TIDMAZN
RNS Number : 6102X
AstraZeneca PLC
27 April 2023
AstraZeneca
27 April 2023
Q1 2023 results
Strong start to the year with stable Total Revenue and 15%
growth excluding COVID-19 medicines [1]
Revenue and EPS summary
Q1 2023
------ --------- ---------
% Change
$m Actual CER [2]
-------------------------------- ------ --------- ---------
* Product Sales 10,566 (4) 1
* Alliance Revenue [3] 286 88 90
* Collaboration Revenue(3) 27 (89) (89)
--------------------------------- ------ --------- ---------
Total Revenue 10,879 (4) -
--------------------------------- ------ --------- ---------
Total Revenue ex
COVID-19 10,725 10 15
Reported [4] EPS [5] $1.16
* 4x * 4x
Core [6] EPS $1.92 1 6
--------------------------------- ------ --------- ---------
Financial performance (Q1 2023 figures unless otherwise stated ,
growth numbers at CER)
-- Total Revenue stable at $10,879m, despite a decline of $1,460m from COVID-19 medicines
-- Excluding COVID-19 medicines, Total Revenue increased 15% and Product Sales increased 16%
-- Total Revenue from Oncology medicines increased 19%, CVRM [7]
22%, R&I [8] 8%, and Rare Disease 14%
-- Core Gross margin of 83%, up four percentage points,
reflecting the decline in sales of lower margin COVID--19
medicines, the cost of production in prior periods, and a mix shift
to more speciality medicines
-- Core Operating margin of 36%, up one percentage point,
reflecting a $220m increase in Core Other operating income, which
included a gain from the divestment of Pulmicort Flexhaler rights
in the US
-- Core EPS increased 6% to $1.92
-- Reiterating guidance for FY 2023 Total Revenue and Core EPS
Pascal Soriot, Chief Executive Officer, AstraZeneca, said:
" AstraZeneca had a strong start to 2023, with Total Revenue
excluding COVID-19 medicines increasing 15%. Our performance in
Emerging Markets was particularly strong and I am impressed by the
growth and pace of innovation I see in China, which underscores the
competitive advantage of our leading presence in this country.
Our pipeline momentum continued with positive Phase III results
for a Lynparza-plus-Imfinzi combination in ovarian cancer, Imfinzi
in lung cancer, and promising new data for Enhertu across a range
of cancer types. Additionally, in the year to date we have started
six new Phase III trials and are on track to initiate 30 over the
course of 2023.
Finally, I would like to thank Leif Johansson for his
outstanding leadership during his time as Chair of the Board, and
his contribution to our return to growth strategy. Leif has been a
tremendous partner to me, and I look forward to building the same
strong partnership with our new Chair, Michel Demar é ."
Key milestones achieved since the prior results
-- Key read outs: positive results for Lynparza and Imfinzi in
ovarian cancer (DUO-O), Imfinzi in NSCLC [9] (AEGEAN) and Enhertu
in multiple tumour types (DESTINY-PanTumor02). Tagrisso showed a
statistically significant improvement in overall survival in NSCLC
(ADAURA)
-- Key regulatory approvals: EU approvals for Imfinzi and Imjudo
in HCC [10] (HIMALAYA) and NSCLC (POSEIDON), Calquence maleate
tablet formulation, and positive CHMP recommendation for Ultomiris
in NMOSD [11] . China approvals for Enhertu in HER2--positive [12]
breast cancer (DESTINY-Breast03) and Calquence in mantle cell
lymphoma
As announced on 11 April 2023, AstraZeneca's results for Q2 2023
will include a gain of $718m in Core Other operating income
resulting from an update to the contractual relationships for
nirsevimab [13]
Guidance
The Company reiterates guidance for FY 2023 at CER, based on the
average exchange rates through 2022.
Total Revenue is expected to increase by a low-to-mid
single-digit percentage
Excluding COVID-19 medicines, Total Revenue is expected to
increase by a low double-digit percentage
-- Core EPS is expected to increase by a high single-digit to low double-digit percentage
-- While challenging to forecast, Total Revenue from COVID-19
medicines (Vaxzevria [14] and COVID--19 mAbs [15] ) is expected to
decline significantly in FY 2023, with minimal revenue from
Vaxzevria
-- Total Revenue from China is expected to return to growth and
increase by a low single-digit percentage in FY 2023
-- Alliance Revenue and Collaboration Revenue are both expected
to increase [16] , driven by continued growth of our partnered
medicines and success-based milestones
-- Other operating income is expected to increase
-- Core Operating expenses are expected to increase by a
low-to-mid single-digit percentage, driven by investment in recent
launches and the ungating of new trials following pipeline
success
-- The Core Tax Rate is expected to be between 18-22%
The Company is unable to provide guidance on a Reported basis
because it cannot reliably forecast material elements of the
Reported results, including any fair value adjustments arising on
acquisition-related liabilities, intangible asset impairment
charges and legal settlement provisions. Please refer to the
cautionary statements section regarding forward-looking statements
at the end of this announcement.
Currency impact
If foreign exchange rates for April to December 2023 were to
remain at the average rates seen in the month of March 2023, it is
anticipated that FY 2023 Total Revenue and FY 2023 Core EPS would
both incur a low single--digit adverse impact versus the
performance at CER.
The Company's foreign exchange rate sensitivity analysis is
provided in Table 18.
Table 1 : Key elements of Total Revenue performance in Q1
2023
% Change
Revenue type $m Actual CER
---------------------- ------ --------- ----- ---------------------------------------
* Decline of 4% (1% increase
at CER) impacted by lower sales
of COVID-19 medicines
* Strong growth in Oncology,
Product Sales 10,566 (4) 1 CVRM, R&I and Rare Disease
* $220m for Enhertu (Q1 2022:
$76m)
* $43m for Tezspire (Q1 2022:
$3m)
Alliance Revenue 286 88 90 * See Table 6 for further details
* No sales or regulatory milestones
from Lynparza in the quarter
(Q1 2022: $175m)
Collaboration Revenue 27 (89) (89) * See Table 7 for further details
* Excluding COVID-19 medicines,
Q1 2023 Total Revenue increased
Total Revenue 10,879 (4) -- by 10% (15% at CER)
----------------------- ------ --------- ----- ---------------------------------------
Actual
Therapy areas $m % CER %
---------------------- ------ --------- ----- ---------------------------------------
* Strong performance across
key medicines and regions
* No sales or regulatory milestones
from Lynparza in the quarter
Oncology 4,148 14 19 (Q1 2022: $175m)
* Farxiga up 32% (39% CER),
Lokelma up 56% (64% at CER),
roxadustat up 52% (66% CER),
CVRM (6) 2,557 15 22 Brilinta up 3% (5% at CER)
* Fasenra up 10% (13% CER),
Breztri up 67% (73% CER). Saphnelo
and Tezspire continue to grow
rapidly during their launch
phase
* Collaboration Revenue of $nil
(Q1 2022: $70m, relating to
R&I 1,633 3 8 tralokinumab milestone)
* $127m from COVID-19 mAbs (Q1
2022: $469m)
* $28m from Vaxzevria (Q1 2022:
V&I [17] 355 (80) (79) $1,145m)
* Ultomiris up 55% (61% at CER),
offset by decline in Soliris
of 16% (13% at CER)
* Strensiq up 26% (28% at CER)
reflecting strong patient demand
Rare Disease (6) 1,866 10 14 and geographic expansion
Other Medicines 320 (26) (21)
Total Revenue 10,879 (4) -
----------------------- ------ --------- ----- ---------------------------------------
Actual
Regions inc. COVID-19 $m % CER %
---------------------- ------ --------- ----- ---------------------------------------
US 4,299 4 4
* Growth rate impacted by lower
sales of COVID-19 medicines
Emerging Markets 3,162 (6) 1 (numbers ex. COVID-19 below)
----------------------- ------ --------- ----- ---------------------------------------
- China 1,602 (1) 8
- Ex-China Emerging
Markets 1,560 (10) (6)
----------------------- ------ --------- ----- ---------------------------------------
Europe 2,162 (5) -
Established RoW 1,256 (22) (12)
Total Revenue inc.
COVID-19 10,879 (4) -
----------------------- ------ --------- ----- ---------------------------------------
Actual
Regions ex. COVID-19 $m % CER %
---------------------- ------ --------- ----- ---------------------------------------
US 4,299 15 15
Emerging Markets 3,136 14 22
----------------------- ------ --------- ----- ---------------------------------------
* Third consecutive quarter
of growth at CER
* Recovery in inhaled products
following lifting of COVID-19
- China 1,602 2 11 restrictions
- Ex-China Emerging * Timing of Rare Disease tender
Markets 1,534 31 38 orders
----------------------- ------ --------- ----- ---------------------------------------
Europe 2,148 3 9
Established RoW 1,142 (5) 7
Total Revenue ex.
COVID-19 10,725 10 15
----------------------- ------ --------- ----- ---------------------------------------
Table 2 : Key elements of financial performance in Q1 2023
Metric Reported Reported Core Core Comments [18]
change change
---------- -------- ----------- -------- ---------- -----------------------------------------------------------
* Excluding COVID-19 medicines,
Q1 2023 Total Revenue increased
by 10% (15% at CER)
-4% Actual -4% Actual * See Table 1 and the Total Revenue
Total stable at stable at section of this document for further
Revenue $10,879m CER $10,879m CER details
---------- -------- ----------- -------- ---------- -----------------------------------------------------------
Gross 82% 14pp Actual 83% 4pp Actual + Increasing mix of sales from
Margin 14pp CER 4pp CER Oncology and Rare Disease medicines
[19] + Decreasing mix of Vaxzevria sales
* Increasing mix of products with profit-sharing
arrangements
* Variations in Gross Margin can
be expected between periods due
to product seasonality, foreign
exchange fluctuations, cost inflation
and other effects
---------- -------- ----------- -------- ---------- -----------------------------------------------------------
R&D $2,611m 22% Actual $2,300m 5% Actual + Increased investment in the pipeline
expense 28% CER 10% CER + Reported R&D expense was also
impacted by intangible asset impairments
in Q1 2023, and by reversals of
impairments in Q1 2022
* Core R&D-to-Total Revenue ratio
of 21%
(Q1 2022: 19%)
* Year-on-year comparisons can
be impacted by differences in cost
phasing
---------- -------- ----------- -------- ---------- -----------------------------------------------------------
SG&A $4,059m -16% Actual $3,054m 4% Actual + Market development activities
expense -13% CER 8% CER for recent launches
+ Core SG&A-to-Total Revenue ratio
of 28%
(Q1 2022: 26%).
* Reported SG&A in Q1 2022 included a $775m charge for
a legal settlement with Chugai Pharmaceutical Co. Lt
d
* Year-on-year comparisons can
be impacted by differences in cost
phasing
---------- -------- ----------- -------- ---------- -----------------------------------------------------------
Other
operating * Reported and Core OOI includes
income >3x Actual >3x Actual a gain of $241m from the disposal
[20] $379m >3x CER $318m >3x CER of US rights to Pulmicort Flexhaler
---------- -------- ----------- -------- ---------- -----------------------------------------------------------
* See Gross Margin, Expenses and
Operating 16pp Actual 2pp Actual OOI
Margin 23% 16pp CER 36% 1pp CER commentary above
---------- -------- ----------- -------- ---------- -----------------------------------------------------------
Net $287m -10% Actual $240m -4% Actual * Higher interest received on cash
finance -8% CER -3% CER balances, partially offset by higher
expense rates on floating debt and bond
issuances
* Reported also impacted by a reduction
in the discount unwind on acquisition-related
liabilities
---------- -------- ----------- -------- ---------- -----------------------------------------------------------
-10pp -1pp
Actual Actual * Variations in the tax rate can
Tax rate 20% -10pp CER 20% -1pp CER be expected between periods
---------- -------- ----------- -------- ---------- -----------------------------------------------------------
* Further details of differences
>4x Actual 1% Actual between Reported and Core are shown
EPS $1.16 >4x CER $1.92 6% CER in Table 13
---------- -------- ----------- -------- ---------- -----------------------------------------------------------
Table 3 : Pipeline highlights since prior results
announcement
Event Medicine Indication / Trial Event
--------------- ----------- -------------------------------- ------------------------
Regulatory Imfinzi NSCLC (1st-line) (POSEIDON) Regulatory approval (EU)
approvals +/- Imjudo
and other
regulatory
actions
---------------
Imfinzi Hepatocellular carcinoma Regulatory approval (EU)
+ Imjudo (1st-line) (HIMALAYA)
---------------
Enhertu HER2-positive breast cancer Regulatory approval (CN)
(2nd-line) (DESTINY-Breast03)
Calquence Maleate tablet formulation Regulatory approval (EU)
Calquence Mantle cell lymphoma Regulatory approval (CN)
Ultomiris NMOSD Positive CHMP opinion
(EU)
---------------
Regulatory Imfinzi Biliary tract cancer (TOPAZ-1) Regulatory submission
submissions (CN)
or acceptances
Enhertu HER2+ breast cancer (3rd-line) Regulatory submission
(DESTINY-Breast02) (EU)
Beyfortus RSV [21] (MELODY/MEDLEY) Regulatory submission
(JP)
eplontersen ATTRv-PN [22] (NEURO-TTRansform) Regulatory submission
(US)
danicopan PNH with EVH Regulatory submission
(EU)
--------------- ----------- -------------------------------- ------------------------
Major Phase Lynparza Ovarian cancer (1st-line) Primary endpoint met
III data + Imfinzi (DUO-O)
readouts
and other
developments
---------------
Imfinzi NSCLC (neoadjuvant) (AEGEAN) Dual primary endpoints
met
--------------- ----------- -------------------------------- ------------------------
Other pipeline updates
The Phase II/III trial for cotadutide daily formulation in NASH
has been discontinued due to portfolio prioritisation. Development
continues for AZD9550, a weekly injectable GLP-1/glucagon.
In April, the ALXN1840 programme in Wilson Disease was
terminated. The decision was based on feedback from regulatory
authorities on review of data from the Wilson Disease programme,
including the Phase III FoCus and two Phase II mechanistic
trials.
Table 4 : New Phase III trials started since 1 January 2023
Medicine Trial name Indication
------------ -------------- ----------------------------------------
datopotamab AVANZAR NSCLC (1st-line)
deruxtecan
TROPION-Lung07 Non-squamous NSCLC (1st-line)
camizestrant CAMBRIA-1 HR-positive [23] /HER2-negative adjuvant
breast cancer
Tezspire CROSSING Eosinophilic oesophagitis
AZD3152 SUPERNOVA COVID-19 prophylaxis
Ultomiris ARTEMIS Cardiac surgery associated acute kidney
injury
------------ -------------- ----------------------------------------
Corporate and business development
In the quarter, AstraZeneca completed the previously-announced
acquisitions of CinCor Pharma Inc. (CinCor) and Neogene
Therapeutics Inc., and the disposal of US commercial rights to
Pulmicort Flexhaler to Cheplapharm.
AstraZeneca expanded its collaboration with SOPHiA GENETICS to
apply their multimodal technology and expertise to AstraZeneca's
oncology portfolio. The multimodal approach will combine radiomics
analysis of medical imaging data, molecular data, digital
pathology, clinical and biologic data for a more comprehensive
assessment of multimodal signatures.
In March 2023, AstraZeneca signed an investment agreement with
Qingdao High-tech Industrial Development Zone to build a production
and supply site in China for Breztri pressurised metered-dose
inhalers. The Qingdao plant will address the country's growing COPD
burden. China is home to about 100 million patients with COPD,
which is the third leading cause of death in the country.
In April 2023, the contractual relationship between AstraZeneca
and Swedish Orphan Biovitrum AB (Sobi) relating to future sales of
nirsevimab in the US was replaced by a royalty relationship between
Sanofi and Sobi. As a result, a liability representing
AstraZeneca's future obligations to Sobi will be eliminated from
AstraZeneca's Statement of Financial Position, and AstraZeneca will
record a gain of $718m in Core Other operating income in Q2
2023.
Sustainability summary
AstraZeneca published its ninth Sustainability Report and Data
Summary, along with the 2022 TCFD ([24]) Report and related case
studies. AstraZeneca also hosted an annual Sustainability call for
shareholders, reiterating its continued commitment to deliver
across our pillars; Access to Healthcare, Environmental Protection
and Ethics and Transparency. A recording of the call and
accompanying materials are available on the AstraZeneca IR
website.
Management changes
As previously communicated, Leif Johansson, will retire as Chair
at the conclusion of the Company's Annual General Meeting today, 27
April 2023. Michel Demaré's appointment as Chair will take effect
immediately on Leif's retirement, and Michel will step down as a
member of the Audit Committee.
Conference call
A conference call and webcast for investors and analysts will
begin today, 27 April 2023, at 11:45 UK time. Details can be
accessed via astrazeneca.com .
Reporting calendar
The Company intends to publish its half-year and second-quarter
results on Friday, 28 July 2023.
Operating and financial review
All narrative on growth and results in this section is based on
actual exchange rates, and financial figures are in US$ millions
($m), unless stated otherwise. The performance shown in this
announcement covers the three month period to 31 March 2023 ('the
quarter' or 'Q1 2023') compared to the three month period to 31
March 2022 ('Q1 2022'), unless stated otherwise.
Core financial measures, EBITDA, Net debt, Gross Margin,
Operating Margin and CER are non-GAAP financial measures because
they cannot be derived directly from the Group's Interim Financial
Statements. Management believes that these non-GAAP financial
measures, when provided in combination with Reported results,
provide investors and analysts with helpful supplementary
information to understand better the financial performance and
position of the Group on a comparable basis from period to period.
These non-GAAP financial measures are not a substitute for, or
superior to, financial measures prepared in accordance with
GAAP.
Core financial measures are adjusted to exclude certain
significant items, such as:
-- Amortisation and impairment of intangible assets, including
impairment reversals but excluding any charges relating to IT
assets
-- Charges and provisions related to restructuring programmes,
which includes charges that relate to the impact of restructuring
programmes on capitalised IT assets
-- Alexion acquisition-related items, primarily fair value
adjustments on acquired inventories and fair value impact of
replacement employee share awards
-- Other specified items, principally the imputed finance
charges and fair value movements relating to contingent
consideration on business combinations or asset acquisitions, legal
settlements and remeasurement adjustments relating to Other
payables
-- 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 62 of the Annual Report and Form 20-F Information 2022 .
Reference should be made to the Reconciliation of Reported to
Core financial measures table included in the financial performance
section in this announcement.
Gross Margin is the percentage by which Product Sales exceeds
the Cost of Sales, calculated by dividing the difference between
the two by the sales figure. The calculation of Reported and Core
Gross Margin excludes the impact of Alliance Revenue and
Collaboration Revenue and any associated costs, thereby reflecting
the underlying performance of Product Sales.
EBITDA is defined as Reported Profit before tax after adding
back Net finance expense, results from Joint ventures and
associates and charges for Depreciation, amortisation and
impairment. Reference should be made to the Reconciliation of
Reported Profit before tax to EBITDA included in the financial
performance section in this announcement.
Net debt is defined as Interest-bearing loans and borrowings and
Lease liabilities, net of Cash and cash equivalents, Other
investments, and Net derivative financial instruments. Reference
should be made to Note 3 'Net debt' included in the Notes to the
Interim Financial Statements in this announcement.
The Company strongly encourages investors and analysts not to
rely on any single financial measure, but to review AstraZeneca's
financial statements, including the Notes thereto, and other
available Company reports, carefully and in their entirety.
Due to rounding, the sum of a number of dollar values and
percentages in this announcement may not agree to totals.
Total Revenue
Table 5 : Therapy area and medicine performance
Q1 2023
% Change
Product Sales $m % Total Actual CER
---------------------- ------ ------- ------ --------
Oncology 3,920 36 16 21
----------------------- ------ ------- ------ --------
- Tagrisso 1,424 13 9 15
- Imfinzi [25] 900 8 50 56
- Lynparza 651 6 5 10
- Calquence 532 5 28 31
- Enhertu 37 - >3x >3x
- Orpathys 8 - (33) (27)
- Zoladex 227 2 (6) 3
- Faslodex 75 1 (19) (11)
- Others 66 1 (32) (27)
----------------------- ------ ------- ------ --------
BioPharmaceuticals:
CVRM 2,530 23 15 21
----------------------- ------ ------- ------ --------
- Farxiga 1,299 12 30 37
- Brilinta 334 3 3 5
- Lokelma 98 1 56 64
- roxadustat 61 1 49 63
- Andexxa 44 - 34 42
- Crestor 305 3 14 23
- Seloken/Toprol-XL 179 2 (27) (20)
- Onglyza 63 1 (8) (3)
- Bydureon 45 - (33) (32)
- Others 102 1 4 9
----------------------- ------ ------- ------ --------
BioPharmaceuticals:
R&I 1,583 15 5 10
----------------------- ------ ------- ------ --------
- Symbicort 688 6 2 7
- Fasenra 338 3 10 13
- Breztri 144 1 67 73
- Saphnelo 47 - >4x >4x
- Tezspire 11 - n/m n/m
- Pulmicort 221 2 2 9
- Bevespi 15 - (1) 2
- Daliresp/Daxas 13 - (75) (75)
- Others 106 1 (27) (22)
----------------------- ------ ------- ------ --------
BioPharmaceuticals:
V&I 355 3 (80) (78)
----------------------- ------ ------- ------ --------
- COVID-19 mAbs 127 1 (73) (70)
- Vaxzevria 28 - (97) (97)
- Synagis 198 2 (1) 5
- FluMist 2 - n/m n/m
----------------------- ------ ------- ------ --------
Rare Disease 1,866 17 10 14
----------------------- ------ ------- ------ --------
- Soliris 834 8 (16) (13)
- Ultomiris 651 6 55 61
- Strensiq 262 2 26 28
* Koselugo 79 1 >2x >2x
- Kanuma 40 - 4 6
----------------------- ------ ------- ------ --------
Other Medicines 312 3 (26) (21)
----------------------- ------ ------- ------ --------
- Nexium 244 2 (27) (20)
- Others 68 1 (26) (23)
----------------------- ------ ------- ------ --------
Product Sales 10,566 97 (4) 1
----------------------- ------ ------- ------ --------
Alliance Revenue 286 3 88 90
----------------------- ------ ------- ------ --------
Collaboration Revenue 27 - (89) (89)
----------------------- ------ ------- ------ --------
Total Revenue 10,879 100 (4) -
----------------------- ------ ------- ------ --------
Table 6 : Alliance Revenue
Q1 2023
---------------------------
% Change
$m % Total Actual CER
----------------------- --- ------- ------ ---
Enhertu 220 77 >2x >2x
Tezspire 43 15 n/m n/m
Vaxzevria: royalties - - n/m n/m
Other royalty income 20 7 23 24
Other Alliance Revenue 3 1 >3x >3x
------------------------ --- ------- ------ ---
Total 286 100 88 90
------------------------ --- ------- ------ ---
Table 7 : Collaboration Revenue
Q1 2023
---------------------------
% Change
$m % Total Actual CER
--------------------------- ------- ------ ----
Farxiga : sales milestones 24 89 n/m n/m
Other Collaboration
Revenue 3 11 (76) (76)
---------------------------- ------- ------ ----
Total 27 100 (89) (89)
---------------------------- ------- ------ ----
Table 8 : Total Revenue by therapy area
Q1 2023
------------------------------------
% Change
$m % Total Actual CER
-------------------- ------ ------- ------- --------
Oncology 4,148 38 14 19
BioPharmaceuticals 4,545 42 (19) (15)
-------------------- ------ ------- ------- --------
- CVRM 2,557 24 15 22
- R&I 1,633 15 3 8
- V&I 355 3 (80) (79)
-------------------- ------ ------- ------- --------
Rare Disease 1,866 17 10 14
Other Medicines 320 3 (26) (21)
-------------------- ------ ------- ------- --------
Total 10,879 100 (4) -
-------------------- ------ ------- ------- --------
Table 9 : Total Revenue by region
Q1 2023
------------------------------------
% Change
$m % Total Actual CER
-------------------- ------ ------- ------- --------
US 4,299 40 4 4
-------------------- ------ ------- ------- --------
Emerging Markets 3,162 29 (6) 1
-------------------- ------ ------- ------- --------
- China 1,602 15 (1) 8
- Ex-China 1,560 14 (10) (6)
------ ------- ------- --------
Europe 2,162 20 (5) -
Established RoW 1,256 12 (22) (12)
-------------------- ------ ------- ------- --------
Total 10,879 100 (4) -
-------------------- ------ ------- ------- --------
Table 10 : Total Revenue by region - excluding COVID-19
medicines
Q1 2023
------------------------------------
% Change
$m % Total Actual CER
-------------------- ------ ------- ------- --------
US 4,299 40 15 15
-------------------- ------ ------- ------- --------
Emerging Markets 3,136 29 14 22
-------------------- ------ ------- ------- --------
- China 1,602 15 2 11
- Ex-China 1,534 14 31 38
-------------------- ------ ------- ------- --------
Europe 2,148 20 3 9
Established RoW 1,142 11 (5) 7
-------------------- ------ ------- ------- --------
Total 10,725 100 10 15
-------------------- ------ ------- ------- --------
Oncology
Oncology Total Revenue increased by 14% (19% at CER) in Q1 2023
to $4,148m and represented 38% of overall Total Revenue (Q1 2022:
32%). There was no Lynparza Collaboration Revenue in the quarter
(Q1 2022: $175m) and Enhertu Alliance Revenue was $220m (Q1 2022:
$76m). Product Sales increased by 16% (21% at CER) in Q1 2023 to
$3,920m, reflecting new launches and increased patient access
across key brands; partially offset by declines in legacy
medicines.
Tagrisso
Total Revenue Worldwide US Emerging Markets Europe Established
RoW
-------------- --------- --- ---------------- ------ -----------
Q1 2023 $m 1,424 521 444 257 202
Actual change 9% 19% 9% 2% (2%)
CER change 15% 19% 17% 8% 11%
--------------- --------- --- ---------------- ------ -----------
Region Drivers and commentary
---------------- ------------------------------------------------------------
Worldwide * Increased use of Tagrisso in adjuvant and 1st-line
setting and expansion of reimbursed access
US * Increasing demand in 1st-line and adjuvant setting,
partially offset by unfavourable inventory movements
Emerging Markets * Rising demand from increased patient access in China
continues to offset NRDL [26] renewal price reductions
* Recovery from Q4 2022 ordering dynamics in China
Europe * Established standard of care in 1st-line and adjuvant
setting across EU5 [27] , partially offset by pricing
clawbacks in certain markets
Established * Increased use in 1st-line setting and launch acceleration
RoW in adjuvant, including Japan
---------------- ------------------------------------------------------------
Imfinzi
Total Revenue Worldwide US Emerging Markets Europe Established
RoW
----------------- ------------- ----- --------------------- -------- --------------
Q1 2023 $m 900 522 81 163 134
Actual change 50% 66% 39% 31% 33%
CER change 56% 66% 47% 38% 52%
------------------ ------------- ----- --------------------- -------- --------------
Region Drivers and commentary
------------------ ---------------------------------------------------------------------
Worldwide * The Imfinzi revenue line includes sales of Imjudo,
which launched in Q4 2022 following approvals in the
US for patients with unresectable liver cancer (HIMALAYA)
and Stage IV NSCLC (POSEIDON)
* Increased use of Imfinzi in BTC [28] (TOPAZ-1), liver
cancer (HIMALAYA) and lung cancers (POSEIDON, CASPIAN)
US * Continued growth in new patient starts across Stage
III NSCLC and ES-SCLC [29]
* Strong launch in BTC following September 2022 FDA
approval, and growing penetration of Imfinzi + Imjudo
in liver and lung cancers
Emerging Markets * Growth in ex-China driven increased market penetration
in ES-SCLC and NSCLC (PACIFIC), and recovery of diagnosis
and treatment rates following the COVID--19 pandemic
Europe * Increased market penetration in ES-SCLC, launch trajectory
in BTC, growth in the number of reimbursed markets
Established * New reimbursements, strong demand growth in BTC
RoW
------------------ ---------------------------------------------------------------------
Lynparza
Total Revenue Worldwide US Emerging Markets Europe Established
RoW
-------------- --------- ---- ---------------- ------ -----------
Q1 2023 $m 651 268 137 178 68
Actual change (18%) (1%) 13% (47%) 2%
CER change (14%) (1%) 19% (44%) 16%
--------------- --------- ---- ---------------- ------ -----------
Product Sales Worldwide US Emerging Markets Europe Established
RoW
-------------- --------- ---- ---------------- ------ -----------
Q1 2023 $m 651 268 137 178 68
Actual change 5% (1%) 13% 11% 2%
CER change 10% (1%) 19% 18% 16%
--------------- --------- ---- ---------------- ------ -----------
Region Drivers and commentary
---------------- -------------------------------------------------------------
Worldwide * Lynparza remains the leading medicine in the PARP
[30] inhibitor class globally across four tumour types,
as measured by total prescription volume
* No regulatory milestones received in Q1 2023
US * Positive demand growth driven by OlympiA (FDA approval
March 2022) offset by flattening HRD testing rates in
ovarian cancer and destocking following an inventory
build in Q4 2022 in anticipation of PROpel launch
Emerging Markets * Re-enlistment into China's NRDL for ovarian cancer
indications (PSR [31] and BRCAm [32] 1st-line maintenance)
and new enlistment in prostate cancer (PROfound)
Europe * Growth driven by increased uptake in 1st-line HRD-positive
ovarian cancer, gBRCAm [33] HER2--negative early breast
cancer and BRCAm mCRPC, partially offset by new indication
pricing impact and clawbacks in some markets
Established * Growth continues across tumour types
RoW
---------------- -------------------------------------------------------------
Enhert u
Total Revenue Worldwide US Emerging Markets Europe Established
RoW
-------------- --------- --- ---------------- ------ -----------
Q1 2023 $m 257 161 38 55 3
Actual change >2x >2x >4x >2x >5x
CER change >3x >2x >4x >2x >6x
--------------- --------- --- ---------------- ------ -----------
Region Drivers and commentary
---------------- ------------------------------------------------------------------
Worldwide * Combined sales of Enhertu, recorded by Daiichi Sankyo
Company Limited (Daiichi Sankyo) and AstraZeneca, amounted
to $508m in the quarter (Q1 2022: $166m)
* AstraZeneca's Total Revenue of $257m includes $220m
of Alliance Revenue from its share of gross profit and
royalties in territories where Daiichi Sankyo records
product sales
US * US in-market sales, recorded by Daiichi Sankyo, amounted
to $336m in the quarter (Q1 2022: $119m)
* Rapid adoption as new standard of care across all
launched indications including HER2-low mBC [34] with
strong demand continuing from breast cancer launches
Emerging Markets * Strong uptake driven by new approvals and launches
Europe * Continued growth in 2nd-line and 3rd-line+ HER2-positive
metastatic breast cancer
* Increased uptake following launches of 2nd-line+ HER2-positive
gastric cancer and 2nd-line+ HER2-low metastatic breast
cancer after EU approvals in December 2022 and January
2023 respectively (DESTINY-Gastric01, DESTINY-Gastric02,
DESTINY-Breast04)
Established * In Japan, AstraZeneca receives a mid-single-digit
RoW percentage royalty on sales made by Daiichi Sankyo
---------------- ------------------------------------------------------------------
Calquence
Total Revenue Worldwide US Emerging Markets Europe Established
RoW
-------------- --------- --- ---------------- ------ -----------
Q1 2023 $m 532 384 18 108 22
Actual change 28% 13% >2x 95% 76%
CER change 31% 13% >2x >2x 91%
--------------- --------- --- ---------------- ------ -----------
*
Region Drivers and commentary
--------- ----------------------------------------------------------
Worldwide * Increased penetration globally; leading BTKi [35]
in key markets
US * 1st-line patient share broadly stable, some competitive
impact in relapsed refractory setting
* Q1 2023 performance impacted by destocking following
inventory build-up that followed approval of the maleate
tablet formulation
--------- ----------------------------------------------------------
Orpathys
Total Revenue of $9m (Q1 2022: $11m) was driven by the 2021
launch in China, where Orpathys is approved for patients with lung
cancer and MET [36] gene alterations. Orpathys is now included in
the updated NRDL in China for the treatment of patients with NSCLC
with MET exon 14 skipping alterations.
Other Oncology medicines
Q1 2023 Change
Total Revenue $m Actual CER
--------------- ------ -------- ----- ---------------------------------------------
Zoladex 235 (5%) 4% * Increased use in ex-China Emerging Markets
Faslodex 75 (19%) (11%) * Generic competition
Other Oncology 66 (32%) (27%) * Includes Iressa, Arimidex, Casodex and
other older medicines
---------------- ------ -------- ----- ---------------------------------------------
BioPharmaceuticals
BioPharmaceuticals Total Revenue decreased by 19% (15% at CER)
in Q1 2023 to $4,545m, representing 42% of overall Total Revenue
(Q1 2022: 49%). The decrease was driven by declining revenues from
COVID-19 medicines. Growth from Farxiga and newer R&I medicines
offset decreases in some older medicines.
BioPharmaceuticals - CVRM
CVRM Total Revenue increased by 15% (22% at CER) to $2,557m in
Q1 2023, driven by a strong Farxiga performance, and represented
24% of overall Total Revenue (Q1 2022: 19%).
Farxiga
Total Revenue Worldwide US Emerging Markets Europe Established
RoW
-------------- --------- --- ---------------- ------ -----------
Q1 2023 $m 1,324 296 498 393 138
Actual change 32% 53% 27% 24% 39%
CER change 39% 53% 35% 31% 53%
--------------- --------- --- ---------------- ------ -----------
Region Drivers and commentary
---------------- -----------------------------------------------------------------
Worldwide * Farxiga volume is growing faster than the overall
SGLT2 [37] market in all major regions
* Additional benefit from continued growth in the overall
SGLT2 inhibitor class
* Further HF [38] and CKD [39] launches and supportive
updates to treatment guidelines including from ESC [40]
and AHA [41] /ACC [42] /HFSA [43] . HF and CKD indications
now launched in >100 markets
US * Growth driven by HFrEF [44] and CKD for patients with
and without T2D [45]
* Favourable gross-to-net impact in the quarter
* Farxiga continued to gain in-class brand share, driven
by HF and CKD launches
Emerging Markets * Growth despite generic competition in some markets.
Solid growth in ex-China Emerging Markets, particularly
Latin America
Europe * Benefited from the addition of cardiovascular outcomes
trial data to the label, the HFrEF regulatory approval
in November 2020, and CKD regulatory approval in August
2021. HFpEF [46] approval in February 2023
* Continued strong volume growth in the quarter partially
offset by clawbacks
Established * In Japan, AstraZeneca sells to collaborator Ono Pharmaceutical
RoW Co., Ltd, which records in-market sales. Continued volume
growth driven by HF and CKD launches. A milestone payment
from Ono was recorded in the quarter
---------------- -----------------------------------------------------------------
Brilinta
Total Revenue Worldwide US Emerging Markets Europe Established
RoW
-------------- --------- --- ---------------- ------ -----------
Q1 2023 $m 334 179 82 67 6
Actual change 3% 8% 19% (12%) (59%)
CER change 5% 8% 25% (7%) (53%)
--------------- --------- --- ---------------- ------ -----------
Region Drivers and commentary
US * Favourable comparison due to COVID-19 impact in Q1
2022
Emerging Markets * Growth in all major Emerging Markets regions following
COVID-19 recovery
Europe * European sales negatively impacted by clawbacks
---------------- ---------------------------------------------------------
Lokelma
Total Revenue increased 56% (64% at CER) to $98m in Q1 2023.
Continued progress in Europe, with strong volume growth. In China,
Lokelma was enlisted to the NRDL in January 2022 and is now the
leading potassium binder in the country.
roxadustat
Total Revenue increased 52% (66% at CER) to $62m, with
roxadustat benefitting from increased volumes in China following
NRDL renewal in 2022.
Andexxa
Total Revenue increased 2% (8% at CER) to $44m.
Other CVRM medicines
Q1 2023 Change
Total Revenue $m Actual CER
--------------
Crestor 306 14% 23% * Strong sales growth in Emerging Markets,
partly offset by declines in the US and
Established RoW
Seloken 179 (27%) (20%) * Emerging Markets sales impacted by China
VBP implementation of Betaloc [47] oral
in H2 2021. Betaloc ZOK VBP was implemented
in Q4 2022
Onglyza 63 (8%) (3%) * Continued decline for DPP-IV class
Bydureon 45 (33%) (32%) * Continued competitive pressures
Other CVRM 102 4% 9%
--------------- ------ -------- ----- ---------------------------------------------
BioPharmaceuticals - R&I
Total Revenue of $1,633m from R&I medicines in Q1 2023
increased 3% (8% at CER) and represented 15% of overall Total
Revenue (Q1 2022: 14%). This reflected growth in launch brands:
Fasenra, Tezspire, Breztri and Saphnelo.
Symbicort
Total Revenue Worldwide US Emerging Markets Europe Established
RoW
-------------- --------- ----- ---------------- ------ -----------
Q1 2023 $m 688 233 229 147 79
Actual change 2% (10%) 37% (6%) (14%)
CER change 7% (10%) 48% (1%) (7%)
--------------- --------- ----- ---------------- ------ -----------
Region Drivers and commentary
---------------- -----------------------------------------------------------
Worldwide * Symbicort remains the global market leader within
a stable ICS [48] /LABA [49] class
US * Market share resilience, consolidating leadership
in a declining ICS/LABA market
* Generic entry expected in the US in 2023
Emerging Markets * Post-COVID-19 recovery in China and channel inventory
rebuild
Europe * Resilient market share in growing ICS/LABA market,
offset by pricing pressure
Established * Inventory destocking in some markets and generic erosion
RoW in Japan
---------------- -----------------------------------------------------------
Fasenra
Total Revenue Worldwide US Emerging Markets Europe Established
RoW
-------------- --------- --- ---------------- ------ -----------
Q1 2023 $m 338 201 14 88 35
Actual change 10% 6% >2x 17% (4%)
CER change 13% 6% >2x 23% 7%
--------------- --------- --- ---------------- ------ -----------
Region Drivers and commentary
---------------- -------------------------------------------------------
Worldwide * Continues to be market leader in severe eosinophilic
asthma in major markets, and leads in the IL-5 [50]
class
US * Strong underlying demand growth, partially offset
in the quarter by inventory dynamics
Emerging Markets * Strong volume growth driven by launch acceleration
across key markets
Europe * Expanded leadership in severe eosinophilic asthma
Established * Maintained leadership of the dynamic market [51] in
RoW Japan
---------------- -------------------------------------------------------
Breztri
Total Revenue Worldwide US Emerging Markets Europe Established
RoW
-------------- --------- --- ---------------- ------ -----------
Q1 2023 $m 144 81 38 15 10
Actual change 67% 53% 71% >3x 52%
CER change 73% 53% 85% >3x 73%
--------------- --------- --- ---------------- ------ -----------
Region Drivers and commentary
---------------- -----------------------------------------------------------
Worldwide * Continues to gain market share within the growing
FDC [52] triple class across major markets
US * Consistent share growth within the FDC triple class
in new-to-brand [53] and total market
Emerging Markets * Maintained market share leadership in China within
the FDC triple class
Europe * Sustained growth across markets as new launches continue
to progress
Established * Increasing new-to-brand market share within COPD plus
RoW ACO [54] in Japan
---------------- -----------------------------------------------------------
Saphnelo
Total Revenue Worldwide US Emerging Markets Europe Established
RoW
-------------- --------- --- ---------------- ------ -----------
Q1 2023 $m 47 44 - 1 2
Actual change >4x >4x n/m >3x >4x
CER change >4x >4x n/m >4x >5x
--------------- --------- --- ---------------- ------ -----------
Region Drivers and commentary
--------- ---------------------------------------------------------
Worldwide * Demand acceleration in the US, where Saphnelo has
new-to-brand leadership in the i.v. [55] segment for
SLE [56] , and the ongoing launches in Europe and Japan
--------- ---------------------------------------------------------
Tezspire
Total Revenue Worldwide US Emerging Markets Europe Established
RoW
-------------- --------- ---- ---------------- ------ -----------
Q1 2023 $m 54 43 - 7 4
Actual change >10x >10x n/m n/m n/m
CER change >10x >10x n/m n/m n/m
--------------- --------- ---- ---------------- ------ -----------
Region Drivers and commentary
----------- ----------------------------------------------------------
Worldwide * Tezspire is approved in the US, EU and Japan (as well
as other countries) for the treatment of severe asthma
without biomarker or phenotypic limitation.
* Amgen records sales in the US, and AstraZeneca records
its share of US gross profits as Alliance Revenue
* AstraZeneca books Product Sales in markets outside
the US
* Combined sales of Tezspire by AstraZeneca and Amgen
were $105m in the quarter
US * Increasing new-to-brand market share with majority
of patients new to biologics
Europe * Achieved and maintained new-to-brand leadership in
key markets
* Pre-filled pen approved in January 2023
Established * Japan achieved new-to-brand leadership by month two
RoW
----------- ----------------------------------------------------------
Other R&I medicines
Q1 2023 % Change
Total Revenue $m Actual CER
-------------- ------ -------- ----- ------------------------------------------
Pulmicort 221 2% 9% * Revenues increased in Emerging Markets
with continued recovery of nebulisation
demand post COVID-19 and market share
in China stabilising
* Revenue from the US declined 54%
Bevespi 15 (1%) 2%
Daliresp 13 (75%) (75%) * Impacted by uptake of multiple generics
following loss of exclusivity in the US
Other R&I 113 (48%) (45%) * Collaboration Revenue of $nil (Q1 2022:
$70m)
* Product Sales of $106m decreased 27%
(22% at CER) due to generic competition
------------------- ------ -------- ----- ------------------------------------------
BioPharmaceuticals - V&I
Total Revenue from V&I medicines declined by 80% (79% at
CER) to $355m (Q1 2022: $1,814m) and represented 3% of overall
Total Revenue (Q1 2022: 16%).
COVID-19 mAbs
Total Revenue Worldwide US Emerging Markets Europe Established
RoW
-------------- --------- --- ---------------- ------ -----------
Q1 2023 $m 127 - 8 4 115
Actual change (73%) n/m (91%) (94%) >10x
CER change (70%) n/m (91%) (94%) >10x
--------------- --------- --- ---------------- ------ -----------
Region Drivers and commentary
----------- --------------------------------------------------------
US * No revenue in the quarter following the completion
of US government contract deliveries in Q4 2022, and
the revision of Evusheld's emergency use authorisation
in January 2023
Established * Deliveries in Japan
RoW
----------- --------------------------------------------------------
Vaxzevria
Total Revenue Worldwide US Emerging Markets Europe Established
RoW
-------------- --------- --- ---------------- ------ -----------
Q1 2023 $m 28 - 18 10 -
Actual change (98%) n/m (97%) (93%) n/m
CER change (97%) n/m (97%) (92%) n/m
--------------- --------- --- ---------------- ------ -----------
Region Drivers and commentary
--------- -------------------------------------------------------
Worldwide * Revenue in the quarter decreased by 98% (97% at CER)
due to the conclusion of Vaxzevria contracts
--------- -------------------------------------------------------
Other V&I medicines
Q1 2023 % Change
Total Revenue $m Actual CER
------------------ ---- -------- ----- ---------------------------------------
Synagis 198 (1%) 5%
FluMist 2 n/m n/m * Normal seasonality
------------------ ---- -------- ----- ---------------------------------------
Rare Disease
Total Revenue from Rare Disease medicines increased by 10% (14%
at CER) in Q1 2023 to $1,866m, representing 17% of overall Total
Revenue (Q1 2022: 15%).
Performance was driven by the durability of the C5 [57]
franchise, Soliris and Ultomiris growth in neurology indications
and expansion into new markets.
Soliris
Total Revenue Worldwide US Emerging Markets Europe Established
RoW
-------------- --------- ----- ---------------- ------ -----------
Q1 2023 $m 834 448 115 183 88
Actual change (16%) (24%) 63% (17%) (18%)
CER change (13%) (24%) 77% (12%) (10%)
--------------- --------- ----- ---------------- ------ -----------
Region Drivers and commentary
---------------- -----------------------------------------------------------
US * Performance impacted by successful conversion of Soliris
patients to Ultomiris in PNH, aHUS [58] and gMG [59]
, partially offset by Soliris growth in NMOSD
Emerging Markets * Growth from expansion into new markets and favourable
timing of tender orders in some markets
Europe, * Decline driven by successful conversion of Soliris
Established patients to Ultomiris, slightly offset by growth in
RoW NMOSD
---------------- -----------------------------------------------------------
Ultomiris
Total Revenue Worldwide US Emerging Markets Europe Established
RoW
-------------- --------- --- ---------------- ------ -----------
Q1 2023 $m 651 381 13 159 98
Actual change 55% 73% (46%) 52% 39%
CER change 61% 73% (45%) 61% 61%
--------------- --------- --- ---------------- ------ -----------
Region Drivers and commentary
---------------- --------------------------------------------------------------
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
Emerging Markets * Impacted by inventory movements at third-party distributors
due to AstraZeneca bringing distribution in-house
Europe * Growth driven by strong demand generation following
new launch markets
Established * Rapid conversion from Soliris in Japan
RoW
---------------- --------------------------------------------------------------
Strensiq
Total Revenue Worldwide US Emerging Markets Europe Established
RoW
-------------- --------- --- ---------------- ------ -----------
Q1 2023 $m 262 205 15 21 21
Actual change 26% 28% 70% 10% 7%
CER change 28% 28% 58% 17% 22%
--------------- --------- --- ---------------- ------ -----------
Region Drivers and commentary
--------- -------------------------------------------------------------
Worldwide * Performance driven by strong patient demand and geographic
expansion
--------- -------------------------------------------------------------
Other Rare Disease medicines
Q1 2023 % Change
Total Revenue $m Actual CER Commentary
---------------- ---- -------- ----- --------------------------------------------
Koselugo 79 >2x >2x * Growth driven by expansion in new markets
Kanuma 40 4% 6% * Continued demand growth in ex-US markets
---------------- ---- -------- ----- --------------------------------------------
Other medicines (outside the main therapy areas)
Q1 2023 % Change
Total Revenue $m Actual CER Commentary
--------------- ------ -------- ----- ------------------------------------------
Nexium 248 (26%) (20%) * Generic launches in Japan in the latter
part of 2022
Others 72 (26%) (22%) * Continued impact of generic competition
--------------- ------ -------- ----- ------------------------------------------
Financial performance
Table 11 : Reported Profit and Loss
Q1 2023 Q1 2022 % Change
$m $m Actual CER
------------------------ ------- ------- ------ -------
Total Revenue 10,879 11,390 (4) -
- Product Sales 10,566 10,980 (4) 1
- Alliance Revenue 286 152 88 90
- Collaboration Revenue 27 258 (89) (89)
------------------------- ------- ------- ------ -------
Cost of sales (1,905) (3,511) (46) (43)
------------------------- ------- ------- ------ -------
Gross profit 8,974 7,879 14 19
Gross Margin 82.0% 68.0% +14pp +14pp
------------------------- ------- ------- ------ -------
Distribution expense (134) (125) 7 12
% Total Revenue 1.2% 1.1% - -
R&D expense (2,611) (2,133) 22 28
% Total Revenue 24.0% 18.7% -5pp -5pp
SG&A expense (4,059) (4,840) (16) (13)
% Total Revenue 37.3% 42.5% +5pp +5pp
OOI [60] & expense 379 97 >3x >3x
% Total Revenue 3.5% 0.9% +3pp +2pp
------------------------- ------- ------- ------ -------
Operating profit 2,549 878 >2x >2x
Operating Margin 23.4% 7.7% +16pp +16pp
------------------------- ------- ------- ------ -------
Net finance expense (287) (319) (10) (8)
Joint ventures and
associates - (6) (96) (96)
------------------------- ------- ------- ------ -------
Profit before tax 2,262 553 >4x >4x
------------------------- ------- ------- ------ -------
Taxation (458) (165) >2x >2x
Tax rate 20% 30%
------------------------- ------- ------- ------ -------
Profit after tax 1,804 388 >4x >4x
------------------------- ------- ------- ------ -------
Earnings per share $1.16 $0.25 >4x >4x
------------------------- ------- ------- ------ -------
Table 12 : Reconciliation of Reported Profit before tax to
EBITDA
Q1 2023 Q1 2022 % Change
$m $m Actual CER
--------------------------- ------- ------- ------ -------
Reported Profit before
tax 2,262 553 >4x >4x
Net finance expense 287 319 (10) (8)
Joint ventures and
associates - 6 (96) (96)
Depreciation, amortisation
and impairment 1,502 1,309 15 18
---------------------------- ------- ------- ------ -------
EBITDA 4,051 2,187 85 92
---------------------------- ------- ------- ------ -------
EBITDA for the comparative Q1 2022 was negatively impacted by
$1,180m unwind of inventory fair value uplift recognised on the
acquisition of Alexion. This unwind had $36m negative impact on Q1
2023 and will continue to be minimal in future quarters.
Table 13 : Reconciliation of Reported to Core financial
measures: Q1 2023
Q1 2023 Reported Restructuring Intangible Acquisition Other Core Core
Asset Amortisation of Alexion % Change
& Impairments
$m $m $m $m $m $m Actual CER
------------------ -------- ------------- ------------------- ----------- ------ ------- ------ --------
Gross profit 8,974 95 8 37 2 9,116 - 4
Gross Margin 82.0% 83.3% +4pp +4pp
------------------- -------- ------------- ------------------- ----------- ------ ------- ------ --------
Distribution
expense (134) - - - - (134) 8 13
R&D expense (2,611) 30 280 2 (1) (2,300) 5 10
SG&A expense (4,059) 41 954 2 8 (3,054) 4 8
------------------- -------- ------------- ------------------- ----------- ------ ------- ------ --------
Total operating
expense (6,804) 71 1,234 4 7 (5,488) 4 9
------------------- -------- ------------- ------------------- ----------- ------ ------- ------ --------
Other operating
income & expense 379 (61) - - - 318 >3x >3x
------------------- -------- ------------- ------------------- ----------- ------ ------- ------ --------
Operating
profit 2,549 105 1,242 41 9 3,946 - 4
Operating
Margin 23.4% 36.3% +2pp +1pp
------------------- -------- ------------- ------------------- ----------- ------ ------- ------ --------
Net finance
expense (287) - - - 47 (240) (4) (3)
Taxation (458) (24) (231) (9) (9) (731) (5) (1)
------------------- -------- ------------- ------------------- ----------- ------ ------- ------ --------
EPS $1.16 $0.05 $0.66 $0.02 $0.03 $1.92 1 6
------------------- -------- ------------- ------------------- ----------- ------ ------- ------ --------
Profit and Loss drivers
Gross profit
-- The change in Gross Margin (Reported and Core) in the quarter was impacted by:
-- Positive mix effects. The increased contribution from Rare
Disease and Oncology medicines had a positive impact on the Gross
Margin. Vaxzevria sales, which are also dilutive to gross margin,
declined substantially
-- Negative mix effects. The rising contribution of Product
Sales with profit sharing arrangements (Lynparza, Enhertu and
Tezspire) has a negative impact on gross margin because AstraZeneca
records product revenues in certain markets but pays away half of
the gross profit to its collaboration partners. Emerging Markets,
where gross margins tend to be below the Company average, grew as a
proportion of Total Revenue excluding COVID-19 medicines
-- Positive impact from cost of production in prior periods
-- Reported Gross profit was also impacted by a reduction in the
unwind of the fair value adjustment to Alexion inventories at the
date of acquisition. In Q1 2023, the negative impact of the fair
value uplift unwind on Cost of Sales was $36m (Q1 2022:
$1,180m)
-- Variations in Gross Margin performance between periods can
continue to be expected, due to product seasonality, foreign
exchange fluctuations, cost inflation and other effects. The full
impact of cost inflation is not seen in the Income Statement until
older inventory built at lower cost has been sold; for some product
lines the lag between inflation and impact can be several
quarters
R&D expense
-- The change in R&D expense (Reported and Core) was impacted by:
-- Recent positive data read outs for several high priority
medicines that have ungated late-stage trials
-- Investment in platforms, new technology and capabilities to enhance R&D productivity
Reported R&D expense was also impacted by intangible asset
impairments in the quarter, and reversals of intangible asset
impairments in Q1 2022
SG&A expense
-- The change in SG&A Expense (Reported and Core) was driven
primarily by market development activities for launches
-- Reported SG&A Expense was also impacted by amortisation
of intangible assets related to the Alexion acquisition and other
acquisitions and collaborations. In Q1 2022, the Reported SG&A
expense included a $775m legal settlement with Chugai
Pharmaceutical Co. Ltd
Other operating income
Reported Other operating income of $379m included a gain on the
disposal of the US rights to Pulmicort Flexhaler, disposal proceeds
on the sale of tangible assets, and royalties on certain
medicines
Net finance expense
-- The reduction in Net finance expense (Reported and Core) was
primarily driven by an increase in finance income on cash
investments, which benefited from higher interest rates. That was
partially offset by increased interest expense on floating rate
debt, and the interest on the $3.8bn of bonds issued in the
quarter
-- Reported Net finance expense also benefited from a reduction
in the discount unwind on acquisition related liabilities
Taxation
-- The effective Reported Tax rate for the three months to 31
March 2023 was 20% (Q1 2022: 30%) and the Core Tax rate was 20% (Q1
2022: 21%). The Reported Tax rate in the prior period was impacted
by Non-Core charges on the level of Reported Profit before tax
-- The net cash paid for the quarter was $225m (Q1 2022: $228m)
representing 10% of Reported Profit before tax (Q1 2022: 41%). The
cash tax rate of 10% benefits from the phasing of tax payments
-- On 23 March 2023, the UK Government presented the draft
legislation in relation to the new global minimum tax framework to
the House of Commons and this is now proceeding through the UK
Parliamentary process. This is expected to be brought into effect
in the UK from 2024. The Company is currently assessing the
potential impact of these draft rules upon its financial
statements
Table 14 : Cash Flow summary
Q1 2023 Q1 2022 Change
$m $m $m
-------------------------------------------- ------- ------- -------
Reported Operating profit 2,549 878 1,671
Depreciation, amortisation and impairment 1,502 1,309 193
Decrease in working capital and short-term
provisions 242 1,804 (1,562)
Gains on disposal of intangible assets (249) (10) (239)
Non-cash and other movements (429) (327) (102)
Interest paid (257) (194) (63)
Taxation paid (225) (228) 3
--------------------------------------------- ------- ------- -------
Net cash inflow from operating activities 3,133 3,232 (99)
--------------------------------------------- ------- ------- -------
Net cash inflow before financing activities 1,887 3,064 (1,177)
--------------------------------------------- ------- ------- -------
Net cash outflow from financing activities (2,031) (3,740) 1,709
--------------------------------------------- ------- ------- -------
In Q1 2022, the Reported Operating profit of $878m included a
negative impact of $1,180m relating to the unwind of the inventory
fair value uplift recognised on the acquisition of Alexion. This
was offset by a corresponding item (positive impact of $1,180m) in
Decrease in working capital and short-term provisions. Overall, the
unwind of the fair value uplift had no impact on Net cash inflow
from operating activities. This unwind had $36m negative impact on
Q1 2023 and will continue to be minimal in future quarters.
The change in Net cash inflow before financing activities is
primarily driven by the movement in Purchase of intangible assets
of $1,079m, including the acquisition of CinCor, in the quarter to
31 March 2023.
The change in Net cash outflow from financing activities is
primarily driven by the issue of bonds of $3,826m, offset by the
repayment of loans and borrowings of $2,004m and dividends paid of
$3,047m in the quarter to 31 March 2023.
Included within Net cash inflow before financing activities is a
movement in the profit-participation liability of $175m, resulting
from the cash receipt from Sobi in Q1 2023 after achievement of a
regulatory milestone. The associated cash flow is presented within
investing activities.
Capital expenditure
Capital expenditure amounted to $247m in the quarter (Q1 2022:
$219m).
Table 15 : Net debt summary
At 31 At 31 At 31
Mar 2023 Dec 2022 Mar 2022
$m $m $m
--------------------------------------------------- --------- --------- ---------
Cash and cash equivalents 6,232 6,166 5,762
Other investments 230 239 61
---------------------------------------------------- --------- --------- ---------
Cash and investments 6,462 6,405 5,823
---------------------------------------------------- --------- --------- ---------
Overdrafts and short-term borrowings (667) (350) (805)
Lease liabilities (962) (953) (949)
Current instalments of loans (2,958) (4,964) (1,264)
Non-current instalments of loans (26,916) (22,965) (28,081)
---------------------------------------------------- --------- --------- ---------
Interest-bearing loans and borrowings (Gross debt) (31,503 ) (29,232) (31,099 )
---------------------------------------------------- --------- --------- ---------
Net derivatives (21) (96) 59
---------------------------------------------------- --------- --------- ---------
Net debt (25,062 ) (22,923) (25,217 )
---------------------------------------------------- --------- --------- ---------
Net debt increased by $2,139m in the quarter to date to
$25,062m. 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, 4.875% Notes due 2028, 4.900% Notes due 2030, 2.250% Notes
due 2031 and 4.875% Notes due 2033 (the "AstraZeneca Finance
Notes"). Each series of AstraZeneca Finance Notes has been fully
and unconditionally guaranteed by AstraZeneca PLC. AstraZeneca
Finance is 100% owned by AstraZeneca PLC and each of the guarantees
by AstraZeneca PLC is full and unconditional and joint and
several.
The AstraZeneca Finance Notes are senior unsecured obligations
of AstraZeneca Finance and rank equally with all of AstraZeneca
Finance's existing and future senior unsecured and unsubordinated
indebtedness. The guarantee by AstraZeneca PLC of the AstraZeneca
Finance Notes is the senior unsecured obligation of AstraZeneca PLC
and ranks equally with all of AstraZeneca PLC's existing and future
senior unsecured and unsubordinated indebtedness. Each guarantee by
AstraZeneca PLC is effectively subordinated to any secured
indebtedness of AstraZeneca PLC to the extent of the value of the
assets securing such indebtedness. The AstraZeneca Finance Notes
are structurally subordinated to indebtedness and other liabilities
of the subsidiaries of AstraZeneca PLC, none of which guarantee the
AstraZeneca Finance Notes.
AstraZeneca PLC manages substantially all of its operations
through divisions, branches and/or investments in subsidiaries and
affiliates. Accordingly, the ability of AstraZeneca PLC to service
its debt and guarantee obligations is also dependent upon the
earnings of its subsidiaries, affiliates, branches and divisions,
whether by dividends, distributions, loans or otherwise.
Please refer to the consolidated financial statements of
AstraZeneca PLC in our Annual Report on Form 20-F and reports on
Form 6-K with our quarterly financial results as filed or furnished
with the SEC [61] for further financial information regarding
AstraZeneca PLC and its consolidated subsidiaries. For further
details, terms and conditions of the AstraZeneca Finance Notes
please refer to AstraZeneca PLC's reports on Form 6-K furnished to
the SEC on 3 March 2023 and 28 May 2021.
Pursuant to Rule 13-01 and Rule 3-10 of Regulation S-X under the
Securities Act of 1933, as amended (the "Securities Act"), we
present below the summary financial information for AstraZeneca
PLC, as Guarantor, excluding its consolidated subsidiaries, and
AstraZeneca Finance, as the issuer, excluding its consolidated
subsidiaries. The following summary financial information of
AstraZeneca PLC and AstraZeneca Finance is presented on a combined
basis and transactions between the combining entities have been
eliminated. Financial information for non-guarantor entities has
been excluded. Intercompany balances and transactions between the
obligor group and the non-obligor subsidiaries are presented on
separate lines.
Table 16 : Obligor group summarised Statement of comprehensive
income
Q1 2023 Q1 2022
$m $m
------------------------------------------------------------------ ------- -------
Total Revenue - -
Gross profit - -
Operating loss - (1)
Loss for the period (237) (155)
Transactions with subsidiaries that are not issuers or guarantors 7,502 164
------------------------------------------------------------------- ------- -------
Table 17 : Obligor group summarised Statement of financial
position
At 31 Mar 2023 At 31 Mar 2022
$m $m
----------------------------------------------------------------- -------------- --------------
Current assets 10 19
Non-current assets - -
Current liabilities (2,952) (1,682)
Non-current liabilities (26,747) (25,605)
Amounts due from subsidiaries that are not issuers or guarantors 14,067 8,652
Amounts due to subsidiaries that are not issuers or guarantors (296) (297)
------------------------------------------------------------------ -------------- --------------
Foreign exchange
The Company's transactional currency exposures on
working-capital balances, which typically extend for up to three
months, are hedged where practicable using forward foreign exchange
contracts against the individual companies' reporting currency.
Foreign exchange gains and losses on forward contracts for
transactional hedging are taken to profit or loss. In addition, the
Company's external dividend payments, paid principally in pounds
sterling and Swedish krona, are fully hedged from announcement to
payment date.
Table 18 : Currency sensitivities
The Company provides the following currency-sensitivity
information:
Average Annual impact ($m) of 5%
rates vs USD strengthening (FY2023
average rate vs FY 2022
average) ([62])
--------- ------------- --------------------------------------------------- --------------------------
Currency Primary FY YTD Change Mar 2023 Change Total Core Operating
Relevance 2022 2023 [64] (%) [65] [66] Revenue Profit
[63] (%)
EUR Total Revenue 0.95 0.93 2 0.93 2 323 159
CNY Total Revenue 6.74 6.85 (1) 6.90 (2) 309 174
JPY Total Revenue 131.59 132.35 (1) 133.77 (2) 181 122
Other
([67]) 385 202
---------- ------------- -------- --------- ------ -------- -------- -------- ----------------
Operating
GBP expense 0.81 0.82 (2) 0.82 (2) 46 (92)
Operating
SEK expense 10.12 10.43 (3) 10.47 (3) 7 (55)
Sustainability
Since the last quarterly report, AstraZeneca:
Access to healthcare
-- Partnership for Health System Sustainability and Resilience
(PHSSR) published country reports in Belgium, Ireland, and the
Netherlands, and key findings were presented at events held in
those countries. PHSSR also launched a health system sustainability
index in Germany in collaboration with key stakeholders.
AstraZeneca is a founding member and one of six global partners of
the PHSSR, which is now active in more than 30 countries
worldwide
-- Strengthened healthcare innovation in China, partnering with
government and the healthcare ecosystem, building on the Company's
position as an industry leader and on its 30-year history. During
events attended by CEO Pascal Soriot, the Company made the
following announcements:
-- New investment to build a manufacturing plant in Qingdao city
to produce Breztri pressurised metered-dose inhalers (pMDI) for
COPD patients in China. The local investment provides increased
access to a life-changing medicine for Chinese patients to meet a
very significant unmet need, and helps to tackle the burden of COPD
on the health system in China
-- Partnership with Shandong province to establish an innovative
rare diseases diagnosis and treatment hub
-- Partnership with the Chinese Red Cross Foundation to
revitalise rural parts of China through an RMB 30 million
investment to enhance health services and support disaster
relief
-- Healthy Heart Africa programme launched in eight of 10 new
countries planned by 2024, working with implementing partners ACHAP
and PATH, in addition to the existing nine countries of operation.
Over 34 million blood pressure screenings have been conducted since
screenings began in 2015, with over one million screenings in
February alone, and more than 10,600 healthcare workers trained to
date, as at end of February 2023
-- Renewed Young Health Programme commitments in five countries
(Canada, France, Italy, Israel and Sweden). Directly reached more
than 700,000 young people with health information and trained more
than 35,000 young people, healthcare professionals and others, in
39 countries
-- A.Catalyst Network, AstraZeneca's interconnected and dynamic
global network of more than 20 health innovation hubs, has now
launched in Africa. The Africa health innovation hub will focus on
disease education, early diagnosis, technology and data generation,
to reduce mortality rates and improve patient quality of life. The
Company also signed a partnership with MedSol Ai Solutions to
develop Melusi Breast AI, a state-of-the-art Wi-Fi ultrasound probe
for rapid breast cancer detection
Environmental protection
-- CEO Pascal Soriot convened the SMI Health Systems Task Force
which announced joint minimum climate and sustainability targets
for pharmaceutical suppliers in March 2023, to address greenhouse
gas emissions across the value chain and reduce the complexity for
suppliers of multiple requirements
-- The Company's commitment to reducing its Scope 3 indirect
greenhouse gas emissions is shown by its target of 95% of suppliers
by spend covering purchased goods and services and capital goods,
and 50% of suppliers by spend covering upstream transportation and
distribution and business travel, to have science-based targets by
the end of 2025. AstraZeneca was also recognised in March by CDP as
a 2022 Supplier Engagement Rating Leader
-- Committed to the Business Leaders' Open Call to Accelerate
Action on Water, which coincided with the UN 2023 Water Conference.
The Company's efforts are underpinned by a partnership with the WWF
and membership of the Alliance for Water Stewardship. AstraZeneca
works with suppliers and across sectors to improve water
resilience, focusing on 100 priority water basins. Starting in
2024, the Company will invest $5 million per year to fund nature
restoration and water stewardship projects in the communities where
it operates. Details are included in the Biodiversity Statement,
published alongside the 2022 Sustainability Report and Data
Summary
-- Marked UN International Day of Forests by reflecting on AZ
Forest progress. AZ Forest is the Company's global initiative to
plant and maintain over 50 million trees worldwide by end of 2025,
in partnership with expert delivery partners focused on forest
landscape restoration, and by investing in community-led projects
adapted to the local context. More than 10.5 million trees have
been planted to date in Australia, Ghana, Indonesia, the UK and the
US
Ethics and transparency
-- Marked International Women's Day (IWD) in March, including an
article published on "championing women in the workplace and
beyond", highlighting what AstraZeneca is doing to champion women
and promote a culture of inclusion and diversity, including
advancing women's careers in science, technology, engineering, and
mathematics (STEM) inside and outside the Company. AstraZeneca also
recognised UN International Day of Women and Girls in Science in
February, a day dedicated to promoting equal access for women and
girls to participate in STEM careers. Currently 39.8% of
STEM-related positions at AstraZeneca are held by women
-- Marked UN International Day for the Elimination of Racial
Discrimination in March, with an update on the progress AstraZeneca
has made against its racial equity commitments since becoming a
founding member of the World Economic Forum Partnering for Racial
Justice in Business initiative
-- Recognised Neurodiversity Celebration Week across the
organisation with events across the organisation including an
experience lab designed to give colleagues an opportunity to
experience what it is like to live with autism, sensory processing
disorder and other neurodiversities
-- Reported the results of the first employee Ethics Survey
2022, carried out to gain a deeper understanding of employee
perspectives on ethics at AstraZeneca and identify opportunities
for improvement. Almost 7,000 employees participated, 97% of whom
know how to raise a concern, with 88% saying it is easy to do the
right thing in their day-to-day work
Research and development
This section covers R&D events and milestones that have
occurred since the prior results announcement on 9 February 2023,
up to and including events on 26 April 2023.
A comprehensive view of AstraZeneca's pipeline of medicines in
human trials can be found in the latest clinical trials appendix,
available on www.astrazeneca.com/investor-relations . The clinical
trials appendix includes tables with details of the ongoing
clinical trials for AstraZeneca medicines and new molecular
entities in the pipeline.
Oncology
AstraZeneca presented new data across its diverse portfolio of
cancer medicines at two major medical congresses during the
quarter: the 2023 American Society of Clinical Oncology
Genitourinary Cancers Symposium (ASCO GU) in February and American
Association for Cancer Research (AACR) in April. At ASCO GU,
AstraZeneca presented 11 abstracts spanning three approved
medicines and four pipeline medicines. At AACR, AstraZeneca
presented 70 abstracts showcasing new data across 21 pipeline
molecules and eight marketed products across the oncology
portfolio.
AstraZeneca completed an exclusive global license agreement with
KYM Biosciences Inc. for CMG901, a potential first-in-class
antibody drug conjugate targeting Claudin 18.2, a promising
therapeutic target in gastric cancers, with a molecule monomethyl
auristatin E (MMAE) warhead. CMG901 is currently being evaluated in
a Phase I trial for the treatment of Claudin 18.2-positive solid
tumours, including gastric cancer with preliminary results showing
an encouraging profile for CMG901.
-- Significant new trials that achieved first patient dosed during the period included:
-- CAMBRIA-1, a Phase III trial of camizestrant vs standard
endocrine therapy in ER+/HER2- early breast cancer after at least 2
years of standard adjuvant endocrine therapy
Tagrisso
Event Commentary
----------- ------ ------------------------------------------------------
Phase III ADAURA Met key secondary endpoint demonstrating statistically
trial read significant and clinically meaningful improvement
out in OS [68] compared to placebo in the adjuvant
treatment of patients with early-stage EGFRm
[69] NSCLC after complete tumour resection with
curative intent. (March 2023)
----------- ------ ------------------------------------------------------
Imfinzi and Imjudo
Event Commentary
------------- ------ -------------------------------------------------------
Approval EU Imfinzi in combination with Imjudo for the 1st-line
treatment of adult patients with advanced or
unresectable HCC. (HIMALAYA, February 2023)
Imfinzi in combination with Imjudo for the treatment
of adult patients with metastatic NSCLC. (POSEIDON,
February 2023)
Presentation: AEGEAN Results from interim EFS analysis of the AEGEAN
AACR Phase III trial, presented at AACR, demonstrated
statistically significant and clinically meaningful
32% reduction in risk of disease recurrence,
progression events or death for Imfinzi in combination
with neoadjuvant chemotherapy before surgery
and as adjuvant monotherapy after surgery versus
neoadjuvant chemotherapy alone followed by surgery
for patients with resectable early-stage NSCLC.
(April 2023)
------------- ------ -------------------------------------------------------
Lynparza
Event Commentary
--------------- ---------------- -----------------------------------------------------
Presentation: PROpel final Results from the final prespecified OS analysis
ASCO GU OS of the PROpel Phase III trial, presented at ASCO
GU, demonstrated Lynparza in combination with
abiraterone resulted in median OS improvement
of 7.4-months vs standard of care in mCRPC (not
statistically significant). (February 2023)
FDA ODAC US
The FDA will convene a meeting of the ODAC on
28 April 2023 to discuss the sNDA [70] for Lynparza
in combination with abiraterone for the treatment
of mCRPC. (PROpel, March 2023)
Phase III DUO-O ( Lynparza Met primary endpoint demonstrating a statistically
trial read-out and Imfinzi) significant and clinically meaningful improvement
in PFS versus chemotherapy plus bevacizumab in
newly diagnosed patients with advanced high-grade
epithelial ovarian cancer without tumour BRCA
mutations. (April 2023)
--------------- ---------------- -----------------------------------------------------
Calquence
Event Commentary
----------- ----- ----------------------------------------------------
Approval EU Maleate tablet formulation. (ELEVATE-PLUS, February
2023)
Conditional China Patients with mantle cell lymphoma who have received
approval at least one prior therapy. (ACE-LY-004 and Phase
I/II trial in Chinese patients, March 2023)
----------- ----- ----------------------------------------------------
Enhertu
Event Commentary
--------- ------------------ ------------------------------------------------------
Approval China Patients with unresectable or metastatic HER2-positive
breast cancer who have received one or more prior
anti-HER2-based regimens, based on DESTINY--Breast03
trial. (February 2023)
Phase II DESTINY-PanTumor02 Met the prespecified target for objective response
read out rate and demonstrated durable response across
multiple HER2-expressing advanced solid tumours
in heavily pre-treated patients. (DESTINY-PanTumor02,
March 2023)
--------- ------------------ ------------------------------------------------------
BioPharmaceuticals - CVRM
eplontersen
Event Commentary
------------- ---------------- -------------------------------------------------------------
Presentation: NEURO-TTRansform Detailed results from the NEURO-TTRansform Phase
AAN III trial in patients with hereditary transthyretin-mediated
amyloid polyneuropathy (ATTRv-PN) presented at
the American Academy of Neurology (AAN) 2023
Annual Meeting showed that eplontersen met all
co-primary and secondary endpoints at 66 weeks
versus an external placebo group. (April 2023).
------------- ---------------- -------------------------------------------------------------
cotadutide
Event Commentary
----------- --------------- ----------------------------------------------------
Termination PROXYMO ADVANCE Strategic decision to discontinue the development
of once-daily cotadutide and focus on AZD9550,
a once-weekly injectable GLP-1 glucagon co-agonist,
and the broader NASH pipeline. (March 2023)
----------- --------------- ----------------------------------------------------
BioPharmaceuticals - R&I
Significant new trials that achieved first patient dosed during
the period included:
-- CROSSING, a Phase III trial of Tezspire in eosinophilic oesophagitis
Fasenra
Event Commentary
--------------- ------- -------------------------------------------------------
Phase III MIRACLE Met the primary endpoint, demonstrating a statistically
trial read-out significant reduction in annual asthma exacerbation
rate (AAER) over 48 weeks compared to placebo
in patients in China with a history of uncontrolled
asthma.
Phase III TATE Met the primary endpoints, demonstrating that
trial read-out the safety and tolerability profile in severe
eosinophilic asthma patients aged 6 to 11 years
was consistent with previous trials in patients
ages 12 years and older.
--------------- ------- -------------------------------------------------------
BioPharmaceuticals - V&I
AstraZeneca highlighted new data across its Vaccines and Immune
Therapies portfolio at the 33rd European Congress of Clinical
Microbiology & Infectious Diseases (ECCMID) in April 2023. The
company presented 15 abstracts, including four oral
presentations.
AZD3152
Event Commentary
------------- -------------------------------------------------------
Presentation: US AstraZeneca presented the first in vitro neutralisation
ECCMID 2023 data on AZD3152, including activity against past
and currently circulating COVID-19 variants.
The data showed that AZD3152 neutralises all
known variants of concern to date. (April 2023)
------------- -------------------------------------------------------
Flumist
Event Commentary
---------- ----- -------------------------------------------------------------
Regulatory Japan As previously announced in 2015, Daiichi Sankyo
approval has responsibility for the development and commercialisation
of FluMist Quadrivalent in Japan, and holds the
marketing authorisation following approval in
Japan in March 2023. AstraZeneca will supply
FluMist Quadrivalent to Daiichi Sankyo, and will
receive development milestones and sales-related
payments post launch. (March 2023)
---------- ----- -------------------------------------------------------------
Beyfortus
Event Commentary
------------- ------ ---------------------------------------------------------
Publication: MELODY Serum samples were collected from 2,143 infants
Nature to characterise the duration of RSV nAb [71]
levels following nirsevimab administration. Nirsevimab
recipients had RSV nAb levels >140-fold higher
than baseline at day 31, and remained >50-fold
higher at day 151 and >7-fold higher at day 361.
(April 2023)
Presentation: MUSIC At ECCMID 2023, AstraZeneca presented results
ECCMID 2023 from the MUSIC trial for nirsevimab in immunocompromised
children <= 24 months of age. A single dose of
nirsevimab was well tolerated and no safety concerns
arose over 151 days. (April 2023)
Contract In April 2023, AstraZeneca, Sanofi and Sobi simplified
update their contractual arrangements relating to the
development and commercialisation of nirsevimab
in the US. The updated arrangements replaced
the cash flows from AstraZeneca to Sobi with
a royalty relationship between Sanofi and Sobi.
Sanofi continues to lead commercialisation globally,
and AstraZeneca will co-promote Beyfortus in
the UK, Germany, Italy, Spain, Japan and China.
(April 2023)
------------- ------ ---------------------------------------------------------
Rare Disease
Alexion, AstraZeneca Rare Disease, showcased the potential for
its pioneering therapies to redefine the treatment landscape for
certain rare neurological diseases at the American Academy of
Neurology (AAN) Annual Meeting. Alexion presented 18 abstracts,
including seven oral presentations, across generalised myasthenia
gravis (gMG), neuromyelitis optica spectrum disorder (NMOSD) and
dermatomyositis.
-- Significant new trials that achieved first patient dosed during the period included:
-- ARTEMIS, a Phase III trial assessing the efficacy of a single
dose of Ultomiris compared with placebo in reducing the risk of the
clinical consequences of acute kidney injury in adult participants
with CKD who undergo non-emergent cardiac surgery with
cardiopulmonary bypass.
Ultomiris
Event Commentary
-------- ----------------------------------------------
Positive EU Recommended for approval in the EU by CHMP for
opinion the treatment of adults with NMOSD
-------- ----------------------------------------------
ALXN1840
Event Commentary
----------- -------------- ---------------------------------------------------
Termination Wilson Disease In April, the ALXN1840 programme in Wilson Disease
programme was terminated. The decision was based on feedback
from regulators, on review of data from the Wilson
Disease programme, including the Phase III FoCus
and two Phase II mechanistic trials
----------- -------------- ---------------------------------------------------
Interim Financial Statements
Table 19 : Condensed consolidated statement of comprehensive
income: Q1 2023
For the quarter ended 31 March 2023 2022
$m $m
------- -------
Total Revenue [72] 10,879 11,390
Product Sales 10,566 10,980
Alliance Revenue 286 152
Collaboration Revenue 27 258
------------------------------------------------------------------------------------------- ------- -------
Cost of sales (1,905) (3,511)
------------------------------------------------------------------------------------------- ------- -------
Gross profit 8,974 7,879
------------------------------------------------------------------------------------------- ------- -------
Distribution expense (134) (125)
Research and development expense (2,611) (2,133)
Selling, general and administrative expense (4,059) (4,840)
Other operating income and expense 379 97
------------------------------------------------------------------------------------------- ------- -------
Operating profit 2,549 878
------------------------------------------------------------------------------------------- ------- -------
Finance income 78 17
Finance expense (365) (336)
Share of after tax losses in associates and joint ventures - (6)
------------------------------------------------------------------------------------------- ------- -------
Profit before tax 2,262 553
------------------------------------------------------------------------------------------- ------- -------
Taxation (458) (165)
------------------------------------------------------------------------------------------- ------- -------
Profit for the period 1,804 388
------------------------------------------------------------------------------------------- ------- -------
Other comprehensive income
Items that will not be reclassified to profit or loss
Remeasurement of the defined benefit pension liability (10) 335
Net gains on equity investments measured at fair value through other comprehensive income 46 18
Fair value movements related to own credit risk on bonds designated as fair value through
profit or loss 2 -
Tax on items that will not be reclassified to profit or loss 24 (94)
------------------------------------------------------------------------------------------- ------- -------
62 259
------- -------
Items that may be reclassified subsequently to profit or loss
Foreign exchange arising on consolidation 314 (219)
Foreign exchange arising on designated liabilities in net investment hedges (7) (32)
Fair value movements on cash flow hedges 56 5
Fair value movements on cash flow hedges transferred to profit and loss (75) 11
Fair value movements on derivatives designated in net investment hedges 16 (8)
Tax on items that may be reclassified subsequently to profit or loss 12 1
------------------------------------------------------------------------------------------- ------- -------
316 (242)
------- -------
Other comprehensive income, net of tax 378 17
------------------------------------------------------------------------------------------- ------- -------
Total comprehensive income for the period 2,182 405
------------------------------------------------------------------------------------------- ------- -------
Profit attributable to:
------------------------------------------------------------------------------------------- ------- -------
Owners of the Parent 1,803 386
Non-controlling interests 1 2
------------------------------------------------------------------------------------------- ------- -------
1,804 388
------- -------
Total comprehensive income attributable to:
------------------------------------------------------------------------------------------- ------- -------
Owners of the Parent 2,181 405
Non-controlling interests 1 -
------------------------------------------------------------------------------------------- ------- -------
2,182 405
------- -------
Basic earnings per $0.25 Ordinary Share $1.16 $0.25
Diluted earnings per $0.25 Ordinary Share $1.16 $0.25
Weighted average number of Ordinary Shares in issue (millions) 1,549 1,548
Diluted weighted average number of Ordinary Shares in issue (millions) 1,560 1,561
------------------------------------------------------------------------------------------- ------- -------
Table 20 : Condensed consolidated statement of financial
position
At 31 Mar At 31 Dec At 31 Mar
2023 2022 2022
$m $m $m
------------------------------------------------------------------ --------- --------- ---------
Assets
Non-current assets
Property, plant and equipment 8,644 8,507 9,061
Right-of-use assets 955 942 954
Goodwill 20,001 19,820 19,963
Intangible assets 39,291 39,307 41,265
Investments in associates and joint ventures 77 76 63
Other investments 1,157 1,066 1,174
Derivative financial instruments 116 74 87
Other receivables 682 835 864
Deferred tax assets 3,498 3,263 4,195
------------------------------------------------------------------- --------- --------- ---------
74,421 73,890 77,626
--------- --------- ---------
Current assets
Inventories 4,967 4,699 7,624
Trade and other receivables 10,289 10,521 8,683
Other investments 230 239 61
Derivative financial instruments 40 87 54
Intangible assets - - 96
Income tax receivable 508 731 367
Cash and cash equivalents 6,232 6,166 5,762
Assets held for sale - 150 -
------------------------------------------------------------------- --------- --------- ---------
22,266 22,593 22,647
--------- --------- ---------
Total assets 96,687 96,483 100,273
------------------------------------------------------------------- --------- --------- ---------
Liabilities
Current liabilities
Interest-bearing loans and borrowings (3,625) (5,314) (2,069)
Lease liabilities (232) (228) (225)
Trade and other payables (19,210) (19,040) (17,864)
Derivative financial instruments (44) (93) (35)
Provisions (546) (722) (1,423)
Income tax payable (1,203) (896) (1,124)
------------------------------------------------------------------- --------- --------- ---------
(24,860 ) (26,293) (22,740 )
--------- --------- ---------
Non-current liabilities
Interest-bearing loans and borrowings (26,916) (22,965) (28,081)
Lease liabilities (730) (725) (724)
Derivative financial instruments (133) (164) (47)
Deferred tax liabilities (2,795) (2,944) (5,626)
Retirement benefit obligations (1,128) (1,168) (1,991)
Provisions (914) (896) (949)
Other payables (3,400) (4,270) (3,756)
------------------------------------------------------------------- --------- --------- ---------
(36,016 ) (33,132) (41,174 )
--------- --------- ---------
Total liabilities (60,876 ) (59,425) (63,914 )
------------------------------------------------------------------- --------- --------- ---------
Net assets 35,811 37,058 36,359
------------------------------------------------------------------- --------- --------- ---------
Equity
Capital and reserves attributable to equity holders of the Parent
Share capital 387 387 387
Share premium account 35,159 35,155 35,131
Other reserves 2,068 2,069 2,050
Retained earnings (1,825) (574) (1,228)
------------------------------------------------------------------- --------- --------- ---------
35,789 37,037 36,340
Non-controlling interests 22 21 19
------------------------------------------------------------------- --------- --------- ---------
Total equity 35,811 37,058 36,359
------------------------------------------------------------------- --------- --------- ---------
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 2022 387 35,126 2,045 1,710 39,268 19 39,287
------------------------ -------- -------- --------- --------- ------------- --------------- -------
Profit for the period - - - 386 386 2 388
Other comprehensive
income - - - 19 19 (2) 17
Transfer to other
reserves - - 5 (5) - - -
Transactions with
owners
Dividends - - - (3,046) (3,046) - (3,046)
Issue of Ordinary
Shares - 5 - - 5 - 5
Share-based payments
charge for the period - - - 182 182 - 182
Settlement of share
plan awards - - - (474) (474) - (474)
Net movement - 5 5 (2,938) (2,928) - (2,928)
------------------------ -------- -------- --------- --------- ------------- --------------- -------
At 31 Mar 2022 387 35,131 2,050 (1,228) 36,340 19 36,359
------------------------ -------- -------- --------- --------- ------------- --------------- -------
At 1 Jan 2023 387 35,155 2,069 (574) 37,037 21 37,058
------------------------ -------- -------- --------- --------- ------------- --------------- -------
Profit for the period - - - 1,803 1,803 1 1,804
Other comprehensive
income - - - 378 378 - 378
Transfer to other
reserves - - (1) 1 - - -
Transactions with
owners
Dividends - - - (3,047) (3,047) - (3,047)
Issue of Ordinary
Shares - 4 - - 4 - 4
Share-based payments
charge for the period - - - 132 132 - 132
Settlement of share
plan awards - - - (518) (518) - (518)
------------------------ -------- -------- --------- --------- ------------- --------------- -------
Net movement - 4 (1) (1,251) (1,248) 1 (1,247)
------------------------ -------- -------- --------- --------- ------------- --------------- -------
(1,825
At 31 Mar 2023 387 35,159 2,068 ) 35,789 22 35,811
------------------------ -------- -------- --------- --------- ------------- --------------- -------
Table 22 : Condensed consolidated statement of cash flows
For the quarter ended 31 March 2023 2022
$m $m
Cash flows from operating activities
Profit before tax 2,262 553
Finance income and expense 287 319
Share of after tax losses of associates and
joint ventures - 6
Depreciation, amortisation and impairment 1,502 1,309
Decrease in working capital and short-term provisions 242 1,804
Gains on disposal of intangible assets (249) (10)
Non-cash and other movements (429) (327)
------------------------------------------------------- ------- -------
Cash generated from operations 3,615 3,654
------------------------------------------------------- ------- -------
Interest paid (257) (194)
Tax paid (225) (228)
------------------------------------------------------- ------- -------
Net cash inflow from operating activities 3,133 3,232
------------------------------------------------------- ------- -------
Cash flows from investing activities
Acquisition of subsidiaries, net of cash acquired (189) -
Payments upon vesting of employee share awards
attributable to business combinations (23) (55)
Payment of contingent consideration from business
combinations (214) (182)
Purchase of property, plant and equipment (247) (219)
Disposal of property, plant and equipment 125 -
Purchase of intangible assets (1,223) (144)
Disposal of intangible assets 264 385
Movement in profit-participation liability 175 -
Purchase of non-current asset investments - (4)
Disposal of non-current asset investments 10 32
Movement in short-term investments, fixed deposits
and other investing instruments 9 21
Payments to associates and joint ventures - (5)
Interest received 67 3
------------------------------------------------------- ------- -------
(1,246
Net cash outflow from investing activities ) (168 )
------------------------------------------------------- ------- -------
Net cash inflow before financing activities 1,887 3,064
------------------------------------------------------- ------- -------
Cash flows from financing activities
Proceeds from issue of share capital 4 5
Issue of loans and borrowings 3,826 -
Repayment of loans and borrowings (2,004) (4)
Dividends paid (3,047) (2,971)
Hedge contracts relating to dividend payments 27 (77)
Repayment of obligations under leases (67) (74)
Movement in short-term borrowings 97 301
Payment of Acerta Pharma share purchase liability (867) (920)
------------------------------------------------------- ------- -------
(2,031
Net cash outflow from financing activities ) (3,740)
------------------------------------------------------- ------- -------
Net decrease in Cash and cash equivalents in
the period (144) (676)
Cash and cash equivalents at the beginning of
the period 5,983 6,038
Exchange rate effects (11) (9)
------------------------------------------------------- ------- -------
Cash and cash equivalents at the end of the
period 5,828 5,353
------------------------------------------------------- ------- -------
Cash and cash equivalents consist of:
Cash and cash equivalents 6,232 5,762
Overdrafts (404) (409)
------------------------------------------------------- ------- -------
5,828 5,353
------- -------
Notes to the Interim Financial Statements
Note 1: Basis of preparation and accounting policies
These unaudited condensed consolidated Interim financial
statements for the three months ended 31 March 2023 have been
prepared in accordance with International Accounting Standard 34,
'Interim Financial Reporting' (IAS 34), as issued by the
International Accounting Standards Board (IASB), IAS 34 as adopted
by the European Union, UK-adopted IAS 34 and the Disclosure
Guidance and Transparency Rules sourcebook of
the United Kingdom's Financial Conduct Authority and with the
requirements of the Companies Act 2006 as
applicable to companies reporting under those standards.
The unaudited Interim financial statements for the three months
ended 31 March 2023 were approved by
the Board of Directors for publication on 27 April 2023.
This results announcement does not constitute statutory accounts
of the Group within the meaning of sections
434(3) and 435(3) of the Companies Act 2006. The annual
financial statements of the Group for the year ended 31 December
2022 were prepared in accordance with UK-adopted International
Accounting Standards and with the requirements of the Companies Act
2006. The annual financial statements also comply fully with IFRSs
as issued by the IASB and International Accounting Standards as
adopted by the European Union. Except for the estimation of the
interim income tax charge, the Interim Financial Statements have
been prepared applying the accounting policies that were applied in
the preparation of the Group's published consolidated financial
statements for the year ended 31 December 2022.
The comparative figures for the financial year ended 31 December
2022 are not the Group's statutory accounts for that financial
year. Those accounts have been reported on by the Group's auditors
and will be delivered to the registrar of companies; their report
was (i) unqualified, (ii) did not include a reference to any
matters to which the auditors drew attention by way of emphasis
without qualifying their report, and (iii) did not contain a
statement under section 498(2) or (3) of the Companies Act
2006.
Alliance and Collaboration Revenues
Effective 1 January 2023, the Group has updated the presentation
of Total Revenue on the face of the Statement of Comprehensive
Income to include Alliance Revenue as a separate element to
Collaboration Revenue. Alliance Revenue, previously reported within
Collaboration Revenue, comprises income related to sales made by
collaboration partners, where AstraZeneca is entitled to a profit
share, revenue share or royalties, which are recurring in nature
while the collaboration arrangement remains in place. Alliance
Revenue does not include Product Sales where AstraZeneca is leading
commercialisation in a territory. Collaboration Revenue arising
from collaborative arrangements where the Group retains a
significant ongoing economic interest and receives upfront amounts
and event-triggered milestones, which arise from the licensing of
intellectual property, will continue to be reported as
Collaboration Revenue. In collaboration arrangements either
AstraZeneca or the collaborator acts as principal in sales to the
end customer. Where AstraZeneca acts as principal, we record 100%
of sales to the end customer within Product Sales. The revised
presentation reflects the increasing importance of income arising
from profit share arrangements where collaboration partners are
responsible for booking revenues in some or all territories.
The comparative revenue reported in Q1 2023 relating to the
quarter to 31 March 2022 has been retrospectively adjusted to
reflect the new split of Total Revenue, resulting in Alliance
Revenue being reported for the quarter ending 31 March 2022 of
$152m, however the combined total of Alliance Revenue and
Collaboration Revenue is equal to the previously reported
Collaboration Revenue total for the quarter ending 31 March
2022.
Going concern
The Group has considerable financial resources available. As at
31 March 2023, the Group has $13.1bn in financial resources (Cash
and cash equivalent balances of $6.2bn and undrawn committed bank
facilities of $6.9bn available, of which $2.0bn of the facilities
are available until February 2025 and the other $4.9bn are
available until April 2026, with only $3.9bn of borrowings due
within one year). These facilities contain no financial covenants
and were undrawn at 31 March 2023.
The Group's revenues are largely derived from sales of medicines
covered by patents which provide a relatively high level of
resilience and predictability to cash inflows, although government
price interventions in response to budgetary constraints are
expected to continue to adversely affect revenues in some of our
significant markets. The Group, however, anticipates new revenue
streams from both recently launched medicines and those in
development, and the Group has a wide diversity of customers and
suppliers across different geographic areas.
Consequently, the Directors believe that, overall, the Group is
well placed to manage its business risks successfully. Accordingly,
they continue to adopt the going concern basis in preparing the
Interim Financial Statements.
Legal proceedings
The information contained in Note 5 updates the disclosures
concerning legal proceedings and contingent liabilities in the
Group's Annual Report and Form 20-F Information 2022 .
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 $271m have been recorded against
intangible assets during the three months ended 31 March 2023 (Q1
2022: $94m net reversal). Net impairment charges in respect of
medicines in development were $271m (Q1 2022: $77m reversal)
including the $244m impairment of the ALXN1840 intangible asset,
following decision to discontinue this development programme in
Wilsons disease.
The acquisition of CinCor completed on 24 February 2023,
recorded as an asset acquisition, with consideration and net assets
acquired of $1,268m, which included intangible assets acquired of
$780m, $424m of cash and cash equivalents, and $75m of marketable
securities. Contingent consideration of up to $496m could be paid
on achievement of regulatory milestones, those liabilities will be
recorded when milestones are triggered, or performance conditions
have been satisfied.
Note 3: Net debt
The table below provides an analysis of Net Debt and a
reconciliation of Net Cash Flow to the movement in Net Debt. The
Group monitors Net Debt as part of its capital-management policy as
described in Note 28 of the Annual Report and Form 20-F Information
2022 . Net Debt is a non-GAAP financial measure.
Table 23 : Net debt
At 1 Jan 2023 Cash flow Acquisitions Non-cash Exchange movements At 31 Mar 2023
& other
$m $m $m $m $m $m
----------------------------- ------------- --------- ------------ -------- ------------------ --------------
Non-current instalments of
loans (22,965) (3,826) - (7) (118) (26,916)
Non-current instalments of
leases (725) - (6) 6 (5) (730)
------------------------------ ------------- --------- ------------ -------- ------------------ --------------
Total long-term debt (23,690 ) (3,826) (6 ) (1) (123) (27,646 )
Current instalments of loans (4,964) 2,004 - 2 - (2,958)
Current instalments of leases (228) 72 (2) (73) (1) (232)
Commercial paper - (74) - - - (74)
Bank collateral received (89) (10) - - - (99)
Other short-term borrowings
excluding overdrafts (78) (13) - - 1 (90)
Overdrafts (183) (218) - - (3) (404)
------------------------------ ------------- --------- ------------ -------- ------------------ --------------
Total current debt (5,542 ) 1,761 (2 ) (71 ) (3) (3,857 )
------------------------------ ------------- --------- ------------ -------- ------------------ --------------
Gross borrowings (29,232 ) (2,065) (8 ) (72 ) (126) (31,503 )
Net derivative financial
instruments (96) (17) - 92 - (21)
------------------------------ ------------- --------- ------------ -------- ------------------ --------------
Net borrowings (29,328 ) (2,082) (8 ) 20 (126) (31,524 )
Cash and cash equivalents 6,166 74 - - (8) 6,232
Other investments - current 239 (9) - - - 230
------------------------------ ------------- --------- ------------ -------- ------------------ --------------
Cash and investments 6,405 65 - - (8 ) 6,462
------------------------------ ------------- --------- ------------ -------- ------------------ --------------
Net debt (22,923 ) (2,017) (8) 20 (134) (25,062 )
------------------------------ ------------- --------- ------------ -------- ------------------ --------------
Non-cash movements in the period include fair value adjustments
under IFRS 9 Financial Instruments.
The Group has agreements with some bank counterparties whereby
the parties agree to post cash collateral on financial derivatives,
for the benefit of the other, equivalent to the market valuation of
the derivative positions above a predetermined threshold. The
carrying value of such cash collateral held by the Group at 31
March 2023 was $99m (31 December 2022: $89m) and the carrying value
of such cash collateral posted by the Group at 31 March 2023 was
$164m (31 December 2022: $162m).
The equivalent GAAP measure to Net debt is 'liabilities arising
from financing activities', which excludes the amounts for cash and
overdrafts, other investments and non-financing derivatives shown
above and includes the Acerta Pharma share purchase liability of
$792m (31 December 2022: $1,646m), which is shown in current other
payables.
Net debt increased by $2,139m in the year to date to $25,062m.
Details of the committed undrawn bank facilities are disclosed
within the going concern section of Note 1.
During the three months ended 31 March 2023, there were no
changes to the Company's solicited credit ratings issued by
Standard and Poor's (long term: A; short term: A-1) and from
Moody's (long term: A3; short term: P--2).
Note 4: Financial Instruments
As detailed in the Group's most recent annual financial
statements, the principal financial instruments consist of
derivative financial instruments, other investments, trade and
other receivables, cash and cash equivalents, trade and other
payables, lease liabilities and interest-bearing loans and
borrowings.
The Group has certain equity investments that are categorised as
Level 3 in the fair value hierarchy that are held at $217m at 31
March 2023 (31 December 2022: $186m) and for which fair value gains
of $1m have been recognised in the three months ended 31 March 2023
(31 March 2022: $nil). 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 gains on equity investments measured at fair value
through other comprehensive income in the Condensed consolidated
statement of comprehensive income for the three months ended 31
March 2023 are Level 1 fair value measurements, valued based on
quoted prices in active markets.
Financial instruments measured at fair value include $1,162m of
other investments, $4,459m held in money-market funds, $291m of
loans designated at fair value through profit or loss and ($21m) of
derivatives as at 31 March 2023. With the exception of derivatives
being Level 2 fair valued, certain equity investments as described
above and an equity warrant of $20m categorised as Level 3, the
aforementioned balances are Level 1 fair valued. Financial
instruments measured at amortised cost include $61m of fixed
deposits and $164m of cash collateral pledged to counterparties.
The total fair value of interest-bearing loans and borrowings at 31
March 2023, which have a carrying value of $31,503m in the
Condensed consolidated statement of financial position, was
$30,576m.
Table 24 : Financial instruments - contingent consideration
2023 2022
Diabetes alliance Other Total Total
$m $m $m $m
------------------ --------- -------- ---------
At 1 January 2,124 98 2,222 2,865
--------------------------------------------- ------------------ --------- -------- ---------
Additions through business combinations - 60 60 -
Settlements (212) (2) (214) (182)
Disposals - - - (121)
Discount unwind 31 2 33 42
--------------------------------------------- ------------------ --------- -------- ---------
At 31 March 1,943 158 2,101 2,604
--------------------------------------------- ------------------ --------- -------- ---------
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 $1,943m (31 December 2022: $2,124m)
would increase/decrease by $194m with an increase/decrease in sales
of 10%, as compared with the current estimates.
Note 5: Legal proceedings and contingent liabilities
AstraZeneca is involved in various legal proceedings considered
typical to its business, including litigation and investigations,
including Government investigations, relating to product liability,
commercial disputes, infringement of intellectual property (IP)
rights, the validity of certain patents, anti-trust law and sales
and marketing practices. The matters discussed below constitute the
more significant developments since publication of the disclosures
concerning legal proceedings in the Company's Annual Report and
Form 20-F Information 2022 (the Disclosures).
As discussed in the Disclosures, the majority of claims involve
highly complex issues. Often these issues are subject to
substantial uncertainties and, therefore, the probability of a
loss, if any, being sustained and/or an estimate of the amount of
any loss is difficult to ascertain.
Unless specifically identified below, AstraZeneca considers each
of the claims to represent a contingent liability or a contingent
asset where the matter is brought by AstraZeneca, and discloses
information with respect to the nature and facts of the cases in
accordance with IAS 37.
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 first quarter of 2023 and to
27 April 2023
Patent litigation
Enhertu
US patent proceedings
As previously disclosed, in December 2020 and January 2021,
AstraZeneca and Daiichi Sankyo, Inc. filed post-grant review (PGR)
petitions with the US Patent and Trademark Office (USPTO) alleging,
inter alia, that the Seagen patent is invalid for lack of written
description and enablement. The USPTO initially declined to
institute the PGRs, but, in April 2022, the USPTO granted the
rehearing requests, instituting both PGR petitions. Seagen
subsequently disclaimed all patent claims at issue in one of the
PGR proceedings. In July 2022, the USPTO reversed its institution
decision and declined to institute the other PGR petition.
AstraZeneca and Daiichi Sankyo, Inc. requested reconsideration of
the decision not to institute review of the patent. In February
2023, the USPTO reinstituted the PGR proceeding. An oral hearing is
scheduled for August 2023.
Lynparza
US patent proceedings
As previously disclosed, in December 2022, AstraZeneca received
a Paragraph IV notice letter from an abbreviated new drug
application (ANDA) filer relating to patents listed in the FDA
Orange Book with reference to Lynparza. In February 2023, in
response to the Paragraph IV notice, AstraZeneca, MSD International
Business GmbH, and the University of Sheffield initiated ANDA
litigation against Natco Pharma Limited (Natco) in the US District
Court for the District of New Jersey. In the complaint, AstraZeneca
alleged that Natco's generic version of Lynparza, if approved and
marketed, would infringe patents listed in the FDA Orange Book with
reference to Lynparza. No trial date has been scheduled.
Movantik
US patent proceedings
AstraZeneca has resolved by settlement the previously disclosed
patent infringement lawsuit brought by Aether Therapeutics, Inc. in
the US District Court for the District of Delaware against
AstraZeneca, Nektar Therapeutics and Daiichi Sankyo, Inc., relating
to Movantik. This matter is now concluded.
Symbicort
US patent proceedings
AstraZeneca has resolved via settlement the previously disclosed
ANDA litigations with Mylan Pharmaceuticals Inc. and Kindeva Drug
Delivery L.P. (together, the Defendants). In those actions,
AstraZeneca alleged that the Defendants' generic versions of
Symbicort, if approved and marketed, would infringe various
AstraZeneca patents. This matter is now concluded.
Tagrisso
Patent proceedings outside the US
In Russia, in October 2021, AstraZeneca filed a lawsuit in the
Arbitration Court of the Moscow Region (the Court) against
Axelpharm, LLC to prevent it from obtaining authorisation to market
a generic version of Tagrisso prior to the expiration of
AstraZeneca's patents covering Tagrisso. The lawsuit also names the
Ministry of Health of the Russian Federation as a third party. In
March 2022, the Court dismissed the lawsuit. In June 2022, the
dismissal was affirmed on appeal. In January 2023, the dismissal
was affirmed on further appeal. This matter is now concluded.
Product liability litigation
Nexium and Losec/Prilosec
US proceedings
In the US, AstraZeneca is defending various previously disclosed
lawsuits brought in federal and state courts involving multiple
plaintiffs claiming that they have been diagnosed with various
injuries following treatment with proton pump inhibitors (PPIs),
including Nexium and Prilosec. The vast majority of those lawsuits
relate to allegations of kidney injuries. In August 2017, the
pending federal court cases were consolidated in a multidistrict
litigation (MDL) proceeding in the US District Court for the
District of New Jersey for pre-trial purposes. A bellwether trial
has been scheduled for October 2023, with subsequent bellwether
trials scheduled for November 2023 and January 2024. In addition to
the MDL cases, there are cases filed in several state courts around
the US; a case that was previously set to go to trial in Delaware
state court was dismissed in October 2022.
In addition, AstraZeneca has been defending various lawsuits
involving allegations of gastric cancer following treatment with
proton pump inhibitors (PPIs), including Nexium and Prilosec. One
such claim is filed in the US District Court for the Middle
District of Louisiana has been scheduled to go to trial in April
2024.
Onglyza and Kombiglyze
US proceedings
As previously disclosed, in the US, AstraZeneca is defending
various lawsuits alleging heart failure, cardiac injuries, and/or
death from treatment with Onglyza or Kombiglyze. In February 2018,
the Judicial Panel on Multidistrict Litigation ordered the transfer
of various pending federal actions to the US District Court for the
Eastern District of Kentucky (the District Court) for consolidated
pre-trial proceedings with the federal actions pending in the
District Court. The District Court granted AstraZeneca's motion for
summary judgment in August 2022, and plaintiffs are in the process
of appealing that decision. In the California State Court
coordinated proceeding, AstraZeneca's motion for summary judgment
was granted in March 2022. Plaintiffs appealed, and in April 2023,
the California Appellate Court affirmed the lower court's decision
to grant summary judgment.
Commercial Litigation
Viela Bio, Inc. Shareholder Litigation
US proceedings
In February 2023, AstraZeneca was served with a lawsuit filed in
the Delaware State Court against AstraZeneca and certain officers,
on behalf of a putative class of Viela Bio, Inc. (Viela)
shareholders. The complaint alleges that defendants breached their
fiduciary duty to Viela shareholders in the course of Viela's 2021
merger with Horizon Therapeutics, plc. This case remains in the
preliminary stages.
Definiens
In Germany, in July 2020, AstraZeneca received a notice of
arbitration filed with the German Institution of Arbitration from
the sellers of Definiens AG (the Sellers) regarding the 2014 Share
Purchase Agreement (SPA) between AstraZeneca and the Sellers. The
Sellers claim that they are owed approximately $140m in earn-outs
under the SPA. The arbitration hearing took place in March 2023 and
AstraZeneca awaits a decision.
PARP Inhibitor Royalty Dispute
In October 2012, Tesaro, Inc. (now wholly owned by
GlaxoSmithKline plc, 'GSK') entered into two worldwide,
royalty-bearing patent license agreements with AstraZeneca related
to GSK's product niraparib. In May 2021, AstraZeneca filed a
lawsuit against GSK in the Commercial Court of England and Wales
alleging that GSK has failed to pay all of the royalties due on
niraparib sales under the license agreements. The case was
transferred to the Chancery Division and a trial took place in
March 2023. In April 2023, the court issued a decision in
AstraZeneca's favour.
Pay Equity Litigation (US)
AstraZeneca was defending a putative class and collective action
matter in the US District Court for the Northern District of
Illinois brought by three named plaintiffs, who are former
AstraZeneca pharmaceutical sales representatives. The case involved
claims under the federal and Illinois Equal Pay Acts, with the
plaintiffs alleging they were paid less than male employees who
performed substantially similar and/or equal work. The plaintiffs
sought various damages on behalf of themselves and the putative
class and/or collective, including without limitation backpay,
liquidated damages, compensatory and punitive damages, attorneys'
fees, and interest. In January 2023, the District Court granted
AstraZeneca's motion to dismiss plaintiffs' complaint. In March
2023, plaintiffs filed a Second Amended Complaint.
Portola Shareholder Litigation
In the US, in connection with Alexion's July 2020 acquisition of
Portola Pharmaceuticals, Inc (Portola), Alexion assumed litigation
to which Portola is a party. In January 2020, putative securities
class action lawsuits were filed in the US District Court for the
Northern District of California against Portola and certain
officers and directors, on behalf of purchasers of Portola publicly
traded securities during the period 8 January 2019 through 26
February 2020. The operative complaints allege that defendants made
materially false and/or misleading statements or omissions with
regard to Andexxa. In June 2022, the parties reached a settlement
in principle of this matter. In March 2023, the court granted final
approval of the settlement. This matter is now concluded.
Alexion Shareholder Litigation (US)
In December 2016, putative securities class action lawsuits were
filed in the US District Court for the District of Connecticut (the
District Court) against Alexion and certain officers and directors,
on behalf of purchasers of Alexion publicly traded securities
during the period 30 January 2014 through 26 May 2017. The amended
complaint alleges that defendants engaged in securities fraud,
including by making misrepresentations and omissions in its public
disclosures concerning Alexion's Soliris sales practices,
management changes, and relateds investigations. In August 2021,
the District Court issued a decision denying in part Defendants'
motion to dismiss the matter. The Court granted Plaintiffs' motion
for class certification in April 2023.
Syntimmune
In connection with Alexion's prior acquisition of Syntimmune,
Inc., (Syntimmune) in December 2020, Alexion was served with a
lawsuit filed by the stockholders' representative for Syntimmune in
Delaware State Court that alleged, among other things, breaches of
contractual obligations relating to the 2018 merger agreement. The
stockholders' representative alleges that Alexion failed to meet
its obligations under the merger agreement to use commercially
reasonable efforts to achieve the milestones. Alexion also filed a
claim for breach of the representations in the 2018 merger
agreement. A trial is scheduled for the matter in July 2023.
Government investigations/proceedings
Brazilian tax assessment matter (Brazil)
As previously disclosed, in August 2019, the Brazilian Federal
Revenue Service provided a Notice of Tax and Description of the
Facts (the Tax Assessment) to two Alexion subsidiaries (the Brazil
Subsidiaries), as well as to two additional entities, a logistics
provider utilised by Alexion and a distributor. The Tax Assessment
focuses on the importation of Soliris vials pursuant to Alexion's
free drug supply to patients programme in Brazil.
Alexion prevailed in the first level of administrative appeals
in the Brazilian federal administrative proceeding system based on
a deficiency in the Brazil Tax Assessment. The decision was subject
to an automatic (ex officio) appeal to the second level of the
administrative courts. In March 2023, the second level of the
administrative courts issued a decision to remand the matter to the
first level of administrative courts for a determination on the
merits.
Note 6: Subsequent events
In April 2023, the contractual relationship between AstraZeneca
and Sobi relating to future sales of nirsevimab in the US was
replaced by a royalty relationship between Sanofi and Sobi. As a
result, a liability representing AstraZeneca's future obligations
to Sobi will be eliminated from AstraZeneca's Statement of
Financial Position, and AstraZeneca will record a gain of $718m in
Core Other operating income in Q2 2023.
Table 25 : Q1 2023 - Product Sales year-on-year analysis
[73]
World US Emerging Markets Europe Established RoW
$m Act CER $m % chg $m Act CER $m Act CER $m Act CER
% chg % chg % chg % chg % chg % chg % chg % chg
-------------------- ------ ----- ------ ----- ----- ----- ----- ------ ----- ----- ------ ----- ----- --------
Oncology 3,920 16 21 1,704 24 966 8 16 760 17 24 490 4 19
Tagrisso 1,424 9 15 521 19 444 9 17 257 2 8 202 (2) 11
Imfinzi 900 50 56 522 66 81 39 47 163 31 38 134 33 52
Lynparza 651 5 10 268 (1) 137 13 19 178 11 18 68 2 16
Calquence 532 28 31 384 13 18 n/m n/m 108 95 n/m 22 76 91
Enhertu 37 n/m n/m - - 24 n/m n/m 10 n/m n/m 3 n/m n/m
Orpathys 8 (33) (27) - - 8 (33) (27) - - - - - -
Zoladex 227 (6) 3 3 (25) 167 - 10 33 (5) 1 24 (32) (22)
Faslodex 75 (19) (11) 4 (33) 37 (14) (7) 10 (39) (35) 24 (13) 1
Others 66 (32) (27) 2 (28) 50 (31) (27) 1 (55) (52) 13 (32) (22)
-------------------- ------ ----- ------ ----- ----- ----- ----- ------ ----- ----- ------ ----- ----- --------
BioPharmaceuticals:
CVRM 2,530 15 21 622 19 1,165 14 22 557 16 22 186 4 19
Farxiga 1,299 30 37 296 53 498 27 35 393 24 31 112 15 29
Brilinta 334 3 5 179 8 82 19 25 67 (12) (7) 6 (59) (53)
Lokelma 98 56 64 56 45 11 n/m n/m 11 98 n/m 20 29 50
roxadustat 61 49 63 - - 61 49 63 - - - - - -
Andexxa 44 34 42 20 (13) - - - 15 58 66 9 n/m n/m
Crestor 305 14 23 14 (22) 241 22 32 16 48 56 34 (18) (7)
Seloken /Toprol-XL 179 (27) (20) - - 173 (27) (21) 4 3 (3) 2 (23) (19)
Onglyza 63 (8) (3) 14 (26) 37 9 17 9 (17) (17) 3 (32) (17)
Bydureon 45 (33) (32) 38 (32) 1 44 45 7 (38) (34) (1) n/m n/m
Others 102 4 9 5 (25) 61 19 27 35 (5) (4) 1 (63) (59)
-------------------- ------ ----- ------ ----- ----- ----- ----- ------ ----- ----- ------ ----- ----- --------
BioPharmaceuticals:
R&I 1,583 5 10 617 (4) 533 22 31 292 5 11 141 (6) 3
Symbicort 688 2 7 233 (10) 229 37 48 147 (6) (1) 79 (14) (7)
Fasenra 338 10 13 201 6 14 n/m n/m 88 17 23 35 (4) 7
Breztri 144 67 73 81 53 38 71 85 15 n/m n/m 10 52 73
Saphnelo 47 n/m n/m 44 n/m - - - 1 n/m n/m 2 n/m n/m
Tezspire 11 n/m n/m - - - - - 7 n/m n/m 4 n/m n/m
Pulmicort 221 2 9 10 (54) 182 11 19 20 12 19 9 (31) (25)
Bevespi 15 (1) 2 9 (15) 2 9 21 4 55 64 - - -
Daliresp /Daxas 13 (75) (75) 9 (80) 1 (19) (17) 2 (6) (2) 1 35 (36)
Others 106 (27) (22) 30 (44) 67 (9) (1) 8 (54) (50) 1 (12) (7)
-------------------- ------ ----- ------ ----- ----- ----- ----- ------ ----- ----- ------ ----- ----- --------
BioPharmaceuticals:
V&I 355 (80) (78) - n/m 104 (84) (83) 98 (66) (64) 153 (66) (62)
COVID-19 mAbs 127 (73) (70) - n/m 8 (91) (91) 4 (94) (93) 115 n/m n/m
Vaxzevria 28 (97) (97) - n/m 18 (96) (96) 10 (93) (92) - n/m n/m
Synagis 198 (1) 5 - - 78 17 21 82 (5) - 38 (18) (7)
FluMist 2 n/m n/m - - - - - 2 n/m n/m - - -
-------------------- ------ ----- ------ ----- ----- ----- ----- ------ ----- ----- ------ ----- ----- --------
Rare Disease 1,866 10 14 1,094 7 173 51 57 387 7 14 212 7 21
Soliris 834 (16) (13) 448 (24) 115 63 77 183 (17) (12) 88 (18) (10)
Ultomiris 651 55 61 381 73 13 (46) (45) 159 52 61 98 39 61
Strensiq 262 26 28 205 28 15 70 58 21 10 17 21 7 22
Koselugo 79 n/m n/m 41 34 24 n/m n/m 11 n/m n/m 3 n/m n/m
Kanuma 40 4 6 19 3 6 (1) (6) 13 5 10 2 31 44
-------------------- ------ ----- ------ ----- ----- ----- ----- ------ ----- ----- ------ ----- ----- --------
Other medicines 312 (26) (21) 36 (8) 205 - 8 22 (38) (37) 49 (66) (62)
Nexium 244 (27) (20) 29 (12) 156 8 17 12 (19) (15) 47 (67) (62)
Others 68 (26) (23) 7 19 49 (18) (13) 10 (52) (52) 2 (63) (58)
-------------------- ------ ----- ------ ----- ----- ----- ----- ------ ----- ----- ------ ----- ----- --------
Total Product Sales 10,566 (4) 1 4,073 2 3,146 (5) 2 2,116 1 7 1,231 (23) (13)
-------------------- ------ ----- ------ ----- ----- ----- ----- ------ ----- ----- ------ ----- ----- --------
Table 26 : Alliance Revenue
Q1 2023 Q1 2022
$m $m
----------------------- ------- -------
Enhertu 220 76
Tezspire 43 3
Vaxzevria: royalties - 56
Other royalty income 20 16
Other Alliance Revenue 3 1
------------------------ ------- -------
Total 286 152
------------------------ ------- -------
Table 27 : Collaboration Revenue
Q1 2023 Q1 2022
$m $m
--------------------------------- ------- -------
Lynparza : regulatory milestones - 175
Farxiga : sales milestones 24 -
tralokinumab: sales milestones - 70
Other Collaboration Revenue 3 13
---------------------------------- ------- -------
Total 27 258
---------------------------------- ------- -------
Table 28 : Other Operating Income and Expense
Q1 2023 Q1 2022
$m $m
----------------------------------------------- ------- -------
brazikumab licence termination funding 38 35
Divestment of US rights to Pulmicort Flexhaler 241 -
Other 100 62
------------------------------------------------ ------- -------
Total 379 97
------------------------------------------------ ------- -------
Other shareholder information
Financial calendar
Announcement of half year and second quarter 2023 results: 28 July 2023
Announcement of nine month and third quarter 2023 results: 9 November 2023
Announcement of full year and fourth quarter 2023 results: 8 February 2024
Dividends are normally paid as follows:
First interim: Announced with the half year results and paid in September
Second interim: Announced with full year results and paid in March
The record date for the first interim dividend for 2023, payable
on 11 September 2023, will be 11 August 2023. The ex-dividend date
will be 10 August 2023.
Contacts
For details on how to contact the Investor Relations Team,
please click here . For Media contacts, click here .
Addresses for correspondence
Registered office Registrar and Swedish Central US depositary
transfer office Securities Depository Deutsche Bank Trust
Company Americas
1 Francis Crick Equiniti Limited Euroclear Sweden American Stock Transfer
Avenue Aspect House AB PO Box 191 6201 15th Avenue
Cambridge Biomedical Spencer Road SE-101 23 Stockholm Brooklyn
Campus Lancing NY 11219
Cambridge West Sussex
CB2 0AA BN99 6DA
United Kingdom United Kingdom Sweden United States
+44 (0) 20 3749
5000 0800 389 1580 +46 (0) 8 402 9000 +1 (888) 697 8018
+44 (0) 121 415
7033 +1 (718) 921 8137
db@astfinancial.com
Trademarks
Trademarks of the AstraZeneca group of companies appear
throughout this document in italics. Medical publications also
appear throughout the document in italics. AstraZeneca, the
AstraZeneca logotype and the AstraZeneca symbol are all trademarks
of the AstraZeneca group of companies. Trademarks of companies
other than AstraZeneca that appear in this document include
Arimidex and Casodex, owned by AstraZeneca or 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 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] The COVID-19 medicines are Vaxzevria, Evusheld, and AZD3152
- the COVID-19 antibody currently in development.
[2] Constant exchange rates. The differences between Actual
Change and CER Change are due to foreign exchange movements between
periods in 2023 vs 2022. CER financial measures are not accounted
for according to generally accepted accounting principles (GAAP)
because they remove the effects of currency movements from Reported
results.
[3] Effective 1 January 2023, the Group has updated the
presentation of Total Revenue. For further details of the
presentation of Alliance Revenue and Collaboration Revenue, see the
basis of preparation and accounting policy section of the Notes to
the Interim Financial Statements section.
[4] 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.
[5] Earnings per share.
[6] Core financial measures are adjusted to exclude certain
items. The differences between Reported and Core measures are
primarily due to costs relating to the acquisition of Alexion,
amortisation of intangibles, impairments and restructuring charges.
A full reconciliation between Reported EPS and Core EPS is provided
in Table 13 in the Financial performance section of this
document.
[7] Cardiovascular, Renal and Metabolism.
[8] Respiratory & Immunology.
[9] Non-small cell lung cancer.
[10] Hepatocellular carcinoma.
[11] Neuromyelitis optica spectrum disorder.
[12] Human epidermal growth factor receptor 2.
[13] nirsevimab is approved in the EU with the Beyfortus trademark.
[14] Vaxzevria is AstraZeneca's trademark for the Company's
supply of the AstraZeneca COVID-19 Vaccine. In the financial tables
in this report, 'Vaxzevria Total Revenue' includes royalties from
sub-licensees that produce and supply the AstraZeneca COVID--19
Vaccine under their own trademarks, recorded in Alliance
Revenue.
[15] Monoclonal antibodies. The COVID-19 mAbs are Evusheld and AZD3152.
[16] For Alliance Revenue and Collaboration Revenue, the
comparable amounts for FY 2022 are $749m and $604m
respectively.
[17] Vaccines & Immune Therapies.
[18] In Table 2, the plus and minus symbols denote the
directional impact of the item being discussed, e.g. a '+' symbol
next to an R&D expense comment indicates that the item
increased the R&D expense relative to the prior year.
[19] The calculation of Reported and Core Gross Margin excludes
the impact of Alliance Revenue and Collaboration Revenue.
[20] Income from disposals of assets and businesses, where the
Group does not retain a significant ongoing economic interest,
continue to be recorded in Other Operating Income and Expense in
the Company's financial statements.
[21] Respiratory syncytial virus.
[22] Hereditary transthyretin-mediated amyloid polyneuropathy.
[23] Hormone receptor.
[24] Taskforce on Climate-related Financial Disclosures.
[25] Product Sales shown in the Imfinzi line include Product
Sales from Imjudo
[26] National reimbursement drug list.
[27] France, Germany, Italy, Spain, UK.
[28] Biliary tract cancer.
[29] Extensive-stage small cell lung cancer.
[30] Poly ADP ribose polymerase.
[31] Platinum sensitive relapse
[32] Breast cancer gene mutation.
[33] Germline (hereditary) breast cancer gene mutation.
[34] Metastatic breast cancer.
[35] Bruton tyrosine kinase inhibitor.
[36] Mesenchymal-epithelial transition.
[37] Sodium-glucose cotransporter 2.
[38] Heart failure.
[39] Chronic kidney disease.
[40] European Society of Cardiology.
[41] American Heart Association.
[42] American College of Cardiology.
[43] Heart Failure Society of America.
[44] Heart failure with reduced ejection fraction.
[45] Type-2 diabetes.
[46] Heart failure with preserved ejection fraction.
[47] Betaloc is the brand name for Seloken in China.
[48] Inhaled corticosteroid.
[49] Long-acting beta-agonist.
[50] Interleukin-5.
[51] The 'dynamic market' refers to patients who have recently
changed their medicine. For biologic medicines, it captures
patients who have adopted a biologic medicine for the first time,
and patients who have switched from one biologic brand to
another.
[52] Fixed dose combination.
[53] 'New-to-brand' share represents a medicine's share in the
dynamic market
[54] Asthma COPD overlap.
[55] Intravenous injection.
[56] Systemic lupus erythematosus.
[57] Complement component 5.
[58] Atypical haemolytic uraemic syndrome.
[59] Generalised myasthenia gravis.
[60] Other Operating Income.
[61] Securities Exchange Commission.
[62] Based on best prevailing assumptions around currency
profiles.
[63] Based on average daily spot rates 1 Jan 2022 to 31 Dec
2022.
[64] Based on average daily spot rates 1 Jan 2023 to 31 Mar
2023.
[65] Based on average daily spot rates 1 Mar 2023 to 31 Mar
2023.
[66] Change vs the average spot rate for the previous year
[67] Other currencies include AUD, BRL, CAD, KRW and RUB.
[68] Overall survival.
[69] Epidermal growth factor receptor mutation.
[70] Supplemental new drug application.
[71] Neutralising antibody.
[72] Effective 1 January 2023, the Group has updated the
presentation of Total Revenue. See Note 1 for further details of
the presentation of Alliance Revenue.
[73] The table provides an analysis of year-on-year Product
Sales, with Actual and CER growth rates reflecting year-on-year
growth. Due to rounding, the sum of a number of dollar values and
percentages may not agree to totals.
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END
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