TIDMAZN
RNS Number : 9054F
AstraZeneca PLC
10 November 2022
AstraZeneca PLC
10 November 2022 07:00 GMT
YTD and Q3 2022 results
Record number of regulatory approvals and guidance uplift
underpinned by strong business performance
Revenue and EPS summary
YTD 2022 Q3 2022
------ -------- ------- ------ -------- ---
% Change % Change
$m Actual CER [1] $m Actual CER
------------------------ ------ -------- ------- ------ -------- ---
- Product Sales 32,200 29 35 10,590 9 16
- Collaboration Revenue 944 >2x >2x 392 >3x >3x
------------------------- ------ -------- ------- ------ -------- ---
Total Revenue 33,144 30 37 10,982 11 19
------------------------- ------ -------- ------- ------ -------- ---
Reported [2] EPS [3] $1.54 >4x >4x $1.06 n/m n/m
Core [4] EPS $5.28 47 52 $1.67 55 70
------------------------- ------ -------- ------- ------ -------- ---
YTD 2022 Financial performance ( growth numbers and commentary
at CER [5] )
-- Total Revenue increased 37% to $33,144m, with growth coming
from all disease areas, and from the addition of Alexion, which was
incorporated into the Group's results from 21 July 2021
-- Oncology Total Revenue increased 24%, inclusive of milestone
payments from MSD [6] for Lynparza. Oncology Product Sales
increased 20%. Total Revenue from R&I [7] increased 4%, CVRM
[8] increased 19% [9] and Rare Disease increased 10% (9)
-- Core Gross Margin of 81%, up six percentage points at CER,
reflecting the lower revenue from initial Vaxzevria contracts and
the increased share of specialty care medicines
-- Core Total Operating Expense increased 26%, reflecting the
addition of Alexion, continued investment in new launches and the
pipeline, to deliver sustainable long-term growth
-- Core Operating Margin of 32%, up six percentage points at
CER, benefitting from favourable phasing and product mix
-- Core EPS increased 52% to $5.28
-- FY 2022 Core EPS at constant exchange rates now expected to
increase by a high twenties to low thirties percentage, vs previous
guidance of a mid-to-high twenties increase. At actual exchange
rates, FY 2022 Core EPS growth is anticipated to be impacted by a
currency headwind [10] of a mid-to-high single-digit percentage,
versus previous guidance of a mid single-digit headwind
Key milestones achieved since the prior results
-- Key data: Positive Phase III read-outs for danicopan in
PNH-EVH [11] (ALPHA) and for capivasertib in 2nd-line HR-positive,
metastatic breast cancer (CAPItello-291)
-- Key regulatory approvals: 19 approvals in major markets since
H1 2022 results, including US approvals for Enhertu in HER2 [12]
-low breast cancer (DESTINY-Breast04) and advanced NSCLC [13]
(DESTINY-Lung02), Imjudo and Imfinzi in advanced liver cancer
(HIMALAYA), Imfinzi in advanced biliary tract cancer (TOPAZ--1); EU
approval for Beyfortus for the prevention of RSV [14] lower
respiratory tract disease (MELODY/MEDLEY); EU and Japan approvals
for Ultomiris in gMG [15] (CHAMPION-MG), Tezspire in severe asthma
(NAVIGATOR) and Lynparza in early breast cancer (OlympiA)
-- Other regulatory milestones: US Priority Review for Lynparza
for 1st-line metastatic castration-resistant prostate cancer
(PROpel)
Pascal Soriot, Chief Executive Officer, AstraZeneca, said:
"AstraZeneca continues to see the benefit of our sustained
investment in R&D, with 19 major regulatory approvals since our
last earnings call.
After a strong performance in the year to date, we have
increased our Core EPS guidance for the full year 2022.
Additionally, recent encouraging data for several of our pipeline
programmes have given us the confidence to proceed with additional
late-stage clinical trials as we maintain our focus on delivery of
our growth ambitions.
I would also like to highlight the announcement at COP27 to
accelerate the delivery of our net zero strategy. Our company
intends to lead by example on this increasingly important objective
for the world."
Guidance
The Company updates its FY 2022 guidance at CER, due to the
strong performance in the year to date. The guided range for FY
2022 Core EPS has been increased to a high twenties to low thirties
percentage; the final outcome within that range will depend on the
timing of Evusheld deliveries and collaboration milestones linked
to regulatory events.
At actual exchange rates, it is anticipated that FY 2022 Total
Revenue growth will also be impacted by a currency headwind of a
mid single-digit percentage, and that FY 2022 Core EPS growth will
be impacted by a currency headwind of a mid-to-high single-digit
percentage (see 'Currency impact', below).
Total Revenue is expected to increase by a low twenties
percentage (unchanged)
Core EPS is expected to increase by a high twenties to low
thirties percentage
(previously mid-to-high twenties percentage)
Other elements of the Income Statement are expected to be
broadly in line with the indications issued in the Company's H1
2022 results announcement (29 July 2022).
AstraZeneca continues to recognise geopolitical and supply chain
uncertainties on overall business performance. Variations in
performance between quarters can be expected to continue.
The Company is unable to provide guidance on a Reported basis
because AstraZeneca cannot reliably forecast material elements of
the Reported result, 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
The growth numbers in the guidance above are provided at CER,
based on the average exchange rates through 2021.
If foreign-exchange rates for November to December 2022 were to
remain at the spot rates seen on 31 October 2022, it is anticipated
that FY 2022 Total Revenue would incur a mid single-digit adverse
impact versus the performance at CER, and FY 2022 Core EPS would
incur a mid-to-high single-digit adverse impact (previously a mid
single-digit adverse impact).
The Company's foreign-exchange rate sensitivity analysis is
provided in Table 17.
Table 1 : Key elements of Total Revenue performance in Q3
2022
% Change
Revenue type $m Actual CER
----------------------- ------ ------ ---- -----------------------------------------
Product Sales 10,590 9 16 Strong Oncology and BioPharmaceuticals
sales
$1,734m from medicines acquired
with Alexion
Collaboration Revenue 392 >3x >3x $160m for Enhertu (Q3 2021: $52m)
$26m for Tezspire (Q3 2021: $nil)
Milestones of $75m for Lynparza,
$62m for Nexium and $40m for
tralokinumab
Total Revenue 10,982 11 19
------------------------ ------ ------ ---- -----------------------------------------
Disease areas $m Actual CER
----------------------- ------ ------ ---- -----------------------------------------
Good performance across key medicines
Oncology 4,039 20 27 and regions
CVRM (9) 2,351 11 18 Farxiga achieved its third consecutive
blockbuster quarter with $1,103m
in revenues
R&I 1,499 1 5 Growth across Breztri and Fasenra
offsetting a decline in Pulmicort
of 33% (31% at CER) primarily
due to the impact of VBP [16]
implementation and COVID-19 lockdowns
in China
$180m from Vaxzevria [18] (Q3
2021: $1,050m)
$536m from Evusheld (Q3 2021:
V&I [17] 878 (29) (24) $nil)
$518m from Ultomiris which was
Rare Disease (9) 1,741 4 11 up 37% (47% at CER)
Includes a Collaboration Revenue
milestone of $62m for Nexium.
Nexium revenue in Q3 2021 was
negatively impacted by a transition
Other Medicines 474 34 50 in distribution partners
Total Revenue 10,982 11 19
------------------------ ------ ------ ---- -----------------------------------------
Regions inc. Vaxzevria $m Actual CER
----------------------- ------ ------ ---- -----------------------------------------
Decline due to lower sales of
Vaxzevria (growth rates excluding
Emerging Markets 2,856 (10) (4) Vaxzevria shown below)
Q3 2021 was negatively impacted
by Tagrisso inventory phasing
and stock compensation following
- China 1,541 3 8 NRDL [19] changes
- Ex-China Emerging Decline due to lower sales of
Markets 1,316 (21) (15) Vaxzevria
US 4,650 34 34
Europe 2,065 8 23
Established RoW 1,412 7 26
Total Revenue inc.
Vaxzevria 10,982 11 19
------------------------ ------ ------ ---- -----------------------------------------
Contribution of medicines acquired
Regions exc. Vaxzevria $m Actual CER with Alexion
----------------------- ------ ------ ---- -----------------------------------------
Emerging Markets 2,826 13 20 $102m
- China 1,541 3 8
- Ex-China Emerging
Markets 1,285 26 37 $102m
US 4,650 34 34 $1,069m
Europe 2,002 14 30 $351m
Established RoW 1,325 22 45 $212m
Total Revenue exc.
Vaxzevria 10,803 23 31 $1,734m
------------------------ ------ ------ ---- -----------------------------------------
Table 2 : Key elements of financial performance in Q3 2022
Metric Reported Reported Core Core Comments [20]
change change
----------- -------- ----------- -------- ---------- ----------------------------------------------------------
See Table 1 and the Total
Total 11% Actual 11% Actual Revenue section of this document
Revenue $10,982m 19% CER $10,982m 19% CER for further details
----------- -------- ----------- -------- ---------- ----------------------------------------------------------
Gross 72% 10pp Actual 81% 6pp Actual + Addition of Alexion
Margin 11pp CER 7pp CER + Increasing mix of Oncology
[21] sales
* Impact from profit-sharing arrangements (e.g.
Lynparza)
* Reported Gross Margin impacted by unwind of Alexion
inventory fair value adjustment
----------- -------- ----------- -------- ---------- ----------------------------------------------------------
+ Addition of Alexion
+ Increased investment in
the pipeline following ungating
of additional late-stage trials
Reported R&D Expense in Q3
2021 included a $1,172m impairment
charge
Core R&D-to-Total Revenue
-32% Actual 10% Actual ratio of 21%
R&D Expense $2,458m -28% CER $2,357m 16% CER (Q3 2021: 22%)
----------- -------- ----------- -------- ---------- ----------------------------------------------------------
+ Addition of Alexion
+ Market development activities
for recent launches, including
Evusheld
+ Core SG&A-to-Total Revenue
SG&A 5% Actual 10% Actual ratio of 29%
Expense $4,277m 9% CER $3,160m 16% CER (Q3 2021: 29%)
----------- -------- ----------- -------- ---------- ----------------------------------------------------------
Other
Operating
Income >2x Actual >2x Actual Includes income from royalties
[22] $106m >2x CER $107m >3x CER and prior transactions
----------- -------- ----------- -------- ---------- ----------------------------------------------------------
Operating 28pp Actual 8pp Actual See Gross Margin and Expenses
Margin 11% 30pp CER 31% 9pp CER commentary above
----------- -------- ----------- -------- ---------- ----------------------------------------------------------
+ Foreign exchange movements
+ Interest rate increase on
floating rate liabilities
Reported impacted by discount
Net Finance 1% Actual 16% Actual unwind on acquisition-related
Expense $324m 2% CER $254m 14% CER liabilities
----------- -------- ----------- -------- ---------- ----------------------------------------------------------
18% Core Tax Rate in the quarter
reflected geographical mix
of profits and favourable
adjustments to prior year
tax liabilities in a number
of major jurisdictions
Reported affected by a $883m
deferred tax credit arising
from a legal entity reorganisation
to integrate Alexion
-3pp Variations in the tax rate
Actual can be expected to continue
Tax Rate -78% n/m 18% -3pp CER quarter to quarter
----------- -------- ----------- -------- ---------- ----------------------------------------------------------
Further details of differences
55% Actual between Reported and Core
EPS $1.06 n/m $1.67 70% CER are shown in Table 12
----------- -------- ----------- -------- ---------- ----------------------------------------------------------
Table 3 : Pipeline highlights since prior results
announcement
Event Medicine Indication / Trial Event
--------------- ------------ ------------------------------ ------------------------
Regulatory Tagrisso NSCLC (adjuvant) (ADAURA) Regulatory approval (JP)
approvals
and other
regulatory
actions
Imfinzi Biliary tract cancer (TOPAZ-1) Regulatory approval (US)
Imfinzi Liver cancer (1st-line) Regulatory approval (US)
(HIMALAYA)
Lynparza gBRCA [23] breast cancer Regulatory approval (EU,
(adjuvant) (OlympiA) JP)
Lynparza HRD [24] -positive advanced Regulatory approval (CN)
ovarian cancer (1st-line
maint.) (PAOLA-1)
Enhertu HER2-low breast cancer Regulatory approval (US)
(3rd-line) (DESTINY-Breast04)
Enhertu HER2m [25] NSCLC (2nd-line+) Regulatory approval (US)
(DESTINY-Lung02)
Calquence Maleate tablet formulation Regulatory approval (US)
Forxiga CKD [26] (DAPA-CKD) Regulatory approval (CN)
Tezspire Severe asthma (NAVIGATOR) Regulatory approval (EU,
JP)
Beyfortus RSV (MELODY/MEDLEY) Regulatory approval (EU)
Evusheld COVID-19 (PROVENT/TACKLE) Regulatory approval (JP)
Evusheld COVID-19 (TACKLE) Regulatory approval (EU)
Soliris PNH and aHUS [27] Regulatory approval (CN)
Ultomiris gMG (CHAMPION-MG) Regulatory approval (EU,
JP)
Koselugo NF1-PN [28] (SPRINT) Regulatory approval (JP)
Regulatory Lynparza Prostate cancer (1st-line) Priority Review (US)
submissions (PROpel)
or acceptances
---------------
Enhertu HER2-low breast cancer Regulatory submission
(3rd-line) (DESTINY-Breast04) (CN)
---------------
Farxiga HFpEF [29] (DELIVER) Regulatory submission
/Forxiga (US, EU, JP, CN)
Ultomiris NMOSD [30] (CHAMPION-NMOSD) Regulatory submission
(US, EU, JP)
--------------- ------------ ------------------------------ ------------------------
Major Phase capivasertib HR+/HER2-neg breast cancer Primary endpoint met
III data (1st-line)
readouts (CAPItello-291)
and other
developments
---------------
monalizumab Recurrent or metastatic Efficacy threshold not
HNSCC [31] met
(2nd-line) (INTERLINK-1)
---------------
Fasenra EoE [32] (MESSINA) One of two dual-primary
endpoints not met
Soliris Guillain-Barré syndrome Primary endpoint not met
danicopan PNH with extravascular Primary endpoint met
haemolysis
--------------- ------------ ------------------------------ ------------------------
Corporate and business development
In October 2022, AstraZeneca entered a definitive agreement to
acquire LogicBio Therapeutics, Inc. (NASDAQ: LOGC), a pioneering
genomic medicine company. The proposed acquisition aims to rapidly
accelerate Alexion's growth in genomic medicines through LogicBio's
unique technology, experienced rare disease R&D team, and
expertise in pre-clinical development.
Sustainability summary
AstraZeneca attended COP27, where the Sustainable Markets
Initiative Health Systems Task Force collectively made significant
commitments to tackle the climate crisis, setting a benchmark for
others to drive action at scale. Some commitment highlights include
supply chain emissions, which drive approximately 50% of healthcare
emissions: the Task Force members have committed to align on a set
of common supplier standards and jointly explore green
transportation corridors. The patient care pathway drives
approximately 45% of healthcare emissions, and the Task Force has
committed to build an end-to-end care pathway emissions standard to
measure emissions across the care pathway, as well as align and
publish product-level lifecycle management assessment data to
increase transparency on emissions. The Task Force has also
committed to leverage digital health solutions to decarbonise
clinical trials.
Conference call
A conference call and webcast for investors and analysts will
begin today, 10 November 2022, at 11:45 GMT. Details can be
accessed via astrazeneca.com .
Reporting calendar
The Company intends to publish its full year and fourth quarter
results on Thursday 9 February 2022.
Operating and financial review
All narrative on growth and results in this section is based on
actual exchange rates, and financial figures are in US$ millions
($m), unless stated otherwise. Unless stated otherwise, the
performance shown in this announcement covers the nine-month period
to 30 September 2022 ('the year to date' or 'YTD 2022') compared to
the nine-month period to 30 September 2021 (YTD 2021), or the
three-month period to 30 September 2022 ('the quarter' or 'Q3
2022') compared to the three-month period to 30 September 2021 (Q3
2021).
Core financial measures, EBITDA, Net Debt, CER, Initial
Collaboration Revenue and Ongoing Collaboration Revenue 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 as well as Post Alexion
Acquisition Group Review items
-- Alexion acquisition-related items, primarily fair value
adjustments on acquired inventories and fair value impact of
replacement employee share awards
-- Other specified items, principally the imputed finance charge
relating to contingent consideration on business combinations,
legal settlements and the one off deferred tax credit arising from
the internal reorganisation to integrate Alexion
-- 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 54 of the Annual Report and Form 20-F Information 2021 .
Reference should be made to the Reconciliation of Reported to
Core financial measures table included in the financial performance
section in this announcement.
Gross Margin, previously termed Gross Profit 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 Gross Margin excludes
the impact of 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.
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.
Ongoing Collaboration Revenue is defined as Collaboration
Revenue excluding Initial Collaboration Revenue (which is defined
as Collaboration Revenue that is recognised at the date of
completion of an agreement or transaction, in respect of upfront
consideration). Ongoing Collaboration Revenue comprises, among
other items, royalties, milestone revenue and profit-sharing
income. Reference should be made to the Collaboration Revenue table
in this Operating and financial review.
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 4 : Disease area and medicine performance
YTD 2022 Q3 2022
----------------------------- -----------------------------
% Change % Change
Product Sales $m % Total Actual CER $m % Total Actual CER
---------------------- ------ ------- ------ ---- ------ ------- ------ ----
Oncology 10,885 33 14 20 3,797 35 15 22
----------------------- ------ ------- ------ ---- ------ ------- ------ ----
- Tagrisso 4,102 12 11 16 1,398 13 12 20
- Imfinzi 2,031 6 14 19 737 7 19 26
- Lynparza 1,949 6 13 19 659 6 12 19
- Calquence 1,469 4 74 77 566 5 60 63
- Enhertu 52 - >5x >5x 23 - >4x >4x
- Orpathys 34 - >3x >3x 11 - 11 16
- Zoladex 717 2 - 6 240 2 (4) 5
- Faslodex 259 1 (21) (14) 81 1 (21) (10)
- Iressa 90 - (39) (37) 27 - (35) (31)
- Arimidex 85 - (20) (16) 24 - (28) (23)
- Casodex 63 - (48) (45) 21 - (46) (40)
- Others 34 - (9) (1) 10 - (18) (10)
----------------------- ------ ------- ------ ---- ------ ------- ------ ----
BioPharmaceuticals:
CVRM (9) 6,907 21 13 18 2,348 21 11 19
----------------------- ------ ------- ------ ---- ------ ------- ------ ----
- Farxiga 3,204 10 49 58 1,101 10 38 50
- Brilinta 1,013 3 (10) (7) 338 3 (10) (7)
- Lokelma 208 1 71 80 79 1 59 69
- Roxadustat 148 - 2 4 57 1 4 9
- Andexxa (9) 111 - 7 14 41 - 5 17
- Crestor 824 2 (2) 4 277 3 (7) -
- Seloken/Toprol-XL 705 2 (6) (2) 238 2 2 10
- Bydureon 207 1 (29) (28) 66 1 (30) (29)
- Onglyza 205 1 (28) (25) 66 1 (21) (17)
- Others 282 1 (9) (7) 85 1 (11) (8)
----------------------- ------ ------- ------ ---- ------ ------- ------ ----
BioPharmaceuticals:
R&I 4,318 13 (3) - 1,427 13 (4) 1
----------------------- ------ ------- ------ ---- ------ ------- ------ ----
- Symbicort 1,919 6 (6) (2) 630 6 (7) (1)
- Fasenra 1,015 3 13 17 353 3 10 15
- Breztri 282 1 >2x >2x 103 1 >2x >2x
- Saphnelo 69 - >10x >10x 33 - >10x >10x
- Pulmicort 479 1 (33) (31) 145 1 (33) (31)
- Daliresp 161 - (5) (4) 52 - (4) (3)
- Bevespi 43 - 11 13 14 - 6 8
- Others 350 1 (21) (20) 97 1 (36) (33)
----------------------- ------ ------- ------ ---- ------ ------- ------ ----
BioPharmaceuticals:
V&I 3,607 11 51 59 873 8 (27) (21)
----------------------- ------ ------- ------ ---- ------ ------- ------ ----
- Vaxzevria 1,713 5 (20) (16) 173 2 (83) (81)
- Evusheld 1,451 4 n/m n/m 537 5 n/m n/m
- Synagis 384 1 >2x >2x 104 1 (15) (1)
- FluMist 59 - (22) (13) 59 1 (19) (10)
----------------------- ------ ------- ------ ---- ------ ------- ------ ----
Rare Disease (9) 5,236 16 4 10 1,741 16 4 11
----------------------- ------ ------- ------ ---- ------ ------- ------ ----
- Soliris (9) 2,918 9 (7) (2) 901 8 (13) (6)
- Ultomiris (9) 1,371 4 27 35 518 5 37 47
- Strensiq (9) 687 2 13 15 237 2 17 20
- Koselugo 149 - >2x >2x 48 - 82 81
- Kanuma (9) 111 - 6 11 37 - 1 5
----------------------- ------ ------- ------ ---- ------ ------- ------ ----
Other Medicines 1,247 4 (4) 4 404 4 17 30
----------------------- ------ ------- ------ ---- ------ ------- ------ ----
- Nexium 986 3 (1) 8 311 3 20 36
- Others 261 1 (12) (10) 93 1 9 13
----------------------- ------ ------- ------ ---- ------ ------- ------ ----
Product Sales 32,200 97 29 35 10,590 96 9 16
----------------------- ------ ------- ------ ---- ------ ------- ------ ----
Collaboration Revenue 944 3 >2x >2x 392 4 >3x >3x
----------------------- ------ ------- ------ ---- ------ ------- ------ ----
Total Revenue 33,144 100 30 37 10,982 100 11 19
----------------------- ------ ------- ------ ---- ------ ------- ------ ----
Table 5 : Collaboration Revenue
YTD 2022 Q3 2022
-------------------------- --------------------------
% Change % Change
$m % Total Actual CER $m % Total Actual CER
---------------------- --- ------- ------ ---- --- ------- ------ ----
Enhertu : alliance
revenue [33] 332 35 >2x >2x 159 41 >3x >3x
Tezspire: alliance
revenue 42 4 n/m n/m 26 7 n/m n/m
Lynparza : regulatory
milestones 250 26 n/m n/m 75 19 n/m n/m
Tralokinumab: sales
milestone 110 12 n/m n/m 40 10 n/m n/m
Vaxzevria : royalties 67 7 (19) (22) 6 2 (87) (87)
Other royalty income 54 6 - - 18 5 (4) (3)
Other Collaboration
Revenue 89 9 (4) 12 68 17 >10x >10x
----------------------- --- ------- ------ ---- --- ------- ------ ----
Total 944 100 >2x >2x 392 100 >3x >3x
----------------------- --- ------- ------ ---- --- ------- ------ ----
Table 6 : Total Revenue by disease area
YTD 2022 Q3 2022
---------------------- ----------------------------- ------------------------------
% Change % Change
$m % Total Actual CER $m % Total Actual CER
---------------------- ------ ------- ------- --- ------ ------- ------- ----
Oncology 11,493 35 19 24 4,039 37 20 27
BioPharmaceuticals(9) 15,078 45 16 21 4,728 43 (2) 4
----------------------- ------ ------- ------- --- ------ ------- ------- ----
- CVRM (9) 6,927 21 13 19 2,351 21 11 18
- R&I 4,478 14 - 4 1,499 14 1 5
- V&I 3,673 11 49 56 878 8 (29) (24)
----------------------- ------ ------- ------- --- ------ ------- ------- ----
Rare Disease(9) 5,236 16 4 10 1,741 16 4 11
Other Medicines 1,337 4 (5) 3 474 4 34 50
----------------------- ------ ------- ------- --- ------ ------- ------- ----
Total 33,144 100 30 37 10,982 100 11 19
----------------------- ------ ------- ------- --- ------ ------- ------- ----
Table 7 : Total Revenue by region
YTD 2022 Q3 2022
----------------- ----------------------------- ------------------------------
% Change % Change
$m % Total Actual CER $m % Total Actual CER
----------------- ------ ------- ------- --- ------ ------- ------- ----
Emerging Markets 9,013 27 5 8 2,856 26 (10) (4)
------------------ ------ ------- ------- --- ------ ------- ------- ----
- China 4,597 14 (2) (1) 1,541 14 3 8
- Ex-China 4,415 13 13 20 1,316 12 (21) (15)
------------------ ------ ------- ------- --- ------ ------- ------- ----
US 13,132 40 58 58 4,650 42 34 34
Europe 6,429 19 24 37 2,065 19 8 23
Established RoW 4,570 14 38 55 1,412 13 7 26
------------------ ------ ------- ------- --- ------ ------- ------- ----
Total 33,144 100 30 37 10,982 100 11 19
------------------ ------ ------- ------- --- ------ ------- ------- ----
Table 8 : Total Revenue by region - excluding Vaxzevria
YTD 2022 Q3 2022
----------------- ----------------------------- -----------------------------
% Change % Change
$m % Total Actual CER $m % Total Actual CER
----------------- ------ ------- ------- --- ------ ------- ------- ---
Emerging Markets 8,262 25 10 15 2,826 26 13 20
------------------ ------ ------- ------- --- ------ ------- ------- ---
- China 4,551 14 (3) (2) 1,541 14 3 8
- Ex-China 3,711 11 33 44 1,285 12 26 37
------------------ ------ ------- ------- --- ------ ------- ------- ---
US 13,053 39 57 57 4,650 42 34 34
Europe 6,104 18 37 52 2,002 18 14 30
Established RoW 3,945 12 33 50 1,325 12 22 45
------------------ ------ ------- ------- --- ------ ------- ------- ---
Total 31,364 95 35 42 10,803 98 23 31
------------------ ------ ------- ------- --- ------ ------- ------- ---
Oncology
Oncology Total Revenue increased by 19% (24% at CER) in YTD 2022
to $11,493m and represented 35% of overall Total Revenue (YTD 2021:
38%). This included Lynparza Collaboration Revenue of $250m (YTD
2021: $nil) and Enhertu Collaboration Revenue of $335m (YTD 2021:
$137m). Product Sales increased by 14% (20% at CER) in YTD 2022 to
$10,885m, reflecting new launches and increased patient access for
Tagrisso, Imfinzi, Lynparza and Calquence partially offset by
declines in some older medicines. Oncology Total Revenue grew 20%
(27% at CER) in Q3 benefiting from new launches for Imfinzi,
Calquence and Enhertu and improvement in rates of lung cancer
diagnosis and treatment.
Tagrisso
Total Revenue Worldwide Emerging Markets US Europe Established
RoW
-------------- --------- ---------------- ----- ------ -----------
YTD 2022 $m 4,102 1,211 1,472 777 642
Actual change 11% 20% 14% 7% (4%)
CER change 16% 22% 14% 19% 10%
--------------- --------- ---------------- ----- ------ -----------
Region Drivers and commentary
---------------- -------------------------------------------------------------
Worldwide Increased use of Tagrisso in adjuvant and 1st-line setting
Emerging Markets Increased 1st-line use in China and continued growth
in other Emerging Markets
Rising demand from increased patient access in China
continues to offset the impact of the March 2021 NRDL
price reduction
Q3 2022 growth of 29% (35% at CER) benefited from the
comparison to Q3 2021, which was negatively impacted
by inventory phasing and stock compensation relating
to NRDL changes in March 2021
In China, COVID-19 related lockdowns continued to have
an adverse impact in Q3, though at a lower level than
Q2
US Increased EGFR [34] testing rates
Greater use in 1st-line with longer duration of treatment
and increasing adjuvant penetration, partially offset
by lower 2nd-line use
Europe Greater use in 1st-line and adjuvant settings, with
longer duration of treatment, partially offset by lower
2nd-line use
Established Increased use in 1st-line setting and launch progress
RoW in adjuvant including Japan
Q3 Total Revenue decline of 12% (growth of 5% at CER)
impacted by a COVID-19 wave in Japan
---------------- -------------------------------------------------------------
Imfinzi
Total Revenue Worldwide Emerging Markets US Europe Established
RoW
-------------- --------- ---------------- ----- ------ -----------
YTD 2022 $m 2,031 224 1,102 402 303
Actual change 14% 6% 20% 16% -
CER change 19% 9% 20% 29% 14%
--------------- --------- ---------------- ----- ------ -----------
Region Drivers and commentary
---------------- -------------------------------------------------------------
Worldwide Increased use of Imfinzi to treat patients with ES-SCLC
[35]
Recovery in rates of diagnosis and treatment following
the COVID-19 pandemic
Q3 Worldwide Total Revenue growth of 19% (26% at CER)
Emerging Markets Growth in ex-China, offset by an adverse impact in CRT
[36] rates and hospital use of infused oncology medicines
due to COVID-19 lockdowns in several major cities in
China
US New patient starts across Stage III NSCLC and ES-SCLC
A strong launch in biliary tract cancer after approval
by the US FDA in September based on the TOPAZ-1 Phase
III trial
Europe Increased market penetration in ES-SCLC, growth in the
number of reimbursed markets, an ongoing recovery in
rates of diagnosis and treatment
Established New reimbursements
RoW
---------------- -------------------------------------------------------------
Lynparza
Total Revenue Worldwide Emerging Markets US Europe Established
RoW
-------------- --------- ---------------- --- ------ -----------
YTD 2022 $m 2,199 358 896 743 202
Actual change 28% 27% 13% 63% 8%
CER change 33% 30% 13% 75% 22%
--------------- --------- ---------------- --- ------ -----------
Product Sales Worldwide Emerging Markets US Europe Established
RoW
-------------- --------- ---------------- --- ------ -----------
YTD 2022 $m 1,949 358 896 493 202
Actual change 13% 27% 13% 8% 8%
CER change 19% 30% 13% 20% 22%
--------------- --------- ---------------- --- ------ -----------
Region Drivers and commentary
---------------- ----------------------------------------------------------------
Worldwide Lynparza remains the leading medicine in the PARP [37]
-inhibitor class globally across four tumour types,
as measured by total prescription volume
Total Revenue includes $250m in regulatory milestones
received from MSD and recognised in Europe, in respect
of the approval in the US and EU for the adjuvant treatment
of patients with gBRCAm [38] breast cancer, based on
the data from the OlympiA Phase III trial
Q3 Product Sales growth of 12% (19% at CER)
Emerging Markets Increased patient access following admission to China's
NRDL as a 1st-line maintenance treatment for BRCAm [39]
ovarian cancer patients, with effect from March 2021;
also launches in other markets
US US launch in early breast cancer following US FDA [40]
approval in March based on data from the OlympiA Phase
III trial
Growth in use in breast, ovarian and prostate cancers
Europe Increasing HRD testing rates and use in 1st-line HRD-positive
ovarian cancer, increased Lynparza uptake in BRCAm mCRPC
[41] and gBRCAm HER2-negative advanced breast cancer
and the EU launch in gBRCAm early breast cancer following
EMA [42] approval in August based on data from the OlympiA
Phase III trial
Established New product launches and high levels of HRD testing
RoW in Japan
---------------- ----------------------------------------------------------------
Enhert u
Total Revenue Worldwide Emerging Markets US Europe Established
RoW
-------------- --------- ---------------- --- ------ -----------
YTD 2022 $m 387 51 254 77 4
Actual change >2x >6x >2x >4x >10x
CER change >2x >6x >2x >4x >10x
--------------- --------- ---------------- --- ------ -----------
Region Drivers and commentary
---------------- ---------------------------------------------------------------
Worldwide Excluding Japan, Enhertu global in-market sales recorded
by Daiichi Sankyo Company Limited (Daiichi Sankyo) and
AstraZeneca, amounted to $750m in the year to date (YTD
2021: $293m)
AstraZeneca's Total Revenue of $387m includes $335m
of Collaboration Revenue from its share of gross profit
in territories where Daiichi Sankyo records product
sales and royalties on sales in Japan
Q3 Worldwide Total Revenue growth of >3x
Emerging Markets Strong uptake in early launch markets
US US in-market sales, recorded by Daiichi Sankyo, amounted
to $532m in the year to date (YTD 2021: $253m)
US launches in 2nd-line HER2-positive metastatic breast
cancer after US FDA approval in May based on data from
the DESTINY-Breast03 Phase III trial; and in 3rd-line+
HER2-low metastatic breast cancer after US FDA approval
in August based on the DESTINY-Breast04 Phase III trial
Europe Growth in 3rd-line+ HER2-positive metastatic breast
and launch in 2nd-line HER2-positive metastatic breast
cancer after EMA approval in July based on data from
the DESTINY-Breast03 Phase III trial
Established In Japan, AstraZeneca receives a mid-single-digit percentage
RoW royalty on sales made by Daiichi Sankyo
---------------- ---------------------------------------------------------------
Calquence
Total Revenue Worldwide Emerging Markets US Europe Established
RoW
-------------- --------- ---------------- ----- ------ -----------
YTD 2022 $m 1,469 28 1,192 200 49
Actual change 74% >2x 58% >2x >4x
CER change 77% >2x 58% >3x >5x
--------------- --------- ---------------- ----- ------ -----------
Region
--------- ------------------------------------------------------------------
Worldwide Q3 Worldwide Total Revenue growth of 60% (63% at CER)
US Increased new patient market share led to a strong performance,
despite continued COVID--19 impacts on CLL [43] diagnosis
rates
Maleate tablet formulation launch in August resulted
in uptake by patients taking proton pump inhibitors
and demand due to channel inventory build
Europe Increased market share in new patient starts after launches
in the region
--------- ------------------------------------------------------------------
Orpathys
Orpathys Total Revenue of $35m in the year to date (YTD 2021:
$10m), growth was driven by the 2021 launch in China, where it is
approved for patients with lung cancer and MET [44] gene
alterations.
Other Oncology medicines
YTD 2022 % Change
Total Revenue $m Actual CER
--------------- ------- -------- ----- ----------------------------------------------
Zoladex 738 1% 7% Increased use in ex-China Emerging Markets,
offsetting a price cut in Japan
Faslodex 259 (21%) (14%) Generic competition
Iressa 90 (39%) (37%) Continued share loss to next generation
TKIs [45]
Arimidex 85 (20%) (16%)
Casodex 63 (48%) (45%) Ongoing impact from VBP implementation
Other Oncology 34 (9%) (1%)
---------------- ------- -------- ----- ----------------------------------------------
BioPharmaceuticals
Including Vaccines & Immune Therapies medicines,
BioPharmaceuticals Total Revenue increased by 16% (21% at CER) in
YTD 2022 to $15,078m, representing 45% of overall Total Revenue
(YTD 2021: 51%). Growth was driven by strong Farxiga performance
and growth in Evusheld.
Cardiovascular, Renal & Metabolism
CVRM Total Revenue increased by 13% (19% at CER) to $6,927m in
YTD 2022, driven by a strong Farxiga performance, and represented
21% of overall Total Revenue (YTD 2021: 24%).
Farxiga
Total Revenue Worldwide Emerging Markets US Europe Established
RoW
-------------- --------- ---------------- --- ------ -----------
YTD 2022 $m 3,208 1,224 748 955 281
Actual change 49% 40% 48% 64% 48%
CER change 58% 46% 48% 82% 64%
--------------- --------- ---------------- --- ------ -----------
Region
---------------- -----------------------------------------------------------------
Worldwide Farxiga volume is growing faster than the overall SGLT2
[46] market in all major regions
Additional benefit from growth in the overall SGLT2
inhibitor class
Further HF [47] and CKD launches and updated treatment
guidelines including from ESC [48] and AHA [49] /ACC
[50] /HFSA [51] . HF and CKD indications now launched
in >100 markets
Emerging Markets Growth despite generic competition in some markets.
Solid growth in ex-China Emerging Markets, particularly
Latin America
In China, Forxiga's NRDL status was renewed in the fourth
quarter of 2021. Benefit from uACR [52] and MRF [53]
screening programs
US Regulatory approval for HEFrEF [54] in May 2020, treatment
of CKD in May 2021
Both approvals included patients with and without T2D
[55]
Farxiga continued to gain in-class brand share, driven
by HF and CKD launches
Europe The beneficial addition of cardiovascular outcomes trial
data to the label, the HFrEF regulatory approval in
November 2020, and CKD regulatory approval in August
2021
Forxiga continued gaining in-class market share in
the period
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
---------------- -----------------------------------------------------------------
Brilinta
Total Revenue Worldwide Emerging Markets US Europe Established
RoW
-------------- --------- ---------------- ---- ------ -----------
YTD 2022 $m 1,013 222 538 215 38
Actual change (10%) (13%) (4%) (18%) (20%)
CER change (7%) (11%) (4%) (9%) (16%)
--------------- --------- ---------------- ---- ------ -----------
Region
---------------- --------------------------------------------------------
Emerging Markets Adverse impact from Brilinta's inclusion in China's
VBP programme
Strong growth in ex-China Emerging Markets
US, Europe Slower market recovery of oral antiplatelet therapies
following the pandemic
---------------- --------------------------------------------------------
Lokelma
Lokelma Total Revenue increased 71% (80% at CER) to $208m in YTD
2022, driven by Lokelma extending its branded market share lead in
the US and also achieving total potassium binder market share
leadership in the period. Continued progress in Europe from recent
launches across the region where Lokelma extended its market share
in the period. In China, Lokelma admitted to the NRDL with effect
from 1 January 2022.
Andexxa
On a pro forma basis, Andexxa Total Revenue increased 17% (24%
at CER) to $121m.
Roxadustat
Total Revenue increased 2% (4% at CER) to $151m. Total Revenue
also increased quarter-on-quarter, with roxadustat benefitting from
increased volumes in China following NRDL price cuts.
Other CVRM medicines
YTD 2022 % Change
Total Revenue $m Actual CER
------------------
Crestor 825 (2%) 4% Sales growth at CER driven by Emerging
Markets, offset by declines in the US
and Europe
Seloken 706 (6%) (2%) Emerging Markets sales impacted by China
VBP implementation of Betaloc [56] oral
in H2 2021. Betaloc ZOK VBP to be implemented
in Q4 2022
Onglyza 205 (28%) (25%) Ongoing impact from VBP implementation
Bydureon 207 (29%) (28%) Continued competitive pressures
Other CVRM 282 (9%) (7%)
------------------ ----- -------- ----- -------------------------------------------------
Respiratory & Immunology
Total Revenue from R&I medicines was stable in YTD 2022
(increased 4% at CER) at $4,478m and represented 14% of overall
Total Revenue (YTD 2021: 18%). In the third quarter, R&I Total
Revenue grew 5% at CER primarily driven by the performance of
recent launch brands, including Fasenra, Tezspire, Breztri and
Saphnelo, and revenue milestones; this growth more than offset the
sustained erosion of Pulmicort revenue following its inclusion in
VBP in China in Q4 2021, and a marginal decline in Symbicort
revenue.
Symbicort
Total Revenue Worldwide Emerging Markets US Europe Established
RoW
-------------- --------- ---------------- ----- ------ -----------
YTD 2022 $m 1,919 476 718 445 280
Actual change (6%) 4% (11%) (11%) (3%)
CER change (2%) 8% (11%) (1%) 3%
--------------- --------- ---------------- ----- ------ -----------
Region
---------------- --------------------------------------------------------------
Worldwide Symbicort remains the global market leader within stable
ICS [57] /LABA [58] class
Emerging Markets Growth in Emerging Markets driven primarily by market
share growth in China, Latin America and Asia Area
US Strong market share performance, consolidating leadership
in a declining ICS/LABA market, offset by pricing pressure
Europe Resilient market share in growing ICS/LABA market, offset
by pricing pressure
Established Double digit growth in Canada and Australia/New Zealand,
RoW driven by market share gain
Sales in Japan declined due to generic erosion and the
annual mandatory price reduction in April 2022
---------------- --------------------------------------------------------------
Fasenra
Total Revenue Worldwide Emerging Markets US Europe Established
RoW
-------------- --------- ---------------- --- ------ -----------
YTD 2022 $m 1,015 30 649 229 107
Actual change 13% 99% 17% 9% (10%)
CER change 17% 95% 17% 21% -
--------------- --------- ---------------- --- ------ -----------
Region
---------------- -----------------------------------------------------------------
Worldwide Fasenra continues to be market leader in severe eosinophilic
asthma in major markets, and leading in the IL-5 class
Emerging Markets Strong volume growth driven by launch acceleration in
Brazil and other markets
US Maintained a strong new-to-brand share in the severe
uncontrolled asthma market
Europe Market leader in new-to-brand share of the severe uncontrolled
asthma market
Established Maintained market leadership in Japan, partially offset
RoW by price erosion and impact in the dynamic market related
to surge in COVID-19 cases
---------------- -----------------------------------------------------------------
Breztri
Total Revenue Worldwide Emerging Markets US Europe Established
RoW
-------------- --------- ---------------- --- ------ -----------
YTD 2022 $m 282 71 164 22 25
Actual change >2x 76% >2x >5x 43%
CER change >2x 78% >2x >6x 66%
--------------- --------- ---------------- --- ------ -----------
Region
---------------- -----------------------------------------------------------
Worldwide Breztri continued to gain market share within growing
fixed-dose triple class across major markets
Emerging Markets In China, the FDC triple class continued to penetrate
the inhaled maintenance market whose growth has been
impacted by COVID-19
Breztri continued its market share leadership within
the fixed-dose triple class
US Consistent new-to-brand and total market share growth
within the fixed-dose triple class
Europe Sustained growth across markets as new launches continue
to progress
Established Strong new-to-brand market share performance in Japan
RoW within COPD [59] , with the market impacted by access
restrictions related to surge in COVID-19 cases
---------------- -----------------------------------------------------------
Saphnelo
Total Revenue of $69m in the year to date (YTD 2021: $1m) was
driven by sales acceleration in the US, where Saphnelo achieved
NBRx leadership in the i.v. [60] segment for SLE [61] and received
a permanent J-code facilitating reimbursement. Growth was further
supported by a strong launch in Germany and steady growth in
Japan.
Tezspire
Tezspire is approved in the US, EU and Japan for the treatment
of severe asthma without biomarker or phenotypic limitation. Total
Revenue of $42m in the year to date (YTD 2021: $nil) was comprised
entirely of Collaboration Revenue, and reflected the strong early
launch performance in the US. Amgen records sales in the US and
AstraZeneca records its share of gross profits in the US as
Collaboration Revenue.
Other R&I medicines
YTD 2022 % Change
Total Revenue $m Actual CER
-------------- ------- -------- ----- -------------------------------------------------
Pulmicort 479 (33%) (31%) Revenue from Emerging Markets decreased
41% to $339m, impacted by VBP implementation
in China and lower rates of elective surgery
and limited access to nebulisation centres
due to COVID-19 lockdowns
Daliresp 161 (5%) (4%)
Bevespi 43 11% 13%
Other R&I 469 3% 4% Collaboration Revenue of $118m (YTD 2021:
$12m), including $111m of milestones relating
to tralokinumab (YTD 2021: nil)
Product Sales of $350m decreased 21% (20%
at CER)
------------------- ------- -------- ----- -------------------------------------------------
Vaccines & Immune Therapies
Total Revenue from V&I medicines increased to $3,673m (YTD
2021: $2,465m) and represented 11% of overall Total Revenue (YTD
2021: 10%).
Vaxzevria
Total Revenue Worldwide Emerging Markets US Europe Established
RoW
-------------- --------- ---------------- --- ------ -----------
YTD 2022 $m 1,780 751 79 325 625
Actual change (20%) (34%) n/m (56%) 82%
CER change (16%) (35%) n/m (51%) 96%
--------------- --------- ---------------- --- ------ -----------
Region
---------------- -----------------------------------------------------------------
Worldwide Revenue in the third quarter decreased by 83% (82% at
CER) due to the conclusion of many of the initial Vaxzevria
contracts
Emerging Markets $46m of Collaboration Revenue came from a Chinese sub-licensee
producing vaccines for export
Revenue in the third quarter decreased by 95% (96% at
CER)
US Purchases by the US government for donation overseas
No revenue recorded in the second and third quarters
Europe Revenue in the third quarter decreased by 62% (56% at
CER) vs Q3 2021
Established Sales in Japan, Canada and Australia
RoW Revenue in the third quarter decreased by 63% (59% at
CER)
---------------- -----------------------------------------------------------------
Evusheld
Total Revenue Worldwide Emerging Markets US Europe Established
RoW
-------------- --------- ---------------- --- ------ -----------
YTD 2022 $m 1,450 167 850 198 235
Actual change n/m n/m n/m n/m n/m
CER change n/m n/m n/m n/m n/m
--------------- --------- ---------------- --- ------ -----------
Region
---------------- -------------------------------------------------------------
US Evusheld received Emergency Use Authorisation for the
prevention of COVID-19 in December 2021
AstraZeneca continued to fulfil the US Government's
order for 1.7m units
Emerging Markets Multiple government contracts in Central and Eastern
Europe, Latin America and South East Asia
Europe Approved in the EU for prevention of COVID-19 in March
2022 and treatment in September 2022
Established Approved in Japan for prevention and treatment of COVID-19
RoW in August 2022
---------------- -------------------------------------------------------------
Other V&I medicines
YTD 2022 % Change
Total Revenue $m Actual CER
-------------- --- ------ ----- ----------------------------------------------
Synagis 384 >2x >2x Strong RSV season
Ex-US rights reverted to AstraZeneca after
30 June 2021, from AbbVie Inc.
In Q3 2022, Synagis sales decreased by
15% (1% CER)
FluMist 59 (22%) (13%)
--------------- --- ------ ----- ----------------------------------------------
Rare Disease
On a pro forma basis, Total Revenue from Rare Disease medicines
increased by 4% (10% at CER) in YTD 2022 to $5,236m, representing
16% of overall Total Revenue.
Performance was driven by the durability of the C5 franchise,
Soliris and Ultomiris, following Ultomiris gMG launch and expansion
into new markets, and continued Soliris NMOSD growth.
Strensiq and Koselugo performances were driven by continued
patient demand and market expansion efforts, respectively.
These tables show pro forma growth rates for each of the
medicines acquired with Alexion, calculated by comparing YTD 2022
revenues with the medicine's revenues from 1 January 2021 to 30
September 2021.
Soliris
Total Revenue Worldwide Emerging Markets US Europe Established
RoW
----------------- --------- ---------------- ----- ------ -----------
YTD 2022 $m 2,918 218 1,688 627 385
Actual change(9) (7%) (29%) (3%) (20%) 20%
CER change(9) (2%) (9%) (3%) (10%) 34%
------------------ --------- ---------------- ----- ------ -----------
Region
------ -----------------------------------------------------------------
US Performance impacted by successful conversion to Ultomiris
in PNH, aHUS and gMG, partially offset by Soliris growth
in NMOSD
Ex-US Growth driven by continued expansion of neurology indications,
gMG and NMOSD, in new markets
------ -----------------------------------------------------------------
Ultomiris
Total Revenue Worldwide Emerging Markets US Europe Established
RoW
----------------- --------- ---------------- --- ------ -----------
YTD 2022 $m 1,371 34 771 347 219
Actual change(9) 27% >2x 23% 55% -
CER change(9) 35% >3x 23% 74% 18%
------------------ --------- ---------------- --- ------ -----------
Region
--------- -----------------------------------------------------------
Worldwide Performance driven by gMG launch in the US and expansion
into new markets
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 Performance driven by successful conversion from Soliris
across PNH, aHUS and gMG with increased utilisation
from complement-naïve patients in gMG
Ex-US Rapid conversion in new launch markets
--------- -----------------------------------------------------------
Other Rare Disease medicines
YTD 2022 % Change
Total Revenue $m Actual CER Commentary
------------- --- ------ --- ----------------------------------------------
Strensiq (9) 687 13% 15% Performance driven by strong patient demand
Koselugo 149 >2x >2x Growth driven by expansion in new markets
and tender market order timing
Kanuma (9) 111 6% 11% Continued demand growth in ex-US markets
------------- --- ------ --- ----------------------------------------------
Other medicines (outside the main disease areas)
YTD 2022 % Change
Total Revenue $m Actual CER Commentary
--------------- ------- -------- ----- -------------------------------------------
Nexium 1,063 (3%) 7% Collaboration Revenue of $78m (YTD 2021:
$92m)
Nexium (oral) was included in China's
VBP programme implemented in February
2021 and Nexium i.v. was implemented in
the fifth round of VBP in October 2021
Others 273 (12%) (10%)
--------------- ------- -------- ----- -------------------------------------------
Financial performance
Table 9 : Reported Profit and Loss
YTD 2022 YTD 2021 % Change Q3 2022 Q3 2021 % Change
$m $m Actual CER $m $m Actual CER
------------------------ -------- -------- ------ ----- ------- ------- ------ --------
Total Revenue 33,144 25,406 30 37 10,982 9,866 11 19
- Product Sales 32,200 25,043 29 35 10,590 9,741 9 16
- Collaboration Revenue 944 363 >2x >2x 392 125 >3x >3x
------------------------- -------- -------- ------ ----- ------- ------- ------ --------
Cost of Sales (9,491) (7,812) 21 28 (2,982) (3,757) (21) (18)
------------------------- -------- -------- ------ ----- ------- ------- ------ --------
Gross Profit 23,653 17,594 34 40 8,000 6,109 31 41
Gross Margin 70.5% 68.8% +2pp +2pp 71.8% 61.4% +10pp +11pp
------------------------- -------- -------- ------ ----- ------- ------- ------ --------
Distribution Expense (380) (322) 18 25 (126) (120) 5 13
% Total Revenue 1.1% 1.3% - - 1.1% 1.2% - -
R&D Expense (7,137) (7,152) - 4 (2,458) (3,610) (32) (28)
% Total Revenue 21.5% 28.2% +7pp +7pp 22.4% 36.6% +14pp +14pp
SG&A Expense (13,798) (10,117) 36 41 (4,277) (4,090) 5 9
% Total Revenue 41.6% 39.8% -2pp -1pp 38.9% 41.5% +3pp +3pp
OOI [62] & Expense 325 1,345 (76) (75) 106 37 >2x >2x
% Total Revenue 1.0% 5.3% -4pp -4pp 1.0% 0.4% +1pp +1pp
------------------------- -------- -------- ------ ----- ------- ------- ------ --------
Operating Profit/(Loss) 2,663 1,348 98 >2x 1,245 (1,674) n/m n/m
Operating Margin 8.0% 5.3% +3pp +3pp 11.3% -17.0% +28pp +30pp
------------------------- -------- -------- ------ ----- ------- ------- ------ --------
Net Finance Expense (936) (922) 1 6 (324) (320) 1 2
Joint Ventures and
Associates (4) (55) (93) (91) 1 (7) n/m n/m
------------------------- -------- -------- ------ ----- ------- ------- ------ --------
Profit/(Loss) before
tax 1,723 371 >4x >4x 922 (2,001) n/m n/m
------------------------- -------- -------- ------ ----- ------- ------- ------ --------
Taxation 668 90 >7x >7x 720 350 >2x >2x
Tax rate -39% -24% -78% -18%
------------------------- -------- -------- ------ ----- ------- ------- ------ --------
Profit/(Loss) after
tax 2,391 461 >5x >5x 1,642 (1,651) n/m n/m
------------------------- -------- -------- ------ ----- ------- ------- ------ --------
Earnings per share $1.54 $0.33 >4x >4x $1.06 $(1.10) n/m n/m
------------------------- -------- -------- ------ ----- ------- ------- ------ --------
Table 10 : Reconciliation of Reported Profit before tax to
EBITDA
YTD 2022 YTD 2021 % Change Q3 2022 Q3 2021 % Change
$m $m Actual CER $m $m Actual CER
--------------------------- -------- -------- ------ ---- ------- ------- ------ ----
Reported Profit/(Loss)
before tax 1,723 371 >4x >4x 922 (2,001) n/m n/m
Net Finance Expense 936 922 1 6 324 320 1 2
Joint Ventures and
Associates 4 55 (93) (91) (1) 7 n/m n/m
Depreciation, Amortisation
and Impairment 4,000 4,338 (8) (4) 1,334 2,788 (52) (49)
---------------------------- -------- -------- ------ ---- ------- ------- ------ ----
EBITDA 6,663 5,686 17 26 2,579 1,114 >2x >2x
---------------------------- -------- -------- ------ ---- ------- ------- ------ ----
EBITDA of $6,663m in the year to date (YTD 2021: $5,686m) has
been negatively impacted by the $3,175m (YTD 2021: $1,044m) unwind
of inventory fair value uplift recognised on the acquisition of
Alexion. EBITDA of $2,579m in the quarter (Q3 2021: $1,114m) has
been negatively impacted by the $857m (Q3 2021: $1,044m) unwind of
inventory fair value uplift recognised on the acquisition of
Alexion. The unwind of inventory fair value is expected to depress
EBITDA over the year in line with associated revenues, and by a
smaller amount in 2023.
Table 11 : Reconciliation of Reported to Core financial
measures: YTD 2022
YTD 2022 Reported Restructuring Intangible Acquisition Other Core Core
Asset Amortisation of Alexion % Change
& Impairments
$m $m $m $m $m $m Actual CER
------------------ -------- ----- ----- ----- ------- -------- ------ ----
Gross Profit 23,653 156 24 3,186 (1) 27,018 43 48
Gross Margin 70.5% 81.0% +7pp +6pp
------------------- -------- ----- ----- ----- ------- -------- ------ ----
Distribution
Expense (380) 2 - - - (378) 17 24
R&D Expense (7,137) 57 83 23 - (6,974) 25 29
1,197
SG&A Expense (13,798) 263 3,060 35 [63] (9,243) 20 24
------------------- -------- ----- ----- ----- ------- -------- ------ ----
Total Operating
Expense (21,315) 322 3,143 58 1,197 (16,595) 22 26
------------------- -------- ----- ----- ----- ------- -------- ------ ----
Other Operating
Income & Expense 325 (8) - - - 317 (76) (76)
------------------- -------- ----- ----- ----- ------- -------- ------ ----
Operating
Profit 2,663 470 3,167 3,244 1,196 10,740 63 69
Operating
Margin 8.0% 32.4% +6pp +6pp
------------------- -------- ----- ----- ----- ------- -------- ------ ----
Net Finance
Expense (936) - - 207 (729) 16 21
(1,078)
Taxation 668 (93) (581) (748) [64] (1,832) 84 90
------------------- -------- ----- ----- ----- ------- -------- ------ ----
EPS $1.54 $0.25 $1.67 $1.61 $0.21 $5.28 47 52
------------------- -------- ----- ----- ----- ------- -------- ------ ----
Table 12 : Reconciliation of Reported to Core financial
measures: Q3 2022
Q3 2022 Reported Restructuring Intangible Acquisition Other Core Core
Asset Amortisation of Alexion % Change
& Impairments
$m $m $m $m $m $m Actual CER
------------------ ------- ----- ----- ----- ------- ------- ------ ----
Gross Profit 8,000 75 8 866 (1) 8,948 21 30
Gross Margin 71.8% 80.8% +6pp +7pp
------------------- ------- ----- ----- ----- ------- ------- ------ ----
Distribution
Expense (126) 1 - - - (125) 5 12
R&D Expense (2,458) 19 77 5 - (2,357) 10 16
SG&A Expense (4,277) 65 979 5 68 (3,160) 10 16
------------------- ------- ----- ----- ----- ------- ------- ------ ----
Total Operating
Expense (6,861) 85 1,056 10 68 (5,642) 10 16
------------------- ------- ----- ----- ----- ------- ------- ------ ----
Other Operating
Income & Expense 106 1 - - - 107 >2x >3x
------------------- ------- ----- ----- ----- ------- ------- ------ ----
Operating
Profit 1,245 161 1,064 876 67 3,413 50 63
Operating
Margin 11.3% 31.1% +8pp +9pp
------------------- ------- ----- ----- ----- ------- ------- ------ ----
Net Finance
Expense (324) - - - 70 (254) 16 14
Taxation 720 (32) (194) (202) (871) (579) 31 43
------------------- ------- ----- ----- ----- ------- ------- ------ ----
EPS $1.06 $0.08 $0.56 $0.44 ($0.47) $1.67 55 70
------------------- ------- ----- ----- ----- ------- ------- ------ ----
Profit and Loss drivers
Gross Profit
-- The Gross Margin (Reported and Core) in the year to date was impacted by:
-- Positive mix effects: the increased contribution from Rare
Disease and Oncology medicines had a positive impact on the Gross
Margin
-- Negative mix effects: sales of Vaxzevria and medicines with
profit-sharing arrangements (primarily Lynparza) had a dilutive
impact on the Gross Margin
-- Pricing pressure relating to procurement programmes in China
-- Reported Gross Profit was also impacted by the unwind of the
fair value adjustment to Alexion inventories at the date of
acquisition. The fair value uplift is expected to unwind through
Reported Cost of Sales in line with associated revenues, and in YTD
2022, the impact of the fair value uplift unwind on Cost of Sales
was $3,175m (YTD 2021: $1,044m)
-- Currency fluctuations had a small positive impact on Gross
Margin in the year to date. Currency fluctuations may have a
positive or negative impact on Gross Margin in future quarters
-- Variations in Gross Margin performance between periods can be expected to continue
R&D Expense
-- Reported and Core R&D Expense was impacted by:
-- The acquisition of Alexion in July 2021
-- Recent positive data read outs for several high priority
medicines that ungated late-stage Oncology trials
-- The advancement of a number of mid-stage clinical development
programmes in BioPharmaceuticals
-- Investment in platforms, new technology and capabilities to enhance R&D productivity
-- The decrease in Reported R&D Expense is primarily due to
the prior year including an impairment charge of $1,172m,
recognised in Q3 2021 on an intangible asset related to the
acquisition of Ardea Biosciences, Inc.
SG&A Expense
-- The increase in Reported and Core SG&A Expense was driven by:
-- The acquisition of Alexion
-- Market development activities for recent launches
-- Reported SG&A Expense was also impacted by amortisation
of intangible assets related to the Alexion acquisition and other
acquisitions and collaborations, and a $775m legal settlement with
Chugai
Other Operating Income
-- Reported Other Operating Income of $325m consisted primarily
of royalties and disposal proceeds on small divestments, including
the divestment of rights to Plendil in the second quarter
-- In YTD 2021, Reported Other Operating Income of $1,345m
included $776m of divestment gains from AstraZeneca's share of
Viela Bio, Inc. and $309m from the commercial rights to Crestor in
over 30 countries in Europe (excluding UK and Spain)
Net Finance Expense
-- The increase in Reported and Core Net Finance Expense in the
year to date was driven by financing costs on debt for the Alexion
transaction , with a reduction in the discount unwind on
acquisition-related liabilities, including the Diabetes Alliance
which impacted Reported Net Finance Expense
-- In Q3 2022, the Net Finance Expense was also impacted by rising interest rates
Taxation
-- The effective Reported Tax Rate for the nine months to 30
September 2022 was (39%) and the Core tax rate was 18%, and (24%)
and 17% respectively in the nine months to 30 September 2021
-- The Reported Tax Rate for the nine months included a one-time
favourable net adjustment of $883m to deferred taxes arising from
an internal reorganisation to integrate the Alexion organisation
which took place in the quarter. The legal entity reorganisation
did not result in any corporate income tax payable however did
result in an estimated one-off deferred tax adjustment of $883m at
Q3 to reflect the substantively enacted tax effects which would
arise in impacted jurisdictions going forwards. A further $47m
credit movement is included in OCI. This adjustment is based upon
full-year forecast estimates and therefore may change for the full
year results. This adjustment was excluded from the Core tax
charge
-- 2021 Reported and Core Tax Rates were impacted by one-off
items in 2021, including the non-taxable gain on the divestment of
Viela and updates to estimates of prior period tax liabilities
following settlements with tax authorities
-- The net cash paid for the year to date was $1,335m (YTD 2021:
$1,198m) representing 77% of Reported Profit before tax (YTD 2021:
323%). The cash tax amount increased due to the increase in profits
and the impact of Non-core charges on the level of Reported Profit
before tax and effects of US rules around deferral of tax relief on
R&D costs. The cash tax rate decreased compared to 2021 due to
the impact in YTD 2021 of low Reported Profit before tax
-- The Reported Tax rate of (39%) was lower than the Core Tax
Rate of 18% primarily due to the impact of the aforementioned
internal restructuring. YTD 2022 Reported and Core Tax rates also
benefited from the geographical mix of profits and favourable
adjustments to prior year tax liabilities in a number of major
jurisdictions
-- On 20 July 2022, the UK Government issued draft legislation
in relation to the new global minimum tax framework, expected to be
brought into effect in the UK from 2024. The UK corporation tax
rate continues to be expected to increase to 25%, effective April
2023. The Company is currently assessing potential impact of these
draft rules upon its financial statements
Table 13 : Cash Flow summary
YTD 2022 YTD 2021 Change
$m $m $m
------------------------------------------------- -------- -------- --------
Reported Operating Profit 2,663 1,348 1,315
Depreciation, Amortisation and Impairment 4,000 4,338 (338)
Decrease in Working Capital and Short-term
Provisions 3,458 2,063 1,395
Gains on Disposal of Intangible Assets (88) (371) 283
Gains on Disposal of Investments in Associates
and Joint Ventures - (776) 776
Fair value movements on contingent consideration
arising from business combinations 293 33 260
Non-Cash and Other Movements (973) (370) (603)
Interest Paid (608) (522) (86)
Taxation Paid (1,335) (1,198) (137)
-------------------------------------------------- -------- -------- --------
Net Cash Inflow from Operating Activities 7,410 4,545 2,865
-------------------------------------------------- -------- -------- --------
Net Cash Inflow/(Outflow) before Financing
Activities 4,699 (5,600) 10,299
-------------------------------------------------- -------- -------- --------
Net Cash (Outflow)/Inflow from Financing
Activities (6,465) 4,700 (11,165)
-------------------------------------------------- -------- -------- --------
The increase in Net Cash Inflow from Operating Activities of
$2,865m primarily reflected an underlying
improvement in business performance, including the contribution
from Alexion.
The Reported Operating Profit of $2,663m in the period includes
a negative impact of $3,175m relating to the unwind of the
inventory fair value uplift recognised on the acquisition of
Alexion. This is offset by a corresponding item (positive impact of
$3,175m) in Decrease in Working Capital and Short-term Provisions.
Overall, the unwind of the fair value uplift has no impact on Net
Cash Inflow from Operating Activities.
The change in Working Capital and Short-term Provisions of
$1,395m, whilst being positively impacted by the aforementioned
inventory fair value uplift unwind, has been adversely impacted by
the reduction of Vaxzevria working capital balances predominantly
within Trade and other payables.
Capital Expenditure
Capital Expenditure amounted to $719m in the year to date (YTD
2021: $768m) including expenditure relating to Alexion. The Company
anticipates stable Capital Expenditure in FY 2022 relative to FY
2021.
Table 14 : Net Debt summary
At 30 At 31 At 30
Sep 2022 Dec 2021 Sep 2021
$m $m $m
--------------------------------------------------- --------- --------- ---------
Cash and cash equivalents 4,458 6,329 7,067
Other investments 440 69 82
---------------------------------------------------- --------- --------- ---------
Cash and investments 4,898 6,3 98 7,149
---------------------------------------------------- --------- --------- ---------
Overdrafts and short-term borrowings (743) (387 ) (605)
Lease liabilities (878) (987 ) (962)
Current instalments of loans (4,665) (1,273 ) (2,139)
Non-current instalments of loans (23,013) (28,134 ) (28,206)
---------------------------------------------------- --------- --------- ---------
Interest-bearing loans and borrowings (Gross Debt) (29,299 ) (30,781) (31,912 )
---------------------------------------------------- --------- --------- ---------
Net derivatives (141) 61 90
---------------------------------------------------- --------- --------- ---------
Net Debt (24,542 ) (24,322 ) (24,673 )
---------------------------------------------------- --------- --------- ---------
Net Debt increased by $220m in the year to date to $24,542m.
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 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, 1.750% Notes due 2028
and 2.250% Notes due 2031 (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 [65] 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 Form 6-K furnished to the SEC on
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 15 : Obligor group summarised Statement of comprehensive
income
YTD 2022 YTD 2021
$m $m
------------------------------------------------------------------ -------- --------
Total Revenue - -
Gross Profit - -
Operating loss (3) (131)
Loss for the period (404) (553)
Transactions with subsidiaries that are not issuers or guarantors 502 5,731
------------------------------------------------------------------- -------- --------
Table 16 : Obligor group summarised Statement of financial
position
At 30 Sep 2022 At 30 Sep 2021
$m $m
----------------------------------------------------------------- -------------- --------------
Current assets 5 12
Non-current assets - -
Current liabilities (3,067) (2,347)
Non-current liabilities (22,556) (25,721)
Amounts due from subsidiaries that are not issuers or guarantors 7,349 12,137
Amounts due to subsidiaries that are not issuers or guarantors (301) (299)
------------------------------------------------------------------ -------------- --------------
Foreign exchange
The Company's transactional currency exposures on
working-capital balances, which typically extend for up to three
months, are hedged where practicable using forward foreign-exchange
contracts against the individual companies' reporting currency.
Foreign-exchange gains and losses on forward contracts for
transactional hedging are taken to profit or loss. In addition, the
Company's external dividend payments, paid principally in pounds
sterling and Swedish krona, are fully hedged from announcement to
payment date.
Table 17 : Currency sensitivities
The Company provides the following currency-sensitivity
information:
Average spot Annual impact of 5% strengthening in
rates vs USD Spot rate vs USD FY average rate vs USD ($m) ([66])
------------- ------------------ ------------------------------------
Currency Primary FY YTD Change 31 Oct 2022 Change [69] Total Core
Relevance 2021 [67] 2022 [68] (%) (%) Revenue Operating
Profit
CNY Total Revenue 6.43 6.62 (3) 7.31 (12) 277 158
EUR Total Revenue 0.85 0.94 (10) 1.01 (16) 317 160
JPY Total Revenue 109.83 128.34 (14) 148.02 (26) 229 158
Other ([70]) 420 196
---------------------------- ---------- ---------- ------ ----------- ----------- ----------- -----------
Operating
GBP Expense 0.73 0.80 (9) 0.86 (16) 61 (93)
Operating
SEK Expense 8.58 9.92 (13) 10.98 (22) 6 (82)
Sustainability
Since the last quarterly report, AstraZeneca:
Access to healthcare
-- CEO Pascal Soriot spoke at the UN General Assembly (UNGA)
alongside heads of state and global leaders, including UN Secretary
General António Guterres and World Health Organization (WHO)
Director-General Dr Tedros, on "Ending the COVID-19 Pandemic
through Equitable Access to Vaccines, Tests and Treatments"
-- Progressed, with the Partnership for Health System
Sustainability and Resilience (PHSSR), research in 13 Phase 2
countries, with key findings to be presented at the Global PHSSR
Summit on 22-23 November. PHSSR launch events were held in Saudi
Arabia and Brazil. Vietnam signed a three-year MoU with the
Ministry of Health, including implementation projects furthering
PHSSR recommendations
-- Expanded the Healthy Heart Africa (HHA) programme into
Nigeria in collaboration with the Nigeria Ministry of Health and
the National Primary Healthcare Development Agency, and its
implementing partner PSI. HHA also expanded into Zanzibar in
collaboration with the Zanzibar Ministry of Health and its
implementing partner HIPZ. Over 29 million blood pressure
screenings have been conducted since launch in 2015
-- Supported the largest delegation at the One Young World
Summit in Manchester, with over 80 Young Health Programme (YHP)
scholars and young AstraZeneca employees attending, together with
senior executives who also hosted a site visit and workshops at the
AstraZeneca Macclesfield site. The Company also announced a US
$50,000 Lead2030 grant with One Young World, to support youth-led
non-profits tackling air pollution for healthy people and a healthy
planet
Environmental protection
-- AstraZeneca attended COP27, where through the Sustainable
Markets Initiative Health Systems Task Force made significant
commitments to tackle the climate crisis, setting a benchmark for
others to drive action at scale. This is the first time the global
health sector has taken collective action to decarbonise, across
our supply chains, patient care pathways, and clinical trials.
-- Participated in the launch of the Sustainable Markets
Initiative China Council, endorsed by President Xi Jinping and HM
King Charles III, in his former role as HRH Prince of Wales.
-- Attended the inaugural meeting of the SMI China Council at
the CEO and Senior Executive Team level, which provides an
important forum for cross-sector collaboration on sustainability.
The Company was the only healthcare company invited to attend,
offering the opportunity for a leadership role in accelerating
action on climate change and supporting sustainability goals for a
healthy society and planet
-- Engaged at the World Economic Forum Sustainable Development
Impact Meetings in New York during Climate Week, driving thought
leadership on a range of topics including the interconnection of
health and climate, accelerating the delivery of net-zero health
systems, the circular economy and health equity. The Company's
integrated approach to sustainability also included engagements on
inclusion and diversity and health systems resilience
-- Marked the fifth anniversary of Climate Group's global
electric transport initiative, EV100, by participating in a Climate
Week panel event on "Steering the global market towards EV100,"
sharing the experience of working towards its goal of a fully
electric vehicle fleet by end of 2025 as a key part of the Ambition
Zero Carbon programme
-- Participated in a World Water Week event in Stockholm,
Sweden, to share its water stewardship strategy and how it is
improving circularity at its sites to reduce reliance on natural
resources and improve water quality, increasing water efficiency at
a local level and building climate resilience
-- Spoke at a Reuters panel discussion "Drive environmental
sustainability across biopharma to create meaningful system-wide
change" on the connection between climate and health, and the
industry's role in accelerating the delivery of net-zero health
systems
-- Published a concept letter in collaboration with regulators,
academics, and industry as part of PREMIER, a European Innovative
Health Initiative project led by the Company to find solutions to
managing pharmaceutical pollution. The paper discusses how greener
design could help minimise the impact on the environment of active
pharmaceutical ingredients excreted from patients
-- Received the prestigious Indiana Department of Environmental
Management Governor's Award for Environmental Excellence in the
category of 'Five-Year Continuous Improvement' for its
manufacturing site in Mount Vernon, Indiana
Ethics and transparency
-- Marked International Day of the Girl with its
#GirlsBelongHere2022 initiative in collaboration with Plan
International, welcoming more than 350 young women across 35
countries to step into leadership positions, join boardroom
conversations and participate in roundtables and masterclasses. All
of the Senior Executive Team participated, including country and
regional leadership teams. Regions and functions also drove their
own initiatives
-- Furthered its commitment to gender and health equity through
YHP awarding 80% of "Step Up" grants totalling $160,000 to
women-led non-profit organisations working to improve the health of
young people in their communities
-- Launched a #ScienceCan sustainability campaign to shine a
spotlight on the Company's work to drive sustainability across its
interconnected strategic priorities through pioneering science. The
campaign outlines the efforts to build a sustainable future for
people, society, and the planet. All employees are being asked to
crowdsource ideas in teams and identify ways to support the
delivery of the Company's sustainability goals and identify
objectives for 2023, to effect change from the grassroots level
-- Celebrated its annual Power of Diversity day with the launch
of a refreshed Global Inclusion and diversity strategy setting out
priorities across three focus areas - Inclusion, Diversity and
External Impact
-- Marked Global Ethics Day with the launch of its annual Code
of Ethics training for all employees, and with the launch of its
Supplier Diversity Programme in Sweden, progressing the target to
launch supplier diversity programmes in 10 countries by 2025 to
accelerate inclusion and growth of local small and diverse
businesses
Research and development
This section covers R&D events and milestones that have
occurred since the prior results announcement on 29 July 2022, up
to and including events announced on 9 November 2022.
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 data across its diverse portfolio of
cancer medicines at two major medical congresses during the
quarter: the IASLC 2022 World Conference on Lung Cancer (WCLC) in
August, and the European Society for Medical Oncology (ESMO) in
September. At ESMO, 75 abstracts featured 15 approved and potential
new medicines from AstraZeneca across 13 different tumour
types.
Significant new trials in Oncology initiated during the period
included TROPION-Lung07 a Phase III trial of datopotamab deruxtecan
in 1st-line PDL1 [71] -low NSCLC patients with PD-L1 TPS [72]
<50% and LATIFY, a Phase III trial of ceralasertib in
combination with Imfinzi in NSCLC patients whose disease has
progressed on or after prior anti-PD-L1 therapy and platinum-based
chemotherapy.
Tagrisso
At WCLC in August, preliminary results from the SAVANNAH Phase
II trial showed that Tagrisso plus Orpathys demonstrated an ORR
[73] of 49% (95% CI [74] 39-59%) in patients with EGFRm NSCLC with
high levels of MET overexpression and/or amplification, defined as
IHC90+ [75] and/or FISH10+ [76] , whose disease progressed on
treatment with Tagrisso. This combination is being further
evaluated in the SAFFRON Phase III trial.
During the period, Tagrisso was approved in Japan for the
adjuvant treatment of patients with EGFRm NSCLC after surgery based
on the results from the global ADAURA Phase III trial.
Updated results from follow-up of the ADAURA Phase III trial
presented at ESMO in September demonstrated a sustained, clinically
meaningful improvement in disease free survival compared to placebo
in the adjuvant treatment of patients with early-stage (IB, II and
IIIA) EGFRm NSCLC after complete tumour resection, with nearly
three in four patients treated with adjuvant Tagrisso alive and
disease-free at four years.
Imfinzi and Imjudo
During the period, Imfinzi was approved in the US for the
treatment of patients with locally advanced or metastatic biliary
tract cancer, in combination with chemotherapy, based on the
results from the TOPAZ-1 Phase III trial. In October, Imfinzi in
combination with a single priming dose of Imjudo (tremelimumab) was
approved in the US for the 1st-line treatment of patients with
unresectable HCC based on the results from the HIMALAYA Phase III
trial.
At ESMO, updated TOPAZ-1 results for Imfinzi plus chemotherapy
(gemcitabine plus cisplatin) in biliary tract cancer showed
enhanced clinical efficacy after an additional 6.5 months of
follow-up, demonstrating a 24% reduction in the risk of death
versus chemotherapy alone (based on a hazard ratio of 0.76; 95% CI,
0.64-0.91). Updated median OS [77] was 12.9 months versus 11.3 with
chemotherapy. More than two times as many patients were estimated
to be alive at two years versus chemotherapy alone (23.6% versus
11.5%).
Lynparza
In August, Lynparza was approved in the European Union for the
adjuvant treatment of patients with gBRCAm high-risk early breast
cancer and in Japan for BRCAm patients in the same setting based on
the results from the OlympiA Phase III trial.
During the period, the Company and MSD received US regulatory
submission acceptance with Priority Review for Lynparza in
combination with abiraterone and prednisone or prednisolone for the
treatment of adult patients with mCRPC based on the PROpel Phase
III trial.
At ESMO, AstraZeneca presented positive long-term follow-up
results from the PAOLA-1 Phase III trial in the pre-specified
descriptive analysis of the HRD-positive subgroup, and from the
SOLO-1 Phase III trial in patients with BRCA mutations of Lynparza
with or without bevacizumab. Both trials showed clinically
meaningful improvements in OS. Further results showed PFS [78] in
combination with bevacizumab for HRD-positive patients, versus
active comparator, bevacizumab, and as monotherapy for patients
with BRCA mutations, versus placebo, respectively. Five-year
follow-up of the PAOLA-1 Phase III trial demonstrated that 65% of
HRD-positive patients treated with Lynparza plus bevacizumab were
alive at five years versus 48.4% treated with bevacizumab and
placebo. Data from the SOLO-1 Phase III trial demonstrated 67% of
advanced ovarian cancer patients with BRCA mutations treated with
Lynparza were alive at seven years versus 47% on placebo.
In September, Lynparza was approved in China for the maintenance
treatment of HRD-positive patients with advanced ovarian cancer who
are in complete or partial response to 1st-line platinum-based
chemotherapy in combination with bevacizumab, based on the PAOLA-1
Phase III trial.
During the period, AstraZeneca and MSD announced the voluntary
withdrawal of the Lynparza indication for patients with gBRCAm
advanced ovarian cancer who have been treated with three or more
lines of chemotherapy. The decision to withdraw was made in
consultation with the US FDA and based on a recent subgroup
analysis that indicated a potential detrimental effect on OS for
Lynparza compared to the chemotherapy control arm in the subgroup
of patients who had received three or more lines of
chemotherapy.
Calquence
In August, AstraZeneca's new maleate tablet formulation of
Calquence was approved in the US for all current indications,
including adult patients with CLL, SLL [79] and for patients with
relapsed or refractory MCL [80] , under accelerated approval based
on results from the ELEVATE-PLUS trials. The tablet can be taken
with gastric acid-reducing agents, including proton pump
inhibitors, antacids and H2-receptor antagonists.
Enhertu
In August, AstraZeneca and Daiichi Sankyo's Enhertu was approved
in the US for the treatment of patients with unresectable or
metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have
received a prior chemotherapy in the metastatic setting or
developed disease recurrence during or within six months of
completing adjuvant chemotherapy. The approval by the US FDA was
based on positive results from the DESTINY-Breast04 Phase III
trial.
During the period, Enhertu was also approved in the US for the
treatment of adult patients with unresectable or metastatic NSCLC
whose tumours have activating HER2 mutations and who have received
a prior systemic therapy. The accelerated approval by the US FDA
was based on the results of the DESTINY-Lung02 Phase II trial.
In August, positive high-level results from the DESTINY-Breast02
Phase III trial of Enhertu versus physician's choice of treatment
showed the trial met the primary endpoint, demonstrating a
statistically significant and clinically meaningful improvement in
PFS in patients with HER2-positive unresectable and/or metastatic
breast cancer previously treated with trastuzumab emtansine. The
trial also met the key secondary endpoint of improved OS.
Datopotamab deruxtecan (Dato-DXd)
At WCLC in August, initial results from the TROPION-Lung02 Phase
Ib trial demonstrated promising clinical activity and a tolerable
safety profile for Dato-DXd in combination with pembrolizumab with
or without platinum chemotherapy in patients with previously
untreated or pre-treated, advanced or metastatic NSCLC.
The data showed an ORR in the overall population of 37% (median
follow-up of 6.5 months) in patients treated with Dato-DXd and
pembrolizumab (doublet therapy) and an ORR of 41% (median follow-up
of 4.4 months) in patients receiving Dato-DXd, pembrolizumab and
platinum chemotherapy (triplet therapy). A DCR [81] of 84% was seen
with both the doublet and triplet combination therapy in the
overall population that comprised both 1st-line and 2nd-line
settings.
In previously untreated patients, ORRs of 62% (eight of the 13
patients receiving doublet therapy) and 50% (10 of 20 patients
receiving triplet therapy) were observed. Eight partial responses
were seen in patients receiving doublet therapy and 10 partial
responses (three pending confirmation) were seen in patients
receiving triplet therapy. A DCR of 100% was observed with doublet
therapy and a DCR of 90% was observed with triplet therapy.
Camizestrant
In October, positive high-level results from the SERENA-2 Phase
II trial showed that AstraZeneca's next-generation oral selective
estrogen receptor degrader camizestrant met the primary endpoint of
demonstrating a statistically significant and clinically meaningful
PFS benefit at both 75mg and 150mg dose levels versus Faslodex
(fulvestrant) 500mg in post-menopausal patients with estrogen
receptor-positive locally advanced or metastatic breast cancer,
previously treated with endocrine therapy.
Capivasertib
In October, positive high-level results from the CAPItello-291
Phase III trial showed that AstraZeneca's AKT [82] inhibitor
capivasertib in combination with Faslodex (fulvestrant)
demonstrated a statistically significant and clinically meaningful
improvement in PFS versus placebo plus Faslodex in patients with
HR-positive, HER2-low or HER2-negative locally advanced or
metastatic breast cancer, following recurrence or progression on or
after endocrine therapy (with or without a CDK4/6 [83]
inhibitor).
Monalizumab
During the quarter, AstraZeneca informed Innate Pharma SA that
the INTERLINK-1 Phase III trial will be discontinued, as a result
of the trial not meeting a pre-defined threshold for efficacy at a
planned futility interim analysis, with the decision being
recommended by an Independent Data Monitoring Committee.
INTERLINK-1 evaluated monalizumab in combination with cetuximab
versus cetuximab in patients with recurrent or metastatic squamous
cell carcinoma of the head and neck who have been previously
treated with platinum-based chemotherapy and PD-L1 inhibitors.
BioPharmaceuticals - CVRM
Farxiga
Full data from the DELIVER Phase III trial was presented at the
European Society of Cardiology Congress in August 2022. In the
trial, which evaluated Farxiga in patients with heart failure with
preserved ejection fraction, Farxiga reduced the composite outcome
of cardiovascular death or worsening of heart failure by 18% with
all individual components contributing to the superiority of the
primary endpoint. The findings were consistent across key subgroups
examined and extend the benefits of Farxiga to the full spectrum of
patients with heart failure irrespective of left ventricular
ejection fraction status. The trial also showed a symptom benefit
in patient-reported outcomes measured by the Kansas City
Cardiomyopathy Questionnaire total symptom score. In a separate
pre-specified pooled analysis from the Phase III DAPA-HF and
DELIVER trials, Farxiga demonstrated reduction in cardiovascular
death by 14% and reduction in death from any cause by 10% in
patients with heart failure irrespective of ejection fraction.
In September 2022, Forxiga was approved for the treatment of
chronic kidney disease in China based on the data from the DAPA-CKD
trial.
Eplontersen
In the period, AstraZeneca and Ionis Pharmaceuticals, Inc.
presented data from the NEURO-TTransform Phase III trial in
patients with hereditary transthyretin-mediated amyloid
polyneuropathy (ATTRv-PN) at the International Symposium on
Amyloidosis. In the trial, eplontersen demonstrated a significant
and clinically meaningful change from baseline for co-primary and
secondary endpoints at 35 weeks compared to external placebo group.
On the co-primary endpoint of serum transthyretin concentration
from baseline, eplontersen showed an 81.2% reduction.
BioPharmaceuticals - R&I
AstraZeneca presented new data across the R&I portfolio at
the European Respiratory Society (ERS) International Congress 2022,
with a total of 78 accepted abstracts, including 14 late breakers
and 21 oral presentations.
Tezspire
In September, Tezspire was approved in the EU as an add-on
maintenance treatment in patients 12 years and older with severe
asthma who are inadequately controlled with high dose inhaled
corticosteroids plus another medicinal product. Also in September,
Tezspire was approved in Japan for the treatment of bronchial
asthma in patients with severe or refractory disease in whom asthma
symptoms cannot be controlled with mid- or high-dose inhaled
corticosteroids and other long-term maintenance therapies.
Results from the DESTINATION Phase III extension trial were
presented at ERS 2022. Tezspire demonstrated an overall long-term
safety and efficacy profile consistent with the PATHWAY Phase II
and NAVIGATOR Phase III trials, sustained over 104 weeks in a broad
population of severe asthma patients regardless of biomarker
status.
Additional analyses of the CASCADE Phase II and NAVIGATOR Phase
III trials were also presented at the ERS International Congress
2022. The CASCADE Phase II mechanistic trial showed Tezspire as the
first biologic to reduce mucus plugging compared to placebo.
Reduction in mucus score with Tezspire was correlated with
improvements in lung function. Mucus plugging as a clinical feature
may predict the risk of future exacerbations and lung function
decline in severe asthma.
Fasenra
During the period, AstraZeneca discontinued the Phase III MAHALE
trial for the treatment of non-cystic fibrosis bronchiectasis, due
to strategic portfolio prioritisation; this discontinuation was not
related to any safety or efficacy findings.
In October 2022, AstraZeneca disclosed results from the MESSINA
Phase III trial, evaluating Fasenra for the treatment of
eosinophilic esophagitis. In the trial, Fasenra did not meet one of
the two dual-primary endpoints, demonstrating a statistically
significant improvement in histological disease remission but not
in dysphagia symptoms compared to placebo. No new safety concerns
were identified. The company will continue to analyse the complete
data set and results will be shared at an upcoming medical
meeting.
Tozorakimab
Data from the ACCORD-2 Phase II trial examined tozorakimab, in
patients hospitalised with COVID-19. Results showed that patients
receiving tozorakimab on top of standard of care had a 32 percent
relative risk reduction in respiratory failure and death, this
increased to 57% in IL-33 high patients (IL-33 high was defined as
a baseline IL-33 level of >30.15 U/ml). This data suggests
tozorakimab may be a novel therapy for patients with acute
respiratory failure.
BioPharmaceuticals - V&I
Beyfortus (nirsevimab)
In November 2022, Beyfortus was approved in the EU for the
prevention of RSV lower respiratory tract disease in newborns and
infants during their first RSV season. The European Commission is
the first regulatory body to grant approval to Beyfortus. The
approval was based on results from the Beyfortus clinical
development programme, including the MELODY Phase III, MEDLEY Phase
II/III and Phase IIb trials.
Evusheld
In August 2022, Evusheld was granted Special Approval for
Emergency in Japan for adults and adolescents for both prevention
(pre-exposure prophylaxis) and treatment of symptomatic disease
caused by SARS-CoV-2 infection. In prevention, Evusheld is approved
for use in those whom SARS-CoV-2 vaccination is not recommended and
who may have an inadequate response to a COVID-19 vaccine due to
immunodeficiencies. Recipients of Evusheld for prevention should
not be currently infected with or have had recent known exposure to
a person infected with SARS-CoV-2. In treatment, Evusheld is
approved for those with risk factors for severe SARS-CoV-2
infection who do not require supplemental oxygen. The decision
marked the first global marketing approval for Evusheld as a
treatment for COVID-19.
In September 2022, Evusheld was approved in the EU for the
treatment of adults and adolescents with COVID - 19 who do not
require supplemental oxygen and who are at increased risk of
progressing to severe COVID - 19. Both the Japan and EU treatment
approvals were based on results from the TACKLE Phase III treatment
trial.
In October 2022, the FDA updated the authorised Fact Sheets for
Evusheld to inform health care providers and individuals that
Evusheld may not be effective at preventing COVID-19 caused by
SARSCoV-2 viral variants that Evusheld does not neutralise.
Vaxzevria
In October 2022, Vaxzevria had its conditional marketing
authorisation in the EU converted into a standard marketing
authorisation by the EMA. The standard marketing authorisation
covers the use of Vaxzevria in both a primary vaccination series,
and as a third dose booster.
As the primary vaccination needs of the US are being met
already, AstraZeneca has decided that it will not submit a
Biologics Licence Application for Vaxzevria in the US. The Company
will continue to focus its efforts on ensuring availability of
Vaxzevria elsewhere around the world, including submissions for its
use as a booster.
Rare Disease
Soliris
During the period, AstraZeneca received results from the GBS-301
Phase III trial, conducted in Japan, evaluating Soliris on top of
standard-of-care IVIg [84] as a treatment for Guillain-Barré
Syndrome. Soliris, on top of IVIg, did not achieve statistical
significance on the primary endpoint of time to first reaching a
Hughes FG s core <= 1.
During the period, Soliris received full approval in China for
the treatment of PNH and aHUS.
Ultomiris
In August 2022, Ultomiris was approved in Japan for the
treatment of adult patients with gMG who are anti-acetylcholine
receptor antibody-positive and whose symptoms are difficult to
control with high-dose intravenous immunoglobulin therapy or
plasmapheresis.
In September 2022, Ultomiris was approved in Europe as an add-on
to standard therapy for the treatment of adult patients with gMG
who are anti-acetylcholine receptor antibody-positive.
Approvals by the Japanese Ministry of Health, Labour and Welfare
and the European Commission, were based on positive results from
the CHAMPION-MG Phase III trial which sho wed that Ultomiris was
superior to placebo in the primary endpoint of change from baseline
in the Myasthenia Gravis-Activities of Daily Living Profile
(MG-ADL) total score at Week 26, a patient-reported scale that
assesses patients' abilities to perform daily activities.
During the period, AstraZeneca discontinued the Phase III trial
for Ultomiris in complement-mediated thrombotic microangiopathy,
due to strategic portfolio prioritisation. This discontinuation was
not related to any safety or efficacy findings.
In October 2022, AstraZeneca presented new data showing
significant advances for the treatment of anti-aquaporin-4
antibody-positive NMOSD at the European Committee for Treatment and
Research in Multiple Sclerosis Congress based on results from the
Ultomiris CHAMPION-NMOSD Phase III trial. These new data and
insights underscored the critical role of C5 inhibition in treating
AQP4 antibody-positive NMOSD which, when treated with Ultomiris,
the first and only long-acting C5 inhibitor, demonstrated zero
relapses with a median treatment duration of 73 weeks.
Koselugo
In September, Koselugo was approved in Japan for paediatric
patients with NF1-PN.
Danicopan (ALXN2040)
During the period, the Company announced that danicopan, an
add-on to Ultomiris or Soliris, met the primary endpoint in Phase
III ALPHA trial for patients with paroxysmal nocturnal
haemoglobinuria who experience clinically significant extravascular
haemolysis. Interim results demonstrated statistically significant
improvement compared to placebo in haemoglobin levels from baseline
to week 12. AstraZeneca will present these data at a forthcoming
medical meeting and intends to proceed with regulatory submissions
in the coming months.
Interim financial statements
Table 18 : Condensed consolidated statement of comprehensive
income: YTD 2022
For the nine months ended 30 September 2022 2021
$m $m
-------- --------
Total Revenue 33,144 25,406
Product Sales 32,200 25,043
Collaboration Revenue 944 363
--------------------------------------------------------------------------------------------- -------- --------
Cost of Sales (9,491) (7,812)
--------------------------------------------------------------------------------------------- -------- --------
Gross profit 23,653 17,594
--------------------------------------------------------------------------------------------- -------- --------
Distribution expense (380) (322)
Research and development expense (7,137) (7,152)
Selling, general and administrative expense (13,798) (10,117)
Other operating income and expense 325 1,345
--------------------------------------------------------------------------------------------- -------- --------
Operating profit 2,663 1,348
--------------------------------------------------------------------------------------------- -------- --------
Finance income 50 42
Finance expense (986) (964)
Share of after tax losses in associates and joint ventures (4) (55)
--------------------------------------------------------------------------------------------- -------- --------
Profit before tax 1,723 371
--------------------------------------------------------------------------------------------- -------- --------
Taxation 668 90
--------------------------------------------------------------------------------------------- -------- --------
Profit for the period 2,391 461
--------------------------------------------------------------------------------------------- -------- --------
Other comprehensive (loss)/income
--------------------------------------------------------------------------------------------- -------- --------
Items that will not be reclassified to profit or loss
Remeasurement of the defined benefit pension liability 1,283 592
Net (losses)/gains on equity investments measured at fair value through other comprehensive
income (21) 144
Fair value movements related to own credit risk on bonds designated as fair value through
profit or loss 1 4
Tax on items that will not be reclassified to profit or loss (291) 71
--------------------------------------------------------------------------------------------- -------- --------
972 811
-------- --------
Items that may be reclassified subsequently to profit or loss
Foreign exchange arising on consolidation (2,493) (368)
Foreign exchange arising on designated borrowings in net investment hedges (321) (275)
Fair value movements on cash flow hedges (214) (103)
Fair value movements on cash flow hedges transferred to profit or loss 250 137
Fair value movements on derivatives designated in net investment hedges 33 22
Costs of hedging (11) (6)
Tax on items that may be reclassified subsequently to profit or loss 95 37
--------------------------------------------------------------------------------------------- -------- --------
(2,661) (556)
-------- --------
Other comprehensive (loss)/income, net of tax (1,689) 255
--------------------------------------------------------------------------------------------- -------- --------
Total comprehensive income for the period 702 716
--------------------------------------------------------------------------------------------- -------- --------
Profit attributable to:
--------------------------------------------------------------------------------------------- -------- --------
Owners of the Parent 2,387 459
Non-controlling interests 4 2
--------------------------------------------------------------------------------------------- -------- --------
2,391 461
-------- --------
Total comprehensive income attributable to:
--------------------------------------------------------------------------------------------- -------- --------
Owners of the Parent 701 714
Non-controlling interests 1 2
--------------------------------------------------------------------------------------------- -------- --------
702 716
-------- --------
Basic earnings per $0.25 Ordinary Share $1.54 $0.33
Diluted earnings per $0.25 Ordinary Share $1.53 $0.33
Weighted average number of Ordinary Shares in issue (m) 1,548 1,374
Diluted weighted average number of Ordinary Shares in issue (m) 1,560 1,382
--------------------------------------------------------------------------------------------- -------- --------
Table 19 : Condensed consolidated statement of comprehensive
income: Q3 2022
For the quarter ended 30 September 2022 2021
$m $m
------- --------
Total Revenue 10,982 9,866
Product Sales 10,590 9,741
Collaboration Revenue 392 125
--------------------------------------------------------------------------------------------- ------- --------
Cost of Sales (2,982) (3,757)
--------------------------------------------------------------------------------------------- ------- --------
Gross profit 8,000 6,109
--------------------------------------------------------------------------------------------- ------- --------
Distribution expense (126) (120)
Research and development expense (2,458) (3,610)
Selling, general and administrative expense (4,277) (4,090)
Other operating income and expense 106 37
--------------------------------------------------------------------------------------------- ------- --------
Operating profit/(loss) 1,245 (1,674)
--------------------------------------------------------------------------------------------- ------- --------
Finance income 15 15
Finance expense (339) (335)
Share of after tax profits/(losses) in associates and joint ventures 1 (7)
--------------------------------------------------------------------------------------------- ------- --------
Profit/(Loss) before tax 922 (2,001)
--------------------------------------------------------------------------------------------- ------- --------
Taxation 720 350
--------------------------------------------------------------------------------------------- ------- --------
Profit/(Loss) for the period 1,642 (1,651)
--------------------------------------------------------------------------------------------- ------- --------
Other comprehensive loss
Items that will not be reclassified to profit or loss
Remeasurement of the defined benefit pension liability 252 (100)
Net (losses)/gains on equity investments measured at fair value through other comprehensive
income (9) 171
Fair value movements related to own credit risk on bonds designated as fair value through
profit or loss (1) 2
Tax on items that will not be reclassified to profit or loss (16) 19
--------------------------------------------------------------------------------------------- ------- --------
226 92
------- --------
Items that may be reclassified subsequently to profit or loss
Foreign exchange arising on consolidation (1,167) (427)
Foreign exchange arising on designated borrowings in net investment hedges (126) (45)
Fair value movements on cash flow hedges (76) (44)
Fair value movements on cash flow hedges transferred to profit or loss 119 64
Fair value movements on derivatives designated in net investment hedges (1) 15
Costs of hedging 2 (4)
Tax on items that may be reclassified subsequently to profit or loss 49 19
--------------------------------------------------------------------------------------------- ------- --------
(1,200) (422)
------- --------
Other comprehensive loss, net of tax (974) (330)
--------------------------------------------------------------------------------------------- ------- --------
Total comprehensive income/(loss) for the period 668 (1,981)
--------------------------------------------------------------------------------------------- ------- --------
Profit/(Loss) attributable to:
--------------------------------------------------------------------------------------------- ------- --------
Owners of the Parent 1,640 (1,652)
Non-controlling interests 2 1
--------------------------------------------------------------------------------------------- ------- --------
1,642 (1,651)
------- --------
Total comprehensive income/(loss) attributable to:
--------------------------------------------------------------------------------------------- ------- --------
Owners of the Parent 667 (1,982)
Non-controlling interests 1 1
--------------------------------------------------------------------------------------------- ------- --------
668 (1,981)
------- --------
Basic earnings per $0.25 Ordinary Share $1.06 $(1.10)
Diluted earnings per $0.25 Ordinary Share $1.05 $(1.10)
Weighted average number of Ordinary Shares in issue (m) 1,548 1,496
Diluted weighted average number of Ordinary Shares in issue (m) 1,559 1,496
--------------------------------------------------------------------------------------------- ------- --------
Table 20 : Condensed consolidated statement of financial
position
At 30 Sep 2022 At 31 Dec 2021 At 30 Sep 2021
$m $m $m
------------------------------------------------------------------ -------------- -------------- --------------
Assets
Non-current assets
Property, plant and equipment 8,352 9,183 9,214
Right-of-use assets 875 988 948
Goodwill 19,707 19,997 20,081
Intangible assets 39,585 42,387 44,104
Investments in associates and joint ventures 53 69 39
Other investments 1,049 1,168 1,546
Derivative financial instruments 112 102 90
Other receivables 792 895 811
Deferred tax assets 3,436 4,330 3,697
------------------------------------------------------------------- -------------- -------------- --------------
73,961 79,119 80,530
-------------- -------------- --------------
Current assets
Inventories 5,078 8,983 10,528
Trade and other receivables 9,336 9,644 8,258
Other investments 440 69 82
Derivative financial instruments 105 83 60
Intangible assets 82 105 100
Income tax receivable 725 663 596
Cash and cash equivalents 4,458 6,329 7,067
Assets held for sale - 368 -
------------------------------------------------------------------- -------------- -------------- --------------
20,224 26,244 26,691
-------------- -------------- --------------
Total assets 94,185 105,363 107,221
------------------------------------------------------------------- -------------- -------------- --------------
Liabilities
Current liabilities
Interest-bearing loans and borrowings (5,408) (1,660) (2,744)
Lease liabilities (210) (233) (229)
Trade and other payables (17,694) (18,938) (18,663)
Derivative financial instruments (68) (79) (54)
Provisions (377) (768) (972)
Income tax payable (1,093) (916) (987)
------------------------------------------------------------------- -------------- -------------- --------------
(24,850) (22,594) (23,649)
-------------- -------------- --------------
Non-current liabilities
Interest-bearing loans and borrowings (23,013) (28,134) (28,206)
Lease liabilities (668) (754) (733)
Derivative financial instruments (290) (45) (6)
Deferred tax liabilities (3,479) (6,206) (6,400)
Retirement benefit obligations (919) (2,454) (2,449)
Provisions (930) (956) (726)
Other payables (4,882) (4,933) (5,140)
------------------------------------------------------------------- -------------- -------------- --------------
(34,181) (43,482) (43,660)
-------------- -------------- --------------
Total liabilities (59,031) (66,076) (67,309)
------------------------------------------------------------------- -------------- -------------- --------------
Net assets 35,154 39,287 39,912
------------------------------------------------------------------- -------------- -------------- --------------
Equity
Capital and reserves attributable to equity holders of the Parent
Share capital 387 387 387
Share premium account 35,137 35,126 35,118
Other reserves 2,081 2,045 2,039
Retained earnings (2,471) 1,710 2,200
------------------------------------------------------------------- -------------- -------------- --------------
35,134 39,268 39,744
Non-controlling interests 20 19 168
------------------------------------------------------------------- -------------- -------------- --------------
Total equity 35,154 39,287 39,912
------------------------------------------------------------------- -------------- -------------- --------------
Table 21 : 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 2021 328 7,971 2,024 5,299 15,622 16 15,638
---------------------------- -------- -------- --------- --------- ------------- --------------- -------
Profit for the period - - - 459 459 2 461
Other comprehensive
income - - - 255 255 - 255
Transfer to other
reserves - - 15 (15) - - -
Transactions with
owners:
Dividends - - - (3,884) (3,884) - (3,884)
Issue of Ordinary
Shares 59 27,147 - - 27,206 - 27,206
Changes in non-controlling
interest - - - - - 150 150
Share-based payments
charge for the period - - - 384 384 - 384
Settlement of share
plan awards - - - (811) (811) - (811)
Issue of replacement
share awards upon
acquisition - - - 513 513 - 513
---------------------------- -------- -------- --------- --------- ------------- --------------- -------
Net movement 59 27,147 15 (3,099) 24,122 152 24,274
---------------------------- -------- -------- --------- --------- ------------- --------------- -------
At 30 Sep 2021 387 35,118 2,039 2,200 39,744 168 39,912
---------------------------- -------- -------- --------- --------- ------------- --------------- -------
At 1 Jan 2022 387 35,126 2,045 1,710 39,268 19 39,287
---------------------------- -------- -------- --------- --------- ------------- --------------- -------
Profit for the period - - - 2,387 2,387 4 2,391
Other comprehensive
loss - - - (1,686) (1,686) (3) (1,689)
Transfer to other
reserves - - 36 (36) - - -
Transactions with
owners:
Dividends - - - (4,486) (4,486) - (4,486)
Issue of Ordinary
Shares - 11 - - 11 - 11
Share-based payments
charge for the period - - - 471 471 - 471
Settlement of share
plan awards - - - (831) (831) - (831)
---------------------------- -------- -------- --------- --------- ------------- --------------- -------
Net movement - 11 36 (4,181) (4,134) 1 (4,133)
---------------------------- -------- -------- --------- --------- ------------- --------------- -------
(2,471
At 30 Sep 2022 387 35,137 2,081 ) 35,134 20 35,154
---------------------------- -------- -------- --------- --------- ------------- --------------- -------
Table 22 : Condensed consolidated statement of cash flows
For the nine months ended 30 September 2022 2021
$m $m
Cash flows from operating activities
Profit before tax 1,723 371
Finance income and expense 936 922
Share of after tax losses of associates and
joint ventures 4 55
Depreciation, amortisation and impairment 4,000 4,338
Decrease in working capital and short-term provisions 3,458 2,063
Gains on disposal of intangible assets (88) (371)
Gains on disposal of investments in associates
and joint ventures - (776)
Fair value movements on contingent consideration
arising from business combinations 293 33
Non-cash and other movements (973) (370)
------------------------------------------------------- ------- --------
Cash generated from operations 9,353 6,265
------------------------------------------------------- ------- --------
Interest paid (608) (522)
Tax paid (1,335) (1,198)
------------------------------------------------------- ------- --------
Net cash inflow from operating activities 7,410 4,545
------------------------------------------------------- ------- --------
Cash flows from investing activities
Acquisition of subsidiaries, net of cash acquired - (9,263)
Payments upon vesting of employee share awards
attributable to business combinations (297) (203)
Payment of contingent consideration from business
combinations (570) (470)
Purchase of property, plant and equipment (719) (768)
Disposal of property, plant and equipment 17 10
Purchase of intangible assets (1,298) (714)
Disposal of intangible assets and assets held
for sale 442 584
Purchase of non-current asset investments (28) (190)
Disposal of non-current asset investments 42 -
Movement in short-term investments, fixed deposits
and other investing instruments (321) 120
Payments to associates and joint ventures (5) (55)
Disposal of investments in associates and joint
ventures - 776
Interest received 26 28
------------------------------------------------------- ------- --------
Net cash outflow from investing activities (2,711) (10,145)
------------------------------------------------------- ------- --------
Net cash inflow/(outflow) before financing
activities 4,699 (5,600)
------------------------------------------------------- ------- --------
Cash flows from financing activities
Proceeds from issue of share capital 11 10
Repayment of loans and borrowings (1,261) (2,934)
Issue of loans - 11,942
Dividends paid (4,364) (3,856)
Hedge contracts relating to dividend payments (127) (28)
Repayment of obligations under leases (182) (173)
Movement in short-term borrowings 378 (261)
Payment of Acerta Pharma share purchase liability (920) -
------------------------------------------------------- ------- --------
Net cash (outflow)/inflow from financing activities (6,465) 4,700
-------------------------------------------------------
Net decrease in cash and cash equivalents in
the period (1,766) (900)
Cash and cash equivalents at the beginning of
the period 6,038 7,546
Exchange rate effects (86) (73)
------------------------------------------------------- ------- --------
Cash and cash equivalents at the end of the
period 4,186 6,573
------------------------------------------------------- ------- --------
Cash and cash equivalents consist of:
Cash and cash equivalents 4,458 7,067
Overdrafts (272) (494)
------------------------------------------------------- ------- --------
4,186 6,573
------- --------
Notes to the Interim financial statements
Note 1: Basis of preparation and accounting policies
These unaudited condensed consolidated Interim financial
statements for the nine months ended 30 September 2022 have been
prepared in accordance with International Accounting Standard 34,
'Interim Financial Reporting' (IAS 34), as issued by the
International Accounting Standards Board (IASB), IAS 34 as adopted
by the European Union, UK-adopted IAS 34 and the Disclosure
Guidance and Transparency Rules sourcebook of the United Kingdom's
Financial Conduct Authority and with the requirements of the
Companies Act 2006 as applicable to companies reporting under those
standards.
The unaudited Interim financial statements for the nine months
ended 30 September 2022 include Alexion's results for the period.
Alexion's post-acquisition results were consolidated into the
Group's results from 21 July 2021 therefore the respective
comparative periods shown are not entirely comparable with the
current period.
The unaudited Interim financial statements for the nine months
ended 30 September 2022 were approved by the Board of Directors for
publication on 10 November 2022.
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 2021 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 2021.
The comparative figures for the financial year ended 31 December
2021 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.
Global and/or geopolitical events
There were no material accounting impacts identified relating to
COVID-19 during the nine months ended 30 September 2022.
The Group's current focus is to continue compliant business
operations in Russia and Ukraine, focussing on safeguarding our
employees, ensuring continuity of supply of essential and
life-saving medicines and contributing to humanitarian relief
efforts. There are no material accounting impacts arising from the
conflict impacting our YTD 2022 reporting. The situation is dynamic
and any future impact on our business is uncertain.
The Group will continue to monitor these areas of increased
judgement, estimation and risk for material changes.
Going concern
The Group has considerable financial resources available. As at
30 September 2022, the Group had $9.3bn in financial resources
(Cash and cash-equivalent balances of $4.5bn and undrawn committed
bank facilities of $4.9bn available, with only $5.6bn of borrowings
due within one year). These facilities contain no financial
covenants, were undrawn at 30 September 2022 and are now available
until April 2026.
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 affect adversely 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, the going concern basis has been adopted in these
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 2021 .
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 net impairment charges of $44m have been recorded against
intangible assets during the nine months ended 30 September 2022
(YTD 2021: $1,492m net charge). Net impairment charges in respect
of medicines in development and launched medicines were $61m (YTD
2021: $1,371m) and $nil (YTD 2021: $121m charge) respectively.
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
2021 . Net Debt is a non-GAAP financial measure.
Table 23 : Net Debt
At 1 Jan 2022 Cash flow Non-cash Exchange movements At 30 Sep 2022
& other
$m $m $m $m $m
------------- --------- -------- ------------------ --------------
Non-current instalments of loans (28,134) - 4,662 459 (23,013)
Non-current instalments of leases (754) - 28 58 (668)
-------------------------------------------------- -------- -------- -------- ----- ---------
Total long-term debt (28,888) - 4,690 517 (23,681 )
Current instalments of loans (1,273) 1,261 (4,653) - (4,665)
Current instalments of leases (233) 186 (181) 18 (210)
Commercial paper - (249) - - (249)
Bank collateral received (93) (66) - - (159)
Other short-term borrowings excluding overdrafts (3) (63) - 3 (63)
Overdrafts (291) (8) - 27 (272)
-------------------------------------------------- --------
Total current debt (1,893) 1,061 (4,834 ) 48 (5,618 )
-------------------------------------------------- -------- -------- -------- ----- ---------
Gross borrowings (30,781) 1,061 (144 ) 565 (29,299 )
Net derivative financial instruments 61 73 (275) - (141)
-------------------------------------------------- -------- -------- -------- ----- ---------
Net borrowings (30,720) 1,134 (419 ) 565 (29,440 )
Cash and cash equivalents 6,329 (1,758) - (113) 4,458
Other investments - current 69 375 - (4) 440
-------------------------------------------------- --------
Cash and investments 6,398 (1,383 ) - (117) 4,898
-------------------------------------------------- -------- -------- -------- ----- ---------
Net Debt (24,322) (249 ) (419 ) 448 (24,542 )
-------------------------------------------------- -------- -------- -------- ----- ---------
Non-cash movements in the period include fair value adjustments
under IFRS 9.
The Group has agreements with some bank counterparties whereby
the parties agree to post cash collateral on financial derivatives,
for the benefit of the other, equivalent to the market valuation of
the derivative positions above a predetermined threshold. The
carrying value of such cash collateral held by the Group at 30
September 2022 was $159m (31 December 2021: $93m) and the carrying
value of such cash collateral posted by the Group at 30 September
2022 was $376m (31 December 2021: $47m). Cash collateral posted by
the Group is presented within Other investments - current as at 30
September 2022.
Restricted cash and cash equivalents as at 30 September 2022
totalled $94m (31 December 2021: $47m).
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
$1,618m (31 December 2021: $2,458m), $852m of which is shown in
current other payables and $766m is shown in non-current other
payables.
Net Debt increased by $220m in the year to date to $24,542m.
Details of the committed undrawn bank facilities are disclosed
within the going concern section of Note 1.
During the nine months ended 30 September 2022, there were no
changes to the Company's solicited credit ratings issued by
Standard and Poor's (long term: A-; short term: A-2) 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 held at $175m at 30
September 2022 (31 December 2021: $104m) that are categorised as
Level 3 in the fair value hierarchy and for which fair value gains
of $50m (FY 2021: $nil) have been recognised in the nine months
ended 30 September 2022. 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 nine months
ended 30 September 2022 are Level 1 fair value measurements, valued
based on quoted prices in active markets.
Financial instruments measured at fair value include $1,489m of
other investments, $2,816m held in money-market funds, $295m of
loans designated at fair value through profit or loss and ($141m)
of derivatives as at 30 September 2022. With the exception of
derivatives being Level 2 fair valued, the aforementioned balances
are Level 1 fair valued. The total fair value of interest-bearing
loans and borrowings at 30 September 2022, which have a carrying
value of $29,299m in the Condensed consolidated statement of
financial position, was $27,664m.
Table 24 : Financial instruments - contingent consideration
2022 2021 [85]
Diabetes alliance Other Total Total
$m $m $m $m
---------------- ----------------- ----- ----- -----
At 1 January 2,544 321 2,865 3,323
----------------- ----------------- ----- ----- -----
Settlements (561) (9) (570) (470)
Disposals - (121) (121) -
Revaluations 320 (27) 293 60
Discount unwind 121 5 126 169
----------------- ----------------- ----- ----- -----
At 30 September 2,424 169 2,593 3,082
----------------- ----------------- ----- ----- -----
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 $2,424m (31 December 2021: $2,544m)
would increase/decrease by $242m with an increase/decline in sales
of 10%, as compared with the current estimates.
Note 5: Pensions and other post-retirement benefit
obligations
The net pensions and other post-retirement benefit obligations
position, as recorded under IAS 19, at 30 September 2022 was a
liability of $821m (31 December 2021: $2,454m liability). Pension
schemes in a net surplus position at 30 September 2022 totalled
$98m (31 December 2021: $nil) and are recorded within Other
receivables in non-current assets. Pension schemes in a net deficit
position at 30 September 2022 totalled $919m (31 December 2021:
$2,454m) and are recorded within Retirement benefit obligations in
non-current liabilities.
The decrease in the net liability of $1,633m is driven by
actuarial gains of $1,283m that have been reflected within the
Condensed consolidated statement of comprehensive income.
Changes in actuarial assumptions, primarily movements in
discount rates, led to a decrease in the net liability in the year
to date of $3,541m (a decrease in UK, Sweden, US and RoW
liabilities of $2,271m, $776m, $301m and $193m respectively), which
reflected increases in corporate bond yields. These movements were
partially offset by decreases in the pension fund asset values in
the year to date of $2,258m (a decrease in UK, Sweden and US assets
of $1,802m, $172m and $294m respectively and an increase in RoW of
$10m).
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 2021 and the Interim Financial Statements for
the six months ended 30 June 2022 (the Disclosures). Unless noted
otherwise below or in the Disclosures, no provisions have been
established in respect of the claims discussed below.
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 that a provision has been
taken, AstraZeneca considers each of the claims to represent a
contingent liability and discloses information with respect to the
nature and facts of the cases in accordance with IAS 37.
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 third quarter of 2022 and to
10 November 2022
Patent litigation
Enhertu
US patent proceedings
As previously disclosed, in October 2020, Seagen Inc. (Seagen)
filed a complaint against Daiichi Sankyo Company, Limited in the US
District Court for the Eastern District of Texas (the District
Court) alleging that Enhertu infringes a Seagen patent. AstraZeneca
co-commercialises Enhertu with Daiichi Sankyo, Inc. in the US.
After trial in April 2022, the jury found that the patent was
infringed and awarded Seagen $41.82m in past damages. In July 2022,
the District Court entered final judgment and declined to enhance
damages on the basis of wilfulness. The parties await consideration
of post-trial motions.
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. have requested reconsideration
of the decision not to institute review of the patent.
Farxiga
US patent proceedings
As previously disclosed, i n 2018, in response to Paragraph IV
notices, AstraZeneca initiated ANDA litigation against Zydus
Pharmaceuticals (USA) Inc. (Zydus) in the US District Court for the
District of Delaware (the District Court). In May 2021, the trial
against Zydus proceeded and in October 2021, the District Court
issued a decision finding the asserted claims of AstraZeneca's
patent as valid and infringed by Zydus's ANDA product. In August
2022, Zydus appealed the District Court's decision.
Patent proceedings outside the US
As previously disclosed, in Canada, since January 2021,
AstraZeneca has been defending against invalidity and/or
non-infringement allegations advanced by Teva and Sandoz against
all three Forxiga-related patents listed on the Canadian Patent
Register. The parties have resolved these matters and these
proceedings are now concluded.
Faslodex
Patent Proceedings outside the US
As previously disclosed, in Japan, Sandoz K.K. and Sun Pharma
Japan Ltd (Sun) sought to invalidate the Faslodex formulation
patent at the Japan Patent Office (JPO) and AstraZeneca is
defending the challenged patent. Sun has withdrawn from the JPO
patent challenge. In May 2022, the JPO held the hearing in the
matter and issued its preliminary decision in September 2022
upholding various claims of the challenged patent and determining
that other patent claims were invalid. A final JPO decision is
forthcoming.
Lokelma
US patent proceedings
In August 2022, in response to Paragraph IV notices, AstraZeneca
initiated ANDA litigation against multiple generic filers in the US
District Court for the District of Delaware. No trial date has been
scheduled.
Symbicort
US patent proceedings
As previously disclosed, AstraZeneca is involved in ongoing ANDA
patent litigation with Mylan Pharmaceuticals Inc. (Mylan) and
Kindeva Drug Delivery L.P. (Kindeva) brought in the US District
Court for the Northern District of West Virginia (the District
Court). A trial in the matter was held in May 2022 and closing
arguments were held in June 2022. A decision is awaited.
As previously disclosed, in April 2022, AstraZeneca filed a
separate ANDA action against Mylan and Kindeva in the District
Court asserting infringement of a patent covering Symbicort. In
June 2022, Mylan and Kindeva responded and claimed noninfringement
of the asserted patent and that the asserted patent is invalid. A
trial in the matter is scheduled for December 2022.
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.
In the previously disclosed California State Court coordinated
proceeding, AstraZeneca's motion for summary judgment was granted
in March 2022. The District Court granted AstraZeneca's motion for
summary judgment in August 2022. Plaintiffs are in the process of
appealing both decisions.
Nexium and Losec/Prilosec
US proceedings
As previously disclosed, in the US, AstraZeneca is defending
various 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 particular,
in May 2017, counsel for a group of such plaintiffs claiming that
they have been diagnosed with kidney injuries filed a motion with
the Judicial Panel on Multidistrict Litigation (JPML) seeking the
transfer of any currently pending federal court cases as well as
any similar, subsequently filed cases to a coordinated and
consolidated pre-trial multidistrict litigation (MDL) proceeding.
In August 2017, the JPML granted the motion and consolidated the
pending federal court cases in an MDL proceeding in federal court
in New Jersey for pre-trial purposes. A trial in the MDL previously
scheduled for November 2022 has been rescheduled to March 2023. 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 lawsuits involving
allegations of gastric cancer following treatment with PPIs. One
such claim is filed in the US District Court for the Middle
District of Louisiana and was scheduled to go to trial in January
2023. That case has been postponed and a new trial date has not yet
been set.
Commercial litigation
AZD1222 Securities Litigation
US proceedings
As previously disclosed, in January 2021, putative securities
class action lawsuits were filed in the US District Court for the
Southern District of New York 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 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 court
granted AstraZeneca's motion to dismiss the Amended Complaint with
prejudice, disallowing any further amendments. Plaintiffs have
appealed this decision.
US 340B Litigations and Proceedings
US proceedings
As previously disclosed, in September 2021, AstraZeneca was
served with a class-action antitrust complaint filed in federal
court in New York by Mosaic Health alleging a conspiracy to
restrict access to 340B discounts in the diabetes market through
contract pharmacies. In September 2022, the court granted
Defendants' motion to dismiss the Complaint. Plaintiffs are now
seeking leave to amend their complaint.
Table 25 : YTD 2022 - Product Sales year-on-year analysis
[86]
World Emerging Markets US Europe Established RoW
$m Act % chg CER % chg $m Act % chg CER % chg $m % chg $m Act % chg CER % chg $m Act % chg CER % chg
-------------------- ------ --------- --------- ----- --------- --------- ------ ----- ----- --------- --------- ----- --------- ---------
Oncology 10,885 14 20 2,723 12 15 4,695 24 2,037 12 24 1,430 (2) 11
Tagrisso 4,102 11 16 1,211 20 22 1,472 14 777 7 19 642 (4) 10
Imfinzi 2,031 14 19 224 6 9 1,102 20 402 16 29 303 - 14
Lynparza 1,949 13 19 358 27 30 896 13 493 8 20 202 8 22
Calquence 1,469 74 77 28 n/m n/m 1,192 58 200 n/m n/m 49 n/m n/m
Enhertu 52 n/m n/m 34 n/m n/m - - 14 n/m n/m 4 n/m n/m
Orpathys 34 n/m n/m 34 n/m n/m - - - - - - - -
Zoladex 717 - 6 507 9 13 11 2 100 (11) (2) 99 (23) (12)
Faslodex 259 (21) (14) 121 (1) 5 15 (37) 44 (53) (48) 79 (12) 2
Iressa 90 (39) (37) 75 (39) (37) 6 (33) 2 (53) (48) 7 (41) (33)
Arimidex 85 (20) (16) 66 (19) (16) - 25 1 (79) (85) 18 (19) (7)
Casodex 63 (48) (45) 44 (53) (52) - (99) - (87) (85) 19 (28) (18)
Others 34 (9) (1) 21 (2) 4 1 n/m 4 (3) 8 8 (34) (25)
-------------------- ------ --------- --------- ----- --------- --------- ------ ----- ----- --------- --------- ----- --------- ---------
BioPharmaceuticals:
CVRM* 6,907 13 18 3,181 9 14 1,783 9 1,413 25 39 530 18 32
Farxiga 3,204 49 58 1,224 40 46 748 48 955 64 82 277 49 65
Brilinta 1,013 (10) (7) 222 (13) (11) 538 (4) 215 (18) (9) 38 (20) (16)
Lokelma 208 71 80 15 n/m n/m 122 50 21 n/m n/m 50 74 n/m
Roxadustat 148 2 4 148 2 4 - - - - - - - -
Andexxa* 111 7 14 - - - 62 (25) 29 43 55 20 n/m n/m
Crestor 824 (2) 4 630 6 10 50 (15) 30 (31) (24) 114 (17) (7)
Seloken/Toprol-XL 705 (6) (2) 689 (6) (2) - n/m 9 6 8 7 (13) (6)
Bydureon 207 (29) (28) 2 - 2 177 (27) 28 (34) (27) - (97) (94)
Onglyza 205 (28) (25) 98 (35) (31) 60 (3) 30 (37) (30) 17 (31) (29)
Others 282 (9) (7) 153 1 4 26 (32) 96 (13) (11) 7 (37) (30)
-------------------- ------ --------- --------- ----- --------- --------- ------ ----- ----- --------- --------- ----- --------- ---------
BioPharmaceuticals:
R&I 4,318 (3 ) - 1,102 (16 ) (14 ) 1,963 12 795 (13 ) (3) 458 (3 ) 5
Symbicort 1,919 (6) (2) 476 4 8 718 (11) 445 (11) (1) 280 (3) 3
Fasenra 1,015 13 17 30 99 95 649 17 229 9 21 107 (10) -
Breztri 282 n/m n/m 71 76 78 164 n/m 22 n/m n/m 25 43 66
Saphnelo 69 n/m n/m - - - 66 n/m 1 n/m n/m 2 n/m n/m
Pulmicort 479 (33) (31) 339 (41) (41) 53 1 50 1 12 37 8 16
Daliresp 161 (5) (4) 2 (16) (11) 151 (2) 7 (39) (33) 1 (20) (18)
Bevespi 43 11 13 4 32 35 31 10 7 5 16 1 17 37
Others 350 (21) (20) 180 (14) (13) 131 40 34 (74) (71) 5 (52) (47)
-------------------- ------ --------- --------- ----- --------- --------- ------ ----- ----- --------- --------- ----- --------- ---------
BioPharmaceuticals:
V&I 3,607 51 59 995 (7) (6) 942 n/m 693 (20 ) (12 ) 977 n/m n/m
Vaxzevria 1,713 (20) (16) 684 (35) (36) 79 n/m 325 (56) (51) 625 82 96
Evusheld 1,451 n/m n/m 167 n/m n/m 850 n/m 199 n/m n/m 235 n/m n/m
Synagis 384 n/m n/m 144 n/m n/m 2 (91) 123 51 63 115 n/m n/m
FluMist 59 (22) (13) - (74) (74) 11 (52) 46 (10) 3 2 n/m n/m
-------------------- ------ --------- --------- ----- --------- --------- ------ ----- ----- --------- --------- ----- --------- ---------
Rare Disease* 5,236 4 10 315 (10 ) 8 3,175 7 1,079 (2) 10 667 11 26
Soliris* 2,918 (7) (2) 218 (29) (9) 1,688 (3) 627 (20) (10) 385 20 34
Ultomiris* 1,371 27 35 34 n/m n/m 771 23 347 55 74 219 - 18
Strensiq* 687 13 15 25 35 25 546 16 59 (4) 8 57 - 16
Koselugo 149 n/m n/m 22 n/m n/m 114 57 13 n/m n/m - - -
Kanuma* 111 6 11 16 9 7 56 10 33 (1) 12 6 11 20
-------------------- ------ --------- --------- ----- --------- --------- ------ ----- ----- --------- --------- ----- --------- ---------
Other medicines 1,247 (4 ) 4 608 (18 ) (14 ) 112 (17 ) 95 (29 ) (25 ) 432 50 72
Nexium 986 (1) 8 437 (24) (19) 94 (4) 37 (22) (13) 418 51 73
Others 261 (12) (10) 171 5 7 18 (52) 58 (33) (31) 14 39 48
-------------------- ------ --------- --------- ----- --------- --------- ------ ----- ----- --------- --------- ----- --------- ---------
Total Product Sales 32,200 29 35 8,924 5 8 12,670 56 6,112 19 32 4,494 39 56
-------------------- ------ --------- --------- ----- --------- --------- ------ ----- ----- --------- --------- ----- --------- ---------
Table 26 : Q3 2022 - Product Sales year-on-year analysis
[87]
World Emerging Markets US Europe Established RoW
$m Act % chg CER % chg $m Act % chg CER % chg $m % chg $m Act % chg CER % chg $m Act % chg CER % chg
-------------------- ------ --------- --------- ----- --------- --------- ----- ----- ----- --------- --------- ----- --------- ---------
Oncology 3,797 15 22 931 15 21 1,716 27 696 9 25 454 (9 ) 9
Tagrisso 1,398 12 20 406 29 35 521 18 268 4 19 203 (12) 5
Imfinzi 737 19 26 90 15 19 413 30 135 12 29 99 (1) 18
Lynparza 659 12 19 117 22 26 314 16 164 6 22 64 (5) 12
Calquence 566 60 63 12 n/m n/m 457 48 79 n/m n/m 18 n/m n/m
Enhertu 23 n/m n/m 15 n/m n/m - - 6 n/m n/m 2 n/m n/m
Orpathys 11 11 16 11 11 16 - - - - - - - -
Zoladex 240 (4) 5 176 4 11 4 43 31 (17) (5) 29 (28) (13)
Faslodex 81 (21) (10) 40 (4) 5 5 (39) 12 (49) (41) 24 (19) -
Iressa 27 (35) (31) 22 (33) (29) 2 (47) 1 (49) (56) 2 (30) (19)
Arimidex 24 (28) (23) 18 (25) (21) - n/m - (93) n/m 6 (29) (17)
Casodex 21 (46) (40) 17 (40) (37) - n/m (1) n/m n/m 5 (46) (33)
Others 10 (18) (10) 7 (13) (6) - - 1 (20) (8) 2 (38) (25)
-------------------- ------ --------- --------- ----- --------- --------- ----- ----- ----- --------- --------- ----- --------- ---------
BioPharmaceuticals:
CVRM* 2,348 11 19 1,081 9 16 632 9 469 20 37 166 11 30
Farxiga 1,101 38 50 410 28 38 279 38 329 55 78 83 35 57
Brilinta 338 (10) (7) 76 (1) - 187 (6) 65 (23) (12) 10 (36) (34)
Lokelma 79 59 69 9 n/m n/m 45 37 8 n/m n/m 17 31 59
Roxadustat 57 4 9 57 4 8 - - - - - - - -
Andexxa* 41 5 17 - - - 20 (29) 11 2 17 10 n/m n/m
Crestor 277 (7) - 216 (4) 2 15 (16) 9 (17) (4) 37 (16) -
Seloken/Toprol-XL 238 2 10 233 2 10 - n/m 3 9 22 2 (18) (18)
Bydureon 66 (30) (29) - (4) (1) 58 (28) 8 (40) (31) - n/m n/m
Onglyza 66 (21) (17) 32 (24) (19) 20 12 9 (45) (37) 5 (34) (32)
Others 85 (11) (8) 48 9 15 8 (24) 27 (27) (25) 2 (52) (45)
-------------------- ------ --------- --------- ----- --------- --------- ----- ----- ----- --------- --------- ----- --------- ---------
BioPharmaceuticals:
R&I 1,427 (4 ) 1 371 (12 ) (8 ) 663 9 244 (17 ) (5 ) 149 (6 ) 4
Symbicort 630 (7) (1) 169 13 18 237 (13) 133 (14) (2) 91 (6) 2
Fasenra 353 10 15 12 87 78 229 15 77 2 16 35 (15) (2)
Breztri 103 n/m n/m 28 n/m n/m 58 n/m 8 n/m n/m 9 38 68
Saphnelo 33 n/m n/m - - - 32 n/m - - - 1 n/m n/m
Pulmicort 145 (33) (31) 103 (40) (40) 16 (6) 14 (4) 9 12 - 10
Daliresp 52 (4) (3) 1 74 87 49 (1) 2 (43) (35) - (55) (54)
Bevespi 14 6 8 2 12 22 10 11 2 (22) (11) - 95 25
Others 97 (36) (33) 56 (25) (21) 32 (5) 8 (81) (77) 1 (55) (44)
-------------------- ------ --------- --------- ----- --------- --------- ----- ----- ----- --------- --------- ----- --------- ---------
BioPharmaceuticals:
V&I 873 (27) (21) 134 (78 ) (78 ) 305 670 182 (28 ) (16 ) 252 (12) 2
Vaxzevria 173 (83) (81) 24 (96) (97) - - 62 (62) (56) 87 (63) (59)
Evusheld 537 n/m n/m 73 n/m n/m 294 n/m 57 n/m n/m 113 n/m n/m
Synagis 104 (15) (1) 37 n/m n/m - n/m 17 (55) (48) 50 (4) 17
FluMist 59 (19) (10) - n/m n/m 11 (53) 46 (7) 6 2 n/m n/m
-------------------- ------ --------- --------- ----- --------- --------- ----- ----- ----- --------- --------- ----- --------- ---------
Rare Disease* 1,741 4 11 110 36 61 1,084 7 345 (10) 6 202 (1) 18
Soliris* 901 (13) (6) 84 32 69 523 (13) 190 (27) (15) 104 (5) 10
Ultomiris* 518 37 47 4 (40) (37) 315 49 122 40 63 77 7 32
Strensiq* 237 17 20 8 73 53 192 22 18 (10) 4 19 (8) 12
Koselugo 48 82 81 7 n/m n/m 36 42 5 n/m n/m - - -
Kanuma* 37 1 5 7 15 (1) 18 7 10 (15) - 2 2 21
-------------------- ------ --------- --------- ----- --------- --------- ----- ----- ----- --------- --------- ----- --------- ---------
Other medicines 404 17 30 213 5 12 37 (9 ) 28 (21 ) (15 ) 126 93 n/m
Nexium 311 20 36 148 (5) 3 31 (3) 10 (7) 8 122 n/m n/m
Others 93 9 13 65 37 44 6 (28) 18 (27) (25) 4 (22) (19)
-------------------- ------ --------- --------- ----- --------- --------- ----- ----- ----- --------- --------- ----- --------- ---------
Total Product Sales 10,590 9 16 2,840 (9 ) (3) 4,437 30 1,964 3 18 1,349 2 20
-------------------- ------ --------- --------- ----- --------- --------- ----- ----- ----- --------- --------- ----- --------- ---------
Table 27 : Collaboration Revenue
YTD 2022 YTD 2021
$m $m
--------------------------------- -------- ----------
Enhertu : alliance revenue 332 134
Tezspire: alliance revenue 42 -
Lynparza : regulatory milestones 250 -
Tralokinumab: sales milestones 110 -
Vaxzevria: royalties 67 83
Other royalty income 54 54
Other Collaboration Revenue 89 92
---------------------------------- -------- ----------
Total 944 363
---------------------------------- -------- ----------
Table 28 : Other Operating Income and Expense
YTD 2022 YTD 2021
$m $m
------------------------------------------- -------- --------
Brazikumab licence termination funding 104 77
Divestment of rights to Plendil 61 -
Divestment of Viela Bio, Inc. shareholding - 776
Crestor (Europe ex-UK and Spain) - 309
Other 160 183
-------------------------------------------- -------- --------
Total 325 1,345
-------------------------------------------- -------- --------
Other shareholder information
Financial calendar
Announcement of full year and fourth quarter results 9 February 2023
Announcement of first quarter 2023 results 27 April 2023
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
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
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Cambridge Biomedical Spencer Road SE-101 23 Stockholm Brooklyn
Campus Lancing NY 11219
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United Kingdom United Kingdom Sweden United States
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+44 (0) 121 415
7033 +1 (718) 921 8137
db@astfinancial.com
Trademarks
Trademarks of the AstraZeneca group of companies appear
throughout this document in italics. Medical publications also
appear throughout the document in italics. AstraZeneca, the
AstraZeneca logotype and the AstraZeneca symbol are all trademarks
of the AstraZeneca group of companies. Trademarks of companies
other than AstraZeneca that appear in this document include
Arimidex and Casodex, owned by AstraZeneca or Juvisé (depending on
geography); Beyfortus, a trademark of Sanofi Pasteur Inc.; Enhertu,
a trademark of Daiichi Sankyo; Losec, owned by AstraZeneca or
Cheplapharm (depending upon geography); Seloken, owned by
AstraZeneca or Taiyo Pharma Co., Ltd (depending on geography);
Synagis, owned by AstraZeneca or Sobi aka Swedish Orphan Biovitrum
AB (publ). (depending on geography); and Tezspire, a trademark of
Amgen, Inc .
Information on or accessible through AstraZeneca's websites,
including astrazeneca.com , does not form part of and is not
incorporated into this announcement.
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led
biopharmaceutical company that focuses on the discovery,
development, and commercialisation of prescription medicines in
Oncology, Rare Disease, and BioPharmaceuticals, including
Cardiovascular, 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 2022 vs 2021. 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] 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.
[3] Earnings per share.
[4] Core financial measures are adjusted to exclude certain
items. The differences between Reported and Core measures are
primarily due to items related to the acquisition of Alexion,
amortisation of intangibles, impairments, restructuring charges,
and, as previously disclosed, a charge to provisions relating to a
legal settlement with Chugai Pharmaceutical Co. Ltd (Chugai) that
led to a payment of $775m in Q2 2022. A full reconciliation between
Reported EPS and Core EPS is provided in Tables 12 and 13 in the
Financial performance section of this document.
[5] In FY 2022, Total Revenue from Koselugo is included in Rare
Disease (FY 2021: Oncology) and Total Revenue from Andexxa is
included in BioPharmaceuticals: CVRM (FY 2021: Rare Disease). The
growth rate shown for each disease area has been calculated as
though these changes had been implemented in FY 2021.
[6] AstraZeneca is collaborating with MSD (Merck & Co., Inc.
in the US and Canada) to develop and commercialise Lynparza.
[7] Respiratory & Immunology.
[8] Cardiovascular, Renal and Metabolism.
[9] YTD 2022 growth rates on medicines acquired with Alexion
have been calculated on a pro forma basis comparing to the
corresponding period in the prior year; Q3 2022 growth rates have
been calculated comparing to the corresponding 92--day period in
the prior year, which covers both pre-acquisition and
post-acquisition performance. The growth rates shown for the Rare
Disease and CVRM disease areas include these pro forma
adjustments.
[10] The anticipated impact of foreign exchange movements on FY
2022 results assumes that exchange rates through November to
December 2022 remain at the spot rates seen on 31 October 2022.
[11] Paroxysmal nocturnal haemoglobinuria with extravascular haemolysis.
[12] Human epidermal growth factor receptor 2.
[13] Non-small cell lung cancer.
[14] Respiratory syncytial virus.
[15] Generalised myasthenia gravis.
[16] Volume-based procurement.
[17] Vaccines & Immune Therapies.
[18] 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 Collaboration
Revenue from sub-licensees that produce and supply the AstraZeneca
COVID--19 Vaccine under their own trademarks.
[19] National reimbursement drug list.
[20] In Table 2, the plus and minus symbols denote the
directional impact of the item being discussed, e.g. a '+' symbol
next to a R&D Expense comment indicates that the item increased
the R&D Expense relative to the prior year.
[21] Gross Profit is defined as Total Revenue minus Cost of
Sales. The calculation of Reported and Core Gross Margin excludes
the impact of Collaboration Revenue and any associated costs,
thereby reflecting the underlying performance of Product Sales.
[22] Where AstraZeneca does not retain a significant ongoing
interest in medicines or potential new medicines, income from
divestments is reported within Reported and Core Other Operating
Income and Expense in the Company's financial statements.
[23] Germline (hereditary) breast cancer gene.
[24] Homologous recombination deficiency.
[25] Human epidermal growth factor receptor mutant.
[26] Chronic kidney disease.
[27] Atypical haemolytic uraemic syndrome.
[28] Neurofibromatosis type 1 plexiform neurofibromas.
[29] Heart failure with preserved ejection fraction.
[30] Neuromyelitis optica spectrum disorder.
[31] Head and neck squamous cell carcinoma.
[32] Eosinophilic esophagitis.
[33] Alliance revenue (previously referred to as share of gross
profits) comprises income arising from collaborative arrangements,
where AstraZeneca is entitled to a profit share, but does not
include product sales where AstraZeneca is leading
commercialisation in a territory. Alliance revenue is included
within Collaboration Revenue.
[34] Epidermal growth factor receptor.
[35] Extensive-stage small cell lung cancer.
[36] Chemoradiation therapy.
[37] Poly ADP ribose polymerase.
[38] Germline (hereditary) breast cancer gene mutation.
[39] Breast cancer gene mutation.
[40] US Food and Drug Administration.
[41] Metastatic castration resistant prostate cancer.
[42] European Medicines Agency.
[43] Chronic lymphocytic leukaemia.
[44] Mesenchymal-epithelial transition.
[45] Tyrosine kinase inhibitor.
[46] Sodium-glucose cotransporter 2.
[47] Heart failure.
[48] European Society of Cardiology.
[49] American Heart Association.
[50] American College of Cardiology.
[51] Heart Failure Society of America.
[52] Urine albumin creatine ratio.
[53] Measured renal function.
[54] Heart failure with reserved ejection fraction.
[55] Type-2 diabetes.
[56] Betaloc is the brand name for Seloken in China.
[57] Inhaled corticosteroid.
[58] Long-acting beta-agonist.
[59] Chronic obstructive pulmonary disease.
[60] Intravenous injection.
[61] Systemic lupus erythematosus.
[62] Other Operating Income.
[63] Other SG&A Expense of $1,197m predominantly includes
the $775m charge to provisions relating to the legal settlement
with Chugai and $293m of fair value movements on contingent
consideration arising from business combinations.
[64] Other Taxation of ($1,078m) includes an estimated one-off
favourable net adjustment of ($883m) to deferred taxes arising from
an internal reorganisation to integrate the Alexion
organisation.
[65] Securities Exchange Commission.
[66] Based on best prevailing assumptions around currency
profiles.
[67] Based on average daily spot rates in FY 2021.
[68] Based on average daily spot rates 1 Jan 2022 to 30 Sep
2022.
[69] Change vs the average spot rate for the previous year
[70] Other currencies include AUD, BRL, CAD, KRW and RUB.
[71] Programmed death ligand 1.
[72] Tumour Proportion Score.
[73] Overall response rate.
[74] Confidence interval.
[75] An ImmunoHistoChemistry score of greater than 90.
[76] A Fluorescence In Situ Hybridization score of greater than
10.
[77] Overall survival.
[78] Progression free survival.
[79] Small lymphocytic lymphoma.
[80] Mantle cell lymphoma.
[81] Disease Control Rate.
[82] Serine/threonine protein kinase.
[83] Cycline-dependent kinase 4/6.
[84] Intravenous immunoglobulin.
[85] As at 30 September 2021, Alexion's contingent liabilities
of $300m had been recognised in Contingent consideration. After the
acquisition date IFRSs permit the acquirer to retrospectively
adjust the provisional amounts recognised for a business
combination during the measurement period to reflect new
information obtained about facts and circumstances that existed as
of the acquisition date and, if known, would have affected the
measurement of the amounts recognised as of that date. During the
measurement period these liabilities were reclassed and reported
within Other payables as at 31 December 2021. The comparative 2021
column therefore excludes these liabilities.
[86] 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. *YTD 2022 growth rates on
medicines acquired with Alexion have been calculated on a pro forma
basis comparing to the corresponding period in the prior year. The
growth rates shown for Rare Disease and CVRM disease area totals
include these pro forma adjustments.
[87] 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. *Q3 2022 growth rates have
been calculated comparing to the corresponding 92-day period in the
prior year, which covers both pre-acquisition and post-acquisition
performance. The growth rates shown for Rare Disease and CVRM
disease area totals include these pro forma adjustments.
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END
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(END) Dow Jones Newswires
November 10, 2022 02:00 ET (07:00 GMT)
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