REG - AstraZeneca PLC - 1st Quarter Results
27/04/2023 07:00
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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 (#_ftn1)
Revenue and EPS summary
Q1 2023
% Change
$m Actual CER 2 (#_ftn2)
- Product Sales 10,566 (4) 1
- Alliance Revenue 3 (#_ftn3) 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 (#_ftn4) EPS 5 (#_ftn5) $1.16 >4x >4x
Core 6 (#_ftn6) 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
(#_ftn7) 22%, R&I 8 (#_ftn8) 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 Demaré."
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 (#_ftn9) (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 (#_ftn10) (HIMALAYA) and NSCLC (POSEIDON), Calquence maleate tablet
formulation, and positive CHMP recommendation for Ultomiris in NMOSD 11
(#_ftn11) . China approvals for Enhertu in HER2‑positive 12 (#_ftn12)
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 (#_ftn13)
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 (#_ftn14) and COVID‑19 mAbs 15 (#_ftn15) ) 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 (#_ftn16) , 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
Product Sales 10,566 (4) 1 * Decline of 4% (1% increase at CER) impacted by lower sales of COVID-19
medicines
* Strong growth in Oncology, CVRM, R&I and Rare Disease
Alliance Revenue 286 88 90 * $220m for Enhertu (Q1 2022: $76m)
* $43m for Tezspire (Q1 2022: $3m)
* See Table 6 for further details
Collaboration Revenue 27 (89) (89) * No sales or regulatory milestones from Lynparza in the quarter (Q1 2022:
$175m)
* See Table 7 for further details
Total Revenue 10,879 (4) -- * Excluding COVID-19 medicines, Q1 2023 Total Revenue increased by 10% (15% at
CER)
Therapy areas $m Actual % CER %
Oncology 4,148 14 19 * Strong performance across key medicines and regions
* No sales or regulatory milestones from Lynparza in the quarter (Q1 2022:
$175m)
CVRM(6)( ) 2,557 15 22 * Farxiga up 32% (39% CER), Lokelma up 56% (64% at CER), roxadustat up 52%
(66% CER), Brilinta up 3% (5% at CER)
R&I 1,633 3 8 * 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 tralokinumab
milestone)
V&I 17 (#_ftn17) 355 (80) (79) * $127m from COVID-19 mAbs (Q1 2022: $469m)
* $28m from Vaxzevria (Q1 2022: $1,145m)
Rare Disease(6)( ) 1,866 10 14 * 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 and geographic
expansion
Other Medicines 320 (26) (21)
Total Revenue 10,879 (4) -
Regions inc. COVID-19 $m Actual % CER %
US 4,299 4 4
Emerging Markets 3,162 (6) 1 * Growth rate impacted by lower sales of COVID-19 medicines (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) -
Regions ex. COVID-19 $m Actual % CER %
US 4,299 15 15
Emerging Markets 3,136 14 22
- China 1,602 2 11 * Third consecutive quarter of growth at CER
* Recovery in inhaled products following lifting of COVID-19 restrictions
- Ex-China Emerging Markets 1,534 31 38 * Timing of Rare Disease tender 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 change Core Core Comments 18 (#_ftn18)
change
Total Revenue $10,879m -4% Actual stable at CER $10,879m -4% Actual stable at CER * Excluding COVID-19 medicines, Q1 2023 Total Revenue increased by 10% (15% at
CER)
* See Table 1 and the Total Revenue section of this document for further
details
Gross Margin 19 (#_ftn19) 82% 14pp Actual 14pp CER 83% 4pp Actual 4pp CER + Increasing mix of sales from Oncology and Rare Disease medicines
+ 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 expense $2,611m 22% Actual 28% CER $2,300m 5% Actual 10% CER + Increased investment in the pipeline
+ 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 expense $4,059m -16% Actual -13% CER $3,054m 4% Actual 8% CER + Market development activities 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. Ltd
* Year-on-year comparisons can be impacted by differences in cost phasing
Other operating income 20 (#_ftn20) $379m >3x Actual >3x CER $318m >3x Actual >3x CER * Reported and Core OOI includes a gain of $241m from the disposal of US
rights to Pulmicort Flexhaler
Operating Margin 23% 16pp Actual 16pp CER 36% 2pp Actual 1pp CER * See Gross Margin, Expenses and OOI
commentary above
Net finance expense $287m -10% Actual -8% CER $240m -4% Actual -3% CER * Higher interest received on cash balances, partially offset by higher rates
on floating debt and bond issuances
* Reported also impacted by a reduction in the discount unwind on
acquisition-related liabilities
Tax rate 20% -10pp Actual -10pp CER 20% -1pp Actual -1pp CER * Variations in the tax rate can be expected between periods
EPS $1.16 >4x Actual >4x CER $1.92 1% Actual 6% CER * Further details of differences between Reported and Core are shown in Table
13
Table 3: Pipeline highlights since prior results announcement
Event Medicine Indication / Trial Event
Regulatory approvals and other regulatory actions Imfinzi +/- Imjudo NSCLC (1st-line) (POSEIDON) Regulatory approval (EU)
Imfinzi + Imjudo Hepatocellular carcinoma (1st-line) (HIMALAYA) Regulatory approval (EU)
Enhertu HER2-positive breast cancer (2nd-line) (DESTINY-Breast03) Regulatory approval (CN)
Calquence Maleate tablet formulation Regulatory approval (EU)
Calquence Mantle cell lymphoma Regulatory approval (CN)
Ultomiris NMOSD Positive CHMP opinion (EU)
Regulatory submissions Imfinzi Biliary tract cancer (TOPAZ-1) Regulatory submission (CN)
or acceptances
Enhertu HER2+ breast cancer (3rd-line) (DESTINY-Breast02) Regulatory submission (EU)
Beyfortus RSV 21 (#_ftn21) (MELODY/MEDLEY) Regulatory submission (JP)
eplontersen ATTRv-PN 22 (#_ftn22) (NEURO-TTRansform) Regulatory submission (US)
danicopan PNH with EVH Regulatory submission (EU)
Major Phase III data readouts and other developments Lynparza + Imfinzi Ovarian cancer (1st-line) (DUO-O) Primary endpoint met
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 deruxtecan AVANZAR NSCLC (1st-line)
TROPION-Lung07 Non-squamous NSCLC (1st-line)
camizestrant CAMBRIA-1 HR-positive 23 (#_ftn23) /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 $718m in Core Other operating income in Q2 2023.
Sustainability summary
AstraZeneca published its ninth Sustainability Report and Data Summary, along
with the 2022 TCFD(( 24 (#_ftn24) )) Report and related case studies.
AstraZeneca also hosted an annual Sustainability call for shareholders,
reiterating its continued commitment to deliver across our pillars; Access to
Healthcare, Environmental Protection and Ethics and Transparency. A recording
of the call and accompanying materials are available on the AstraZeneca IR
website.
Management changes
As previously communicated, Leif Johansson, will retire as Chair at the
conclusion of the Company's Annual General Meeting today, 27 April 2023.
Michel Demaré's appointment as Chair will take effect immediately on Leif's
retirement, and Michel will step down as a member of the Audit Committee.
Conference call
A conference call and webcast for investors and analysts will begin today, 27
April 2023, at 11:45 UK time. Details can be accessed via astrazeneca.com
(https://www.astrazeneca.com/) .
Reporting calendar
The Company intends to publish its half-year and second-quarter results on
Friday, 28 July 2023.
Operating and financial review
All narrative on growth and results in this section is based on actual
exchange rates, and financial figures are in US$ 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
(https://www.astrazeneca.com/content/dam/az/Investor_Relations/annual-report-2022/pdf/AstraZeneca_AR_2022.pdf)
.
Reference should be made to the Reconciliation of Reported to Core financial
measures table included in the financial performance section in this
announcement.
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 (#_ftn25) 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 (#_ftn26) 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
(#_ftn27) , partially offset by pricing clawbacks in certain markets
Established RoW * Increased use in 1st-line setting and launch acceleration 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 (#_ftn28) (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 (#_ftn29)
* 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 RoW * New reimbursements, strong demand growth in BTC
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 (#_ftn30) 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
(#_ftn31) and BRCAm 32 (#_ftn32) 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 (#_ftn33) HER2‑negative early breast cancer and BRCAm mCRPC,
partially offset by new indication pricing impact and clawbacks in some
markets
Established RoW * Growth continues across tumour types
Enhertu
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 (#_ftn34) 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 RoW * In Japan, AstraZeneca receives a mid-single-digit percentage royalty on
sales made by Daiichi Sankyo
Calquence
Total Revenue Worldwide US Emerging Markets Europe Established RoW
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 (#_ftn35) 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 (#_ftn36)
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 (#_ftn37) market
in all major regions
* Additional benefit from continued growth in the overall SGLT2 inhibitor
class
* Further HF 38 (#_ftn38) and CKD 39 (#_ftn39) launches and supportive
updates to treatment guidelines including from ESC 40 (#_ftn40) and AHA 41
(#_ftn41) /ACC 42 (#_ftn42) /HFSA 43 (#_ftn43) . HF and CKD indications now
launched in >100 markets
US * Growth driven by HFrEF 44 (#_ftn44) and CKD for patients with and without
T2D 45 (#_ftn45)
* 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 (#_ftn46) approval in February 2023
* Continued strong volume growth in the quarter partially offset by clawbacks
Established RoW * In Japan, AstraZeneca sells to collaborator Ono Pharmaceutical Co., Ltd,
which records in-market sales. Continued volume growth driven by HF and CKD
launches. A 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
(#_ftn47) 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 (#_ftn48)
/LABA 49 (#_ftn49) 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 RoW * Inventory destocking in some markets and generic erosion 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 (#_ftn50) 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 RoW * Maintained leadership of the dynamic market 51 (#_ftn51) in 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 (#_ftn52) triple
class across major markets
US * Consistent share growth within the FDC triple class in new-to-brand 53
(#_ftn53) 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 RoW * Increasing new-to-brand market share within COPD plus ACO 54 (#_ftn54) 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 (#_ftn55) segment for SLE 56 (#_ftn56) , 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 RoW * Japan achieved new-to-brand leadership by month two
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 RoW * Deliveries in Japan
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 (#_ftn57) 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 (#_ftn58) and gMG 59 (#_ftn59) , 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 patients to Ultomiris,
Established RoW slightly offset by growth in 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 RoW * Rapid conversion from Soliris in Japan
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 (#_ftn60) & 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 Asset Amortisation & Impairments Acquisition Other Core Core
of Alexion
% Change
$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 (#_ftn61) 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% strengthening (FY2023 average rate vs FY 2022
average) (( 62 (#_ftn62) ))
rates vs USD
Currency Primary Relevance FY YTD Change Mar 2023 65 (#_ftn65) Change 66 (#_ftn66) Total Revenue Core Operating Profit
2022 63 (#_ftn63)
2023 64 (#_ftn64)
(%) (%)
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 (#_ftn67) )) 385 202
GBP Operating expense 0.81 0.82 (2) 0.82 (2) 46 (92)
SEK Operating 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
(https://www.astrazeneca.com/investor-relations.html) . The clinical trials
appendix includes tables with details of the ongoing clinical trials for
AstraZeneca medicines and new molecular entities in the pipeline.
Oncology
AstraZeneca presented new 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 trial read out ADAURA Met key secondary endpoint demonstrating statistically significant and
clinically meaningful improvement in OS 68 (#_ftn68) compared to placebo in
the adjuvant treatment of patients with early-stage EGFRm 69 (#_ftn69) 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: AACR AEGEAN Results from interim EFS analysis of the AEGEAN 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: ASCO GU PROpel final OS Results from the final prespecified OS analysis 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 (#_ftn70) for Lynparza in combination with abiraterone for the
treatment of mCRPC. (PROpel, March 2023)
Phase III trial read-out DUO-O (Lynparza and Imfinzi) Met primary endpoint demonstrating a statistically 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 approval China Patients with mantle cell lymphoma who have received 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 read out DESTINY-PanTumor02 Met the prespecified target for objective response 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: AAN NEURO-TTRansform Detailed results from the NEURO-TTRansform Phase 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 trial read-out MIRACLE Met the primary endpoint, demonstrating a statistically 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 trial read-out TATE Met the primary endpoints, demonstrating that 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: ECCMID 2023 US AstraZeneca presented the first in vitro neutralisation 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 approval Japan As previously announced in 2015, Daiichi Sankyo 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: Nature MELODY Serum samples were collected from 2,143 infants to characterise the duration
of RSV nAb 71 (#_ftn71) 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: ECCMID 2023 MUSIC At ECCMID 2023, AstraZeneca presented results 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 update In April 2023, AstraZeneca, Sanofi and Sobi simplified 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 opinion EU Recommended for approval in the EU by CHMP for the treatment of adults with
NMOSD
ALXN1840
Event Commentary
Termination Wilson Disease programme In April, the ALXN1840 programme in Wilson Disease 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 (#_ftn72) 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 46 18
comprehensive income
Fair value movements related to own credit risk on bonds designated as fair 2 -
value through profit or loss
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 capital Share premium account Other reserves Retained earnings Total attributable to owners of the parent Non-controlling interests Total equity
$m $m $m $m $m $m $m
At 1 Jan 2022 387 35,126 2,045 1,710 39,268 19 39,287
Profit for the period - - - 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)
At 31 Mar 2023 387 35,159 2,068 (1,825) 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 (23) (55)
combinations
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 9 21
instruments
Payments to associates and joint ventures - (5)
Interest received 67 3
Net cash outflow from investing activities (1,246) (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)
Net cash outflow from financing activities (2,031) (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
(https://www.astrazeneca.com/content/dam/az/Investor_Relations/annual-report-2022/pdf/AstraZeneca_AR_2022.pdf)
.
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
(https://www.astrazeneca.com/content/dam/az/Investor_Relations/annual-report-2022/pdf/AstraZeneca_AR_2022.pdf)
. Net Debt is a non-GAAP financial measure.
Table 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 (#_ftn73)
World US Emerging Markets Europe Established RoW
$m Act % chg CER % chg $m % chg $m Act % chg CER % chg $m Act % chg CER % chg $m Act % chg CER % chg
Oncology 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
(https://www.astrazeneca.com/investor-relations.html#Contacts) . For Media
contacts, click here (https://www.astrazeneca.com/media-centre/contacts.html)
.
Addresses for correspondence
Registered office Registrar and transfer office Swedish Central Securities Depository US depositary
Deutsche Bank Trust Company Americas
1 Francis Crick Avenue Equiniti Limited Euroclear Sweden AB PO Box 191 American Stock Transfer
Cambridge Biomedical Campus Aspect House SE-101 23 Stockholm 6201 15th Avenue
Cambridge Spencer Road Brooklyn
CB2 0AA Lancing NY 11219
West Sussex
BN99 6DA
United Kingdom United Kingdom Sweden United States
+44 (0) 20 3749 5000 0800 389 1580 +46 (0) 8 402 9000 +1 (888) 697 8018
+44 (0) 121 415 7033 +1 (718) 921 8137
db@astfinancial.com (mailto:db@astfinancial.com)
Trademarks
Trademarks of the AstraZeneca group of companies appear throughout this
document in italics. Medical publications also appear throughout the document
in italics. AstraZeneca, the AstraZeneca logotype and the AstraZeneca symbol
are all trademarks of the AstraZeneca group of companies. Trademarks of
companies other than AstraZeneca that appear in this document
include Arimidex and Casodex, owned by AstraZeneca or 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 (https://www.astrazeneca.com/) , does not form part of and is
not incorporated into this announcement.
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical
company that focuses on the discovery, development, and commercialisation of
prescription medicines in Oncology, Rare Disease, and BioPharmaceuticals,
including Cardiovascular, Renal & Metabolism, and Respiratory &
Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries
and its innovative medicines are used by millions of patients worldwide.
Please visit astrazeneca.com (http://www.astrazeneca.com/) and follow the
Company on Twitter @AstraZeneca (http://www.twitter.com/AstraZeneca) .
Cautionary statements regarding forward-looking statements
In order, among other things, to utilise the 'safe harbour' provisions of the
US Private Securities Litigation Reform Act of 1995, AstraZeneca (hereafter
'the Group') provides the following cautionary statement:
This document contains certain forward-looking statements with respect to the
operations, performance and financial condition of the Group, including, among
other things, statements about expected revenues, margins, earnings per share
or other financial or other measures. Although the Group believes its
expectations are based on reasonable assumptions, any forward-looking
statements, by their very nature, involve risks and uncertainties and may be
influenced by factors that could cause actual outcomes and results to be
materially different from those predicted. The forward-looking statements
reflect knowledge and information available at the date of preparation of this
document and the Group undertakes no obligation to update these
forward-looking statements. The Group identifies the forward-looking
statements by using the words 'anticipates', 'believes', 'expects', 'intends'
and similar expressions in such statements. Important factors that could cause
actual results to differ materially from those contained in forward-looking
statements, certain of which are beyond the Group's control, include, among
other things:
‒ the risk of failure to meet regulatory or ethical requirements for
medicine development or approval
‒ the risk of failures or delays in the quality or execution of the
Group's commercial strategies
‒ the risk of pricing, affordability, access and competitive pressures
‒ the risk of failure to maintain supply of compliant, quality
medicines
‒ the risk of illegal trade in the Group's medicines
‒ the impact of reliance on third-party goods and services
‒ the risk of failure in information technology or cybersecurity
‒ the risk of failure of critical processes
‒ the risk of failure to collect and manage data in line with legal
and regulatory requirements and strategic objectives
‒ the risk of failure to attract, develop, engage and retain a
diverse, talented and capable workforce
‒ the risk of failure to meet regulatory or ethical expectations on
environmental impact, including climate change
‒ the risk of the safety and efficacy of marketed medicines being
questioned
‒ the risk of adverse outcome of litigation and/or governmental
investigations
‒ intellectual property-related risks to our products
‒ the risk of failure to achieve strategic plans or meet targets or
expectations
‒ the risk of failure in financial control or the occurrence of fraud
‒ the risk of unexpected deterioration in the Group's financial
position
‒ the impact that global and/or geopolitical events such as the
COVID-19 pandemic and the Russia-Ukraine war may have or continue to have on
these risks, on the Group's ability to continue to mitigate these risks, and
on the Group's operations, financial results or financial condition
Nothing in this document, or any related presentation/webcast, should be
construed as a profit forecast.
- End of document -
1 (#_ftnref1) The COVID-19 medicines are Vaxzevria, Evusheld, and AZD3152 -
the COVID-19 antibody currently in development.
2 (#_ftnref2) 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 (#_ftnref3) 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 (#_ftnref4) 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 (#_ftnref5) Earnings per share.
6 (#_ftnref6) 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 (#_ftnref7) Cardiovascular, Renal and Metabolism.
8 (#_ftnref8) Respiratory & Immunology.
9 (#_ftnref9) Non-small cell lung cancer.
10 (#_ftnref10) Hepatocellular carcinoma.
11 (#_ftnref11) Neuromyelitis optica spectrum
disorder.
12 (#_ftnref12) Human epidermal growth factor
receptor 2.
13 (#_ftnref13) nirsevimab is approved in the EU with
the Beyfortus trademark.
14 (#_ftnref14) 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 (#_ftnref15) Monoclonal antibodies. The COVID-19
mAbs are Evusheld and AZD3152.
16 (#_ftnref16) For Alliance Revenue and
Collaboration Revenue, the comparable amounts for FY 2022 are $749m and $604m
respectively.
17 (#_ftnref17) Vaccines & Immune Therapies.
18 (#_ftnref18) 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 (#_ftnref19) The calculation of Reported and Core
Gross Margin excludes the impact of Alliance Revenue and Collaboration
Revenue.
20 (#_ftnref20) 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 (#_ftnref21) Respiratory syncytial virus.
22 (#_ftnref22) Hereditary transthyretin-mediated
amyloid polyneuropathy.
23 (#_ftnref23) Hormone receptor.
24 (#_ftnref24) Taskforce on Climate-related
Financial Disclosures.
25 (#_ftnref25) Product Sales shown in the Imfinzi line include Product
Sales from Imjudo
26 (#_ftnref26) National reimbursement drug list.
27 (#_ftnref27) France, Germany, Italy, Spain, UK.
28 (#_ftnref28) Biliary tract cancer.
29 (#_ftnref29) Extensive-stage small cell lung cancer.
30 (#_ftnref30) Poly ADP ribose polymerase.
31 (#_ftnref31) Platinum sensitive relapse
32 (#_ftnref32) Breast cancer gene mutation.
33 (#_ftnref33) Germline (hereditary) breast cancer gene mutation.
34 (#_ftnref34) Metastatic breast cancer.
35 (#_ftnref35) Bruton tyrosine kinase inhibitor.
36 (#_ftnref36) Mesenchymal-epithelial transition.
37 (#_ftnref37) Sodium-glucose cotransporter 2.
38 (#_ftnref38) Heart failure.
39 (#_ftnref39) Chronic kidney disease.
40 (#_ftnref40) European Society of Cardiology.
41 (#_ftnref41) American Heart Association.
42 (#_ftnref42) American College of Cardiology.
43 (#_ftnref43) Heart Failure Society of America.
44 (#_ftnref44) Heart failure with reduced ejection fraction.
45 (#_ftnref45) Type-2 diabetes.
46 (#_ftnref46) Heart failure with preserved ejection fraction.
47 (#_ftnref47) Betaloc is the brand name for Seloken in China.
48 (#_ftnref48) Inhaled corticosteroid.
49 (#_ftnref49) Long-acting beta-agonist.
50 (#_ftnref50) Interleukin-5.
51 (#_ftnref51) 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 (#_ftnref52) Fixed dose combination.
53 (#_ftnref53) 'New-to-brand' share represents a medicine's share in the
dynamic market
54 (#_ftnref54) Asthma COPD overlap.
55 (#_ftnref55) Intravenous injection.
56 (#_ftnref56) Systemic lupus erythematosus.
57 (#_ftnref57) Complement component 5.
58 (#_ftnref58) Atypical haemolytic uraemic syndrome.
59 (#_ftnref59) Generalised myasthenia gravis.
60 (#_ftnref60) Other Operating Income.
61 (#_ftnref61) Securities Exchange Commission.
62 (#_ftnref62) Based on best prevailing assumptions around currency
profiles.
63 (#_ftnref63) Based on average daily spot rates 1 Jan 2022 to 31 Dec 2022.
64 (#_ftnref64) Based on average daily spot rates 1 Jan 2023 to 31 Mar 2023.
65 (#_ftnref65) Based on average daily spot rates 1 Mar 2023 to 31 Mar 2023.
66 (#_ftnref66) Change vs the average spot rate for the previous year
67 (#_ftnref67) Other currencies include AUD, BRL, CAD, KRW and RUB.
68 (#_ftnref68) Overall survival.
69 (#_ftnref69) Epidermal growth factor receptor mutation.
70 (#_ftnref70) Supplemental new drug application.
71 (#_ftnref71) Neutralising antibody.
72 (#_ftnref72) 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 (#_ftnref73) 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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