REG - AstraZeneca PLC - Half-year Report
28/07/2023 07:00
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RNS Number : 4875H AstraZeneca PLC 28 July 2023
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 CER 1 (#_ftn1) $m Actual CER
- Product Sales 21,448 (1) 3 10,882 2 5
- Alliance Revenue 2 (#_ftn2) 627 >2x >2x 341 >2x >2x
- Collaboration Revenue(2) 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
Reported 3 (#_ftn3) EPS 4 (#_ftn4) $2.34 >4x >6x $1.17 >5x >9x
Core 5 (#_ftn5) 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 medicines 6 (#_ftn6)
‒ Excluding COVID-19 medicines, Total Revenue increased 16% and
Product Sales increased 15%
‒ Total Revenue from Oncology medicines increased 22%, CVRM 7
(#_ftn7) 20%, R&I 8 (#_ftn8) 10%, and Rare Disease 12%
‒ Core Product Sales Gross Margin 9 (#_ftn9) 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 included 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.
Our pipeline momentum continues with eight positive pivotal trials 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 NSCLC 10 (#_ftn10) (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 HF 11 (#_ftn11) regardless of ejection
fraction (DELIVER), and Beyfortus for the prevention of RSV 12 (#_ftn12) ; EU
approvals for Ultomiris in NMOSD 13 (#_ftn13) ; China approval for Enhertu in
HER2 14 (#_ftn14) -low metastatic breast cancer, Soliris in gMG 15 (#_ftn15)
and Koselugo in neurofibromatosis
‒ Other milestones: capivasertib in combination with Faslodex granted
priority review in the US for advanced HR 16 (#_ftn16) -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 (Vaxzevria 17 (#_ftn17) and
COVID‑19 mAbs 18 (#_ftn18) ) 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 (#_ftn19) , 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.
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 adverse 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&I 20 (#_ftn20) 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
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 Comments 21 (#_ftn21)
change
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 + Increasing mix of sales from Oncology and Rare Disease medicines
+2pp CER + Decreasing mix of Vaxzevria sales
‒ Increasing mix of products with profit-sharing arrangements, where
AstraZeneca books Product Sales and records an expense in COGS 22 (#_ftn22)
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 expense 23 (#_ftn23) $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
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 HFpEF 24 (#_ftn24) (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-PN 25 (#_ftn25) (paediatric) (SPRINT) Regulatory approval (CN)
Soliris gMG Regulatory approval (CN)
Soliris gMG (refractory, children and adolescents) Regulatory approval (EU)
Regulatory submissions Enhertu HER2-positive breast cancer (3rd-line) (DESTINY-Breast02) Regulatory submission (US)
or acceptances
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 PNH 26 (#_ftn26) with EVH 27 (#_ftn27) Regulatory submission (US, JP)
Major Phase III data readouts and other developments Tagrisso EGFRm 28 (#_ftn28) NSCLC (1st-line) (FLAURA2) Primary endpoint met
Lynparza + Imfinzi Endometrial cancer (1st-line) Dual primary endpoint met
(DUO-E)
Lynparza + cediranib Platinum-resistant or -refractory ovarian cancer (GY005) Primary endpoint not met
Imfinzi Resectable, early-stage and locally advanced gastric and gastroesophageal Key secondary endpoint met (pCR 29 (#_ftn29) )
junction cancers (MATTERHORN)
datopotamab deruxtecan NSCLC (2nd- and 3rd-line) Dual primary endpoint met (PFS 30 (#_ftn30) )
(TROPION-Lung01)
Upcoming pipeline catalysts
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
(https://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
pMDI 31 (#_ftn31) 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.
(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.
Sustainability summary
In July 2023, AstraZeneca announced a $400m investment in AstraZeneca's AZ
Forest programme, raising its commitment to plant 200 million trees by 2030.
Global projects involve local communities and ecological experts to deliver
reforestation at scale, as well as to support biodiversity and to sustain
livelihoods.
Management changes
Sharon Barr, currently Senior Vice President, Head of Research and Product
Development of Alexion, will succeed Mene Pangalos as Executive Vice
President, BioPharmaceuticals R&D. Mene is retiring and will step down
from his role early next year, after almost fourteen years with the company
and an illustrious 35-year career. Sharon will report to Chief Executive
Officer, Pascal Soriot and become a member of AstraZeneca's Senior Executive
Team as of 1 August.
Conference call
A conference call and webcast for investors and analysts will begin today, 28
July 2023, at 11:45 UK time. Details can be accessed via astrazeneca.com
(https://www.astrazeneca.com/) .
Reporting calendar
The Company intends to publish its nine month and third quarter results on
Thursday 9 November 2023.
Operating and financial review
All narrative on growth and results in this section is based on actual foreign
exchange rates, and financial figures are in US$ millions ($m), unless stated
otherwise. Unless stated otherwise, the 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 charges and
fair value movements relating to contingent consideration on business
combinations, imputed finance charges and remeasurement adjustments on certain
Other payables arising from intangible asset acquisitions, 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
(https://www.astrazeneca.com/content/dam/az/Investor_Relations/annual-report-2022/pdf/AstraZeneca_AR_2022.pdf)
.
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 Margin) 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.
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 (#_ftn32) 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 mAbs 33 (#_ftn33) 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
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)
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 NRDL 34 (#_ftn34) renewal price effective
March 2023 and competition
Europe * Established standard of care in 1st-line and adjuvant settings across
EU5 35 (#_ftn35) , 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)
* Strong growth across all regions, driven by recent launches (BTC 36
(#_ftn36) , HCC 37 (#_ftn37) , Stage IV NSCLC) and established indications
(Stage III NSCLC, SCLC 38 (#_ftn38) )
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 PARP 39 (#_ftn39) 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 HRD 40
(#_ftn40) 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
(PSR 41 (#_ftn41) and BRCAm 42 (#_ftn42) 1st-line maintenance) and new NRDL
enlistment in prostate cancer (PROfound)
Europe * Growth driven by increased uptake in 1st-line HRD-positive ovarian cancer,
gBRCAm 43 (#_ftn43) 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)
* 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 mBC 44 (#_ftn44) 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 BTKi 45 (#_ftn45) 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 MET 46 (#_ftn46) 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: 47%). Strong
growth 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
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 SGLT2 47 (#_ftn47) market
in all major regions, fuelled by heart failure and CKD 48 (#_ftn48) launches
* Additional benefit from continued growth in the overall SGLT2 inhibitor
class
US * Growth driven by HFrEF 49 (#_ftn49) and CKD for patients with and without
T2D 50 (#_ftn50) 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
Seloken 343 (27%) (20%) * Ongoing impact of China VBP 51 (#_ftn51) implementation
Onglyza 127 (8%) (4%) * Continued decline for DPP-IV 52 (#_ftn52) 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 FDC 53 (#_ftn53) triple
class across major markets
US * Consistent share growth within the FDC triple class in new-to-brand 54
(#_ftn54) 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 COPD 55 (#_ftn55) 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
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 ICS 56 (#_ftn56)
/LABA 57 (#_ftn57) 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
BioPharmaceuticals - V&I
Total Revenue from V&I medicines declined by 77% (76% at CER) to $632m (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% (12% 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 C5 58
(#_ftn58) 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
* 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, aHUS 59 (#_ftn59) 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 * Successful conversion from Soliris to Ultomiris, partially offset by growth
Established RoW 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
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% - -
OOI 60 (#_ftn60) & 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 Other 61 (#_ftn61) Core Core
of Alexion
% Change
$m $m $m $m $m $m Actual CER
Gross profit 18,430 118 16 57 (3) 18,618 3 8
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 Other(54) Core Core
of Alexion
% 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
‒ 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
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 202 293 (91)
business combinations
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 At 31 At 30
Jun 2023 Dec 2022 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.
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 AstraZeneca 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 and guarantee obligations is
also dependent upon the earnings of its subsidiaries, affiliates, branches and
divisions, whether by dividends, distributions, loans or otherwise.
Please refer to the consolidated financial statements of AstraZeneca PLC in
our Annual Report on Form 20-F and reports on Form 6-K with our quarterly
financial results as filed or furnished with the SEC 62 (#_ftn62) for further
financial information regarding AstraZeneca PLC and its consolidated
subsidiaries. For further details, terms and conditions 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 information of
AstraZeneca PLC and AstraZeneca Finance is presented on a combined basis and
transactions between the combining entities have been eliminated. Financial
information for non-guarantor entities has been excluded. Intercompany
balances and transactions between the obligor group and the non-obligor
subsidiaries are presented on separate lines.
Table 17: Obligor group summarised Statement of comprehensive incomec
H1 2023 H1 2022
$m $m
Total Revenue - -
Gross profit - -
Operating loss (2) (2)
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 $m
Current assets 7 7
Non-current assets - -
Current liabilities (4,091) (1,838)
Non-current liabilities (24,165) (23,994)
Amounts due from subsidiaries that are not issuers or guarantors 15,761 7,459
Amounts due to subsidiaries that are not issuers or guarantors (290) (295)
Foreign exchange
The Company's transactional currency exposures on working-capital balances,
which typically extend for up to three months, are hedged where practicable
using forward foreign exchange contracts against the individual companies'
reporting currency. Foreign exchange gains and losses on forward contracts for
transactional hedging are taken to profit or loss. In addition, the Company's
external dividend payments, paid principally in pounds sterling and Swedish
krona, are fully hedged from announcement to payment date.
Table 19: Currency sensitivities
The Company provides the following currency-sensitivity information
Average Annual impact ($m) of 5% strengthening (FY 2023 average rate vs FY 2022
average) (( 63 (#_ftn63) ))
rates vs USD
Currency Primary Relevance FY YTD Change June Change 67 (#_ftn67) Total Revenue Core Operating Profit
2022 64 (#_ftn64)
2023 65 (#_ftn65)
2023 66 (#_ftn66)
(%) (%)
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
Other(( 68 (#_ftn68) )) 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:
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 DemarŽ'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 health 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 exceeded 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 International 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
‒ 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
World 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,
highlighting 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
(https://manufacture2030.com/insights/news/2023/05/activate-program-launches-with-active-pharmaceutical-ingredients-api-suppliers)
, a new programme targeting the reduction of the environmental impact of the
production of active pharmaceutical ingredients, together with Manufacture
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 across 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 events 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
(https://www.astrazeneca.com/investor-relations.html) . 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 11 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 the
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)
Imfinzi and Imjudo
Event Commentary
Phase III trial readout MATTERHORN Met key secondary endpoint demonstrating Imfinzi added to standard-of-care
FLOT 69 (#_ftn69) 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 GI 70 (#_ftn70) 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 Met primary endpoint, demonstrating that Imfinzi in combination with
platinum-based chemotherapy followed by either Imfinzi plus Lynparza or
(Lynparza and Imfinzi) 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 mCRPC 71 (#_ftn71) . (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 chemotherapy 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 ORR 72
(#_ftn72) of 37.1% and DCR 73 (#_ftn73) 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
(IHC 74 (#_ftn74) 1+ or IHC 2+/ISH 75 (#_ftn75) -) 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)
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 partner, 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 partner, Ionis Pharmaceuticals, announced positive top-line
85‑week data for eplontersen in patients with hereditary
transthyretin-mediated 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 who 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, showcased pivotal data in patients with paroxysmal
nocturnal haemoglobinuria PNH experiencing symptoms of clinically significant
extravascular haemolysis. Additional data and analyses were presented focusing
on improving understanding, and management of debilitating rare diseases;
AL 76 (#_ftn76) 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 Positive results showed that, first-in-class oral Factor D inhibitor,
Phase III 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 clinically 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 Revenue 77 (#_ftn77) 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)
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 (48) (12)
comprehensive income
Fair value movements related to own credit risk on bonds designated as fair 4 2
value through profit or loss
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 Unreviewed 78 (#_ftn78) Unreviewed
2023 2022
$m $m
Total Revenue(70) 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)
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 (94) (30)
comprehensive income
Fair value movements related to own credit risk on bonds designated as fair 2 2
value through profit or loss
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
Reviewed 79 (#_ftn79) Audited Reviewed
At 30 Jun At 31 Dec At 30 Jun
2023 2022 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
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
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 202 293
combinations
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 (23) (158)
combinations
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 90 9
instruments
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)
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 and 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 that 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.
(https://www.astrazeneca.com/our-company/leadership.html)
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
believe 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.
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 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.
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 the 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 performed 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 intend 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 only 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 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 report, 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 Comprehensive 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 reported 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 revised
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
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 inflows, although government price interventions in response to
budgetary constraints are expected to continue to adversely affect revenues in
some of our significant markets. The Group, however, anticipates new revenue
streams from both recently launched medicines and those in development, and
the Group has a wide diversity of customers and suppliers across different
geographic areas.
Consequently, the Directors believe that, overall, the Group is well placed to
manage its business risks successfully. Accordingly, they continue to adopt
the going concern basis in preparing the Interim Financial Statements.
Legal proceedings
The information contained in Note 6 updates the disclosures concerning legal
proceedings and contingent liabilities in the Group's Annual Report and Form
20-F Information 2022
(https://www.astrazeneca.com/content/dam/az/Investor_Relations/annual-report-2022/pdf/AstraZeneca_AR_2022.pdf)
.
IAS 12 'Income Taxes'
On 25 May 2023, the IASB issued an amendment to 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 purchase 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 Movement 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
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
(https://www.astrazeneca.com/content/dam/az/Investor_Relations/annual-report-2022/pdf/AstraZeneca_AR_2022.pdf)
. Net Debt is a non-GAAP financial measure.
Table 25: Net debt
At 1 Jan 2023 Cash flow Acquisitions Non-cash Exchange movements At 30 Jun 2023
& other
$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,
other investments, trade and other receivables, cash and cash equivalents,
trade and other payables, lease liabilities and interest-bearing loans and
borrowings.
The Group has certain equity investments that are categorised as Level 3 in
the fair value hierarchy that are held at $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 30 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 presented in Net losses on equity
investments measured at fair value through other comprehensive income in the
Condensed consolidated statement of comprehensive income for the six months
ended 30 June 2023 are Level 1 fair value measurements, valued based on 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 $136m 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 AstraZeneca 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 consideration 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 the Disclosures, the majority of claims involve highly complex
issues. Often these issues are subject to substantial uncertainties and,
therefore, the probability of a loss, if any, being sustained and/or an
estimate of the amount of any loss is difficult to ascertain.
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 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 Judicial 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 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. 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 this 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 the 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.
AstraZeneca 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
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
International 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.
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 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 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 awaits 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 Chancery 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 punitive
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 Northern 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.
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
disclosures 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 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 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 analysis
80 (#_ftn80)
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 % chg $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
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 (#_ftn81)
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 % chg $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
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
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
(https://www.astrazeneca.com/investor-relations.html#Contacts) . For Media
contacts, click here (https://www.astrazeneca.com/media-centre/contacts.html)
.
Addresses for correspondence
Registered office Registrar and transfer office Swedish Central Securities Depository US depositary
Deutsche Bank Trust Company Americas
1 Francis Crick Avenue Equiniti Limited Euroclear Sweden AB PO Box 191 American Stock Transfer
Cambridge Biomedical Campus Aspect House SE-101 23 Stockholm 6201 15th Avenue
Cambridge Spencer Road Brooklyn
CB2 0AA Lancing NY 11219
West Sussex
BN99 6DA
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 (mailto: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 JuvisŽ (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 (https://www.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, Renal & 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 (http://www.astrazeneca.com/) and follow the
Company on Twitter @AstraZeneca (http://www.twitter.com/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
statements, 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 available at the date of preparation of this
document and the Group undertakes no obligation to update these
forward-looking statements. The Group identifies the forward-looking
statements by using the words 'anticipates', 'believes', 'expects', 'intends'
and similar expressions in such statements. Important factors that could cause
actual results to differ 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 -
1 (#_ftnref1) 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 (#_ftnref2) 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 (#_ftnref3) 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 (#_ftnref4) Earnings per share.
5 (#_ftnref5) 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 (#_ftnref6) The COVID-19 medicines are Vaxzevria, Evusheld, and AZD3152 Ð
the COVID-19 antibody currently in development.
7 (#_ftnref7) Cardiovascular, Renal and Metabolism.
8 (#_ftnref8) Respiratory & Immunology.
9 (#_ftnref9) The calculation of Reported and Core Product Sales Gross
Margin (previously termed as Gross Margin) excludes the impact of Alliance
Revenue and Collaboration Revenue.
10 (#_ftnref10) Non-small cell lung cancer.
11 (#_ftnref11) Heart failure.
12 (#_ftnref12) Respiratory syncytial virus.
13 (#_ftnref13) Neuromyelitis optica spectrum
disorder.
14 (#_ftnref14) Human epidermal growth factor
receptor 2.
15 (#_ftnref15) Generalised myasthenia gravis.
16 (#_ftnref16) Hormone receptor.
17 (#_ftnref17) 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 (#_ftnref18) Monoclonal antibodies. The COVID-19
mAbs are Evusheld and AZD3152.
19 (#_ftnref19) For Alliance Revenue and
Collaboration Revenue, the comparable amounts for FY 2022 are $749m and $604m
respectively.
20 (#_ftnref20) Vaccines & Immune Therapies.
21 (#_ftnref21) In Table 2, the plus and minus
symbols denote the directional impact of the item being discussed, e.g. a
Ô+Õ symbol next to an R&D expense comment indicates that the item
increased the R&D expense relative to the prior year.
22 (#_ftnref22) Cost of goods sold.
23 (#_ftnref23) 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
CompanyÕs financial statements.
24 (#_ftnref24) Heart failure with preserved ejection
fraction.
25 (#_ftnref25) Neurofibromatosis type 1 plexiform
neurofibromas.
26 (#_ftnref26) Paroxysmal nocturnal haemoglobinuria.
27 (#_ftnref27) Extravascular haemolysis.
28 (#_ftnref28) Epidermal growth factor receptor
mutation.
29 (#_ftnref29) Pathologic complete response.
30 (#_ftnref30) Progression free survival.
31 (#_ftnref31) Pressure metered dose inhaler.
32 (#_ftnref32) Product Sales shown in the Imfinzi line include Product
Sales from Imjudo
33 (#_ftnref33) COVID-19 monoclonal antibodies. In H1 2023, all COVID-19
mAbs Product Sales were generated from sales of Evusheld
34 (#_ftnref34) National reimbursement drug list.
35 (#_ftnref35) France, Germany, Italy, Spain, UK.
36 (#_ftnref36) Biliary tract cancer.
37 (#_ftnref37) Hepatocellular carcinoma.
38 (#_ftnref38) Small cell lung cancer.
39 (#_ftnref39) Poly ADP ribose polymerase.
40 (#_ftnref40) Homologous recombination deficiency.
41 (#_ftnref41) Platinum sensitive relapse.
42 (#_ftnref42) Breast cancer gene mutation.
43 (#_ftnref43) Germline (hereditary) breast cancer gene mutation.
44 (#_ftnref44) Metastatic breast cancer.
45 (#_ftnref45) Bruton tyrosine kinase inhibitor.
46 (#_ftnref46) Mesenchymal-epithelial transition.
47 (#_ftnref47) Sodium-glucose cotransporter 2.
48 (#_ftnref48) Chronic kidney disease.
49 (#_ftnref49) Heart failure with reduced ejection fraction.
50 (#_ftnref50) Type-2 diabetes.
51 (#_ftnref51) Volume-based procurement.
52 (#_ftnref52) Dipeptidyl peptidase IV.
53 (#_ftnref53) Fixed dose combination.
54 (#_ftnref54) ÔNew-to-brandÕ share represents a medicineÕs share in the
dynamic market.
55 (#_ftnref55) Chronic obstructive pulmonary disease.
56 (#_ftnref56) Inhaled corticosteroid.
57 (#_ftnref57) Long-acting beta-agonist.
58 (#_ftnref58) Complement component 5.
59 (#_ftnref59) Atypical haemolytic uraemic syndrome.
60 (#_ftnref60) Other Operating Income.
61 (#_ftnref61) 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).
62 (#_ftnref62) Securities Exchange Commission.
63 (#_ftnref63) Based on best prevailing assumptions around currency
profiles.
64 (#_ftnref64) Based on average daily spot rates 1 Jan 2022 to 31 Dec 2022.
65 (#_ftnref65) Based on average daily spot rates 1 Jan 2023 to 30 Jun 2023.
66 (#_ftnref66) Based on average daily spot rates 1 Jun 2023 to 30 Jun 2023.
67 (#_ftnref67) Change vs the average spot rate for the previous year
68 (#_ftnref68) Other currencies include AUD, BRL, CAD, KRW and RUB.
69 (#_ftnref69) Fluorouracil, oxaliplatin and docetaxel.
70 (#_ftnref70) Gastrointestinal.
71 (#_ftnref71) Metastatic castration-resistant prostate cancer.
72 (#_ftnref72) Overall response rate.
73 (#_ftnref73) Disease Control Rate.
74 (#_ftnref74) Immunohistochemistry.
75 (#_ftnref75) In situ hybridization.
76 (#_ftnref76) Amyloid light chain.
77 (#_ftnref77) 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.
78 (#_ftnref78) 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.
79 (#_ftnref79) 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.
80 (#_ftnref80) 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.
81 (#_ftnref81) 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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