TIDMAZN
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] $m Actual CER
-------------------------------- ------ --------- --------- ------ --------- ---------
* Product Sales 21,448 (1) 3 10,882 2 5
* Alliance Revenue [2] 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] EPS [4] $2.34 * 4x * 6x $1.17 * 5x * 9x
Core [5] 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]
-- Excluding COVID-19 medicines, Total Revenue increased 16% and Product Sales increased 15%
-- Total Revenue from Oncology medicines increased 22%, CVRM [7]
20%, R&I [8] 10%, and Rare Disease 12%
-- Core Product Sales Gross Margin [9] 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] (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]
regardless of ejection fraction (DELIVER), and Beyfortus for the
prevention of RSV [12] ; EU approvals for Ultomiris in NMOSD [13] ;
China approval for Enhertu in HER2 [14] -low metastatic breast
cancer, Soliris in gMG [15] and Koselugo in neurofibromatosis
-- Other milestones: capivasertib in combination with Faslodex
granted priority review in the US for advanced HR [16] -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] and
COVID--19 mAbs [18] ) is expected to decline significantly in FY
2023
-- Total Revenue from China is expected to return to growth and
increase by a low-to-mid single-digit (previously low single-digit)
percentage in FY 2023
-- Alliance Revenue and Collaboration Revenue are both expected
to increase [19] , driven by continued growth of our partnered
medicines and success-based milestones
-- Core Operating expenses are expected to increase by a
low-to-mid single-digit percentage, driven by investment in recent
launches and the ungating of new trials following pipeline
success
-- The Core Tax Rate is expected to be between 18-22%
The Company is unable to provide guidance on a Reported basis
because it cannot reliably forecast material elements of the
Reported results, including any fair value adjustments arising on
acquisition-related liabilities, intangible asset impairment
charges and legal settlement provisions. Please refer to the
cautionary statements section regarding forward-looking statements
at the end of this announcement.
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
---------------------- ------ --------- ----- ---------------------------------------
* Double-digit growth at CER
in Oncology, CVRM, R&I and Rare
Product Sales 10,882 2 5 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
* Excluding COVID-19 medicines,
Q2 2023 Total Revenue increased
Total Revenue 11,416 6 9 by 14% (17% at CER)
----------------------- ------ --------- ----- ---------------------------------------
Actual
Therapy areas $m % CER %
---------------------- ------ --------- ----- ---------------------------------------
* Strong performance across
key medicines and regions
* No sales or regulatory milestones
from Lynparza in the quarter
Oncology 4,646 22 25 (Q2 2022: $nil)
* Farxiga up 37% (41% CER),
Lokelma up 51% (55% at CER),
roxadustat up 42% (51% CER),
Brilinta declined 5% (3% at
CVRM 2,682 14 18 CER)
* Fasenra up 15% (16% CER),
Breztri up 75% (79% CER). Saphnelo
and Tezspire continue to grow
rapidly during their launch
R&I 1,547 11 14 phase
* COVID-19 mAbs: $180m from
Collaboration Revenue, -$1m
Product Sales (Q2 2022: $445m)
* Vaxzevria : $nil (Q2 2022:
V&I [20] 278 (72) (71) $455m)
* 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
Rare Disease 1,953 8 10 and geographic expansion
* Nexium generic competition
Other Medicines 311 (27) (23) in Japan
Total Revenue 11,416 6 9
----------------------- ------ --------- ----- ---------------------------------------
Actual
Regions inc. COVID-19 $m % 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
----------------------- ------ --------- ----- ---------------------------------------
Actual
Regions ex. COVID-19 $m % 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 Core Core Comments [21]
change change
----------- -------- ----------- -------- ----------- ---------------------------------------------------------
* Excluding COVID-19 medicines,
Q2 2023 Total Revenue increased
by 14% (17% at CER)
* See Table 1 and the Total Revenue
Total 6% Actual 6% Actual section of this document for further
Revenue $11,416m 9% CER $11,416m 9% CER details
----------- -------- ----------- -------- ----------- ---------------------------------------------------------
Product 82% +10pp 82% Stable at + Increasing mix of sales from
Sales Gross Actual Actual Oncology and Rare Disease medicines
Margin +12pp CER +2pp CER + Decreasing mix of Vaxzevria sales
* Increasing mix of products with profit-sharing
arrangements, where AstraZeneca books Product Sale
s
and records an expense in COGS [22] 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
----------- -------- ----------- -------- ----------- ---------------------------------------------------------
+ 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
5% Actual 6% Actual phasing driven by study starts
R&D expense $2,667m 7% CER $2,568m 8% CER and execution
----------- -------- ----------- -------- ----------- ---------------------------------------------------------
SG&A $4,986m 6% Actual $3,296m 5% Actual + Market development for recent
expense 8% CER 8% CER 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 $784m >6x Actual $784m >6x Actual + Reported and Core Other operating
operating >6x CER >6x CER income includes a gain of $712m
income from an update to the contractual
and expense relationships for Beyfortus (nirsevimab)
[23]
----------- -------- ----------- -------- ----------- ---------------------------------------------------------
* See Product Sales Gross Margin,
expenses and Other operating income
commentary above
+17pp * Other operating income contributed
Operating Actual +6pp Actual seven percentage points to Operating
Margin 22% +19pp CER 38% +8pp CER margin in Q2 2023
----------- -------- ----------- -------- ----------- ---------------------------------------------------------
+ Higher rates on floating debt
and bond issuances, partially offset
by higher interest received on
cash balances
+ Reported also impacted by the
Net finance 25% Actual 17% Actual discount unwind on acquisition-related
expense $367m 17% CER $262m 4% CER liabilities
----------- -------- ----------- -------- ----------- ---------------------------------------------------------
+2pp Actual * Variations in the tax rate can
Tax rate 13% n/m 17% +2pp CER be expected between periods
----------- -------- ----------- -------- ----------- ---------------------------------------------------------
* Further details of differences
>5x Actual 25% Actual between Reported and Core are shown
EPS $1.17 >9x CER $2.15 38% CER in Table 14
----------- -------- ----------- -------- ----------- ---------------------------------------------------------
Table 3 : Pipeline highlights since prior results
announcement
Event Medicine Indication / Trial Event
---------------- ------------- -------------------------------------- ------------------------
Regulatory Lynparza Prostate cancer (1st-line) Regulatory approval
approvals (PROpel) (US)
and other
regulatory
actions
Enhertu HER2-low breast cancer Regulatory approval
(3rd-line) (DESTINY-Breast04) (CN)
Farxiga HFpEF [24] (DELIVER) Regulatory approval
(US)
Xigduo Type-2 diabetes (XR Regulatory approval
formulation) (CN)
Beyfortus RSV (MELODY/MEDLEY) Regulatory approval
(US)
Ultomiris NMOSD Regulatory approval
(EU, JP)
Koselugo NF1-PN [25] (paediatric) Regulatory approval
(SPRINT) (CN)
Soliris gMG Regulatory approval
(CN)
Soliris gMG (refractory, children Regulatory approval
and adolescents) (EU)
------------- -------------------------------------- ------------------------
Regulatory Enhertu HER2-positive breast Regulatory submission
submissions cancer (3rd-line) (DESTINY-Breast02) (US)
or acceptances
capivasertib HR+/HER2-negative breast Regulatory submission
cancer (2nd-line) (CAPItello-291) (US, EU, JP), Priority
Review (US)
Fasenra Uncontrolled asthma Regulatory submission
(MIRACLE) (CN)
Beyfortus RSV (MELODY/MEDLEY) Regulatory submission
and Priority Review
( CN )
danicopan PNH [26] with EVH [27] Regulatory submission
(US, JP)
---------------- ------------- -------------------------------------- ------------------------
Major Phase Tagrisso EGFRm [28] NSCLC (1st-line) Primary endpoint met
III data (FLAURA2)
readouts
and other
developments
----------------
Lynparza + Endometrial cancer (1st-line) Dual primary endpoint
Imfinzi met
(DUO-E)
----------------
Lynparza + Platinum-resistant or Primary endpoint not
cediranib -refractory ovarian met
cancer (GY005)
Imfinzi Resectable, early-stage Key secondary endpoint
and locally advanced met (pCR [29] )
gastric and gastroesophageal
junction cancers (MATTERHORN)
datopotamab NSCLC (2nd- and 3rd-line) Dual primary endpoint
deruxtecan met (PFS [30] )
(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.
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 AVANZAR NSCLC (1st-line)
deruxtecan
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] 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 $400m investment in
AstraZeneca's AZ Forest programme, raising its commitment to plant
200 million trees by 2030. Global projects involve local
communities and ecological experts to deliver reforestation at
scale, as well as to support biodiversity and to sustain
livelihoods.
Management changes
Sharon Barr, currently Senior Vice President, Head of Research
and Product Development of Alexion, will succeed Mene Pangalos as
Executive Vice President, BioPharmaceuticals R&D. Mene is
retiring and will step down from his role early next year, after
almost fourteen years with the company and an illustrious 35-year
career. Sharon will report to Chief Executive Officer, Pascal
Soriot and become a member of AstraZeneca's Senior Executive Team
as of 1 August.
Conference call
A conference call and webcast for investors and analysts will
begin today, 28 July 2023, at 11:45 UK time. Details can be
accessed via astrazeneca.com .
Reporting calendar
The Company intends to publish its nine month and third quarter
results on Thursday 9 November 2023.
Operating and financial review
All narrative on growth and results in this section is based on
actual foreign exchange rates, and financial figures are in US$
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 .
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] 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] 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] renewal price effective March 2023 and
competition
Europe * Established standard of care in 1st-line and adjuvant
settings across EU5 [35] , with increased adjuvant treatment
rates in region
Established * Further use in 1st-line setting and launch acceleration
RoW 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] , HCC [37] , Stage IV NSCLC) and
established indications (Stage III NSCLC, SCLC [38]
)
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 * Strong demand growth driven by BTC and HCC
RoW
---------------- ---------------------------------------------------------------
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] 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] 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]
and BRCAm [42] 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] 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 * Growth driven by increased uptake in 1st-line HRD-positive
RoW ovarian cancer
---------------- --------------------------------------------------------------
Enhert u
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] 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 * In Japan, AstraZeneca receives a mid-single-digit
RoW 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]
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] 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] market in all major regions, fuelled by heart
failure and CKD [48] launches
* Additional benefit from continued growth in the overall
SGLT2 inhibitor class
US * Growth driven by HFrEF [49] and CKD for patients with
and without T2D [50] 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 * In Japan, AstraZeneca sells to collaborator Ono Pharmaceutical
RoW 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 * Sales decline in the second quarter driven by generic
RoW 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] implementation
Onglyza 127 (8%) (4%) * Continued decline for DPP-IV [52] 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 * Maintained leadership in Japan
RoW
---------------- ---------------------------------------------------------------
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] triple class across major markets
US * Consistent share growth within the FDC triple class
in new-to-brand [54] 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 * Increasing market share gains within COPD [55] in
RoW 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 * Japan maintained new-to-brand leadership
RoW
----------- ----------------------------------------------------------------
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 * D emand 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] /LABA [57] 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 * Inventory destocking in some markets and generic erosion
RoW 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] 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] 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 * Continued conversion from Soliris and strong demand
RoW 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
Established offset by growth in NMOSD
RoW
---------------- -------------------------------------------------------------
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] & 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 Acquisition Other Core Core
Asset Amortisation of Alexion [61] % Change
& Impairments
$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 Acquisition Other Core Core
Asset Amortisation of Alexion (54) % Change
& Impairments
$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
business combinations 202 293 (91)
Non-cash and other movements (594) (814) 220
Interest paid (483) (386) (97)
Taxation paid (1,061) (1,006) (55)
-------------------------------------------------- ------- ------- -------
Net cash inflow from operating activities 4,851 4,480 371
-------------------------------------------------- ------- ------- -------
Net cash inflow before financing activities 3,085 3,512 (427)
-------------------------------------------------- ------- ------- -------
Net cash outflow from financing activities (3,550) (5,035) 1,485
-------------------------------------------------- ------- ------- -------
In H1 2022, the Reported Operating profit of $1,417m included a
negative impact of $2,318m relating to the unwind of the inventory
fair value uplift recognised on the acquisition of Alexion. This
was offset by a corresponding item (positive impact of $2,318m) in
decrease in working capital and short-term provisions. Overall, the
unwind of the fair value uplift had no impact on Net cash inflow
from operating activities. This unwind had $55m negative impact on
H1 2023 Reported operating profit and offsetting positive impact on
Working capital movements, and will continue to be minimal in
future quarters. As a result of the update to the contractual
relationships between AstraZeneca, Sobi and Sanofi relating to the
future sales of Beyfortus (nirsevimab) in the US, a gain of $712m
has been recorded in non-cash and other movements, with no overall
net impact on the Net cash inflow from operating activities.
The change in Net cash inflow before financing activities is
primarily driven by the movement in Purchase of intangible assets
of $1,436m, including the acquisition of CinCor, in the half year
to 30 June 2023.
Included within Net cash inflow before financing activities is a
movement in the profit-participation liability of $175m, resulting
from the cash receipt from Sobi in Q1 2023 after achievement of a
regulatory milestone. The associated cash flow is presented within
investing activities.
The decrease in Net cash outflow from financing activities of
$1,485m is primarily driven by the Issue of loans and borrowings of
$3,816m, offset by the increase in Repayment of loans and
borrowings of $2,151m.
Capital expenditure
Capital expenditure amounted to $517m in the half to 30 June
2023 (H1 2022: $472m).
Table 16 : Net debt summary
At 30 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] 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%
rates vs USD strengthening (FY 2023
average rate vs FY 2022
average) ([63])
---------- ------------ ------------------------------------------------------ ---------------------------
Currency Primary FY YTD Change June Change Total Core Operating
Relevance 2022 [64] 2023 [65] (%) 2023 [66] [67] Revenue Profit
(%)
EUR Total Revenue 0.95 0.92 3 0.92 3 323 159
CNY Total Revenue 6.74 6.94 (3) 7.17 (6) 309 174
JPY Total Revenue 131.59 134.92 (2) 141.34 (7) 181 122
Other ([68]) 385 202
------------------------------ --------- --------- ------ --------- --------- --------- ----------------
Operating
GBP expense 0.81 0.81 (0) 0.79 2 46 (92)
Operating
SEK 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 Demar '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 , 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 . 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 FLAURA2 Met primary endpoint demonstrating Tagrisso in
trial readout 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: ADAURA Results from updated analysis of the ADAURA Phase
ASCO 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 MATTERHORN Met key secondary endpoint demonstrating Imfinzi
trial readout added to standard-of-care FLOT [69] 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: HIMALAYA Updat ed results showed Imfinzi plus Imjudo demonstrated
ESMO GI [70] 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 DUO-E Met primary endpoint, demonstrating that Imfinzi
trial readout (Lynparza in combination with platinum-based chemotherapy
and Imfinzi) followed by either Imfinzi plus Lynparza or Imfinzi
alone as maintenance therapy resulted in a statistically
significant and clinically meaningful improvement
in PFS compared to standard-of-care chemotherapy
alone in patients with newly diagnosed advanced
or recurrent endometrial cancer. (May 2023)
Approval US Ly nparza in combination with abiraterone and
prednisone or prednisolone for the treatment
of adult patients with deleterious or suspected
deleterious BRCAm mCRPC [71] . (June 2023)
Presentation: DUO-O (Lynparza Results from a plan ned interim analysis of the
ASCO and Imfinzi) 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 GY005 Did not meet primary endpoint in the intent-to-treat
trial readout 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: DESTINY-PanTumor02 Results from a planned interim analysis of the
ASCO DESTINY-PanTumor02 Phase II trial, presented
at ASCO, dem onstrated Enhertu resulted in a
confirmed ORR [72] of 37.1% and DCR [73] of 68.2%
in previously treated patients with HER2-expressing
advanced solid tumours. (June 2023)
Phase II DESTINY-PanTumor02 Primary analysis of the ongoing DESTINY-PanTumor02
trial readout 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 HER 2-low (IHC [74] 1+ or IHC 2+/ISH
[75] -) 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 US Capivasertib in combination with Faslodex for
review 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: TROPION-Lung02 Updated results from the TROPION-Lung02 Phase
ASCO 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 TROPION-Lung01 Met dual primary endpoint demonstra ting statistically
trial readout 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 ANNEXA-I A registrational post-marketing Phase IV trial
readout 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 MATTERHORN AstraZeneca's partner, FibroGen Inc., (FibroGen)
data readout 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 NCT03303066 FibroGen announced positive top-line data from
data readout a Phase III trial in patients receiving concurrent
chemotherapy treatment for non-myeloid malignancies
in China.
(May 2023)
------------- ----------- ----------------------------------------------------
eplontersen
Event Commentary
------------- ---------------- ---------------------------------------------------------------
Phase III NEURO-TTRansform AstraZeneca's partner, Ionis Pharmaceuticals,
data readout 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 INTREPID, The decision to discontinue brazikumab's inflammatory
trials discontinued EXPEDITION 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 FJORD Trial in bullous pemphigoid discontinued for
trial discontinued futility (efficacy). (July 2023)
------------------- ----- --------------------------------------------
BioPharmaceuticals - V&I
AZD3152
Event Commentary
------------ --------- ----------------------------------------------------------
Phase I/III SUPERNOVA Positive high-level results from the Phase I
safety data 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 SUPERNOVA The primary endpoint of the SUPERNOVA has been
update 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] 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: ALPHA Positive results showed that, first-in-class
EHA Phase III oral Factor D inhibitor, danicopan as add-on
to standard of care C5 inhibitor therapy Ultomiris
or Soliris, demonstrated a statistically significant
and clinically meaningful increase in haemoglobin
levels and maintained disease control in patients
with PNH who experience 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] 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 comprehensive income (48) (12)
Fair value movements related to own credit risk on bonds designated as fair value through
profit or loss 4 2
Tax on items that will not be reclassified to profit or loss (5) (275)
-------------------------------------------------------------------------------------------- ------- -------
(42) 746
------- -------
Items that may be reclassified subsequently to profit or loss
Foreign exchange arising on consolidation 105 (1,326)
Foreign exchange arising on designated liabilities in net investment hedges (101) (195)
Fair value movements on cash flow hedges 89 (138)
Fair value movements on cash flow hedges transferred to profit and loss (71) 131
Fair value movements on derivatives designated in net investment hedges 40 34
Costs of hedging (1) (13)
Tax on items that may be reclassified subsequently to profit or loss 12 46
-------------------------------------------------------------------------------------------- ------- -------
73 (1,461)
------- -------
Other comprehensive income/(loss), net of tax 31 (715)
-------------------------------------------------------------------------------------------- ------- -------
Total comprehensive income for the period 3,655 33
-------------------------------------------------------------------------------------------- ------- -------
Profit attributable to:
-------------------------------------------------------------------------------------------- ------- -------
Owners of the Parent 3,621 746
Non-controlling interests 3 2
-------------------------------------------------------------------------------------------- ------- -------
3,624 748
------- -------
Total comprehensive income attributable to:
-------------------------------------------------------------------------------------------- ------- -------
Owners of the Parent 3,652 33
Non-controlling interests 3 -
-------------------------------------------------------------------------------------------- ------- -------
3,655 33
------- -------
Basic earnings per $0.25 Ordinary Share $2.34 $0.48
Diluted earnings per $0.25 Ordinary Share $2.32 $0.48
Weighted average number of Ordinary Shares in issue (millions) 1,549 1,548
Diluted weighted average number of Ordinary Shares in issue (millions) 1,560 1,561
-------------------------------------------------------------------------------------------- ------- -------
Table 21 : Condensed consolidated statement of comprehensive
income: Q2 2023
For the quarter ended 30 June Unreviewed [78] 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 comprehensive
income (94) (30)
Fair value movements related to own credit risk on bonds designated as fair value
through
profit or loss 2 2
Tax on items that will not be reclassified to profit or loss (29) (181)
--------------------------------------------------------------------------------------- --------------- ----------
(104) 487
--------------- ----------
Items that may be reclassified subsequently to profit or loss
Foreign exchange arising on consolidation (209) (1,107)
Foreign exchange arising on designated liabilities in net investment hedges (94) (163)
Fair value movements on cash flow hedges 33 (143)
Fair value movements on cash flow hedges transferred to profit and loss 4 120
Fair value movements on derivatives designated in net investment hedges 24 42
Costs of hedging (1) (13)
Tax on items that may be reclassified subsequently to profit or loss - 45
--------------------------------------------------------------------------------------- --------------- ----------
(243) (1,219)
--------------- ----------
Other comprehensive loss, net of tax (347) (732)
--------------------------------------------------------------------------------------- --------------- ----------
Total comprehensive income/(loss) for the period 1,473 (372)
--------------------------------------------------------------------------------------- --------------- ----------
Profit attributable to:
-------------------------------------------------------------------------------------- --------------- ----------
Owners of the Parent 1,818 360
Non-controlling interests 2 -
--------------------------------------------------------------------------------------- --------------- ----------
1,820 360
--------------- ----------
Total comprehensive income/(loss) attributable to:
-------------------------------------------------------------------------------------- --------------- ----------
Owners of the Parent 1,471 (372)
Non-controlling interests 2 -
--------------------------------------------------------------------------------------- --------------- ----------
1,473 (372)
--------------- ----------
Basic earnings per $0.25 Ordinary Share $1.17 $0.23
Diluted earnings per $0.25 Ordinary Share $1.17 $0.23
Weighted average number of Ordinary Shares in issue (millions) 1,550 1,549
Diluted weighted average number of Ordinary Shares in issue (millions) 1,560 1,560
--------------------------------------------------------------------------------------- --------------- ----------
Table 22 : Condensed consolidated statement of financial
position
Reviewed [79] 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 Share Other Retained Total Non-controlling Total
capital premium reserves earnings attributable interests equity
account to owners
of the
parent
$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 combinations 202 293
Non-cash and other movements (594) (814)
------------------------------------------------------- ------- -------
Cash generated from operations 6,395 5,872
------------------------------------------------------- ------- -------
Interest paid (483) (386)
Tax paid (1,061) (1,006)
------------------------------------------------------- ------- -------
Net cash inflow from operating activities 4,851 4,480
------------------------------------------------------- ------- -------
Cash flows from investing activities
Acquisition of subsidiaries, net of cash acquired (189) -
Payments upon vesting of employee share awards
attributable to business combinations (23) (158)
Payment of contingent consideration from business
combinations (398) (367)
Purchase of property, plant and equipment (517) (472)
Disposal of property, plant and equipment 126 -
Purchase of intangible assets (1,436) (434)
Disposal of intangible assets 288 442
Movement in profit-participation liability 175 -
Purchase of non-current asset investments (26) (28)
Disposal of non-current asset investments 10 35
Movement in short-term investments, fixed deposits
and other investing instruments 90 9
Payments to associates and joint ventures - (5)
Interest received 134 10
------------------------------------------------------- ------- -------
Net cash outflow from investing activities (1,766) (968)
------------------------------------------------------- ------- -------
Net cash inflow before financing activities 3,085 3,512
------------------------------------------------------- ------- -------
Cash flows from financing activities
Proceeds from issue of share capital 8 8
Issue of loans and borrowings 3,816 -
Repayment of loans and borrowings (3,408) (1,257)
Dividends paid (3,069) (2,971)
Hedge contracts relating to dividend payments 27 (77)
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.
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 .
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 . 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]
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 CER $m % chg $m Act CER $m Act CER $m Act CER
% chg % chg % chg % chg % chg % chg % chg % 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]
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 CER $m % chg $m Act CER $m Act CER $m Act CER
% chg % chg % chg % chg % chg % chg % chg % 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 . For Media contacts, click here .
Addresses for correspondence
Registered office Registrar and Swedish Central US depositary
transfer office Securities Depository Deutsche Bank Trust
Company Americas
1 Francis Crick Equiniti Limited Euroclear Sweden American Stock Transfer
Avenue Aspect House AB PO Box 191 6201 15th Avenue
Cambridge Biomedical Spencer Road SE-101 23 Stockholm Brooklyn
Campus Lancing NY 11219
Cambridge West Sussex
CB2 0AA 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
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 Juvis (depending on
geography); Beyfortus, a trademark of Sanofi Pasteur Inc.; Enhertu,
a trademark of Daiichi Sankyo; Losec, owned by AstraZeneca or
Cheplapharm (depending upon geography); Seloken, owned by
AstraZeneca or Taiyo Pharma Co., Ltd (depending on geography);
Synagis, owned by AstraZeneca or Sobi aka Swedish Orphan Biovitrum
AB (publ). (depending on geography); and Tezspire, a trademark of
Amgen, Inc .
Information on or accessible through AstraZeneca's websites,
including astrazeneca.com , does not form part of and is not
incorporated into this announcement.
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led
biopharmaceutical company that focuses on the discovery,
development, and commercialisation of prescription medicines in
Oncology, Rare Disease, and BioPharmaceuticals, including
Cardiovascular, 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 and follow the
Company on Twitter @AstraZeneca .
Cautionary statements regarding forward-looking statements
In order, among other things, to utilise the 'safe harbour'
provisions of the US Private Securities Litigation Reform Act of
1995, AstraZeneca (hereafter 'the Group') provides the following
cautionary statement:
This document contains certain forward-looking statements with
respect to the operations, performance and financial condition of
the Group, including, among other things, statements about expected
revenues, margins, earnings per share or other financial or other
measures. Although the Group believes its expectations are based on
reasonable assumptions, any forward-looking 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] Constant exchange rates. The differences between Actual
Change and CER Change are due to foreign exchange movements between
periods in 2023 vs 2022. CER financial measures are not accounted
for according to generally accepted accounting principles (GAAP)
because they remove the effects of currency movements from Reported
results.
[2] Effective 1 January 2023, the Group has updated the
presentation of Total Revenue. For further details of the
presentation of Alliance Revenue and Collaboration Revenue, see the
Basis of preparation and accounting policies section of the Notes
to the Interim Financial Statements section.
[3] Reported financial measures are the financial results
presented in accordance with UK-adopted International Accounting
Standards and International Financial Reporting Standards (IFRSs)
as issued by the International Accounting Standards Board (IASB)
and International Accounting Standards as adopted by the European
Union.
[4] Earnings per share.
[5] Core financial measures are adjusted to exclude certain
items. The differences between Reported and Core measures are
primarily due to costs relating to the acquisition of Alexion,
amortisation of intangibles, impairments, legal settlements and
restructuring charges. A full reconciliation between Reported EPS
and Core EPS is provided in Table 13 and Table 14 in the Financial
performance section of this document.
[6] The COVID-19 medicines are Vaxzevria, Evusheld, and AZD3152
Ð the COVID-19 antibody currently in development.
[7] Cardiovascular, Renal and Metabolism.
[8] Respiratory & Immunology.
[9] The calculation of Reported and Core Product Sales Gross
Margin (previously termed as Gross Margin) excludes the impact of
Alliance Revenue and Collaboration Revenue.
[10] Non-small cell lung cancer.
[11] Heart failure.
[12] Respiratory syncytial virus.
[13] Neuromyelitis optica spectrum disorder.
[14] Human epidermal growth factor receptor 2.
[15] Generalised myasthenia gravis.
[16] Hormone receptor.
[17] Vaxzevria is AstraZeneca's trademark for the Company's
supply of the AstraZeneca COVID-19 Vaccine. In the financial tables
in this report, 'Vaxzevria Total Revenue' includes royalties from
sub-licensees that produce and supply the AstraZeneca COVID--19
Vaccine under their own trademarks, recorded in Alliance
Revenue.
[18] Monoclonal antibodies. The COVID-19 mAbs are Evusheld and AZD3152.
[19] For Alliance Revenue and Collaboration Revenue, the
comparable amounts for FY 2022 are $749m and $604m
respectively.
[20] Vaccines & Immune Therapies.
[21] 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] Cost of goods sold.
[23] Income from disposals of assets and businesses, where the
Group does not retain a significant ongoing economic interest,
continue to be recorded in Other operating income and expense in
the CompanyÕs financial statements.
[24] Heart failure with preserved ejection fraction.
[25] Neurofibromatosis type 1 plexiform neurofibromas.
[26] Paroxysmal nocturnal haemoglobinuria.
[27] Extravascular haemolysis.
[28] Epidermal growth factor receptor mutation.
[29] Pathologic complete response.
[30] Progression free survival.
[31] Pressure metered dose inhaler.
[32] Product Sales shown in the Imfinzi line include Product
Sales from Imjudo
[33] COVID-19 monoclonal antibodies. In H1 2023, all COVID-19
mAbs Product Sales were generated from sales of Evusheld
[34] National reimbursement drug list.
[35] France, Germany, Italy, Spain, UK.
[36] Biliary tract cancer.
[37] Hepatocellular carcinoma.
[38] Small cell lung cancer.
[39] Poly ADP ribose polymerase.
[40] Homologous recombination deficiency.
[41] Platinum sensitive relapse.
[42] Breast cancer gene mutation.
[43] Germline (hereditary) breast cancer gene mutation.
[44] Metastatic breast cancer.
[45] Bruton tyrosine kinase inhibitor.
[46] Mesenchymal-epithelial transition.
[47] Sodium-glucose cotransporter 2.
[48] Chronic kidney disease.
[49] Heart failure with reduced ejection fraction.
[50] Type-2 diabetes.
[51] Volume-based procurement.
[52] Dipeptidyl peptidase IV.
[53] Fixed dose combination.
[54] ÔNew-to-brandÕ share represents a medicineÕs share in the
dynamic market.
[55] Chronic obstructive pulmonary disease.
[56] Inhaled corticosteroid.
[57] Long-acting beta-agonist.
[58] Complement component 5.
[59] Atypical haemolytic uraemic syndrome.
[60] Other Operating Income.
[61] Other adjustments include fair-value adjustments relating
to contingent consideration on business combinations and other
acquisition-related liabilities, discount unwind on
acquisition-related liabilities (see Note 4) and provision
movements related to certain legal matters, including a $510m
charge to provisions relating to a legal settlement with BMS and
Ono in Q2 2023 (see Note 6).
[62] Securities Exchange Commission.
[63] Based on best prevailing assumptions around currency
profiles.
[64] Based on average daily spot rates 1 Jan 2022 to 31 Dec
2022.
[65] Based on average daily spot rates 1 Jan 2023 to 30 Jun
2023.
[66] Based on average daily spot rates 1 Jun 2023 to 30 Jun
2023.
[67] Change vs the average spot rate for the previous year
[68] Other currencies include AUD, BRL, CAD, KRW and RUB.
[69] Fluorouracil, oxaliplatin and docetaxel.
[70] Gastrointestinal.
[71] Metastatic castration-resistant prostate cancer.
[72] Overall response rate.
[73] Disease Control Rate.
[74] Immunohistochemistry.
[75] In situ hybridization.
[76] Amyloid light chain.
[77] Effective 1 January 2023, the Group has updated the
presentation of Total Revenue. See Note 1 for further details of
the presentation of Alliance Revenue.
[78] The Q2 2023 and Q2 2022 information in respect of the three
months ended 30 June 2023 and 30 June 2022 respectively included
in
the Interim Financial Statements have not been reviewed by
PricewaterhouseCoopers LLP.
[79] The Condensed consolidated statement of financial position
as at 30 June 2023 and 30 June 2022 have been reviewed by
PricewaterhouseCoopers LLP. The Condensed consolidated statement
of financial position as at 31 December 2022 has been audited
by PricewaterhouseCoopers LLP.
[80] The table provides an analysis of year-on-year Product
Sales, with Actual and CER growth rates reflecting year-on-year
growth. Due to rounding, the sum of a number of dollar values and
percentages may not agree to totals.
[81] The table provides an analysis of year-on-year Product
Sales, with Actual and CER growth rates reflecting year-on-year
growth. Due to rounding, the sum of a number of dollar values and
percentages may not agree to totals.
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