. The Group, however, anticipates new revenue streams from both recently launched med icines and
those in development, and the Group has a wide diversity of customers and suppliers across different
geographic areas.
Consequently, the Directors believe that, overall, the Group is well placed to manage its business risks
successfully. Accordingly, they continue to adopt the going concern basis in preparing the Interim Financial
Statements.
Legal proceedings
The information contained in Note 6 updates the disclosures concerning legal proceedings and contingent
liabilities in the Group's Annual Report and Form 20-F Information 2022.
IAS 12 'Income Taxes'
On 25 May 2023, the IASB issued an amendment t o IAS 12 'Income Taxes' to clarify how the effects of the
global minimum tax framework should be accounted for and disclosed effective 1 January 2023. This was
endorsed by the UK Endorsement Board on 19 July 2023 and has been adopted by the Company for 2023
reporting. The Company has applied the exemption to recognising and disclosing information about deferred
tax assets and liabilities related to Pillar 2 income taxes. The Company is currently assessing the potential
impact of these draft rules upon its financial statements.
Note 2: Intangible assets
In accordance with IAS 36 'Impairment of Assets', reviews for triggers of impairment or impairment reversals at
an individual asset or cash generating unit level were conducted, and impairment tests carried out where triggers
were identified. As a result, total impairment charges of $320m have been recorded against intangible assets
during the six months ended 30 June 2023 (H1 2022: $26m net reversal). Net impairment charges in respect of
medicines in development were $320m (H1 2022 : $9m reversal ) including the $244m impairment of the
ALXN1840 intangible asset, following decision to discontinue this development programme in Wilson's disease.
As previously disclosed, on 16 January 2023 AstraZeneca completed the acquisition of Neogene Therapeutics
Inc. (Neogene), a global clinical -stage biotechnology company pioneering the discovery, development and
manufacturing of next -generation T-cell receptor therapies (TCR -Ts). The purcha se price allocation exercise
has completed, with the fair value of total consideration determined at $267m. Intangible assets of $100m and
goodwill of $158m were recognised in the acquisition balance sheet, as well as a cash outflow of $189m net of
cash acquired. Future contingent milestones-based and non-contingent consideration is payable to a maximum
of $120m. Neogene's results have been consolidated into the Group's results from 16 January 2023.
The acquisition of CinCor completed on 24 February 2023, recorded as an asset acquisition, with consideration
and net assets acquired of $1,268m , which included intangible assets acquired of $780m , $424m of cash and
cash equivalents, and $75m of marketable securities. The Condensed consolidated statement of cash flows
includes a $1,204m payment for the intangible assets which is presented net of the $424m cash and cash
equivalents acquired within Purchase of intangible assets, whilst the $75m increase in marketable securities is
presented within Mo vement in short -term investments , fixed deposits and other investing instruments .
Contingent consideration of up to $496m could be paid on achievement of regulatory milestones, and will be
recognised when the associated milestones are triggered.
Note 3: Net debt
===== SIDA 38 =====
38
The table below provides an analysis of Net Debt and a reconciliation of Net Cash Flow to the movement in Net
Debt. The Group monitors Net Debt as part of its capital -management policy as described in Note 28 of the
Annual Report and Form 20-F Information 2022. Net Debt is a non-GAAP financial measure.
Table 25: Net debt
At 1 Jan
2023
Cash
flow
Acquisitions Non-cash
& other
Exchange
movements
At 30 Jun
2023
$m $m $m $m $m $m
Non-current instalments of loans (22,965) (3,827) - 2,587 (124) (24,329)
Non-current instalments of leases (725) (1) (6) 10 - (722)
Total long-term debt (23,690) (3,828) (6) 2,597 (124) (25,051)
Current instalments of loans (4,964) 3,409 - (2,594) 14 (4,135)
Current instalments of leases (228) 141 (2) (146) 4 (231)
Bank collateral received (89) (61) - - - (150)
Other short-term borrowings excluding
overdrafts
(78) (11) - - 11 (78)
Overdrafts (183) (10) - - - (193)
Total current debt (5,542) 3,468 (2) (2,740) 29 (4,787)
Gross borrowings (29,232) (360) (8) (143) (95) (29,838)
Net derivative financial instruments (96) (27) - 179 - 56
Net borrowings (29,328) (387) (8) 36 (95) (29,782)
Cash and cash equivalents 6,166 (455) - - (47) 5,664
Other investments - current 239 (90) - - (1) 148
Cash and investments 6,405 (545) - - (48) 5,812
Net debt (22,923) (932) (8) 36 (143) (23,970)
Non-cash movements in the period include fair value adjustments under IFRS 9 Financial Instruments.
The Group has agreements with some bank counterparties whereby the parties agree to post cash collateral
on financial derivatives, for the benefit of the other, equivalent to the market valuation of the derivative positions
above a predetermined threshold. The carrying value of such cash collateral held by the Group at 30 June 2023
was $150m (31 December 2022: $89m) and the carrying value of such cash collateral posted by the Group at
30 June 2023 was $136m (31 December 2022: $162m).
The equivalent GAAP measure to Net debt is 'liabilities arising from financing activities ', which excludes the
amounts for cash and overdrafts, other investments and non -financing derivatives shown above and includes
the Acerta Pharma share purchase liability of $805m (31 December 2022: $1,646m), which is shown in current
other payables.
Net debt increased by $1,047m in the half to $23,970m. Details of the committed undrawn bank facilities are
disclosed within the going concern section of Note 1.
During the six months ended 30 June 2023, there were no changes to the Company 's solicited credit ratings
issued by Standard and Poor 's (long term : A; short term: A -1) and from Moody 's (long term: A3; short term:
P-2).
Note 4: Financial Instruments
As detailed in the Group 's most recent annual financial statements, the principal financial instruments consist
of derivative financial instruments, ot her investments, trade and other receivables, cash and cash equivalents,
trade and other payables, lease liabilities and interest-bearing loans and borrowings.
The Group has certain equity investments that are categorised as Level 3 in the fair value hier archy that are
held at $247m at 30 June 2023 (31 December 2022: $186m) and for which fair value gains of $1m have been
recognised in the six months ended 3 0 June 2023 (H1 2022: $48m). In the absence of specific market data,
these unlisted investments are held at fair value based on the cost of investment and adjusting as necessary
for impairments and revaluations on new funding rounds, which are seen to approximate the fair value. All other
fair value gains and/or losses that are p resented in Net losses on equity investments measured at fair value
through other comprehensive income in the Condensed consolidated statement of comprehensive income for
===== SIDA 39 =====
39
the six months ended 30 June 2023 are Level 1 fair value measurements, valued based o n quoted prices in
active markets.
Financial instruments measured at fair value include $1,083m of other investments, $4,400m held in money -
market funds, $289m of loans designated at fair value through profit or loss and $56m of derivatives as at 30
June 2023. With the exception of derivatives being Level 2 fair valued, certain equity investments as described
above and an equity warrant of $16m categorised as Level 3, the aforementioned balances are Level 1 fair
valued. Financial instruments measured at amortised cost include $1 36m of cash collateral pledged to
counterparties. The total fair value of interest -bearing loans and borrowings at 30 June 2023, which have a
carrying value of $29,838m in the Condensed consolidated statement of financial position, was $28,591m.
As announced in April 2023, the contractual relationship between AstraZeneca and Swedish Orphan Biovitrum
AB (Sobi) relating to future sales of Beyfortus (nirsevimab) in the US has been replaced by a royalty relationship
between Sanofi and Sobi. As a result, a non-current other payable representing AstraZeneca's future obligations
to Sobi was eliminated from AstraZeneca 's Statement of Financial Position in the quarter, and AstraZ eneca
recorded a gain of $712m in Core Other operating income.
Table 26: Financial instruments - contingent consideration
2023 2022
Diabetes
alliance Other Total Total
$m $m $m $m
At 1 January 2,124 98 2,222 2,865
Additions through business combinations - 60 60 -
Settlements (395) (3) (398) (367)
Disposals - - - (121)
Revaluations 229 (27) 202 293
Discount unwind 62 4 66 85
At 30 June 2,020 132 2,152 2,755
Contingent consideration arising from business combinations is fair valued using decision -tree analysis, with
key inputs including the probability of success, consideration of potential delays and the expected levels of
future revenues.
The contingent con sideration balance relating to BMS 's share of the global diabetes alliance of $ 2,020m
(31 December 2022: $2,124m) would increase/decrease by $202m with an increase/decrease in sales of 10%,
as compared with the current estimates.
Note 5: Pensions and other post-retirement benefit obligations
During the six months ended 30 June 2023 , AstraZeneca Pharmaceuticals PLP terminated its main defined
benefit pension plan. A total of $839m of pension obligations were discharged from the scheme, $142m of which
was settled via a cash payment to the participants and the remaining $697m was transferred to an external
insurer via a buy-out. At 30 June 2023, the plan contained immaterial residual assets and obligations which are
expected to be discharged by the end of 2023, with minimal impact to the income statement.
Note 6: Legal proceedings and contingent liabilities
AstraZeneca is involved in various legal proceedings considered typical to its business, including litigation and
investigations, including Government investigations, relating to product liability, commercial disputes,
infringement of intellectual property (IP) rights, the validity of certain patents, anti -trust law and sales and
marketing practices. The matters discussed below constitute the more significant developments since
publication of the disclosures concerning legal proceedings in the Company's Annual Report and Form 20 -F
Information 2022 (the Disclosures).
As discussed in t he Disclosures, the majority of claims involve highly complex issues. Often these issues are
subject to substantial uncertainties and, therefore, the probability of a loss, if any, being sustained and/or an
estimate of the amount of any loss is difficult to ascertain.
Unless specifically identified below, AstraZeneca considers each of the claims to represent a contingent liability
or a contingent asset where the matter is brought by AstraZeneca, and discloses information with respect to the
===== SIDA 40 =====
40
nature and facts of the cases in accordance with IAS 37 'Provisions, Contingent Liabilities and Contingent
Assets'.
There is one matter concerning legal proceedings in the Disclosures, which is considered probable that an
outflow will be required, but for which we are unable to make an estimate of the possible loss or range of possible
losses at this stage.
In cases that have been settled or adjudicated, or where quantifiable fines and penalties have been assessed
and which are not subject to appeal, or where a loss is probable and we are able to make a reasonable estimate
of the loss, AstraZeneca records the loss absorbed or makes a provision for its best estimate of the expected
loss. The position could change over time and the estimates that the Company made, and upon which the
Company have relied in calculating these provisions are inherently imprecise. There can, therefore, be no
assurance that any losses that result from the outcome of any legal proceedings will not exceed the amount of
the provisions that have been booked in the accounts. The major factors causing this uncertainty are described
more fully in the Disclosures and herein.
AstraZeneca has full confidence in, and will vigorously defend and enforce, its IP.
Matters disclosed in respect of the second quarter of 2023 and to 28 July 2023
Patent litigation
Imfinzi and Imjudo
Patent proceedings in the US and outside the US
As previously disclosed, in March 2022, Bristol-Myers Squibb Co. and E.R. Squibb & Sons, LLC filed a lawsuit
in US District Court for the District of Delaware (the District Court) against AstraZeneca alleging that
AstraZeneca's marketing of Imfinzi infringes several of their patents. In April 2023, Bristol -Myers Squibb Co.,
E.R. Squibb & Sons, LLC, Tasuku Honjo, Ono Pharmaceutical Co., Ltd., and the Dana-Farber Cancer Institute
Inc. filed a separate lawsuit in the District Court against AstraZeneca alleging that AstraZeneca 's marketing of
Imfinzi infringes another of their patents. The cases were subsequently consolidated.
As previously disclosed, in January 2023, Bristol-Myers Squibb Co. and E.R. Squibb & Sons, LLC filed a lawsuit
in US District Court for the District of Delaware against AstraZeneca alleging that AstraZeneca 's marketing of
Imjudo infringes two of their patents.
As previously disclosed, in February 2022, in Japan, Ono Pharmaceuticals filed a lawsuit in Tokyo District Court,
Civil Division against AstraZeneca alleging that AstraZeneca's marketing of Imfinzi in Japan infringes several of
their patents.
In July 2023, AstraZeneca entered into a global settlement agreement with Bristol -Myers Squibb Co., E.R.
Squibb & Sons, LLC, and Ono Pharmaceutical Co., Ltd. that resolves all patent disputes relating to Imfinzi and
Imjudo between the companies. A provision covering both Imfinzi and Imjudo has been taken totalling $510m.
Faslodex
Patent proceedings outside the US
As previously disclosed, in 2021 in Japan, AstraZeneca received notice from the Japan Patent Office (JPO) that
Sandoz K.K. and Sun Pharma Japan Ltd. (Sun) were seeking to invalidate the Faslodex formulation patent.
AstraZeneca defended the challenged patent, and Sun withdrew from the JPO patent challenge. In July 2023,
the JPO issued a final decision upholding various claims of the challenged patent and determining that other
patent claims were invalid.
Product liability litigation
Onglyza and Kombiglyze
US proceedings
In the US, AstraZeneca is defending various lawsuits alleging heart failure, cardiac injuries, and/or death from
treatment with Onglyza or Kombiglyze. In February 2018, the Ju dicial Panel on Multidistrict Litigation ordered
the transfer of various pending federal actions to the US District Court for the Eastern District of Kentucky (the
District Court) for consolidated pre -trial proceedings with the federal actions pending in t he District Court. The
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41
District Court granted AstraZeneca 's motion for summary judgment in August 2022, and plaintiffs are in the
process of appealing that decision. In the California State Court coordinated proceeding, AstraZeneca's motion
for summary jud gment was granted in March 2022. Plaintiffs appealed, and in April 2023, the California
Appellate Court affirmed the lower court's decision to grant summary judgment. Plaintiffs have now appealed to
the California Supreme Court.
Commercial litigation
AZD1222 Securities Litigation (US)
In January 2021, putative securities class action lawsuits were filed in the US District Court for the Southern
District of New York (the District Court) against AstraZeneca PLC and certain officers, on behalf of purchasers
of AstraZeneca publicly traded securities during a period later amended to cover 15 June 2020 through 29
January 2021 (the Amended Complaint) . The Amended Complaint alleges that defendants made materially
false and misleading statements in connection with the development of AZD1222, AstraZeneca 's vaccine for
the prevention of COVID -19. In September 2022, the District Court granted AstraZeneca 's motion to dismiss
the Amended Complaint with prejudice, disallowing any further amendments. Plaintiffs appealed th is decision
and in May of 2023, the US Court of Appeals for the Second Circuit affirmed the dismissal.
PARP Inhibitor Royalty Dispute
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 has
failed to pay all of the royalties due on niraparib sales under the license agreements. The case was transferred
to the Chancery Division and a trial took place in March 2023 . In April 2023, the court issued a decision in
AstraZeneca's favour. GSK has been granted permission to appeal. The appellate hearing window has been
scheduled for January 2024.
Syntimmune
In connection with Alexion 's prior acquisition of Syntimmune, Inc., (Syntimmune) in December 2020, Alexion
was served with a lawsuit filed by the stockholders' representative for Syntimmune in Delaware State Court that
alleged, among other things, breaches of contractual obligations relating to the 2018 merger agreement. The
stockholders' representative alleges that Alexion failed to meet its obligations under the merger agreement to
use commercially reasonable efforts to achieve the milestones. Alexion also filed a claim for breach of the
representations in the 2018 merger agreement. A trial was held in July 2023. A decision is not expected until
2024.
Government investigations/proceedings
US 340B litigations and proceedings
As previously disclosed, in January 2021, AstraZeneca filed a separate lawsuit in the US District Court for th e
District of Delaware (the District Court) alleging that an Advisory Opinion issued by the Department of Health
and Human Services violates the Administrative Procedure Act. In June 2021, the District Court found in favour
of AstraZeneca, invalidating the Advisory Opinion. However, in May 2021, prior to the District Court's ruling, the
US government issued new and separate letters to AstraZeneca (and other companies) asserting that
AstraZeneca's contract pharmacy policy violates the 340B statute. AstraZene ca amended the complaint to
include allegations challenging the letter sent in May 2021, and in February 2022, the District Court ruled in
favour of AstraZeneca invalidating those letters sent by the US Government. In January 2023, the Court of
Appeals affirmed the District Court decision in AstraZeneca 's favour. Final judgment was entered in favour of
AstraZeneca in May 2023 and this matter is now concluded.
Matters disclosed in respect of the first quarter of 2023 and to 27 April 2023
Patent litigation
Enhertu
US patent proceedings
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42
As previously disclosed, 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, inter alia, that the
Seagen patent is invalid for lack of written description and enablement. The USPTO initially declined to institute
the PGRs, but, in April 2022, the USPTO granted the rehearing requests, instituting both PGR petitions. Seagen
subsequently disclaimed all patent claims at issue in one of the PGR proceedings. In July 2022, the USPTO
reversed its institution 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 USPTO reinstituted the PGR proceeding. An oral hearing is scheduled for August 2023.
Lynparza
US patent proceedings
As previously disclosed, in December 2022, AstraZeneca received a Paragraph IV notice letter from an
abbreviated new drug application (ANDA) filer relating to patents listed in the FDA Orange Book with reference
to Lynparza. In February 2023, in response to the Paragraph IV notice, AstraZeneca, MSD Internation al
Business GmbH, and the University of Sheffield initiated ANDA litigation against Natco Pharma Limited (Natco)
in the US District Court for the District of New Jersey. In the complaint, AstraZeneca alleged that Natco's generic
version of Lynparza, if approved and marketed, would infringe patents listed in the FDA Orange Book with
reference to Lynparza. No trial date has been scheduled.
Movantik
US patent proceedings
AstraZeneca has resolved by settlement the previously disclosed patent infringement lawsuit brought by Aether
Therapeutics, Inc. in the US District Court for the District of Delaware against AstraZeneca, Nektar Therapeutics
and Daiichi Sankyo, Inc., relating to Movantik. This matter is now concluded.
Symbicort
US patent proceedings
AstraZeneca has resolved via settlement the previously disclosed ANDA litigations with Mylan Pharmaceuticals
Inc. and Kindeva Drug Delivery L.P. (together, the Defendants). In those actions, AstraZeneca alleged that the
Defendants' generic versions of Symbicort, if approved and marketed, would infringe various AstraZeneca
patents. This matter is now concluded.
Tagrisso
Patent proceedings outside the US
In Russia, in October 2021, AstraZeneca filed a lawsuit in the Arbitration Court of the Moscow Region (the
Court) against Axelpharm, LLC to prevent it from obtaining authorisation to market a generic version of Tagrisso
prior to the expiration of AstraZeneca's patents covering Tagrisso. The lawsuit also names the Ministry of Health
of the Russian Federation as a third party. In March 2022, the Court dismissed the lawsuit. In June 2022, the
dismissal was affirmed on appeal. In January 2023, the dismissal was affirmed on further appeal. This matter
is now concluded.
Product liability litigation
Nexium and Losec/Prilosec
US proceedings
In the US, AstraZeneca is defending various previously disclosed lawsuits brought in federal and state courts
involving multiple plaintiffs claiming that they have been diagnosed with various injuries following treatment with
proton pump inhibitors (PPIs), including Nexium and Prilosec. The vast majority of those lawsuits relate to
allegations of kidney injuries. In August 2017, the pending federal court cases were consolidated in a multidistrict
litigation (MDL) proceeding in the US District Court for the District of New Jersey for pre -trial purposes. A
bellwether trial has been scheduled for October 2023, with subsequent bellwether trials scheduled for November
2023 and January 2024. In addition to the MDL cases, there are cases filed in several state courts around the
US; a case that was previously set to go to trial in Delaware state court was dismissed in October 2022.
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In addition, AstraZeneca has been defending various lawsuits involving allegations of gastric cancer following
treatment with proton pump inhibitors (PPIs), including Nexium and Prilosec. One such claim is filed in the US
District Court for the Middle District of Louisiana has been scheduled to go to trial in April 2024.
Onglyza and Kombiglyze
US proceedings
As previously disclosed, in the US, AstraZeneca is defending various lawsuits alleging heart failure, cardiac
injuries, and/or death from treatment with Onglyza or Kombiglyze. In February 2018, the Judicial Panel on
Multidistrict Litigation ordered the tra nsfer of various pending federal actions to the US District Court for the
Eastern District of Kentucky (the District Court) for consolidated pre -trial proceedings with the federal actions
pending in the District Court. The District Court granted AstraZeneca's motion for summary judgment in August
2022, and plaintiffs are in the process of appealing that decision. In the California State Court coordinated
proceeding, AstraZeneca's motion for summary judgment was granted in March 2022. Plaintiffs appealed, and
in April 2023, the California Appellate Court affirmed the lower court's decision to grant summary judgment.
Commercial Litigation
Viela Bio, Inc. Shareholder Litigation
US proceedings
In February 2023, AstraZeneca was served with a lawsuit filed in the Delaware State Court against AstraZeneca
and certain officers, on behalf of a putative class of Viela Bio, Inc. (Viela) shareholders. The complaint alleges
that defendants breached their fiduciary duty to Viela shareholders in the course of Viela 's 2021 merger with
Horizon Therapeutics, plc. This case remains in the preliminary stages.
Definiens
In Germany, in July 2020, AstraZeneca received a notice of arbitration filed with the German Institution of
Arbitration 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-outs
under the SPA. The arbitration hearing took place in March 2023 and AstraZeneca await s a decision.
PARP Inhibitor Royalty Dispute
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 has
failed to pay all of the royalties due on niraparib sales under the license agreements. The case was transferred
to the Chanc ery Division and a trial took place in March 2023. In April 2023, the court issued a decision in
AstraZeneca's favour.
Pay Equity Litigation (US)
AstraZeneca was defending a putative class and collective action matter in the US District Court for the Northern
District of Illinois brought by three named plaintiffs, who are former AstraZeneca pharmaceutical sales
representatives. The case involved claims under the federal and Illinois Equal Pay Acts, with the plaintiffs
alleging they were paid less than male employees who performed substantially similar and/or equal work. The
plaintiffs sought various damages on behalf of themselves and the putative class and/or collective, including
without limitation backpay, liquidated damages, compensatory and punitiv e damages, attorneys ' fees, and
interest. In January 2023, the District Court granted AstraZeneca 's motion to dismiss plaintiffs ' complaint. In
March 2023, plaintiffs filed a Second Amended Complaint.
Portola Shareholder Litigation
In the US, in connection with Alexion's July 2020 acquisition of Portola Pharmaceuticals, Inc (Portola), Alexion
assumed litigation to which Portola is a party. In January 2020, putative securities class action lawsuits were
filed in the US District Court for the Northe rn District of California against Portola and certain officers and
directors, on behalf of purchasers of Portola publicly traded securities during the period 8 January 2019 through
26 February 2020. The operative complaints allege that defendants made materially false and/or misleading
statements or omissions with regard to Andexxa. In June 2022, the parties reached a settlement in principle of
this matter. In March 2023, the court granted final approval of the settlement. This matter is now concluded.
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44
Alexion Shareholder Litigation (US)
In December 2016, putative securities class action lawsuits were filed in the US District Court for the District of
Connecticut (the District Court) against Alexion and certain officers and directors, on behalf of purchasers of
Alexion publicly traded securities during the period 30 January 2014 through 26 May 2017. The amended
complaint alleges that defendants engaged in securities fraud, including by making misrepresentations and
omissions in its public disclosure s concerning Alexion 's Soliris sales practices, management changes, and
related investigations. In August 2021, the District Court issued a decision denying in part Defendants ' motion
to dismiss the matter. The Court granted Plaintiffs' motion for class certification in April 2023.
Syntimmune
In connection with Alexion 's prior acquisition of Syntimmune, Inc., (Syntimmune) in December 2020, Alexion
was served with a lawsuit filed by the stockholders' representative for Syntimmune in Delaware State Court that
alleged, among other things, breaches of contractual obligations relating to the 2018 merger agreement. The
stockholders' representative alleges that Alexion failed to meet its obliga tions under the merger agreement to
use commercially reasonable efforts to achieve the milestones. Alexion also filed a claim for breach of the
representations in the 2018 merger agreement. A trial is scheduled for the matter in July 2023.
Government investigations/proceedings
Brazilian tax assessment matter (Brazil)
As previously disclosed, in August 2019, the Brazilian Federal Revenue Service provided a Notice of Tax and
Description of the Facts (the Tax Assessment) to two Alexion subsidiaries (the Brazil Subsidiaries), as well as
to two additional entities, a logistics provider utilised by Alexion and a distributor. The Tax Assessment focuses
on the importation of Soliris vials pursuant to Alexion's free drug supply to patients programme in Brazil.
Alexion prevailed in the first level of administrative appeals in the Brazilian federal administrative proceeding
system based on a deficiency in the Brazil Tax Assessment. The decision was subject to an automatic (ex
officio) appeal to the second level of the administrative courts. In March 2023, the second level of the
administrative courts issued a decision to remand the matter to the first level of administrative courts for a
determination on the merits.
Note 7: Subsequent events
In July 2023, Alexion, AstraZeneca Rare Disease (Alexion) and Pfizer Inc. (Pfizer) entered into an agreement
for Alexion to purchase and licence the assets of Pfizer 's early-stage rare disease gene therapy portfolio for a
total consideration of up to $1bn, plus tiered royalties on sales. Alexion plans to close the transaction in Q3
2023, subject to the satisfaction of closing conditions.
Note 8: Additional financial information
Table 27: H1 2023 - Product Sales year-on-year analysis80
The CER information in respect of H1 2023 included in the Interim Financial Statements has not been reviewed
by PricewaterhouseCoopers LLP.
World US Emerging Markets Europe Established RoW
$m Act %
chg
CER %
chg $m
%
ch
g
$m Act %
chg
CER %
chg $m Act %
chg
CER %
chg $m Act %
chg
CER %
chg
Oncology 8,302 17 21 3,666
23 1,953
9 17 1,579
18 21 1,104
13 25
Tagrisso 2,915 8 12 1,102
16 851 6 13 541 6 9 421 (4) 6
Imfinzi 1,976 53 57 1,098
60 183 37 47 339 27 30 356 74 92
Lynparza 1,368 6 10 580 - 278 15 23 365 11 14 145 5 15
Calquence 1,185 31 33 869 18 41 n/m n/m 225 85 92 50 64 75
Enhertu 104 n/m n/m - - 72 n/m n/m 24 n/m n/m 8 n/m n/m
Orpathys 22 (7) - - - 22 (7) - - - - - - -
Zoladex 459 (4) 4 6 (3) 339 2 11 66 (3) 1 48 (32) (24)
Faslodex 153 (14) (7) 7 (37) 81 - 7 16 (50) (48) 49 (10) 1
80 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.
Financial Statements
===== SIDA 45 =====
45
Others 120 (37) (33) 4 (26) 86 (39) (35) 3 (53) (51) 27 (28) (22)
BioPharmaceuticals:
CVRM 5,205 14 19 1,283
11 2,347
12 20 1,168
24 27 407 12 23
Farxiga 2,804 33 39 634 35 1,074
32 41 850 36 40 246 27 39
Brilinta 665 (1) 1 357 2 160 10 17 136 (9) (7) 12 (57) (53)
Lokelma 198 53 59 105 35 24 n/m n/m 25 98 n/m 44 32 47
roxadustat 134 48 59 - - 134 48 59 - - - - - -
Andexxa 89 28 33 37 (12) - - - 29 64 70 23 n/m n/m
Crestor 585 7 14 26 (23) 458 11 18 32 52 54 69 (11) (3)
Seloken/Toprol-XL 343 (27) (20) 1 n/m 333 (27) (21) 6 (6) (6) 3 (26) (11)
Onglyza 127 (8) (4) 36 (11) 67 1 9 16 (21) (18) 8 (31) (28)
Bydureon 89 (37) (37) 73 (38) 2 (1) - 14 (32) (30) - - -
Others 171 (13) (10) 14 (26) 95 (9) (3) 60 (13) (13) 2 (57) (53)
BioPharmaceuticals: R&I 3,066 6 10 1,291
(1) 893 22 31 581 6 9 301 (3) 6
Symbicort 1,288 - 4 434 (10) 405 32 43 284 (9) (6) 165 (13) (6)
Fasenra 744 12 14 468 12 29 66 70 176 15 19 71 (2) 7
Breztri 307 71 76 165 55 81 88 n/m 36 n/m n/m 25 53 65
Saphnelo 115 n/m n/m 107 n/m 1 n/m n/m 3 n/m n/m 4 n/m n/m
Tezspire 30 n/m n/m - - - - - 17 n/m n/m 13 n/m n/m
Pulmicort 346 4 11 17 (54) 273 16 24 36 2 6 20 (23) (17)
Bevespi 29 (1) (1) 17 (23) 3 36 48 9 67 69 - - -
Daliresp/Daxas 30 (72) (72) 24 (77) 1 (16) (14) 5 (11) (5) - (39) (36)
Others 177 (30) (26) 59 (40) 100 (20) (13) 15 (42) (39) 3 (3) -
BioPharmaceuticals: V&I 443 (84) (83) - n/m 149 (83) (82) 114 (78) (77) 180 (75) (72)
COVID-19 mAbs 126 (86) (85) - n/m 5 (95) (95) 7 (95) (95) 114 (6) 6
Vaxzevria 28 (98) (98) - n/m 18 (97) (97) 10 (96) (96) - n/m n/m
Beyfortus 2 n/m n/m - - - - - 2 n/m n/m - - -
Synagis 284 1 8 - n/m 126 17 23 92 (13) (9) 66 3 15
FluMist 3 n/m n/m - n/m - - - 3 n/m n/m - - -
Rare Disease 3,819 9 12 2,290
10 324 57 67 767 5 8 438 (6) 4
Soliris 1,648 (18) (16) 893 (23) 214 60 76 367 (16) (14) 174 (38) (33)
Ultomiris 1,364 60 64 815 79 30 - 2 311 38 42 208 46 62
Strensiq 562 25 26 453 28 24 33 26 42 5 8 43 12 23
Koselugo 159 57 57 89 15 38 n/m n/m 23 n/m n/m 9 - -
Kanuma 86 16 17 40 4 18 95 96 24 5 7 4 12 22
Other medicines 613 (27) (22) 68 (9) 390 (1) 6 48 (28) (27) 107 (65) (61)
Nexium 492 (27) (22) 60 (6) 305 6 14 25 (4) (2) 102 (65) (62)
Others 121 (28) (25) 8 (26) 85 (20) (15) 23 (44) (44) 5 (49) (47)
Total Product Sales 21,448
(1) 3 8,598
4 6,056
- 7 4,257
3 6 2,537
(19) (11)
Table 28: Q2 2023 - Product Sales year-on-year analysis (Unreviewed)81
The Q2 2023 information in respect of the three months ended 30 June 2023 included in the Interim Financial
Statements has not been reviewed by PricewaterhouseCoopers LLP.
World US Emerging Markets Europe Established RoW
$m Act %
chg
CER %
chg $m
%
ch
g
$m Act %
chg
CER %
chg $m Act %
chg
CER %
chg $m Act %
chg
CER %
chg
Oncology 4,382 18 22 1,962
22 987 10 18 819 19 19 614 21 30
Tagrisso 1,491 7 10 581 13 408 2 9 284 11 11 218 (6) 2
Imfinzi 1,076 55 58 576 54 102 35 47 176 23 23 222 n/m n/m
Lynparza 717 7 9 311 - 142 18 28 187 10 11 77 7 15
Calquence 653 34 34 485 22 24 n/m n/m 117 76 78 27 55 64
Enhertu 67 n/m n/m - - 48 n/m n/m 14 n/m n/m 5 n/m n/m
Orpathys 13 22 30 - - 13 22 30 - - - - - -
Zoladex 233 (1) 5 4 25 171 4 13 34 (1) 1 24 (31) (26)
Faslodex 78 (8) (3) 3 (41) 43 16 23 6 (61) (62) 26 (6) 1
Others 54 (42) (39) 2 (24) 36 (48) (44) 1 (50) (51) 15 (24) (21)
BioPharmaceuticals:
CVRM 2,675 14 18 661 5 1,182
10 18 611 32 33 221 19 27
Farxiga 1,505 36 41 339 23 576 36 45 456 48 48 134 39 50
Brilinta 331 (5) (3) 178 (4) 79 1 10 68 (7) (7) 6 (55) (53)
Lokelma 100 51 55 49 26 13 n/m n/m 14 98 n/m 24 34 44
roxadustat 73 46 56 - - 73 46 56 - - - - - -
Andexxa 45 23 26 16 (10) - - - 15 70 74 14 44 49
Crestor 280 - 5 12 (25) 217 - 6 16 56 51 35 (4) 2
Seloken/Toprol-XL 164 (26) (21) 1 - 159 (27) (21) 2 (16) (9) 2 (28) (2)
Onglyza 65 (9) (6) 22 1 30 (7) - 8 (24) (18) 5 (30) (37)
Bydureon 43 (41) (41) 35 (43) 1 (33) (32) 7 (25) (25) - - -
Others 69 (30) (28) 9 (26) 34 (35) (31) 25 (23) (23) 1 (50) (46)
BioPharmaceuticals: R&I 1,483 7 10 674 3 360 22 31 289 6 6 160 1 8
Symbicort 600 (2) 1 200 (10) 177 27 37 137 (11) (11) 86 (12) (5)
Fasenra 406 15 16 267 16 14 37 42 89 14 14 36 - 8
Breztri 163 75 79 84 57 43 n/m n/m 21 n/m n/m 15 54 60
81 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.
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Saphnelo 68 n/m n/m 64 n/m 1 n/m n/m 1 n/m n/m 2 n/m n/m
Tezspire 19 n/m n/m - - - - - 11 n/m n/m 8 n/m n/m
Pulmicort 124 7 13 7 (53) 90 26 36 16 (7) (7) 11 (14) (8)
Bevespi 15 (1) (3) 8 (30) 2 76 90 5 77 73 - - -
Daliresp/Daxas 17 (71) (70) 14 (74) 1 (13) (10) 2 (15) (8) - - -
Others 71 (34) (32) 30 (35) 32 (36) (32) 7 (20) (18) 2 6 5
BioPharmaceuticals: V&I 88 (91) (90) - n/m 46 (80) (78) 15 (93) (93) 27 (90) (89)
COVID-19 mAbs (1) n/m n/m - n/m (3) n/m n/m 3 (96) (97) (1) n/m n/m
Vaxzevria - n/m n/m - n/m - n/m n/m - n/m n/m - n/m n/m
Beyfortus 2 n/m n/m - - - - - 2 n/m n/m - - -
Synagis 87 8 16 - n/m 49 16 27 10 (48) (47) 28 63 75
FluMist - n/m n/m - n/m - - - - n/m n/m - - -
Rare Disease 1,953 8 10 1,196
12 150 65 78 381 2 2 226 (15) (9)
Soliris 814 (21) (19) 445 (23) 99 57 74 184 (15) (15) 86 (50) (47)
Ultomiris 713 64 66 434 84 17 n/m n/m 152 26 26 110 53 64
Strensiq 300 24 25 248 29 9 (1) (4) 21 - (1) 22 16 25
Koselugo 80 28 30 48 2 14 36 38 12 n/m n/m 6 n/m n/m
Kanuma 46 28 30 21 5 11 n/m n/m 12 5 4 2 (4) 3
Other medicines 301 (28) (24) 32 (11) 185 (3) 4 26 (16) (17) 58 (64) (61)
Nexium 248 (28) (23) 30 - 149 3 11 14 16 15 55 (65) (62)
Others 53 (29) (27) 2 (68) 36 (22) (18) 12 (36) (36) 3 (28) (31)
Total Product Sales 10,882
2 5 4,525
7 2,910
5 12 2,141
4 4 1,306
(16) (9)
Table 29: Alliance Revenue
H1 2023 H1 2022
$m $m
Enhertu 475 175
Tezspire 105 16
Vaxzevria: royalties - 60
Other royalty income 41 34
Other Alliance Revenue 6 5
Total 627 290
Table 30: Collaboration Revenue H1 2023 H1 2022
$m $m
Lynparza: regulatory milestones - 175
COVID-19 mAbs: licence fees 180 -
Farxiga: sales milestones 25 -
tralokinumab: sales milestones - 70
Other Collaboration Revenue 15 16
Total 220 261
Table 31: Other operating income and expense H1 2023 H1 2022
$m $m
brazikumab licence termination funding 75 69
Divestment of rights to Plendil - 61
Divestment of US rights to Pulmicort Flexhaler 241 -
Update to the contractual relationships for Beyfortus (nirsevimab) 712 -
Other 135 89
Total 1,163 219
Other shareholder information
Financial calendar
Announcement of nine month and third quarter 2023 results: 9 November 2023
Announcement of full year and fourth quarter 2023 results: 8 February 2024
Dividends are normally paid as follows:
First interim: Announced with the half year results and paid in September
Second interim: Announced with full year results and paid in March
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The record date for the first interim dividend for 2023, payable on 11 September 2023, will be 11 August 2023.
The ex-dividend date will be 10 August 2023.
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 and
transfer office
Swedish Central
Securities Depository
US depositary
Deutsche Bank Trust
Company Americas
1 Francis Crick Avenue
Cambridge Biomedical
Campus
Cambridge
CB2 0AA
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Aspect House
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Lancing
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BN99 6DA
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Box 191
SE-101 23 Stockholm
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6201 15th Avenue
Brooklyn
NY 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. Medical
publications also appear throughout the document in italics. AstraZeneca, the AstraZeneca logotype and the
AstraZeneca symbol are all trademarks of the AstraZeneca group of companies. Trademarks of companies
other than AstraZeneca that appear in this document include Arimidex and Casodex, owned by AstraZeneca or
Juvisé (depending on geography); Beyfortus, a trademark of Sanofi Pasteur Inc.; Enhertu, a trademark of
Daiichi Sankyo; Losec, owned by AstraZeneca or Cheplapharm (depending upon geography); Seloken, owned
by AstraZeneca or Taiyo Pharma Co., Ltd (depending on geography); Synagis, owned by AstraZeneca or Sobi
aka Swedish Orphan Biovitrum AB (publ). (depending on geography); and Tezspire, a trademark of Amgen, Inc.
Information on or accessible through AstraZeneca 's websites, including astrazeneca.com, does not form part
of and is not incorporated into this announcement.
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the
discovery, development, and commercialisation of prescription medicines in Oncology, Rare Disease, and
BioPharmaceuticals, including Cardiovascular, Re nal & Metabolism, and Respiratory & Immunology. Based in
Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions
of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.
Cautionary statements regarding forward-looking statements
In order, among other things, to utilise the 'safe harbour' provisions of the US Private Securities Litigation Reform
Act of 1995, AstraZeneca (hereafter 'the Group') provides the following cautionary statement:
This document contains certain forward -looking statements with respect to the operations, performance and
financial 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 based
on reasonable assumptions, any forward -looking statement s, by their very nature, involve risks and
uncertainties and may be influenced by factors that could cause actual outcomes and results to be materially
different from those predicted. The forward -looking statements reflect knowledge and information availab le at
the date of preparation of this document and the Group undertakes no obligation to update these forward-looking
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48
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 materially from 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 strategic
objectives
‒ 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 our 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 such as the COVID -19 pandemic and the Russia -Ukraine
war may have or continue to have on these risks, on the Group's ability to continue to mitigate these risks,
and on the Group's operations, financial results or financial condition
Nothing in this document, or any related presentation/webcast, should be construed as a profit forecast.
- End of document -