REG - AstraZeneca PLC - Half-year Report
29/07/2022 07:00
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RNS Number : 1686U AstraZeneca PLC 29 July 2022
AstraZeneca PLC
29 July 2022 07:00 GMT
H1 2022 results
Strong revenue performance and R&D success enables further investment in
the pipeline and new launches
Revenue and EPS summary
H1 2022 Q2 2022
% Change % Change
$m Actual CER 1 (#_ftn1) $m Actual CER
- Product Sales 21,610 41 47 10,630 32 38
- Collaboration Revenue 551 n/m n/m 141 (20) (20)
Total Revenue 22,161 43 48 10,771 31 37
Reported 2 (#_ftn2) EPS 3 (#_ftn3) $0.48 (70) (66) $0.23 (45) (46)
Core 4 (#_ftn4) EPS $3.61 43 44 $1.72 92 89
H1 2022 Financial performance (growth numbers and commentary at CER)
‒ Total Revenue increased 48% to $22,161m, with growth coming from all
disease areas and from the addition of Alexion
‒ Total Revenue from Oncology increased 22% 5 (#_ftn5) , including
receipt of a milestone payment. Product Sales from Oncology increased 18%.
Total Revenue from R&I 6 (#_ftn6) increased 3%, CVRM 7 (#_ftn7)
increased 19% 8 (#_ftn8) and Rare Disease increased 10%(8). Excluding a
one-off historical pricing adjustment, Rare Disease increased 8%
‒ Core Gross Margin of 81%, with the second quarter benefitting from
currency fluctuations, and phasing of COVID-19 medicine contracts
‒ Core Operating Margin of 33%. Core Total Operating Expense increased
33%, reflecting the addition of Alexion, and continued investment in new
launches and the pipeline to build industry-leading mid-to-long term growth
‒ Core EPS of $3.61, with the second quarter benefitting from a Core
Tax Rate of 15%. The FY 2022 expectation for the Core Tax Rate remains 18-22%
‒ Interim dividend declared of $0.93 (76.4 pence, 9.49 SEK) per
ordinary share, reflecting the Board's intent to increase to $2.90 in FY 2022,
as announced at FY 2021
‒ FY 2022 Total Revenue guidance at CER increased due to an updated
outlook for COVID-19 medicines and continued strong performance of the overall
business, enabling further investment in the pipeline. With an expectation
that Other Operating Income in H2 2022 will be similar to H1 2022, EPS
guidance is unchanged
Key milestones achieved since the prior results
‒ Key data: Positive read-outs for Farxiga in HFpEF 9 (#_ftn9)
(DELIVER), Imfinzi in early NSCLC 10 (#_ftn10) (AEGEAN), eplontersen in
ATTRv-PN 11 (#_ftn11) (NEURO-TTRansform) and Ultomiris in NMOSD 12 (#_ftn12)
(CHAMPION-NMOSD). Full results from the Enhertu DESTINY-Breast04 trial in
HER2 13 (#_ftn13) -low breast cancer, presented at ASCO
‒ Key approvals: Enhertu for HER2-positive breast cancer
(DESTINY-Breast03) in the US and EU; positive CHMP 14 (#_ftn14) opinions in
the EU for Tezspire in severe asthma (NAVIGATOR), Lynparza 15 (#_ftn15) in
early breast cancer (OlympiA) and Ultomiris in gMG 16 (#_ftn16) (CHAMPION-MG)
‒ Other regulatory milestones: US Priority Review for Imfinzi in
biliary tract cancer (TOPAZ-1) and Enhertu in HER2-low metastatic breast
cancer (DESTINY-Breast04), China Priority Review for Koselugo in NF1-PN 17
(#_ftn17)
Pascal Soriot, Chief Executive Officer, AstraZeneca, said:
"AstraZeneca had a strong financial first half of 2022, and great pipeline
delivery. We announced practice-changing data for several medicines including
Enhertu in breast cancer, Farxiga in heart failure and Ultomiris in
neuromyelitis optica spectrum disorder.
We have made great progress in our efforts to combat COVID-19. Vaxzevria is
estimated to have saved more than six million lives during the first year of
roll-out, and Evusheld has protected hundreds of thousands of
immunocompromised people, enabling them to return to a more normal life.
Evusheld continues to demonstrate activity against new variants.
Given the ongoing performance of our underlying business and the contribution
of our COVID-19 medicines, we are updating our revenue guidance for 2022. This
has enabled us to increase our R&D investment in the exciting number of
pipeline opportunities that can benefit patients and drive long term
sustainable growth for our company. We look forward to announcing the results
of several important late-stage trials this year and next".
Guidance
The Company updates FY 2022 guidance due to strength in its overall business,
an updated outlook for COVID‑19 medicines, as well as increased investment
in R&D to drive long term sustainable growth.
Total Revenue is expected to increase by a low twenties percentage (previously
high teens)
Core EPS is expected to increase by a mid-to-high twenties percentage
(unchanged)
‒ The CER growth rates include the full-year contribution of Vaxzevria
in both FY 2021 and FY 2022
‒ Total Revenue from COVID-19 medicines is anticipated to be broadly
flat versus FY 2021 (previously a low-to-mid twenties percentage decline),
with growth in Evusheld offsetting an expected decline in Vaxzevria sales. The
majority of Vaxzevria revenue in 2022 is expected to come from initial
contracts
‒ As previously indicated, the Gross Margin from the COVID-19
medicines is expected to be lower than the Company average
‒ Core Operating Expenses are expected to increase by a mid-to-high
teens percentage, driven in part by the full year integration of Alexion
expenses. (Previous guidance was a low-to-mid teens percentage increase. The
update is a result of increased R&D spend following positive trial
readouts, and increased spend to support new launches, including Evusheld)
‒ Other Operating Income in H2 2022 is expected to be similar to the
level seen in H1 2022
‒ Emerging Markets Total Revenue, including China, is expected to grow
by a mid single-digit percentage in FY 2022 (unchanged). China Total Revenue
is expected to decline by a mid single-digit percentage in FY 2022
(unchanged), primarily due to the continued NRDL 18 (#_ftn18) and VBP 19
(#_ftn19) programmes impacting various medicines. The Company remains
confident in the longer-term outlook for Emerging Markets, driven by a large
market opportunity, broader patient access and an increased mix of new
medicines
‒ A Core Tax Rate between 18-22% (unchanged)
AstraZeneca continues to recognise and actively manage the heightened risks
from COVID-19 and geopolitical and supply chain uncertainties on overall
business performance. Variations in performance between quarters can be
expected to continue.
The Company is unable to provide guidance on a Reported basis because
AstraZeneca cannot reliably forecast material elements of the Reported result,
including any fair value adjustments arising on acquisition-related
liabilities, intangible asset impairment charges and legal settlement
provisions. Please refer to the cautionary statements section regarding
forward-looking statements at the end of this announcement.
Currency impact
If foreign-exchange rates for July to December 2022 were to remain at the spot
rates seen on 30 June 2022, it is anticipated that FY 2022 Total Revenue would
incur a mid single-digit adverse impact (previously a low single-digit adverse
impact) versus the financials at CER, and, as previously indicated, FY 2022
Core EPS would incur a mid-single-digit adverse impact.
The Company's foreign-exchange rate sensitivity analysis is contained in Table
18.
Table 1: Key elements of Total Revenue performance in Q2 2022
% Change
Revenue type $m Actual CER
Product Sales 10,630 32 38 $1,776m from medicines acquired with Alexion
Collaboration Revenue 141 (20) (20) $100m for Enhertu (Q2 2021: $46m)
$13m for Tezspire (Q2 2021: $nil)
Total Revenue 10,771 31 37
Disease areas $m Actual CER
Oncology 3,810 15 20 Good performance across key medicines and regions, despite lower diagnosis
rates and adverse impact in China from COVID-19-related lockdowns
CVRM(8) 2,356 14 19 Farxiga achieved another blockbuster quarter with $1,104m in revenues in the
quarter
R&I 1,395 (2) 1 Growth across Breztri and Fasenra offsetting a decline in Pulmicort of 30%
(28% at CER) primarily due to the impact of VBP implementation and COVID-19
lockdowns in China
V&I 20 (#_ftn20) 981 7 12 $455m from Vaxzevria 21 (#_ftn21) , $445m from Evusheld
Majority of Vaxzevria revenue from initial contracts
Rare Disease(8) 1,801 6 12 Durable C5 franchise growth, including continued conversion to Ultomiris in
PNH and aHUS and launch in gMG in the US
Excluding a one-off historic pricing adjustment in Q2 that benefitted ex-US
Total Revenue, Rare Disease pro forma revenue growth would have been 2% (8% at
CER)
Other Medicines 427 (17) (10)
Total Revenue 10,771 31 37
Regions inc. Vaxzevria $m Actual CER
Emerging Markets 2,792 (3) 1
- China 1,435 (6) (5) Pricing pressure associated with the NRDL and VBP programmes
COVID-19-related lockdowns
- Ex-China Emerging Markets 1,357 1 7
US 4,348 72 72
Europe 2,080 21 35
Established RoW 1,550 39 55
Total Revenue inc. Vaxzevria 10,771 31 37
Regions exc. Vaxzevria $m Actual CER Contribution of medicines acquired with Alexion
Emerging Markets 2,603 7 11 $81m
- China 1,435 (6) (5)
- Ex-China Emerging Markets 1,167 31 39 $81m
US 4,348 72 72 $1,041m
Europe 1,952 43 59 $377m
Established RoW 1,412 39 56 $277m
Total Revenue exc. Vaxzevria 10,316 41 47 $1,776m
Table 2: Key elements of financial performance in Q2 2022
Metric Reported Reported change Core Core Comments 22 (#_ftn22)
($m or %)
change
Total Revenue $10,771m 31% Actual 37% CER $10,771m 31% Actual 37% CER See Table 1 and the Total Revenue section of this document for further details
Gross Margin 23 (#_ftn23) 72% (1pp) Actual (2pp) CER 83% 10% Actual 8% CER + Addition of Alexion
+ Increasing mix of Oncology sales
+ Positive effect from phasing of COVID-19 contracts
+ Positive impact from currency fluctuations
‒ China impact of NRDL and VBP
‒ Impact from profit-sharing arrangements (e.g. Lynparza)
‒ Reported Gross Margin impacted by unwind of Alexion inventory fair value
adjustment
Foreign exchange fluctuations may have a positive or negative impact on Gross
Margin in future quarters
R&D Expense $2,546m 39% Actual 44% CER $2,431m 35% Actual 40% CER + Addition of Alexion
+ Increased investment in the pipeline following un-gating of additional
late-stage trials
+ One-off $89m impairment (included in Reported and Core) of a pre-paid asset
relating to a discontinued collaboration with an external partner
+ Reversal of the beneficial cost phasing effects seen in Q1 2022
Core R&D-to-Total Revenue ratio of 23% (Q2 2021: 22%)
SG&A Expense $4,681m 51% Actual 56% CER $3,137m 27% Actual 33% CER + Addition of Alexion
+ Market development activities for recent launches, including Evusheld
+ Core SG&A-to-Total Revenue ratio of 29%
(Q2 2021: 30%)
Other Operating Income 24 (#_ftn24) $122m (5%) Actual (5%) CER $112m (12%) Actual (13%) CER Includes $61m divestment from Plendil, and income coming from royalties and
prior transactions
Operating Margin 5% (9pp) Actual (9pp) CER 31% 9% Actual 8% CER See Gross Margin and Expenses
commentary above
Net Finance Expense $293m (8%) Actual 10% CER $223m 1% Actual 26% CER + Alexion debt financing costs
‒ Reported impacted by lower discount unwind on acquisition-related
liabilities
Tax Rate (46%) n/m 15% (8%) Actual (9%) CER 15% tax rate in the quarter reflected geographical mix of profits and
favourable adjustments to prior year tax liabilities in a number of major
jurisdictions
Variations in the tax rate can be expected to continue quarter to quarter
Full year expectation remains 18-22%
EPS $0.23 (45%) Actual (46%) CER $1.72 92% Actual 89% CER Further details of differences between Reported and Core are shown in Table 13
Corporate and business development
In May 2022, AstraZeneca entered into a licence agreement with RQ
Biotechnologies Ltd for a portfolio of early-
stage mAbs 25 (#_ftn25) targeted against SARS-CoV-2, the virus that causes
COVID-19. Under the agreement, AstraZeneca acquired an exclusive worldwide
licence to develop, manufacture and commercialise mAbs against SARS-CoV-2.
Also in May, AstraZeneca completed the sale of commercial rights to Plendil in
35 markets globally, resulting in a $61m gain being recognised in Other
Operating Income in the quarter.
In June 2022, the Company entered into a broad strategic collaboration with
GRAIL, LLC to develop and commercialise companion diagnostic assays for use
with AstraZeneca's therapies. The collaboration will initially focus on
developing companion diagnostic tests to identify patients with high-risk,
early-stage disease, with plans to embark on numerous trials across multiple
indications over the next several years. The deal also encompasses the use of
GRAIL's technology to enable recruitment of patients with early-stage cancer
for AstraZeneca's clinical trials.
In July 2022, AstraZeneca announced an agreement to acquire TeneoTwo, Inc.,
including its Phase I clinical-stage CD19xCD3 T-cell engager, TNB-486,
currently under evaluation in relapsed and refractory B-cell non-Hodgkin
lymphoma. AstraZeneca will acquire all outstanding equity of TeneoTwo in
exchange for an upfront payment of $100m on deal closing. Under the terms of
the agreement, AstraZeneca will make additional contingent R&D-related
milestone payments of up to $805m and additional contingent commercial-related
milestone payments of up to $360m to TeneoTwo's equity holders. The
transaction is expected to close in the third quarter of 2022.
Sustainability summary
Airfinity, an independent provider of global real-time health intelligence,
estimates that the AstraZeneca COVID-19 vaccine saved over six million lives
during the period 8 December 2020 to 8 December 2021. This analysis is based
on data from Imperial College, London, published in The Lancet
(https://doi.org/10.1016/S1473-3099(22)00320-6) in June 2022.
Management changes
AstraZeneca PLC today announced the appointment of Michel DemarŽ as the
Chair-designate of the Board. His appointment followed a robust succession
planning process led by Philip Broadley in his capacity as senior
independent Non-Executive Director.
As previously communicated, Leif Johansson, current Chair of the Board of
AstraZeneca will be retiring at the conclusion of the Company's Annual General
Meeting in April 2023. Michel's appointment is effective immediately
thereafter allowing for a managed handover period over the coming months.
Michel was appointed to the Board of AstraZeneca in September 2019 as an
independent Non-Executive Director and is currently Chair of the Company's
Remuneration Committee and member of the Audit Committee and the Nomination
and Governance Committee. He is a Non-Executive Director of Vodafone Group Plc
and Louis Dreyfus Int'l Holdings BV. He is also Chairman of IMD Business
School and Chairman of Nomoko AG.
Conference call
A conference call and webcast for investors and analysts will begin today, 29
July 2022, at 11:45 BST. Details can be accessed via astrazeneca.com
(https://www.astrazeneca.com/) .
Reporting calendar
The Company intends to publish its year-to-date and third quarter results on
Thursday 10 November 2022.
Table 3: Pipeline highlights since prior results announcement
Event Medicine Indication / Trial Event
Enhertu HER2-positive breast cancer (2nd-line) (DESTINY-Breast03) Regulatory approval (US, EU)
Regulatory approvals and other regulatory actions Lynparza gBRCAm 26 (#_ftn26) breast cancer (adjuvant) (OlympiA) CHMP positive opinion (EU)
Tezspire Severe asthma (NAVIGATOR) CHMP positive opinion (EU)
Ultomiris gMG (CHAMPION-MG) CHMP positive opinion (EU)
Ultomiris Subcutaneous, PNH 27 (#_ftn27) and aHUS 28 (#_ftn28) Regulatory approval (US)
Imfinzi Biliary tract cancer (TOPAZ-1) Priority Review (US), regulatory submission (EU)
Enhertu HER2-low breast cancer (3rd-line) (DESTINY-Breast04) Priority Review (US), regulatory submission (EU, JP)
Enhertu HER2-positive breast cancer (2nd-line) (DESTINY-Breast03) Regulatory submission (CN)
Regulatory submissions PT027 Asthma (MANDALA/DENALI) Regulatory submission (US)
or acceptances
Evusheld COVID-19 (PROVENT/TACKLE) Regulatory submission (JP)
Soliris gMG Regulatory submission (CN)
Koselugo NF1-PN (SPRINT) Priority Review (CN)
Imfinzi NSCLC (neoadjuvant) (AEGEAN) Primary co-endpoint met (pCR)
Major Phase III data readouts and other developments camizestrant HR+ 29 (#_ftn29) /HER2-neg breast cancer (SERENA-6) Fast Track Designation (US)
Farxiga HFpEF (DELIVER) Primary endpoint met
eplontersen ATTRv-PN (NEURO-TTRansform) Primary co-endpoints met
Ultomiris NMOSD (CHAMPION-NMOSD) Primary endpoint met
Table 4: Pipeline - anticipated major news flow
Timing Medicine Indication / Trial Event
H2 2022 Tagrisso NSCLC (adjuvant) (ADAURA) Regulatory decision (JP)
Imfinzi Liver cancer (locoregional) Data readout
(EMERALD-1)
Imfinzi NSCLC (unresectable, Stg. III) (PACIFIC-2) Data readout
Imfinzi NSCLC (1st-line) (PEARL) Data readout
Imfinzi Biliary tract cancer (TOPAZ-1) Regulatory decision
Imfinzi +/- Liver cancer (1st-line) (HIMALAYA) Regulatory decision
tremelimumab
Imfinzi +/- NSCLC (1st-line) (POSEIDON) Regulatory decision
tremelimumab
Lynparza gBRCAm breast cancer (adjuvant) (OlympiA) Regulatory decision (JP)
Lynparza Prostate cancer (1st-line) (PROpel) Regulatory submission (US), regulatory decision
Enhertu HER2-positive breast cancer (3rd-line) (DESTINY-Breast02) Data readout, regulatory submission
Enhertu HER2-positive breast cancer (2nd-line) (DESTINY-Breast03) Regulatory decision
Enhertu HER2-low breast cancer (3rd-line) (DESTINY-Breast04) Regulatory decision, regulatory submission (CN)
Enhertu HER2-positive gastric cancer (2nd-line) (DESTINY-Gastric01) Regulatory decision (EU)
Enhertu HER2m NCSLC (2nd-line+) (DESTINY-Lung01) Regulatory decision
Calquence CLL 30 (#_ftn30) (ELEVATE-TN) Regulatory decision (JP)
capivasertib HR+/HER2-neg breast cancer (1st-line) (CAPItello-291) Data readout
Farxiga HFpEF (DELIVER) Regulatory submission
Forxiga CKD 31 (#_ftn31) (DAPA-CKD) Regulatory decision (CN)
eplontersen ATTRv-PN (NEURO-TTRansform) Regulatory submission (US)
Fasenra EOE 32 (#_ftn32) (MESSINA) Data readout
Tezspire Severe asthma (NAVIGATOR) Regulatory decision
PT027 Asthma (MANDALA/DENALI) Regulatory decision (US)
nirsevimab RSV 33 (#_ftn33) (MELODY/MEDLEY) Regulatory submission (US), regulatory decision (EU)
Evusheld COVID-19 (PROVENT/TACKLE) Regulatory submission (CN)
Evusheld COVID-19 outpatient treatment Regulatory decision
(TACKLE)
Vaxzevria COVID-19 Regulatory submission (US)
Soliris Guillain-BarrŽ syndrome Data readout
Ultomiris gMG (CHAMPION-MG) Regulatory decision
Ultomiris Subcutaneous, PNH and aHUS Regulatory decision (EU)
Ultomiris NMOSD (CHAMPION-NMOSD) Regulatory submission
Koselugo NF1-PN (SPRINT) Regulatory decision (JP)
H1 2023 Tagrisso EGFRm 34 (#_ftn34) NSCLC (1st-line) (FLAURA2) Data readout
Tagrisso EGFRm NSCLC (unresectable Stg. III) (LAURA) Data readout
Imfinzi Bladder cancer (muscle invasive) (NIAGARA) Data readout
Imfinzi Bladder cancer (1st-line) (NILE) Data readout
Imfinzi NSCLC (neoadjuvant) (AEGEAN) Data readout
Imfinzi NSCLC (unresectable, Stg. III) (PACIFIC-2) Regulatory submission
Imfinzi Liver cancer (locoregional) Regulatory submission
(EMERALD-1)
Imfinzi Liver cancer (adjuvant) (EMERALD-2) Data readout, regulatory submission
Imfinzi NSCLC (1st-line) (PEARL) Regulatory submission
Imfinzi SCLC (limited-stage) (ADRIATIC) Data readout
Lynparza gBRCAm 35 (#_ftn35) breast cancer (adjuvant) (OlympiA) Regulatory submission (CN)
Lynparza Ovarian cancer (1st-line) (PAOLA-1) Regulatory decision (CN)
Lynparza + Imfinzi Ovarian cancer (1st-line) (DUO-O) Data readout
Enhertu HER2-low breast cancer (2nd-line) (DESTINY-Breast06) Data readout
capivasertib HR+/HER2-negative breast cancer (1st-line) (CAPItello-291) Regulatory submission
Dato-DXd NSCLC (3rd-line) (TROPION-Lung01) Data readout, regulatory submission
roxadustat Anaemia of myelodysplastic syndrome Data readout
Fasenra EOE (MESSINA) Regulatory submission
nirsevimab RSV (MELODY/MEDLEY) Regulatory submission (JP, CN)
danicopan PNH with extravascular haemolysis Data readout
H2 2023 Tagrisso EGFRm NSCLC (1st-line) (FLAURA2) Regulatory submission
Tagrisso EGFRm NSCLC (unresectable Stg. III) (LAURA) Regulatory submission
Imfinzi Biliary tract cancer (TOPAZ-1) Regulatory submission (CN)
Imfinzi Bladder cancer (muscle invasive) (NIAGARA) Regulatory submission
Imfinzi Bladder cancer (1st-line) (NILE) Regulatory submission
Imfinzi Liver cancer (locoregional) (EMERALD-1) Regulatory submission (CN)
Imfinzi NSCLC (neoadjuvant) (AEGEAN) Regulatory submission
Imfinzi SCLC (limited-stage) (ADRIATIC) Regulatory submission
Lynparza + Imfinzi Endometrial cancer (1st-line) (DUO-E) Data readout
Calquence CLL (ACE-CL-311) Data readout
Calquence MCL 36 (#_ftn36) (1st-line) (ECHO) Data readout
capivasertib TNBC 37 (#_ftn37) (locally adv./met.) Data readout, regulatory submission
(CAPItello-290)
camizestrant HR+/HER2-neg breast cancer (SERENA-6) Data readout
Farxiga Myocardial infarction (DAPA-MI) Data readout
Fasenra EGPA 38 (#_ftn38) (MANDARA) Data readout
Fasenra HES 39 (#_ftn39) (NATRON) Data readout
Soliris gMG Regulatory decision (CN)
Koselugo NF1-PN (SPRINT) Regulatory decision (CN)
ALXN1840 Wilson disease Regulatory submission
danicopan PNH with extravascular haemolysis Regulatory submission
Operating and financial review
All narrative on growth and results in this section is based on actual
exchange rates, and financial figures are in US$ millions ($m), unless stated
otherwise. Unless stated otherwise, the performance shown in this announcement
covers the six-month period to 30 June 2022 ('the half' or 'H1 2022') compared
to the six-month period to 30 June 2021 (H1 2021), or the three-month period
to 30 June 2022 ('the quarter' or 'Q2 2022') compared to the three-month
period to 30 June 2021 (Q2 2021).
Core financial measures, EBITDA, Net Debt, CER, Initial Collaboration Revenue
and Ongoing Collaboration Revenue are non-GAAP financial measures because they
cannot be derived directly from the Group's Interim financial statements.
Management believes that these non-GAAP financial measures, when provided in
combination with Reported results, provide investors and analysts with helpful
supplementary information to understand better the financial performance and
position of the Group on a comparable basis from period to period. These
non-GAAP financial measures are not a substitute for, or superior to,
financial measures prepared in accordance with GAAP.
Core financial measures are adjusted to exclude certain significant items,
such as:
‒ Amortisation and impairment of intangible assets, including
impairment reversals but excluding any charges relating to IT assets
‒ Charges and provisions related to restructuring programmes, which
includes charges that relate to the impact of restructuring programmes on
capitalised IT assets as well as Post Alexion Acquisition Group Review items
‒ Alexion acquisition-related items, primarily fair-value adjustments
on acquired inventories and fair-value impact of replacement employee share
awards
‒ Other specified items, principally the imputed finance charge
relating to contingent consideration on business combinations and legal
settlements
‒ The tax effects of the adjustments above are excluded from the Core
Tax charge
Details on the nature of Core financial measures are provided on page 54 of
the Annual Report and Form 20-F Information 2021
(https://www.astrazeneca.com/content/dam/az/Investor_Relations/annual-report-2021/pdf/AstraZeneca_AR_2021.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, previously termed Gross Profit Margin, is the percentage by
which Product Sales exceeds the Cost of sales, calculated by dividing the
difference between the two by the sales figure. The calculation of Reported
and Core Gross Margin excludes the impact of Collaboration Revenue and any
associated costs, thereby reflecting the underlying performance of Product
Sales.
EBITDA is defined as Reported Profit Before Tax after adding back Net Finance
Expense, results from Joint Ventures and Associates and charges for
Depreciation, Amortisation and Impairment. Reference should be made to the
Reconciliation of Reported Profit Before Tax to EBITDA included in the
financial performance section in this announcement.
Net Debt is defined as Interest-bearing loans and borrowings and Lease
liabilities, net of Cash and cash equivalents, Other investments, and net
derivative financial instruments. Reference should be made to Note 3 'Net
Debt' included in the Notes to the Interim financial statements in this
announcement.
Ongoing Collaboration Revenue is defined as Collaboration Revenue excluding
Initial Collaboration Revenue (which is defined as Collaboration Revenue that
is recognised at the date of completion of an agreement or transaction, in
respect of upfront consideration). Ongoing Collaboration Revenue comprises,
among other items, royalties, milestone revenue and profit-sharing income.
Reference should be made to the Collaboration Revenue table in this Operating
and financial review.
The Company strongly encourages investors and analysts not to rely on any
single financial measure, but to review AstraZeneca's financial statements,
including the Notes thereto, and other available Company reports, carefully
and in their entirety.
Due to rounding, the sum of a number of dollar values and percentages in this
announcement may not agree to totals.
Total Revenue
Table 5: Disease area and medicine performance
H1 2022 Q2 2022
% Change % Change
Product Sales $m % Total Actual CER $m % Total Actual CER
Oncology 7,089 32 14 18 3,701 34 14 18
- Tagrisso 2,704 12 10 14 1,400 13 7 12
- Imfinzi 1,294 6 12 16 695 6 15 20
- Lynparza 1,291 6 14 18 673 6 15 20
- Calquence 903 4 84 87 489 5 74 77
- Enhertu 29 - >6x >6x 18 - >5x >5x
- Orpathys 23 - n/m n/m 11 - n/m n/m
- Zoladex 477 2 2 7 236 2 (3) 2
- Faslodex 178 1 (21) (16) 86 1 (18) (11)
- Iressa 63 - (41) (39) 32 - (32) (29)
- Arimidex 61 - (17) (13) 28 - (1) 5
- Casodex 42 - (49) (47) 21 - (50) (48)
- Others 24 - (4) 3 12 - (8) 1
BioPharmaceuticals: CVRM(8) 4,559 21 14 18 2,352 22 14 19
- Farxiga 2,103 9 55 63 1,103 10 51 59
- Brilinta 675 3 (10) (7) 350 3 (7) (4)
- Lokelma 129 1 79 87 66 1 68 79
- Roxadustat 91 - 1 1 50 - (2) (1)
- Andexxa(8) 70 - 9 12 37 - 5 11
- Crestor 547 2 2 6 280 3 6 11
- Seloken/Toprol-XL 467 2 (9) (7) 223 2 (16) (13)
- Bydureon 141 1 (29) (28) 73 1 (23) (22)
- Onglyza 139 1 (31) (28) 71 1 (28) (25)
- Others 197 1 (9) (7) 99 1 (1) 1
BioPharmaceuticals: R&I 2,891 13 (2) - 1,381 13 (3) 1
- Symbicort 1,288 6 (6) (3) 614 6 (10) (6)
- Fasenra 662 3 14 18 354 3 11 15
- Breztri 179 1 >2x >2x 93 1 66 72
- Saphnelo 36 - n/m n/m 24 - n/m n/m
- Pulmicort 334 2 (33) (32) 116 1 (30) (28)
- Daliresp 109 - (5) (4) 58 1 7 8
- Bevespi 30 - 13 16 15 - 12 17
- Others 253 1 (13) (12) 107 1 (18) (17)
BioPharmaceuticals: V&I 2,734 12 >2x >2x 977 9 10 15
- Vaxzevria 1,540 7 36 41 451 4 (48) (44)
- Evusheld 914 4 n/m n/m 445 4 n/m n/m
- Synagis 280 1 >5x >6x 80 1 >3x >3x
- FluMist - - n/m n/m 1 - n/m n/m
Rare Disease(8) 3,495 16 5 10 1,801 17 6 12
- Soliris(8) 2,017 9 (5) 1 1,027 10 (5) 2
- Ultomiris(8) 853 4 22 28 434 4 23 31
- Strensiq(8) 450 2 11 13 242 2 16 18
- Koselugo 101 - >2x >2x 62 1 >2x >2x
- Kanuma(8) 74 - 9 14 36 - 9 13
Other Medicines 842 4 (11) (6) 418 4 (3) 6
- Nexium 674 3 (9) (2) 343 3 2 12
- Others 168 1 (21) (20) 75 1 (19) (17)
Product Sales 21,610 98 41 47 10,630 99 32 38
Collaboration Revenue 551 2 >2x >2x 141 1 (20) (20)
Total Revenue 22,161 100 43 48 10,771 100 31 37
Table 6: Collaboration Revenue
H1 2022 Q2 2022
% Change % Change
$m % Total Actual CER $m % Total Actual CER
Lynparza: regulatory milestones 175 32 n/m n/m - - n/m n/m
Enhertu: share of gross profits 173 31 >2x >2x 99 70 >2x >2x
Tezspire: share of gross profits 16 3 n/m n/m 13 9 n/m n/m
Vaxzevria: royalties 60 11 83 77 4 3 (87) (88)
Tralokinumab: sales milestone 70 13 n/m n/m - - n/m n/m
Other royalty income 37 7 2 2 20 14 7 9
Other Collaboration Revenue 20 4 (77) (77) 5 4 (93) (93)
Total 551 100 >2x >2x 141 100 (20) (20)
Table 7: Total Revenue by disease area
H1 2022 Q2 2022
% Change % Change
$m % Total Actual CER $m % Total Actual CER
Oncology 7,454 34 18 22 3,810 35 15 20
BioPharmaceuticals 10,350 47 26 31 4,733 44 8 13
- CVRM 4,576 21 14 19 2,356 22 14 19
- R&I 2,979 13 - 3 1,395 13 (2) 1
- V&I 2,795 13 >2x >2x 981 9 7 12
Rare Disease 3,495 16 5 10 1,801 17 6 12
Other Medicines 862 4 (18) (12) 427 4 (17) (10)
Total 22,161 100 43 48 10,771 100 31 37
Table 8: Total Revenue by region
H1 2022 Q2 2022
% Change % Change
$m % Total Actual CER $m % Total Actual CER
Emerging Markets 6,156 28 13 16 2,792 26 (3) 1
- China 3,057 14 (5) (5) 1,435 13 (6) (5)
- Ex-China 3,099 14 38 46 1,357 13 1 7
US 8,482 38 75 75 4,348 40 72 72
Europe 4,364 20 34 45 2,080 19 21 35
Established RoW 3,159 14 59 74 1,551 14 39 55
Total 22,161 100 43 48 10,771 100 31 37
Table 9: Total Revenue by region - excluding Vaxzevria
H1 2022 Q2 2022
% Change % Change
$m % Total Actual CER $m % Total Actual CER
Emerging Markets 5,436 25 9 13 2,603 24 7 11
- China 3,011 14 (6) (7) 1,435 13 (6) (5)
- Ex-China 2,425 11 38 48 1,167 11 31 39
US 8,403 38 74 74 4,348 40 72 72
Europe 4,102 19 53 66 1,952 18 43 59
Established RoW 2,620 12 40 53 1,412 13 39 56
Total 20,561 93 43 48 10,316 96 41 47
Oncology
Oncology Total Revenue increased by 18% (22% at CER) in H1 2022 to $7,454m and
represented 34% of overall Total Revenue (H1 2021: 41%). This included
Lynparza Collaboration Revenue of $175m (H1 2021: $nil) and Enhertu
Collaboration Revenue of $175m (H1 2021: $85m). Product Sales increased by 14%
(18% at CER) in H1 2022 to $7,089m, reflecting new launches and increased
patient access for Tagrisso, Imfinzi, Lynparza and Calquence partially offset
by declines in legacy medicines.
Overall rates of cancer diagnosis, testing and treatment in the half continued
to show a cumulative impact from the COVID-19 pandemic with rates in CLL, lung
cancer and ovarian cancer remaining below pre-COVID-19 baseline, with some
signs of improvement. Rates of breast cancer diagnosis in the US appear to be
approaching normal levels. In China, COVID-19 related lockdowns in several
major cities had an adverse impact during the second quarter.
Tagrisso
Total Revenue Worldwide Emerging Markets US Europe Established RoW
H1 2022 $m 2,704 805 951 509 439
Actual change 10% 16% 11% 9% 1%
CER change 14% 17% 11% 19% 12%
Region Drivers and commentary
Worldwide Increased use of Tagrisso in adjuvant and 1st-line setting
Emerging Markets Increased 1st-line use in China and continued growth in other Emerging Markets
Rising demand from increased patient access in China continues to offset the
impact of the March 2021 NRDL price reduction
In China, COVID-19 related lockdowns in several major cities had an adverse
impact
US Increasing EGFR testing rates.
Greater use in 1st-line
Strong adjuvant launch momentum
Europe Greater use in 1st-line and adjuvant settings, with longer duration of
treatment, partially offset by lower 2nd-line use
Established RoW Increased use in 1st-line setting and launch progress in adjuvant
Imfinzi
Total Revenue Worldwide Emerging Markets US Europe Established RoW
H1 2022 $m 1,294 134 689 267 204
Actual change 12% 1% 15% 18% 1%
CER change 16% 2% 15% 29% 12%
Region Drivers and commentary
Worldwide Increased use of Imfinzi to treat patients with ES-SCLC 40 (#_ftn40) , offset
by impact from lower rates of diagnosis and treatment due to the ongoing
COVID-19 pandemic
Emerging Markets Growth in ex-China, offset by an adverse impact in CRT 41 (#_ftn41) rates and
hospital use of infused oncology medicines due to COVID-19 lockdowns in
several major cities in China during the period
US New patient starts across Stage III NSCLC and ES-SCLC
Europe Increased market penetration in ES-SCLC, growth in the number of reimbursed
markets, offsetting the impact of COVID-19 on rates of diagnosis and treatment
Established RoW New reimbursements
Lynparza
Total Revenue Worldwide Emerging Markets US Europe Established RoW
H1 2022 $m 1,466 241 582 504 139
Actual change 30% 30% 11% 67% 15%
CER change 34% 32% 11% 78% 27%
Product Sales Worldwide Emerging Markets US Europe Established RoW
H1 2022 $m 1,291 241 582 329 139
Actual change 14% 30% 11% 9% 15%
CER change 18% 32% 11% 20% 27%
Region Drivers and commentary
Worldwide Lynparza remains the leading medicine in the PARP 42 (#_ftn42) -inhibitor
class globally across four tumour types, as measured by total prescription
volume
Total Revenue includes a $175m regulatory milestone received from MSD and
recognised in Europe, in respect of the approval in the US for the adjuvant
treatment of patients with breast cancer, based on the data from the OlympiA
Phase III trial
Emerging Markets Increased patient access following admission to China's NRDL as a 1st-line
treatment for ovarian cancer patients, with effect from March 2021; also
launches in other markets
In China, COVID-19-related lockdowns in several major cities had an adverse
impact
US US launch in early breast cancer following US FDA 43 (#_ftn43) approval in
March based on data from the OlympiA Phase III trial
Growth in use in ovarian and prostate cancers
Europe Reimbursements introduced in additional countries, increasing BRCAm-testing
rates, and successful launches in 1st-line BRCAm ovarian, 2nd-line HRRm 44
(#_ftn44) prostate and gBRCAm HER2-negative advanced breast cancer
Established RoW New product launches and high levels of HRD 45 (#_ftn45) testing in Japan
Enhertu
Total Revenue Worldwide Emerging Markets US Europe Established RoW
H1 2022 $m 204 26 130 46 2
Actual change >2x >6x 72% >4x n/m
CER change >2x >6x 72% >4x n/m
Region Drivers and commentary
Worldwide Excluding Japan, Enhertu global in-market sales recorded by Daiichi Sankyo
Company Limited (Daiichi Sankyo) and AstraZeneca, amounted to $397m in the
half (H1 2021: $183m)
AstraZeneca's Total Revenue of $204m includes $175m of Collaboration Revenue
from its share of gross profit in territories where Daiichi Sankyo records
product sales
Emerging Markets Strong uptake in early launch markets
US US in-market sales, recorded by Daiichi Sankyo, amounted to $274m in the half
(H1 2021: $161m)
US launch in 2nd-line HER2-positive metastatic breast cancer after US FDA
approval in May based on data from the DESTINY-Breast03 Phase III trial
Europe Growth in 3rd-line+ HER2-positive metastatic breast cancer in large European
markets
ESMO guidelines updated in late 2021 to include Enhertu use in 2nd-line
Established RoW In Japan, AstraZeneca receives a mid-single-digit percentage royalty on sales
made by Daiichi Sankyo
Calquence
Total Revenue Worldwide Emerging Markets US Europe Established RoW
H1 2022 $m 903 16 735 122 30
Actual change 84% >2x 65% >3x >4x
CER change 87% >2x 65% >4x >5x
Region
US Increased new patient market share led to a strong performance, despite
continued COVID‑19 impacts on CLL diagnosis rates
Europe Increased market share in new patient starts after launches in the region
Orpathys
Orpathys Total Revenue of $24m in the half (H1 2021: $nil) was driven by the
2021 launch in China, where it is approved for patients with lung cancer and
MET 46 (#_ftn46) gene alterations.
Other Oncology medicines
H1 2022 % Change
Total Revenue $m Actual CER
Zoladex 491 3% 8% Increased use in ex-China Emerging Markets, offsetting a price cut in Japan
Faslodex 178 (21%) (16%) Generic competition
Iressa 63 (41%) (39%) Continued share loss to next generation TKI 47 (#_ftn47) s
Arimidex 61 (17%) (13%)
Casodex 42 (49%) (47%) Ongoing impact from VBP implementation
Other Oncology 24 (4%) 3%
BioPharmaceuticals
Including Vaccines & Immune Therapies medicines, BioPharmaceuticals Total
Revenue increased by 26% (31% at CER) in H1 2022 to $10,350m, representing 47%
of overall Total Revenue (H1 2021: 53%). Growth was driven by strong Farxiga
performance and growth in the COVID-19 medicines.
Cardiovascular, Renal & Metabolism
Total Revenue from CVRM medicines increased by 14% (19% at CER) in H1 2022,
driven by a strong Farxiga performance, to $4,576m and represented 21% of
overall Total Revenue (H1 2021: 25%).
Farxiga
Total Revenue Worldwide Emerging Markets US Europe Established RoW
H1 2022 $m 2,105 814 468 627 197
Actual change 55% 46% 55% 69% 54%
CER change 62% 50% 55% 85% 68%
Region
Worldwide Farxiga volume is growing faster than the overall SGLT2 48 (#_ftn48) market
in most major regions
Growth in the SGLT2 inhibitor class
Further HF 49 (#_ftn49) and CKD launches and updated treatment guidelines
including from ESC 50 (#_ftn50) and AHA 51 (#_ftn51) /ACC 52 (#_ftn52)
/HFSA 53 (#_ftn53)
Emerging Markets uACR 54 (#_ftn54) and MRF 55 (#_ftn55) testing programs in China, and solid
growth in ex-China Emerging Markets, particularly Latin America
In China, Forxiga's NRDL status was renewed in the fourth quarter of 2021
US Regulatory approval for HFrEF 56 (#_ftn56) in May 2020, treatment of CKD in
May 2021, and favourable gross-to-net adjustments
Both approvals included patients with and without T2D 57 (#_ftn57)
Farxiga continued to gain in-class brand share, driven by HF and CKD launches
Europe The beneficial addition of cardiovascular outcomes trial data to the label,
the HFrEF regulatory approval in November 2020, and CKD regulatory approval in
August 2021
Forxiga continued gains in-class market share in the period
Established RoW In Japan, sales to collaborator Ono Pharmaceutical Co., Ltd, which records
in-market sales, were $134m (H1 2021: $71m)
Brilinta
Total Revenue Worldwide Emerging Markets US Europe Established RoW
H1 2022 $m 675 146 351 150 28
Actual change (10%) (19%) (2%) (16%) (12%)
CER change (7%) (15%) (2%) (8%) (8%)
Region
Emerging Markets Adverse impact from Brilinta's inclusion in China's VBP programme
Strong growth in ex-China Emerging Markets
US, Europe Fewer elective procedures due to the effects of the pandemic
Lokelma
Total Revenue increased 79% (87% at CER) to $129m in H1, driven by Lokelma
extending its branded market share lead in the US and also achieving total
market share leadership in the period. Continued progress in Europe from
recent launches across the region. In China, Lokelma was included on the NRDL
with effect from 1 January 2022.
Andexxa
On a pro forma basis, Total Revenue increased 25% (28% at CER) to $80m.
Andexxa launched in Japan in May 2022.
Roxadustat
Total Revenue increased 1% to $94m. Total Revenue also increased
quarter-on-quarter, with roxadustat benefitting from increased volumes in
China following NRDL price cuts.
Other CVRM medicines
H1 2022 % Change
Total Revenue $m Actual CER
Crestor 548 2% 6% Sales growth driven in Emerging Markets, offset by declines in the US and
Europe
Seloken 468 (9%) (7%) Emerging Markets sales impacted by China VBP implementation of Betaloc 58
(#_ftn58) oral in H2 2021. Betaloc ZOK VBP to be implemented later in 2022
Onglyza 139 (31%) (28%) Ongoing impact from VBP implementation
Bydureon 141 (29%) (28%) Continued competitive pressures
Other CVRM 197 (9%) (7%)
Respiratory & Immunology
Total Revenue from R&I medicines was stable in H1 2022 (increased 3% at
CER) at $2,979m and represented 13% of overall Total Revenue (H1 2021: 19%).
Symbicort
Total Revenue Worldwide Emerging Markets US Europe Established RoW
H1 2022 $m 1,288 306 481 312 189
Actual change (6%) - (9%) (9%) (1%)
CER change (3%) 3% (9%) (1%) 4%
Region
Worldwide Symbicort remains the global market leader within the ICS 59 (#_ftn59)
/LABA 60 (#_ftn60) class
The global ICS/LABA market continues to be eroded as fixed-dose triple
therapies (LAMA 61 (#_ftn61) /LABA/ICS) continue to launch in major markets
(US, China and Japan)
Emerging Markets Growth in Ex-China Emerging Markets
Continued impact of fixed-dose triple therapy launches and COVID-19
restrictions in China
US Maintained market share and leadership in a declining ICS/LABA market as
fixed-dose triple therapy launches continue
Unfavourable gross-to-net adjustment during the second quarter
Established RoW Sales in Japan continued to decline due to continued generic erosion as well
as the annual mandatory price reduction, which occurred in April
Fasenra
Total Revenue Worldwide Emerging Markets US Europe Established RoW
H1 2022 $m 662 17 419 153 73
Actual change 14% >2x 18% 12% (8%)
CER change 18% >2x 18% 23% 1%
Region
Worldwide Fasenra continued to lead the IL-5 class, in severe eosinophilic asthma, in
major markets (US, Japan and some EU countries)
US Maintained a stable new-to-brand share of the severe uncontrolled asthma class
Europe Growth driven by increased market share performance
Established RoW Increased demand and sustained leadership in new-to-brand prescriptions in
Japan, offset by the mandatory price reduction, which took effect in April
Breztri
Total Revenue Worldwide Emerging Markets US Europe Established RoW
H1 2022 $m 179 43 106 14 16
Actual change >2x 61% >2x >10x 46%
CER change >2x 61% >2x >10x 65%
Region
Worldwide Breztri continued to gain market share within the fixed-dose triple class in
major markets
Emerging Markets Continued its market share leadership within the fixed-dose triple class in
China, which continues to gain share from the ICS/LABA class
COVID-19 restrictions impacted inhaled maintenance market growth
US Increased new-to-brand market share within the fixed-dose triple class
Europe Sustained growth across markets as new launches continue to progress
Established RoW Strong launch performance in Japan
Saphnelo
Total Revenue of $36m in the half (H1 2021: $nil) was driven by the 2021
launch in the US, where Saphnelo has been approved for SLE 62 (#_ftn62) and
received a permanent J-code facilitating reimbursement. In Japan, there was an
adverse impact as COVID-19 lockdowns limited access to hospitals.
Tezspire
Total Revenue of $16m in the half (H1 2021: $nil) was comprised entirely of
Collaboration Revenue and reflected the US launch of Tezspire as add-on
maintenance treatment for patients with severe asthma following US FDA
approval in December 2021. Amgen records sales in the US and AstraZeneca
records its share of gross profits in the US as Collaboration Revenue. US
in-market sales were $36m.
Other R&I medicines
H1 2022 % Change
Total Revenue $m Actual CER
Pulmicort 334 (33%) (32%) Revenue from Emerging Markets decreased 42% (41% at CER) to $236m, impacted by
VBP implementation in China and lower rates of elective surgery and limited
access to nebulisation centres due to COVID-19 lockdowns
Daliresp 109 (5%) (4%)
Bevespi 30 13% 16%
Other R&I 326 9% 9%
Vaccines & Immune Therapies
Total Revenue from Vaccines & Immune Therapies medicines increased to
$2,795m (H1 2021: $1,221m) and represented 13% of overall Total Revenue (H1
2021: 8%).
Vaxzevria
Total Revenue Worldwide Emerging Markets US Europe Established RoW
H1 2022 $m 1,600 720 80 262 538
Actual change 37% 47% n/m (54%) >4x
CER change 42% 47% n/m (50%) >5x
Region
Worldwide The majority of Vaxzevria revenue in H1 2022 came from initial, not-for-profit
contracts
Revenue in the second quarter decreased by 49% (46% at CER)
Emerging Markets Growth was driven by initial and commercial contracts in Latin America and
Asia
$46m of Collaboration Revenue came from a Chinese sub-licensee producing
vaccines for export
Revenue in the second quarter decreased by 57%
US Purchases by the US government for donation overseas
No revenue recorded in the second quarter
Europe Revenue in the second quarter decreased by 63% (59% at CER)
Established RoW Sales in Japan, Canada and Australia
Revenue in the second quarter increased by 36% (50% at CER)
Evusheld
Total Revenue Worldwide Emerging Markets US Europe Established RoW
H1 2022 $m 914 93 556 143 122
Actual change n/m n/m n/m n/m n/m
CER change n/m n/m n/m n/m n/m
Region
US Evusheld received Emergency Use Authorisation for prevention of COVID-19 in
December 2021
In H1 2022, AstraZeneca continued fulfilment of the US Government's order for
1.7m units. The remainder of that order is expected to be fulfilled before the
end of 2022
Emerging Markets Multiple government contracts in Central and Eastern Europe, Latin America and
South East Asia and China. Evusheld is the first non-Chinese medicine to be
used for the prevention of COVID-19 in China
Europe Approved in the EU for prevention of COVID-19 in March 2022
Other V&I medicines
H1 2022 % Change
Total Revenue $m Actual CER
Synagis 280 >5x >6x The year-on-year increase reflects the reversion of ex-US rights to
AstraZeneca following expiry of the collaboration agreement with AbbVie Inc.
on 30 June 2021
FluMist - n/m n/m Normal seasonality of FluMist sales
Rare Disease
On a pro forma basis, Total Revenue from Rare Disease medicines increased by
5% (10% at CER) in H1 2022 to $3,495m. In H1 2022, Rare Disease represented
16% of overall Total Revenue. Excluding a one-off historic pricing adjustment
that benefited ex-US Total Revenue in the second quarter, Rare Disease pro
forma revenue growth would have been 2% (8% at CER). Performance was driven by
continued conversion from Soliris to Ultomiris, and initial uptake of
Ultomiris in gMG following US launch. Strensiq and Koselugo performances were
driven by patient growth and market expansion respectively.
These tables show pro forma growth rates for the medicines acquired with
Alexion, calculated by comparing H1 2022 revenues with the revenues to 30 June
2021 as reported by Alexion.
Soliris
Total Revenue Worldwide Emerging Markets US Europe Established RoW
H1 2022 $m 2,017 134 1,165 437 281
Actual change(8) (5%) (45%) 2% (17%) 34%
CER change(8) 1% (29%) 2% (8%) 46%
Region
US Growth in neurology indications (gMG and NMOSD), offset by continued
conversion from Soliris to Ultomiris
Ex-US Performance driven by neurology growth in new markets and a one-off adjustment
in the second quarter
Ultomiris
Total Revenue Worldwide Emerging Markets US Europe Established RoW
H1 2022 $m 853 30 456 225 142
Actual change(8) 22% >6x 10% 65% (3%)
CER change(8) 28% >6x 10% 81% 11%
Region
Worldwide Continued conversion from Soliris to Ultomiris and expansion into new markets
Quarter-on-quarter revenue growth variability can be expected due to Ultomiris
every eight-week dosing schedule and lower average annual treatment cost per
patient compared to Soliris
US Continued conversion and patient growth in PNH and aHUS, as well as initial
uptake following recent gMG approval and launch
Ex-US Accelerated conversion in newly-launched markets
Other Rare Disease medicines
H1 2022 % Change
Total Revenue $m Actual CER Commentary
Strensiq(8) 450 11% 13% Performance driven by demand growth and one-time benefit from timing of
inventory dynamics
Koselugo 101 >2x >2x Performance driven by expansion in the US and new markets, as well as timing
of certain ex-US tender market orders
Kanuma(8) 74 9% 14% Continued demand growth in ex-US markets
Other medicines (outside the main disease areas)
H1 2022 % Change
Total Revenue $m Actual CER Commentary
Nexium 685 (17%) (11%) Nexium (oral) was included in China's VBP programme implemented in February
2021 and Nexium (i.v. 63 (#_ftn63) ) was implemented in the fifth round of
VBP in October 2021
Others 177 (20%) (19%)
Financial performance
Table 10: Reported Profit and Loss
H1 2022 H1 2021 % Change Q2 2022 Q2 2021 % Change
$m $m Actual CER $m $m Actual CER
Total Revenue 22,161 15,540 43 48 10,771 8,220 31 37
- Product Sales 21,610 15,302 41 47 10,630 8,045 32 38
- Collaboration Revenue 551 238 n/m n/m 141 175 (20) (20)
Cost of Sales (6,509) (4,055) 61 71 (2,998) (2,191) 37 49
Gross Profit 15,652 11,485 36 40 7,773 6,029 29 33
Gross Margin 69.9% 73.5% -4 -4 71.8% 72.8% -1 -2
Distribution Expense (254) (202) 26 32 (129) (103) 25 33
% Total Revenue 1.1% 1.3% - - 1.2% 1.3% - -
R&D Expense (4,679) (3,542) 32 35 (2,546) (1,829) 39 44
% Total Revenue 21.1% 22.8% 2 2 23.6% 22.2% -1 -1
SG&A Expense (9,521) (6,027) 58 62 (4,681) (3,098) 51 56
% Total Revenue 43.0% 38.8% -4 -4 43.5% 37.7% -6 -5
OOI 64 (#_ftn64) & Expense 219 1,308 (83) (83) 122 128 (5) (5)
% Total Revenue 1.0% 8.4% -7 -7 1.1% 1.6% - -
Operating Profit 1,417 3,022 (53) (49) 539 1,127 (52) (53)
Operating Margin 6.4% 19.4% -13 -13 5.0% 13.7% -9 -9
Net Finance Expense (612) (602) 2 9 (293) (319) (8) 10
Joint Ventures and Associates (5) (48) (90) (88) 1 (44) n/m n/m
Profit before tax 800 2,372 (66) (62) 247 764 (68) (75)
Taxation (52) (260) (80) (77) 113 (214) n/m n/m
Tax rate 7% 11% -46% 28%
Profit after tax 748 2,112 (65) (60) 360 550 (35) (37)
Earnings per share $0.48 $1.61 (70) (66) $0.23 $0.42 (45) (46)
Table 11: Reconciliation of Reported Profit before tax to EBITDA
H1 2022 H1 2021 % Change Q2 2022 Q2 2021 % Change
$m $m Actual CER $m $m Actual CER
Reported Profit before tax 800 2,372 (66) (62) 247 764 (68) (75)
Net Finance Expense 612 602 2 9 293 319 (8) 10
Joint Ventures and Associates 5 48 (90) (88) (1) 44 n/m n/m
Depreciation, Amortisation and Impairment 2,666 1,550 72 73 1,357 753 80 82
EBITDA 4,083 4,572 (11) (8) 1,896 1,880 1 1
EBITDA of $4,083m in the half (H1 2021: $4,572m) has been negatively impacted
by the $2,318m (H1 2021: $nil) unwind of inventory fair value uplift
recognised on the acquisition of Alexion. EBITDA of $1,896m in the quarter (Q2
2021: $1,880m) has been negatively impacted by the $1,138m (Q2 2021: $nil)
unwind of inventory fair value uplift recognised on the acquisition of
Alexion. The unwind of inventory fair value is expected to depress EBITDA over
the year in line with associated revenues.
Table 12: Reconciliation of Reported to Core financial measures: H1 2022
H1 2022 Reported Restructuring Intangible Asset Amortisation & Impairments Acquisition Other Core Core
of Alexion
% Change
$m $m $m $m $m $m Actual CER
Gross Profit 15,652 81 16 2,320 - 18,069 57 60
Gross Margin 69.9% 81.1% +7pp +6pp
Distribution Expense (254) 1 - - - (253) 25 32
R&D Expense (4,679) 38 6 18 - (4,617) 34 38
SG&A Expense (9,521) 198 2,081 30 1,129 65 (#_ftn65) (6,083) 25 29
Total Operating Expense (14,454) 237 2,087 48 1,129 (10,953) 29 33
Other Operating Income & Expense 219 (9) - - - 210 (84) (84)
Operating Profit 1,417 309 2,103 2,368 1,129 7,326 69 71
Operating Margin 6.4% 33.1% +5pp +4pp
Net Finance Expense (612) - - 137 (475) 16 24
Taxation (52) (61) (387) (546) (207) (1,253) n/m n/m
EPS $0.48 $0.16 $1.10 $1.18 $0.69 $3.61 43 44
Table 13: Reconciliation of Reported to Core financial measures: Q2 2022
Q2 2022 Reported Restructuring Intangible Asset Amortisation & Impairments Acquisition Other Core Core
of Alexion
% Change
$m $m $m $m $m $m Actual CER
Gross Profit 7,773 30 8 1,139 - 8,950 48 52
Gross Margin 71.8% 82.9% +10pp +8pp
Distribution Expense (129) - - - - (129) 25 33
R&D Expense (2,546) 33 75 7 - (2,431) 35 40
SG&A Expense (4,681) 181 983 13 367 (3,137) 27 33
Total Operating Expense (7,356) 214 1,058 20 367 (5,697) 30 36
Other Operating Income & Expense 122 (10) - - - 112 (12) (13)
Operating Profit 539 234 1,066 1,159 367 3,365 86 87
Operating Margin 5.0% 31.2% +9pp +8pp
Net Finance Expense (293) - - - 70 (223) 1 26
Taxation 113 (46) (196) (266) (86) (481) 32 28
EPS $0.23 $0.12 $0.56 $0.58 $0.23 $1.72 92 89
Profit and Loss drivers
Gross Profit
‒ The Gross Profit Margin (Reported and Core) in the half was impacted
by:
‒ Positive mix effects: the increased contribution from Rare
Disease and Oncology medicines had a positive impact on the Gross Margin
‒ Negative mix effects: sales of Vaxzevria and medicines with
profit-sharing arrangements (primarily Lynparza) had a dilutive impact on the
Gross Margin. In the second quarter, there was less dilution from Vaxzevria
than in previous quarters, due to phasing on Vaxzevria contracts that were
fulfilled in the quarter
‒ Pricing pressure relating to the VBP and NRDL procurement
programmes in China
‒ Reported Gross Profit was also impacted by the unwind of the fair
value adjustment to Alexion inventories at the date of acquisition. The fair
value uplift is expected to unwind through Reported Cost of Sales over 2022 in
line with associated revenues, and in H1 2022, the impact of the fair value
uplift unwind on Cost of Sales was $2,318m
‒ Currency fluctuations had a positive impact in the first half.
Currency fluctuations may have a positive or negative impact on Gross Margin
in future quarters
‒ Variations in Gross Margin performance between periods can be
expected to continue
R&D Expense
‒ The increase in Reported and Core R&D Expense was driven by:
‒ The acquisition of Alexion in July 2021
‒ Recent positive data read outs for several high priority
medicines that ungated late-stage Oncology trials
‒ The advancement of a number of Phase II clinical development
programmes in BioPharmaceuticals
‒ Investment in platforms, new technology and capabilities to
enhance R&D productivity
‒ A one-off $89m impairment of a pre-paid asset relating to a
discontinued collaboration with an external partner
‒ Reported R&D Expense in H1 2022 was also impacted by intangible
asset impairment reversals
SG&A Expense
‒ The increase in Reported and Core SG&A Expense was driven by:
‒ The acquisition of Alexion
‒ Market development activities for recent launches, including
Evusheld
‒ Reported SG&A Expense was also impacted by amortisation of
intangible assets related to the Alexion acquisition and a $775m legal
settlement with Chugai
Other Operating Income
‒ Other Operating Income of $219m consisted primarily of royalties and
disposal proceeds on small divestments, including the divestment of rights to
Plendil in the second quarter
‒ In H1 2021, Other Operating Income of $1,308m included $776m of
divestment gains from AstraZeneca's share of Viela Bio, Inc. and $309m from
the commercial rights to Crestor in over 30 countries in Europe (excluding UK
and Spain)
Net Finance Expense
‒ The increase in Net Finance Expense in the half was driven by
financing costs on debt for the Alexion transaction, increased interest on
tax, and currency fluctuations
Taxation
‒ Reported Tax rate is lower than H1 2021 and Core Tax rate is higher
than H1 2021. Reported tax rate is lower due to impact of non-core charges
on the level of Reported Profit Before Tax in H1 2022 and both Reported and
Core Tax rates were impacted by one-off items in 2021, including the
non-taxable gain on the divestment of Viela and updates to estimates of prior
period tax liabilities following settlements with tax authorities
‒ The net cash paid for the half was $1,006m (H1 2021: $869m)
representing 126% of Reported Profit Before Tax (H1 2021: 37%). The cash tax
rate increased due to the impact of Non-core charges on the level of Reported
Profit Before Tax and effects of US rules around deferral of tax relief on
R&D costs
‒ The Reported Tax rate of 7% was lower than Core Tax rate of 18% due
to the impact of Non-Core charges on the level of Reported Profit Before Tax.
Q2 2022 Reported and Core Tax rates also benefited from the geographical mix
of profits and favourable adjustments to prior year tax liabilities in a
number of major jurisdictions in the quarter
‒ On 20 July 2022, the UK Government issued draft legislation in
relation to the new global minimum tax framework, expected to be brought into
effect in the UK from 2024. The Company is currently assessing potential
impact of these draft rules upon its financial statements.
Dividend
‒ Interim dividend declared of $0.93 (76.4 pence, 9.49 SEK) per
ordinary share
Table 14: Cash Flow summary
H1 2022 H1 2021 Change
$m $m $m
Reported Operating Profit 1,417 3,022 (1,605)
Depreciation, Amortisation and Impairment 2,666 1,550 1,116
Decrease in Working Capital and Short-term Provisions 2,391 857 1,534
Gains on Disposal of Intangible Assets (81) (354) 273
Gains on Disposal of Investments in Associates and Joint Ventures - (776) 776
Fair value movements on contingent consideration arising from business 293 82 211
combinations
Non-Cash and Other Movements (814) (363) (451)
Interest Paid (386) (323) (63)
Taxation Paid (1,006) (869) (137)
Net Cash Inflow from Operating Activities 4,480 2,826 1,654
Net Cash Inflow before Financing Activities 3,512 3,145 367
Net Cash (Outflow)/Inflow from Financing Activities (5,035) 4,558 (9,593)
The increase in Net Cash Inflow from Operating Activities of $1,654m primarily
reflected an underlying
improvement in business performance, including the contribution from Alexion.
The Reported Operating Profit of $1,417m in the period includes a negative
impact of $2,318m relating to the unwind of the inventory fair value uplift
recognised on the acquisition of Alexion. This is offset by a corresponding
item (positive impact of $2,318m) in Decrease in Working Capital and
Short-term Provisions. Overall, the unwind of the fair value uplift has no
impact on Net Cash Inflow from Operating Activities.
The change in Working Capital and Short-term Provisions of $1,534m, whilst
being positively impacted by the aforementioned inventory fair value uplift
unwind, has been adversely impacted by the reduction of Vaxzevria working
capital balances predominantly within Trade and other payables.
Capital Expenditure
Capital Expenditure amounted to $472m in the half (H1 2021: $508m). The
Company anticipates an increase in Capital Expenditure relative to FY 2021,
partly driven by an expansion in its capacity for growth and the acquisition
of Alexion.
Table 15: Net Debt summary
At 30 At 31 At 30
Jun 2022 Dec 2021 Jun 2021
$m $m $m
Cash and cash equivalents 4,817 6,329 15,567
Other investments 70 69 62
Cash and investments 4,887 6,398 15,629
Overdrafts and short-term borrowings (747) (387) (560)
Lease liabilities (905) (987) (690)
Current instalments of loans (1,415) (1,273) (2,136)
Non-current instalments of loans (26,461) (28,134) (24,109)
Interest-bearing loans and borrowings (Gross Debt) (29,528) (30,781) (27,495)
Net derivatives (48) 61 145
Net Debt (24,689) (24,322) (11,721)
Net Debt increased by $367m in the half to $24,689m. Details of the committed
undrawn bank facilities are disclosed within the going concern section of Note
1. Details of the Company's solicited credit ratings are disclosed in Note 3.
Capital allocation
The Board's aim is to continue to strike a balance between the interests of
the business, financial creditors and the Company's shareholders. The
Company's capital allocation priorities include investing in the business and
pipeline, maintaining a strong, investment-grade credit rating, potential
value-enhancing business development opportunities, and supporting the
progressive dividend policy.
In approving the declaration of dividends, the Board considers both the
liquidity of the company and the level of reserves legally available for
distribution. Dividends are paid to shareholders from AstraZeneca PLC, a Group
holding company with no direct operations. The ability of AstraZeneca PLC to
make shareholder distributions is dependent on the creation of profits for
distribution and the receipt of funds from subsidiary companies. The
consolidated Group reserves set out in the Condensed consolidated statement of
financial position do not reflect the profit available for distribution to the
shareholders of AstraZeneca PLC.
Summarised financial information for guarantee of securities of subsidiaries
AstraZeneca Finance LLC ("AstraZeneca Finance") is the issuer of 0.700% Notes
due 2024, 1.200% Notes due 2026, 1.750% Notes due 2028 and 2.250% Notes due
2031 (the "AstraZeneca Finance Notes"). Each series of AstraZeneca Finance
Notes has been fully and unconditionally guaranteed by AstraZeneca PLC.
AstraZeneca Finance is 100% owned by AstraZeneca PLC and each of the
guarantees by AstraZeneca PLC is full and unconditional and joint and several.
The AstraZeneca Finance Notes are senior unsecured obligations of AstraZeneca
Finance and rank equally with all of AstraZeneca Finance's existing and future
senior unsecured and unsubordinated indebtedness. The guarantee by AstraZeneca
PLC of the AstraZeneca Finance Notes is the senior unsecured obligation of
AstraZeneca PLC and ranks equally with all of AstraZeneca PLC's existing and
future senior unsecured and unsubordinated indebtedness. Each guarantee by
AstraZeneca PLC is effectively subordinated to any secured indebtedness of
AstraZeneca PLC to the extent of the value of the assets securing such
indebtedness. The AstraZeneca Finance Notes are structurally subordinated to
indebtedness and other liabilities of the subsidiaries of AstraZeneca PLC,
none of which guarantee the AstraZeneca Finance Notes.
AstraZeneca PLC manages substantially all of its operations through divisions,
branches and/or investments in subsidiaries and affiliates. Accordingly, the
ability of AstraZeneca PLC to service its debt and guarantee obligations is
also dependent upon the earnings of its subsidiaries, affiliates, branches and
divisions, whether by dividends, distributions, loans or otherwise.
Please refer to the consolidated financial statements of AstraZeneca PLC in
our Annual Report on Form 20-F and reports on Form 6-K with our quarterly
financial results as filed or furnished with the SEC for further financial
information regarding AstraZeneca PLC and its consolidated subsidiaries. For
further details, terms and conditions of the AstraZeneca Finance Notes please
refer to AstraZeneca PLC's Form 6-K furnished to the SEC on 28 May 2021.
Pursuant to Rule 13-01 and Rule 3-10 of Regulation S-X under the Securities
Act of 1933, as amended (the "Securities Act"), we present below the summary
financial information for AstraZeneca PLC, as Guarantor, excluding its
consolidated subsidiaries, and AstraZeneca Finance, as the issuer, excluding
its consolidated subsidiaries. The following summary financial information of
AstraZeneca PLC and AstraZeneca Finance is presented on a combined basis and
transactions between the combining entities have been eliminated. Financial
information for non-guarantor entities has been excluded. Intercompany
balances and transactions between the obligor group and the non-obligor
subsidiaries are presented on separate lines.
Table 16: Obligor group summarised Statement of comprehensive income
H1 2022 H1 2021
$m $m
Total revenue - -
Gross profit - -
Operating loss (2) (43)
Loss for the period (275) (336)
Transactions with subsidiaries that are not issuers or guarantors 331 2,582
Table 17: Obligor group summarised Statement of financial position information
At 30 Jun 2022 At 30 Jun 2021
$m $m
Current assets 7 7
Non-current assets - 4
Current liabilities (1,838) (2,341)
Non-current liabilities (23,994) (23,808)
Amounts due from subsidiaries that are not issuers or guarantors 7,459 15,039
Amounts due to subsidiaries that are not issuers or guarantors (295) (295)
Foreign exchange
The Company's transactional currency exposures on working-capital balances,
which typically extend for up to three months, are hedged where practicable
using forward foreign-exchange contracts against the individual companies'
reporting currency. Foreign-exchange gains and losses on forward contracts for
transactional hedging are taken to profit or loss. In addition, the Company's
external dividend payments, paid principally in pounds sterling and Swedish
krona, are fully hedged from announcement to payment date.
Table 18: Currency sensitivities
The Company provides the following currency-sensitivity information:
Exchange Annual impact of 5% strengthening in exchange rate versus USD ($m)(( 66
(#_ftn66) ))
rates versus USD
Currency Primary Relevance FY 2021 67 (#_ftn67) 30 Jun 2022(( 68 (#_ftn68) )) % Change Total Revenue Core Operating Profit
CNY Total Revenue 6.43 6.70 (4) 277 158
EUR Total Revenue 0.85 0.96 (12) 317 160
JPY Total Revenue 109.83 136.34 (19) 229 158
Other(( 69 (#_ftn69) )) 420 196
GBP Operating Expense 0.73 0.82 (12) 61 (93)
SEK Operating Expense 8.58 10.26 (16) 6 (82)
Sustainability
Since the last quarterly report, AstraZeneca:
Access to healthcare
‒ Expanded the Healthy Heart Africa programme into Rwanda in
collaboration with the Rwanda Ministry of Health and PATH, the programme
implementing partner
‒ Launched a collaboration with the Kenya Ministry of Health and Amref
Health Africa to deploy mobile clinics to bring COVID-19 vaccines and
non-communicable disease awareness to hard-to-reach communities across Kenya
‒ Joined EDISON Alliance's One Billion Lives Challenge, to improve
access to innovative and scalable digital health solutions by 2025. As part of
the Challenge, AstraZeneca aims to screen five million patients for lung
cancer using AI-based technology, in collaboration with Qure.ai
‒ Expanded its in-depth health system research as part of the
Partnership for Health System Resilience and Sustainability into 13 new
countries (now 21 in total), with Japan and Greece being the first Phase 2
countries to announce their research results
‒ Announced findings from Young Health Programme-funded research by
RTI International that shows for every $1 invested in evidence-based
interventions to prevent and treat mental health issues among adolescents, $24
in health and economic benefits would be returned to the global economy over
80 years
‒ Also, analysis from health analytics firm Airfinity showed that the
AstraZeneca COVID-19 Vaccine helped save over six million lives during the
period 8 December 2020 to 8 December 2021
Environmental protection
‒ Continued to progress conversion of its fleet to electric/hybrid
vehicles, currently at 59%
‒ Confirmed collaboration with the WHO-led Alliance for Transformative
Action of Climate and Health, to share recommendations with governments on how
to deliver low-carbon, climate resilient healthcare
‒ Wrote, together with SMI 70 (#_ftn70) Health Systems Taskforce, an
editorial
(https://www.devex.com/news/sponsored/opinion-taking-collective-action-to-decarbonize-the-health-care-sector-103291)
calling for the healthcare sector to consider what it can contribute to
decarbonisation
‒ Reinforced its commitment to reforestation through tree planting at
sites around the world, including Algeria, Canada, Ghana, Greece, India, Libya
and the US
‒ Also, the ground source heat pump at AstraZeneca's Discovery Centre
in Cambridge, one of the largest in the UK, became the first of its kind to be
independently certified as a source of renewable heat by the UK Government
Ethics and transparency
‒ Contributed to a study by the Tufts Center for the Study of Drug
Development on clinical trial diversity
‒ Revised sustainability standards in the Company's Expectations of
Third Parties
‒ Celebrated Pride Month with activities across the world focused on
allyship and education to promote progression towards LGBTQIA+ rights and
equality
‒ Was recognised by Diversity Inc in the 'Top 50 Companies for
Diversity' list, for the third successive year
‒ Was recognised as a 2022 Gold Top Global for Supplier Diversity
& Inclusion Champion by WEConnect International
‒ Was awarded the EcoVadis Silver Medal for the second time, in
recognition of the quality of the company's sustainability management system
Research and development
This section covers R&D events and milestones that have occurred since the
prior results announcement.
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 the ASCO 71 (#_ftn71) Annual Meeting, underscoring its ambition
to redefine cancer care. More than 100 abstracts featured 18 approved and
potential new medicines across the Company's industry-leading oncology
portfolio, including one plenary presentation and nine oral presentations.
Significant new trials in Oncology initiated during the period included
ADAURA2, a Phase III trial of Tagrisso in Stage IA2 to IA3 NSCLC after
complete resection, TROPION-Breast02, a Phase III trial of datopotamab
deruxtecan in patients with previously untreated locally recurrent inoperable
or metastatic TNBC not eligible to receive PD-1 72 (#_ftn72) /PD-L1 73
(#_ftn73) inhibitor therapy; and CAPItello-280, a Phase III trial of
capivasertib in combination with docetaxel in participants with metastatic
castrate-resistant prostate cancer.
Imfinzi
During the period, the Company received US regulatory submission acceptance
with Priority Review for Imfinzi in combination with chemotherapy for the
treatment of locally advanced or metastatic biliary tract cancer. The
regulatory submission was based on positive results from the TOPAZ-1 Phase III
trial. The PDUFA 74 (#_ftn74) date 75 (#_ftn75) is anticipated to be during
the third quarter of 2022.
In June 2022, positive high-level results from a planned interim analysis of
the AEGEAN Phase III trial showed treatment with AstraZeneca's Imfinzi in
combination with neoadjuvant chemotherapy before surgery demonstrated a
statistically significant and meaningful improvement in pathologic complete
response compared to neoadjuvant chemotherapy alone for patients with
resectable NSCLC. A statistically significant improvement in major pathologic
response was also observed. The trial will continue as planned to assess the
additional primary endpoint of event-free survival to which the Company,
investigators and participants remain blinded.
In July 2022, Imfinzi was assigned category 1 status in the US NCCN 76
(#_ftn76) guidelines for the 1st-line treatment of patients with biliary tract
cancer, based on the results from the TOPAZ-1 Phase III trial.
Lynparza
During the period, AstraZeneca and MSD's Lynparza was recommended for
marketing authorisation in the EU as monotherapy or in combination with
endocrine therapy for the adjuvant treatment of adult patients with germline
BRCA1/2 mutations who have HER2-negative high-risk early breast cancer
previously treated with neoadjuvant or adjuvant chemotherapy, by the Committee
for CHMP of the EMA, based on the results of the OlympiA Phase III trial.
In July 2022, AstraZeneca and MSD received notification from an Independent
Data Monitoring Committee that data from a pre-specified interim efficacy
analysis of the LYNK-003 Phase III trial of Lynparza in patients with
unresectable or metastatic colorectal cancer was unlikely to demonstrate a
benefit to patients and recommended that the trial be discontinued.
Accordingly, MSD announced that the trial would stop for futility.
Calquence
In June 2022, at the aforementioned ASCO Annual Meeting, updated results from
the ELEVATE-TN Phase III trial showed Calquence maintained a statistically
significant PFS 77 (#_ftn77) benefit versus chlorambucil plus obinutuzumab
and a safety and tolerability profile consistent with the known profile for
Calquence at a median follow up of approximately five years in combination and
as a monotherapy in CLL. Results also showed longer OS 78 (#_ftn78) for
Calquence combined with obinutuzumab compared with chlorambucil combined with
obinutuzumab in previously untreated adults with CLL.
Separately, follow-up data from the ASCEND Phase III trial showed Calquence
demonstrated a sustained PFS benefit at four years based on investigator
assessment compared with investigator's choice of rituximab combined with
either idelalisib or bendamustine in adults with relapsed or refractory CLL.
Enhertu
In May 2022, AstraZeneca and Daiichi Sankyo's Enhertu was approved in the US
for the treatment of patients with unresectable or metastatic HER2-positive
breast cancer who have received a prior anti-HER2-based regimen either in the
metastatic setting, or in the neoadjuvant or adjuvant setting and have
developed disease recurrence during or within six months of completing
therapy. The approval by the US FDA 79 (#_ftn79) was based on positive
results from the DESTINY-Breast03 Phase III trial.
In July 2022, Enhertu was approved for use in the EU as a monotherapy for the
treatment of adult patients with unresectable or metastatic HER2-positive
breast cancer who have received one or more prior anti-HER2-based regimens.
The approval followed the EMA's positive CHMP opinion based on the results
from DESTINY-Breast03 Phase III trial.
At this year's ASCO Annual Meeting, results from the DESTINY-Breast04 Phase
III trial were presented during the Plenary Session. Enhertu demonstrated
superior and clinically meaningful PFS and OS in previously treated patients
with HER2-low unresectable and/or metastatic breast cancer with HR-positive or
HR-negative disease versus standard of care physician's choice of
chemotherapy. Results were simultaneously published in The New England Journal
of Medicine (https://www.nejm.org/doi/full/10.1056/NEJMoa2203690) .
Soon after the presentation of these data, Enhertu was assigned category 1
status in the US NCCN guidelines for the treatment of patients with
(HR-positive and HR-negative) tumours that are HER2-low, who have received at
least one prior line of chemotherapy for metastatic disease and, where the
tumour is HR-positive, are refractory to endocrine therapy. In July, ASCO
guidelines were updated to recommend Enhertu in the same setting.
During the period, based on the results of the DESTINY-Breast04 Phase III
trial, AstraZeneca and Daiichi Sankyo received US regulatory submission
acceptance with Priority Review, EU regulatory submission acceptance, and
completed regulatory submission in Japan.
Camizestrant
During the period, the US FDA granted Fast Track Designation to camizestrant
in combination with palbociclib or abemaciclib in the treatment of in patients
with HR-positive/HER2-negative metastatic breast cancer with detectable
ESR1 80 (#_ftn80) mutations who have not experienced disease progression on
first-line therapy (SERENA-6).
BioPharmaceuticals - CVRM
Brilinta
During the period, AstraZeneca withdrew Brilinta's regulatory submission in
China to prevent acute ischaemic stroke or TIA 81 (#_ftn81) . The submission
was based on the THALES Phase III trial where Brilinta plus aspirin
significantly reduced the rate of stroke and death compared to aspirin alone
in patients with acute ischaemic stroke or TIA. Brilinta was approved in the
US in the aforementioned indication in November 2020.
Farxiga
In May 2022, the Company announced positive high-level results from the
DELIVER Phase III trial where Farxiga showed a statistically significant and
clinically meaningful reduction in the primary endpoint of cardiovascular
death or worsening heart failure. The trial was conducted in patients with
heart failure with mildly reduced or preserved ejection fraction, defined as
left ventricular ejection fraction greater than 40%.
Bydureon
During the period, AstraZeneca received a marketing extension in the EU for
Bydureon BCise to include the treatment of type-2 diabetes in children and
adolescents aged 10 years and above.
Eplontersen
In June 2022, AstraZeneca and Ionis Pharmaceuticals, Inc. announced positive
high-level results from the NEURO-TTRansform Phase III trial for eplontersen
in patients with hereditary transthyretin-mediated amyloid polyneuropathy. In
the trial, eplontersen reached a statistically significant and clinically
meaningful change from baseline for its co-primary endpoint of percent change
in serum TTR 82 (#_ftn82) concentration, reducing TTR protein production.
Eplontersen also reached its co-primary endpoint of change from baseline in
the modified Neuropathy Impairment Score +7, a measure of neuropathic disease
progression, versus the external placebo group. The secondary endpoint of
change from baseline in the Norfolk Quality of Life Questionnaire-Diabetic
Neuropathy was also met, showing that treatment with eplontersen significantly
improved patient-reported quality of life versus the external placebo group.
BioPharmaceuticals - R&I
During the period the Company initiated IRIS, a Phase III trial of Saphnelo in
lupus nephritis.
Tezspire
In July 2022, Tezspire was recommended for approval in the EU by the CHMP for
the treatment of severe asthma. Tezspire is the first and only biologic
approved in a broad population of severe asthma irrespective of biomarker
status.
The GINA 83 (#_ftn83) severe asthma guidelines were updated during the
period, to include anti-TSLP, as an add-on biologic therapy for patients 12
years and over with severe asthma.
PT027
In May 2022, full results from the Phase III MANDALA trial were published in
The New England Journal of Medicine
(https://www.nejm.org/doi/full/10.1056/NEJMoa2203163?query=featured_home) and
presented along with results from the Phase III DENALI trial at the American
Thoracic Society International Conference. The use of PT027, a novel
fixed-dose combination of albuterol and budesonide, as an as-needed rescue
medicine significantly reduced the risk of severe exacerbation by 27% in
patients with asthma, compared with albuterol alone.
BioPharmaceuticals - V&I
Evusheld
Detailed results published in The Lancet Respiratory Medicine
(https://doi.org/10.1016/S2213-2600(22)00180-1) from the Phase III TACKLE
outpatient treatment trial showed that Evusheld provided clinically and
statistically significant protection against progression to severe COVID-19 or
death from any cause compared to placebo, with treatment with Evusheld earlier
in the disease course leading to more favourable outcomes.
A single 600mg intramuscular dose of Evusheld significantly reduced the
relative risk of progressing to severe COVID-19 or death (from any cause) by
50% through Day 29 compared to placebo in non-hospitalised patients with
mild-to-moderate COVID-19 who were symptomatic for seven days or less, the
trial's primary endpoint. In pre-specified analyses of participants who
received treatment within three days of symptom onset, Evusheld reduced the
risk of developing severe COVID-19 or death (from any cause) by 88% compared
to placebo, and the risk reduction was 67% when participants received Evusheld
within five days of symptom onset.
Preclinical pseudovirus assay data from the University of Oxford, published in
Cell (https://doi.org/10.1016/j.cell.2022.06.005) , demonstrated that Evusheld
retains neutralisation activity against the Omicron BA.4 and BA.5 variants.
Nirsevimab
Results from a pre-specified pooled analysis of the pivotal Phase III/IIb
MELODY trial presented at the European Society for Paediatric Infectious
Diseases meeting showed that nirsevimab demonstrated efficacy (relative risk
reduction versus placebo) of 79.5% against medically-attended LRTI 84
(#_ftn84) , such as bronchiolitis or pneumonia, caused by RSV in infants born
at term or preterm entering their first RSV season. The pooled analysis
evaluated healthy preterm and term infants who received the optimised dose of
nirsevimab compared to placebo through Day 151 and showed efficacy of 77.3%
against RSV LRTI hospitalisations.
Vaxzevria
In May 2022, Vaxzevria was granted EMA approval for use in the EU as a third
dose booster in adults.
Airfinity, the provider of global real-time health intelligence, has analysed
data from Imperial College, London, and estimates that Vaxzevria saved over
six million lives during the period 8 December 2020 to 8 December 2021. The
data from Imperial College was published in The Lancet
(https://doi.org/10.1016/S1473-3099(22)00320-6) in June 2022.
Vaxzevria was found to be 73% effective at preventing Omicron-related
infections after a fourth dose in a real-world evidence study
(https://doi.org/10.21203/rs.3.rs-1792139/v1) by Chiang Mai University in
Thailand.
Rare Disease
Ultomiris
In May 2022, the Company announced results of the CHAMPION-NMOSD Phase III
trial demonstrating Ultomiris achieved a statistically significant and
clinically meaningful reduction in the risk of relapse in adults with
anti-aquaporin-4 antibody-positive NMOSD compared to the external placebo arm.
Ultomiris met primary endpoint of time to first on-trial relapse and as
confirmed by an independent adjudication committee; notably, zero adjudicated
relapses were observed over a median treatment duration of 73 weeks.
Ultomiris also received regulatory submission acceptance in China for the
treatment of gMG, as well as positive CHMP opinion in the EU as an add-on to
standard therapy for the treatment of adult patients with gMG. The regulatory
submission were based on positive results from the CHAMPION-MG Phase III
trial. Additionally, Ultomiris subcutaneous formulation received regulatory
approval in the US for the treatment of PNH and aHUS.
Koselugo
Koselugo was granted Priority Review in China for the treatment of NF1-PN in
children 2 years old or over.
ALXN1840
In June 2022, Results from the FoCus Phase III trial in Wilson disease were
presented at the 2022 International Liver Congress. The detailed results
showed ALXN1840, a novel once-daily oral medicine, met its primary endpoint,
demonstrating three-times greater copper mobilisation from tissues compared to
standard of care, including in patients who had been treated previously for an
average of 10 years. Patients taking ALXN1840 experienced rapid copper
mobilisation, with a response at four weeks and sustained through 48 weeks.
Interim financial statements
Table 19: Condensed consolidated statement of comprehensive income - H1 2022
For the half year ended 30 June 2022 2021
$m $m
Total Revenue 22,161 15,540
Product Sales 21,610 15,302
Collaboration Revenue 551 238
Cost of Sales (6,509) (4,055)
Gross profit 15,652 11,485
Distribution expense (254) (202)
Research and development expense (4,679) (3,542)
Selling, general and administrative expense (9,521) (6,027)
Other operating income and expense 219 1,308
Operating profit 1,417 3,022
Finance income 35 27
Finance expense (647) (629)
Share of after tax losses in associates and joint ventures (5) (48)
Profit before tax 800 2,372
Taxation (52) (260)
Profit for the period 748 2,112
Other comprehensive (loss)/income
Items that will not be reclassified to profit or loss
Remeasurement of the defined benefit pension liability 1,031 692
Net losses on equity investments measured at fair value through other (12) (27)
comprehensive income
Fair value movements related to own credit risk on bonds designated as fair 2 2
value through profit or loss
Tax on items that will not be reclassified to profit or loss (275) 52
746 719
Items that may be reclassified subsequently to profit or loss
Foreign exchange arising on consolidation (1,326) 59
Foreign exchange arising on designated borrowings in net investment hedges (195) (230)
Fair value movements on cash flow hedges (138) (59)
Fair value movements on cash flow hedges transferred to profit or loss 131 73
Fair value movements on derivatives designated in net investment hedges 34 7
Costs of hedging (13) (2)
Tax on items that may be reclassified subsequently to profit or loss 46 18
(1,461) (134)
Other comprehensive (loss)/income, net of tax (715) 585
Total comprehensive income for the period 33 2,697
Profit attributable to:
Owners of the Parent 746 2,111
Non-controlling interests 2 1
748 2,112
Total comprehensive income attributable to:
Owners of the Parent 33 2,696
Non-controlling interests - 1
33 2,697
Basic earnings per $0.25 Ordinary Share $0.48 $1.61
Diluted earnings per $0.25 Ordinary Share $0.48 $1.60
Weighted average number of Ordinary Shares in issue (m) 1,548 1,312
Diluted weighted average number of Ordinary Shares in issue (m) 1,561 1,319
Table 20: Condensed consolidated statement of comprehensive income - Q2 2022
For the quarter ended 30 June Unreviewed 85 (#_ftn85) 2022 Unreviewed 2021
$m $m
Total Revenue 10,771 8,220
Product Sales 10,630 8,045
Collaboration Revenue 141 175
Cost of Sales (2,998) (2,191)
Gross profit 7,773 6,029
Distribution expense (129) (103)
Research and development expense (2,546) (1,829)
Selling, general and administrative expense (4,681) (3,098)
Other operating income and expense 122 128
Operating profit 539 1,127
Finance income 18 7
Finance expense (311) (326)
Share of after tax losses in associates and joint ventures 1 (44)
Profit before tax 247 764
Taxation 113 (214)
Profit for the period 360 550
Other comprehensive (loss)/income
Items that will not be reclassified to profit or loss
Remeasurement of the defined benefit pension liability 696 211
Net (losses)/gains on equity investments measured at fair value through other (30) 81
comprehensive income
Fair value movements related to own credit risk on bonds designated as fair 2 1
value through profit or loss
Tax on items that will not be reclassified to profit or loss (181) 146
487 439
Items that may be reclassified subsequently to profit or loss
Foreign exchange arising on consolidation (1,107) 166
Foreign exchange arising on designated borrowings in net investment hedges (163) 72
Fair value movements on cash flow hedges (143) 27
Fair value movements on cash flow hedges transferred to profit or loss 120 (48)
Fair value movements on derivatives designated in net investment hedges 42 (6)
Costs of hedging (13) (1)
Tax on items that may be reclassified subsequently to profit or loss 45 (8)
(1,219) 202
Other comprehensive (loss)/income, net of tax (732) 641
Total comprehensive (loss)/income for the period (372) 1,191
Profit attributable to:
Owners of the Parent 360 550
Non-controlling interests - -
360 550
Total comprehensive (loss)/income attributable to:
Owners of the Parent (372) 1,190
Non-controlling interests - 1
(372) 1,191
Basic earnings per $0.25 Ordinary Share $0.23 $0.42
Diluted earnings per $0.25 Ordinary Share $0.23 $0.42
Weighted average number of Ordinary Shares in issue (m) 1,549 1,312
Diluted weighted average number of Ordinary Shares in issue (m) 1,560 1,318
Table 21: Condensed consolidated statement of financial position
Reviewed 86 (#_ftn86) Audited Reviewed
At 30 Jun 2022 At 31 Dec 2021 At 30 Jun 2021
$m $m $m
Assets
Non-current assets
Property, plant and equipment 8,722 9,183 8,357
Right-of-use assets 905 988 674
Goodwill 19,821 19,997 11,798
Intangible assets 39,900 42,387 20,006
Investments in associates and joint ventures 56 69 48
Other investments 1,124 1,168 1,072
Derivative financial instruments 113 102 124
Other receivables 881 895 565
Deferred tax assets 4,140 4,330 3,723
75,662 79,119 46,367
Current assets
Inventories 6,220 8,983 4,762
Trade and other receivables 8,908 9,644 6,356
Other investments 70 69 62
Derivative financial instruments 109 83 41
Intangible assets 89 105 -
Income tax receivable 704 663 486
Cash and cash equivalents 4,817 6,329 15,567
Assets held for sale - 368 -
20,917 26,244 27,274
Total assets 96,579 105,363 73,641
Liabilities
Current liabilities
Interest-bearing loans and borrowings (2,162) (1,660) (2,696)
Lease liabilities (220) (233) (198)
Trade and other payables (17,821) (18,938) (17,729)
Derivative financial instruments (90) (79) (17)
Provisions (541) (768) (802)
Income tax payable (981) (916) (780)
(21,815) (22,594) (22,222)
Non-current liabilities
Interest-bearing loans and borrowings (26,461) (28,134) (24,109)
Lease liabilities (685) (754) (492)
Derivative financial instruments (180) (45) (3)
Deferred tax liabilities (5,275) (6,206) (2,927)
Retirement benefit obligations (1,310) (2,454) (2,383)
Provisions (892) (956) (620)
Other payables (4,010) (4,933) (5,192)
(38,813) (43,482) (35,726)
Total liabilities (60,628) (66,076) (57,948)
Net assets 35,951 39,287 15,693
Equity
Capital and reserves attributable to equity holders of the Parent
Share capital 387 387 328
Share premium account 35,134 35,126 7,980
Other reserves 2,068 2,045 2,033
Retained earnings (1,657) 1,710 5,335
35,932 39,268 15,676
Non-controlling interests 19 19 17
Total equity 35,951 39,287 15,693
Table 22: 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 2021 328 7,971 2,024 5,299 15,622 16 15,638
Profit for the period - - - 2,111 2,111 1 2,112
Other comprehensive income - - - 585 585 - 585
Transfer to other reserves - - 9 (9) - - -
Transactions with owners:
Dividends - - - (2,490) (2,490) - (2,490)
Issue of Ordinary Shares - 9 - - 9 - 9
Share-based payments charge for the period - - - 160 160 - 160
Settlement of share plan awards - - - (321) (321) - (321)
Net movement - 9 9 36 54 1 55
At 30 Jun 2021 328 7,980 2,033 5,335 15,676 17 15,693
At 1 Jan 2022 387 35,126 2,045 1,710 39,268 19 39,287
Profit for the period - - - 746 746 2 748
Other comprehensive loss - - - (713) (713) (2) (715)
Transfer to other reserves - - 23 (23) - - -
Transactions with owners:
Dividends - - - (3,046) (3,046) - (3,046)
Issue of Ordinary Shares - 8 - - 8 - 8
Share-based payments charge for the period - - - 346 346 - 346
Settlement of share plan awards - - - (677) (677) - (677)
Net movement - 8 23 (3,367) (3,336) - (3,336)
At 30 Jun 2022 387 35,134 2,068 (1,657) 35,932 19 35,951
Table 23: Condensed consolidated statement of cash flows
For the half year ended 30 June 2022 2021
$m $m
Cash flows from operating activities
Profit before tax 800 2,372
Finance income and expense 612 602
Share of after tax losses of associates and joint ventures 5 48
Depreciation, amortisation and impairment 2,666 1,550
Decrease in working capital and short-term provisions 2,391 857
Gains on disposal of intangible assets (81) (354)
Gains on disposal of investments in associates and joint ventures - (776)
Fair value movements on contingent consideration arising from business 293 82
combinations
Non-cash and other movements (814) (363)
Cash generated from operations 5,872 4,018
Interest paid (386) (323)
Tax paid (1,006) (869)
Net cash inflow from operating activities 4,480 2,826
Cash flows from investing activities
Payments upon vesting of employee share awards attributable to business (158) -
combinations
Payment of contingent consideration from business combinations (367) (309)
Purchase of property, plant and equipment (472) (508)
Disposal of property, plant and equipment - 4
Purchase of intangible assets (434) (314)
Disposal of intangible assets and assets held for sale 442 573
Purchase of non-current asset investments (28) (10)
Disposal of non-current asset investments 35 -
Movement in short-term investments, fixed deposits and other investing 9 135
instruments
Payments to associates and joint ventures (5) (55)
Disposal of investments in associates and joint ventures - 776
Interest received 10 27
Net cash (outflow)/inflow from investing activities (968) 319
Net cash inflow before financing activities 3,512 3,145
Cash flows from financing activities
Proceeds from issue of share capital 8 9
Repayment of loans and borrowings (1,257) (611)
Issue of loans - 7,944
Dividends paid (2,971) (2,469)
Hedge contracts relating to dividend payments (77) (22)
Repayment of obligations under leases (134) (111)
Movement in short-term borrowings 316 (182)
Payment of Acerta Pharma share purchase liability (920) -
Net cash (outflow)/inflow from financing activities (5,035) 4,558
Net (decrease)/increase in cash and cash equivalents in the period (1,523) 7,703
Cash and cash equivalents at the beginning of the period 6,038 7,546
Exchange rate effects (35) (52)
Cash and cash equivalents at the end of the period 4,480 15,197
Cash and cash equivalents consist of:
Cash and cash equivalents 4,817 15,567
Overdrafts (337) (370)
4,480 15,197
Responsibility statement of the directors in respect of the half-yearly financial report
We confirm that to the best of our knowledge:
‒ the condensed consolidated Interim financial statements have been
prepared in accordance with IAS 34 'Interim Financial Reporting' as issued by
the International Accounting Standards Board (IASB), IAS 34 as adopted by the
European Union and UK-adopted IAS 34;
‒ the half-yearly management report gives a true and fair view of the
assets, liabilities, financial position and profit or loss of the company;
‒ the half-yearly management report includes a fair review of the
information required by:
a) DTR 4.2.7R of the Disclosure and Transparency Rules, being an indication
of important events that have occurred during the first six months of the
financial year and their impact on the condensed consolidated Interim
financial statements; and a description of the principal risks and
uncertainties for the remaining six months of the year; and
b) DTR 4.2.8R of the Disclosure and Transparency Rules, being related party
transactions that have taken place in the first six months of the current
financial year and that have materially affected the financial position or
performance of the enterprise during that period; and any changes in the
related party transactions described in the last annual report that could do
so.
The Board
The Board of Directors that served during all or part of the six month period
to 30 June 2022 and their respective responsibilities can be found on the
Leadership team section of astrazeneca.com.
(https://www.astrazeneca.com/our-company/leadership.html)
Approved by the Board and signed on its behalf by
Pascal Soriot
Chief Executive Officer
29 July 2022
Independent review report to AstraZeneca PLC
Report on the condensed consolidated interim financial statements
Our conclusion
We have reviewed AstraZeneca PLC's condensed consolidated interim financial
statements (the "Interim financial statements") in the half-yearly financial
report of AstraZeneca PLC for the 6 month period ended 30 June 2022 (the
"period").
Based on our review, nothing has come to our attention that causes us to
believe that the Interim financial statements are not prepared, in all
material respects, in accordance with International Accounting Standard 34,
'Interim Financial Reporting' (IAS 34), as issued by the International
Accounting Standards Board (IASB), IAS 34 as adopted by the European Union
and UK-adopted IAS 34, and the Disclosure Guidance and Transparency Rules
sourcebook of the United Kingdom's Financial Conduct Authority.
The Interim financial statements comprise:
‒ the Condensed consolidated statement of comprehensive income for the
period then ended - H1 2022;
‒ the Condensed consolidated statement of financial position as at 30
June 2022;
‒ the Condensed consolidated statement of changes in equity for the
period then ended;
‒ the Condensed consolidated statement of cash flows for the period
then ended; and
‒ the explanatory notes to the Interim financial statements.
The Interim financial statements included in the half-yearly financial report
of AstraZeneca PLC have been prepared in accordance with International
Accounting Standard 34, 'Interim Financial Reporting' (IAS 34), as issued by
the International Accounting Standards Board (IASB), IAS 34 as adopted by the
European Union and UK-adopted IAS 34, and the Disclosure Guidance and
Transparency Rules sourcebook of the United Kingdom's Financial Conduct
Authority.
Basis for conclusion
We conducted our review in accordance with International Standard on Review
Engagements (UK) 2410, 'Review of Interim Financial Information Performed by
the Independent Auditor of the Entity' issued by the Financial Reporting
Council for use in the United Kingdom. A review of interim financial
information consists of making enquiries, primarily of persons responsible for
financial and accounting matters, and applying analytical and other review
procedures.
A review is substantially less in scope than an audit conducted in accordance
with International Standards on Auditing (UK) and, consequently, does not
enable us to obtain assurance that we would become aware of all significant
matters that might be identified in an audit. Accordingly, we do not express
an audit opinion.
We have read the other information contained in the half-yearly financial
report and considered whether it contains any apparent misstatements or
material inconsistencies with the information in the Interim financial
statements.
Conclusions relating to going concern
Based on our review procedures, which are less extensive than those performed
in an audit as described in the Basis for conclusion section of this report,
nothing has come to our attention to suggest that the directors have
inappropriately adopted the going concern basis of accounting or that the
directors have identified material uncertainties relating to going concern
that are not appropriately disclosed. This conclusion is based on the review
procedures performed in accordance with this ISRE. However, future events or
conditions may cause the group to cease to continue as a going
concern.
Independent review report to AstraZeneca PLC
Responsibilities for the Interim financial statements and the review
Our responsibilities and those of the directors
The half-yearly financial report, including the Interim financial statements,
is the responsibility of, and has been approved by the directors. The
directors are responsible for preparing the half-yearly financial report in
accordance with the Disclosure Guidance and Transparency Rules sourcebook of
the United Kingdom's Financial Conduct Authority. In preparing the half-yearly
financial report, including the Interim financial statements, the directors
are responsible for assessing the group's ability to continue as a going
concern, disclosing, as applicable, matters related to going concern and using
the going concern basis of accounting unless the directors either intend to
liquidate the group or to cease operations, or have no realistic alternative
but to do so.
Our responsibility is to express a conclusion on the Interim financial
statements in the half-yearly financial report based on our review. Our
conclusion, including our Conclusions relating to going concern, is based on
procedures that are less extensive than audit procedures, as described in the
Basis for conclusion paragraph of this report. This report, including the
conclusion, has been prepared for and only for the company for the purpose of
complying with the Disclosure Guidance and Transparency Rules sourcebook of
the United Kingdom's Financial Conduct Authority and for no other purpose. We
do not, in giving this conclusion, accept or assume responsibility for any
other purpose or to any other person to whom this report is shown or into
whose hands it may come save where expressly agreed by our prior consent in
writing.
PricewaterhouseCoopers LLP
Chartered Accountants
London
29 July 2022
Notes to the Interim financial statements
Note 1: Basis of preparation and accounting policies
These unaudited condensed consolidated Interim financial statements for the
six months ended 30 June 2022 have been prepared in accordance with
International Accounting Standard 34, 'Interim Financial Reporting' (IAS 34),
as issued by the International Accounting Standards Board (IASB), IAS 34 as
adopted by the European Union, UK-adopted IAS 34 and the Disclosure Guidance
and Transparency Rules sourcebook of the United Kingdom's Financial Conduct
Authority and with the requirements of the Companies Act 2006 as applicable to
companies reporting under those standards.
The unaudited Interim financial statements for the six months ended 30 June
2022 include Alexion's results for the period. Alexion was consolidated into
the Group's results from 21 July 2021, hence Alexion's results are not
included in the comparative periods shown.
The unaudited Interim financial statements for the six months ended 30 June
2022 were approved by the Board of Directors for publication on 29 July 2022.
This results announcement does not constitute statutory accounts of the Group
within the meaning of sections 434(3) and 435(3) of the Companies Act 2006.
The annual financial statements of the Group for the year ended 31 December
2021 were prepared in accordance with UK-adopted International Accounting
Standards and with the requirements of the Companies Act 2006. The annual
financial statements also comply fully with IFRSs as issued by the IASB and
International Accounting Standards as adopted by the European Union. Except
for the estimation of the interim income tax charge, the Interim financial
statements have been prepared applying the accounting policies that were
applied in the preparation of the Group's published consolidated financial
statements for the year ended 31 December 2021.
The comparative figures for the financial year ended 31 December 2021 are not
the Group's statutory accounts for that financial year. Those accounts have
been reported on by the Group's auditors and have been delivered to the
registrar of companies; their report was (i) unqualified, (ii) did not include
a reference to any matters to which the auditors drew attention by way of
emphasis without qualifying their report, and (iii) did not contain a
statement under section 498(2) or (3) of the Companies Act 2006.
Global and/or geopolitical events
There were no material accounting impacts identified relating to COVID-19
during the six months ended 30 June 2022.
The Group's current focus is to continue compliant business operations in
Russia and Ukraine, focussing on safeguarding our employees, ensuring
continuity of supply of essential and life-saving medicines and contributing
to humanitarian relief efforts. There are no material accounting impacts
arising from the conflict impacting our H1 2022 reporting. The situation is
dynamic and any future impact on our business is uncertain.
Throughout July 2022, a range of EU/US/Swiss and UK sanctions have come into
force placing restrictions on specific business activities and/or individuals
related to on-going business with Russia. We are monitoring closely and our
work in this regard continues to progress to provide assurance over
managements activities to ensure ongoing sanctions compliance.
The Group will continue to monitor these areas of increased judgement,
estimation and risk for material changes.
Going concern
The Group has considerable financial resources available. As at 30 June 2022,
the Group had $9.7bn in financial resources (cash and cash-equivalent balances
of $4.8bn and undrawn committed bank facilities of $4.9bn available until
April 2025, with only $2.4bn of borrowings due within one year). All
facilities contain no financial covenants and were undrawn at 30 June 2022.
The Group's revenues are largely derived from sales of medicines covered by
patents which provide a relatively high level of resilience and predictability
to cash inflows, although government price interventions in response to
budgetary constraints are expected to continue to affect adversely revenues in
some of our significant markets. The Group, however, anticipates new revenue
streams from both recently launched medicines and those in development, and
the Group has a wide diversity of customers and suppliers across different
geographic areas.
Consequently, the Directors believe that, overall, the Group is well-placed to
manage its business risks successfully.
Accordingly, the going concern basis has been adopted in these Interim
financial statements.
Legal proceedings
The information contained in Note 6 updates the disclosures concerning legal
proceedings and contingent liabilities in the Group's Annual Report and Form
20-F Information 2021
(https://www.astrazeneca.com/content/dam/az/Investor_Relations/annual-report-2021/pdf/AstraZeneca_AR_2021.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 reversals of
$26m have been recorded against intangible assets during the six months ended
30 June 2022 (H1 2021: $55m charge). Net impairment reversals in respect of
medicines in development and launched medicines were $9m (H1 2021: $nil) and
$nil (H1 2021: $55m charge) respectively.
Note 3: Net Debt
The table below provides an analysis of Net Debt and a reconciliation of Net
Cash Flow to the movement in Net Debt. The Group monitors Net Debt as part of
its capital-management policy as described in Note 28 of the Annual Report and
Form 20-F Information 2021
(https://www.astrazeneca.com/content/dam/az/Investor_Relations/annual-report-2021/pdf/AstraZeneca_AR_2021.pdf)
. Net Debt is a non-GAAP financial measure.
Table 24: Net Debt
At 1 Jan 2022 Cash flow Non-cash Exchange movements At 30 Jun 2022
& other
$m $m $m $m $m
Non-current instalments of loans (28,134) - 1,409 264 (26,461)
Non-current instalments of leases (754) - 37 32 (685)
Total long-term debt (28,888) - 1,446 296 (27,146)
Current instalments of loans (1,273) 1,257 (1,399) - (1,415)
Current instalments of leases (233) 133 (131) 11 (220)
Commercial paper - (256) - - (256)
Bank collateral (93) (18) - - (111)
Other short-term borrowings excluding overdrafts (3) (42) - 2 (43)
Overdrafts (291) (65) - 19 (337)
Total current debt (1,893) 1,009 (1,530) 32 (2,382)
Gross borrowings (30,781) 1,009 (84) 328 (29,528)
Net derivative financial instruments 61 66 (175) - (48)
Net borrowings (30,720) 1,075 (259) 328 (29,576)
Cash and cash equivalents 6,329 (1,458) - (54) 4,817
Other investments - current 69 2 - (1) 70
Cash and investments 6,398 (1,456) - (55) 4,887
Net Debt (24,322) (381) (259) 273 (24,689)
Non-cash movements in the period include fair-value adjustments under IFRS 9.
The Group has agreements with some bank counterparties whereby the parties
agree to post cash collateral on financial derivatives, for the benefit of the
other, equivalent to the market valuation of the derivative positions above a
predetermined threshold. The carrying value of such cash collateral held by
the Group at 30 June 2022 was $111m (31 December 2021: $93m) and the carrying
value of such cash collateral posted by the Group at 30 June 2022 was $184m
(31 December 2021: $47m). Cash collateral posted by the Group is presented
within Cash and cash equivalents.
Restricted cash and cash equivalents at 30 June 2022 totalled $236m (31
December 2021: $47m), comprising cash collateral posted by the Group and other
items.
The equivalent GAAP measure to Net Debt is 'liabilities arising from financing
activities', which excludes the amounts for cash and overdrafts, other
investments and non-financing derivatives shown above and includes the Acerta
Pharma share purchase liability of $1,590m (31 December 2021: $2,458m), $838m
of which is shown in current other payables and $752m is shown in non-current
other payables.
Net Debt increased by $367m in the year to date to $24,689m. Details of the
committed undrawn bank facilities are disclosed within the going concern
section of Note 1.
During the six months to 30 June 2022, there were no changes to the Company's
solicited credit ratings issued by Standard and Poor's (long term: A-; short
term: A-2) and from Moody's (long term: A3; short term: P‑2).
Note 4: Financial Instruments
As detailed in the Group's most recent annual financial statements, the
principal financial instruments consist of derivative financial instruments,
other investments, trade and other receivables, cash and cash equivalents,
trade and other payables, lease liabilities and interest-bearing loans and
borrowings.
The Group has certain equity investments held at $180m at 30 June 2022 (31
December 2021: $104m) that are categorised as Level 3 in the fair-value
hierarchy and for which fair-value gains of $48m (FY 2021: $nil) have been
recognised in the six months ended 30 June 2022. In the absence of specific
market data, these
unlisted investments are held at fair value based on the cost of investment
and adjusting as necessary for impairments and revaluations on new funding
rounds, which are seen to approximate the fair value. All other fair-value
gains and/or losses that are presented in Net losses on equity investments
measured at fair value through other comprehensive income in the Condensed
consolidated statement of comprehensive income for the six months ended 30
June 2022 are Level 1 fair-value measurements, valued based on quoted prices
in active markets.
Financial instruments measured at fair value include $1,194m of other
investments, $3,098m held in money-market funds, $301m of loans designated at
fair value through profit or loss and $48m of derivatives as at 30 June 2022.
With the exception of derivatives being Level 2 fair-valued, the
aforementioned balances are Level 1 fair-valued. The total fair value of
interest-bearing loans and borrowings at 30 June 2022, which have a carrying
value of $29,528m in the Condensed consolidated statement of financial
position, was $29,019m.
Table 25: Financial instruments - contingent consideration
2022 2021
Diabetes alliance Other Total Total
$m $m $m $m
At 1 January 2,544 321 2,865 3,323
Settlements (358) (9) (367) (309)
Disposals - (121) (121) -
Revaluations 320 (27) 293 82
Discount unwind 81 4 85 112
At 30 June 2,587 168 2,755 3,208
Contingent consideration arising from business combinations is fair-valued
using decision-tree analysis, with key inputs including the probability of
success, consideration of potential delays and the expected levels of future
revenues.
The contingent consideration balance relating to BMS's share of the global
diabetes alliance of $2,587m (31 December 2021: $2,544m) would
increase/decrease by $259m with an increase/decline in sales of 10%, as
compared with the current estimates.
Note 5: Pensions and other post-retirement benefit obligations
The net pensions and other post-retirement benefit obligations position, as
recorded under IAS 19, at 30 June 2022 was a liability of $1,136m (31 December
2021: $2,454m liability). Pension schemes in a net surplus position at 30 June
2022 totalled $174m (31 December 2021: $nil) and are recorded within Other
receivables in non-current assets. Pension schemes in a net deficit position
at 30 June 2022 totalled $1,310m (31 December 2021: $2,454m) and are recorded
within Retirement benefit obligations in non-current liabilities.
The decrease in the net liability of $1,318m is driven by actuarial gains of
$1,031m that have been reflected within the Condensed consolidated statement
of comprehensive income.
Changes in actuarial assumptions, primarily movements in discount rates, led
to a decrease in the net liability in the half of $2,599m (a decrease in UK,
Sweden, US and German liabilities of $1,698m, $518m, $221m and $162m
respectively), which reflected increases in corporate bond yields. These
movements were partially offset by decreases in the pension fund asset values
in the half of $1,563m and experience losses of $5m.
Note 6: Legal proceedings and contingent liabilities
AstraZeneca is involved in various legal proceedings considered typical to its
business, including litigation and investigations, including Government
investigations, relating to product liability, commercial disputes,
infringement of intellectual property (IP) rights, the validity of certain
patents, anti-trust law and sales and marketing practices. The matters
discussed below constitute the more significant developments since publication
of the disclosures concerning legal proceedings in the Company's Annual Report
and Form 20-F Information 2021 (the Disclosures). Unless noted otherwise below
or in the Disclosures, no provisions have been established in respect of the
claims discussed below.
As discussed in the Disclosures, the majority of claims involve highly complex
issues. Often these issues are subject to substantial uncertainties and,
therefore, the probability of a loss, if any, being sustained and/or an
estimate of the amount of any loss is difficult to ascertain.
Unless specifically identified below that a provision has been taken,
AstraZeneca considers each of the claims to represent a contingent liability
and discloses information with respect to the nature and facts of the cases in
accordance with IAS 37.
There is one matter concerning legal proceedings in the Disclosures, which is
considered probable that an outflow will be required, but for which we are
unable to make an estimate of the possible loss or range of possible losses at
this stage.
In cases that have been settled or adjudicated, or where quantifiable fines
and penalties have been assessed and which are not subject to appeal, or where
a loss is probable and we are able to make a reasonable estimate of the loss,
AstraZeneca records the loss absorbed or makes a provision for its best
estimate of the expected loss. The position could change over time and the
estimates that the Company made, and upon which the Company have relied in
calculating these provisions are inherently imprecise. There can, therefore,
be no assurance that any losses that result from the outcome of any legal
proceedings will not exceed the amount of the provisions that have been booked
in the accounts. The major factors causing this uncertainty are described more
fully in the Disclosures and herein.
AstraZeneca has full confidence in, and will vigorously defend and enforce,
its IP.
Matters disclosed in respect of the second quarter of 2022 and to 29 July 2022
Patent litigation
Enhertu
US patent proceedings
As previously disclosed, in October 2020, Seagen Inc. (Seagen) filed a
complaint against Daiichi Sankyo Company, Limited (Daiichi Sankyo) in the US
District Court for the Eastern District of Texas (the Court) alleging that
Enhertu infringes US Patent No. 10,808,039 (the '039 patent). AstraZeneca
co-commercialises Enhertu with Daiichi Sankyo, Inc. in the US. The trial took
place in April 2022. The jury found that the '039 patent was infringed and
awarded Seagen $41.82m in past damages. In July 2022, the Court decided not to
enhance damages based on the jury's finding of willfulness and entered
judgment for Seagen. The parties await consideration of post-trial motions.
As previously disclosed, in December 2020 and January 2021, AstraZeneca and
Daiichi Sankyo filed post-grant review (PGR) petitions with the US Patent and
Trademark Office (USPTO) alleging, inter alia, that the '039 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 AstraZeneca and
Daiichi Sankyo's other PGR petition.
Faslodex
Patent Proceedings outside the US
As previously disclosed, in Japan, Sandoz K.K. and Sun Pharma Japan Ltd are
seeking to invalidate the Faslodex formulation patent at the Japan Patent
Office (JPO) and AstraZeneca is defending the challenged patent. The JPO held
the hearing in the matter in May 2022. A decision is awaited.
Lokelma
US patent proceedings
In July 2022, AstraZeneca received Paragraph IV notices from multiple ANDA
filers relating to patents listed in the FDA Orange Book with reference to
Lokelma. AstraZeneca is reviewing the notices in preparation for litigation.
Symbicort
US patent proceedings
As previously disclosed, AstraZeneca is involved in ongoing ANDA patent
litigation with Mylan Pharmaceuticals Inc. (Mylan) and Kindeva Drug Delivery
L.P. (Kindeva) brought in the US District Court for the Northern District of
West Virginia (the District Court). A trial in the matter was held in May 2022
and closing arguments were held in June 2022. A decision is awaited.
As previously disclosed, in April 2022, AstraZeneca filed a separate ANDA
action against Mylan and Kindeva in the District Court asserting infringement
of a patent covering Symbicort. In June 2022, Mylan and Kindeva responded
and claim noninfringement of the asserted patent and that the asserted patent
is invalid. A trial in the matter is scheduled for November 2022.
Tagrisso
US patent proceedings
As previously disclosed, in September 2021, Puma Biotechnology, Inc. and Wyeth
LLC filed a patent infringement lawsuit in the US District Court for the
District of Delaware against AstraZeneca relating to Tagrisso. A claim
construction hearing has been scheduled for January 2023 and a trial has been
scheduled for May 2024.
Patent proceedings outside the US
As previously disclosed, in Russia, in October 2021, AstraZeneca filed a
lawsuit in the Arbitration Court of the Moscow Region 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, and AstraZeneca is considering its
options.
Commercial litigation
Array BioPharma
As previously disclosed, in the US, in December 2017, AstraZeneca was served
with a complaint filed in New York State court by Array BioPharma, Inc.
(Array) alleging breaches of contractual obligations relating to a 2003
collaboration agreement between AstraZeneca and Array. In May 2022, the
parties resolved this dispute. This matter is now concluded.
Portola Shareholder Litigation
As previously disclosed, 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 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, which is subject to court approval. A provision has been recognised in
the quarter.
Seroquel XR (Antitrust Litigation)
As previously disclosed, in the US, in 2019, AstraZeneca was named in several
related complaints which are currently pending in the US District Court for
the District of Delaware (the Court), including several putative class action
lawsuits that were purportedly brought on behalf of classes of direct
purchasers or end payors of Seroquel XR. The complaints allege that
AstraZeneca and two different generic drug manufacturers violated antitrust
laws when settling patent litigation related to Seroquel XR. In July 2022, in
response to AstraZeneca's motions, the Court dismissed all plaintiffs' claims
to the extent they were based on the settlement with one of the generic
manufacturers but denied the motions with respect to certain claims relating
to the second generic manufacturer and allowed such claims to proceed.
Matters disclosed in respect of the first quarter of 2022 and to 29 April 2022
Patent litigation
Enhertu
US patent proceedings
As previously disclosed, in October 2020, Seagen Inc. (Seagen) filed a
complaint against Daiichi Sankyo Company, Limited (Daiichi Sankyo) in the US
District Court for the Eastern District of Texas alleging that Enhertu
infringes US Patent No. 10,808,039 (the '039 patent). AstraZeneca
co-commercialises Enhertu with Daiichi Sankyo, Inc. in the US. The trial took
place in April 2022. The jury found that the '039 patent was infringed and
awarded Seagen $41.82m in past damages. The parties await the schedules for a
bench trial on equitable issues and for consideration of post-trial motions.
As previously disclosed, in December 2020 and January 2021, AstraZeneca and
Daiichi Sankyo filed post-grant review petitions with the US Patent and
Trademark Office (USPTO) alleging, inter alia, that the '039 patent is invalid
for lack of written description and enablement. The USPTO initially declined
to institute the post-grant reviews, but in April 2022, the USPTO granted the
rehearing requests, instituting both post-grant review petitions. An oral
hearing is scheduled for January 2023 and a decision is expected by April
2023.
Imfinzi
US patent proceedings
In March 2022, Bristol-Myers Squibb Co. and E.R. Squibb & Sons, LLC filed
a lawsuit in US District Court for the District of Delaware against
AstraZeneca alleging that AstraZeneca's marketing of Imfinzi infringes several
of their patents. No trial date has been scheduled.
Patent proceedings outside the US
In February 2022, Ono Pharmaceuticals filed a lawsuit in Tokyo District Court,
Civil Division against AstraZeneca alleging that AstraZeneca's marketing of
Imfinzi in Japan infringes several of their patents. No trial date has been
scheduled.
Symbicort
US patent proceedings
As previously disclosed, AstraZeneca is involved in ongoing ANDA patent
litigation with Mylan Pharmaceuticals Inc. (Mylan) and Kindeva Drug Delivery
L.P. (Kindeva) brought in the US District Court for the Northern District of
West Virginia (the District Court). In March 2022, the US Court of Appeals for
the Federal Circuit (the Federal Circuit) denied AstraZeneca's Combined
Petition for Panel Rehearing and Rehearing En Banc of the Federal Circuit's
December 2021 decision and the case was remanded back to the District Court
for further proceedings. In April 2022, the District Court entered a
Stipulation and Order dismissing patent infringement claims related to various
asserted patents and otherwise narrowing the issues for trial. A trial in the
matter is scheduled to commence in May 2022.
In April 2022, AstraZeneca filed another ANDA action against Mylan and Kindeva
in the District Court asserting patent infringement.
Tagrisso
US patent proceedings
In February 2020, in response to Paragraph IV notices from multiple ANDA
filers, AstraZeneca filed patent infringement lawsuits in the US District
Court for the District of Delaware. In its complaint, AstraZeneca alleged that
a generic version of Tagrisso, if approved and marketed, would infringe a US
Orange Book-listed Tagrisso patent. In the fourth quarter of 2021, AstraZeneca
entered into settlement agreements with Zydus Pharmaceuticals (USA) Inc.,
Cadila Healthcare Limited, MSN Laboratories Pvt. Ltd., and MSN Pharmaceuticals
Inc. In April 2022, AstraZeneca entered into a settlement agreement with
Alembic Pharmaceuticals Limited. These settlements resolve all US patent
litigation between the parties relating to Tagrisso.
Patent proceedings outside the US
In Russia, in October 2021, AstraZeneca filed a lawsuit in the Arbitration
Court of the Moscow Region 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, and AstraZeneca has filed an appeal.
Ultomiris
As previously disclosed, Chugai Pharmaceutical Co., Ltd. (Chugai) filed
lawsuits against Alexion in the Delaware District Court as well as in Tokyo
District Court, alleging that Ultomiris infringed US and Japanese patents held
by Chugai.
In March 2022, Alexion entered into a settlement agreement with Chugai that
resolves all patent disputes between the two companies related to Ultomiris.
In accordance with the settlement agreement, Alexion and Chugai have taken
steps to withdraw patent infringement proceedings filed with US District Court
for the District of Delaware and Tokyo District Court. Under the terms of the
agreement, Alexion made a single payment of $775m in the second quarter of
2022, for which a related charge was recognised through the non-core P&L
in the first quarter of 2022. No further amounts are payable by either party.
Product liability litigation
Onglyza and Kombiglyze
In the US, AstraZeneca is defending various lawsuits alleging heart failure,
cardiac injuries, and/or death from treatment with Onglyza or Kombiglyze. In
February 2018, the Judicial Panel on Multidistrict Litigation ordered the
transfer of various pending federal actions to the US District Court for the
Eastern District of Kentucky (the District Court) for consolidated pre-trial
proceedings with the federal actions pending in the District Court. In the
previously disclosed California State Court coordinated proceeding,
AstraZeneca's motion for summary judgment was granted in March 2022. A motion
for summary judgment is pending in the District Court.
Commercial litigation
Pay Equity Litigation (US)
AstraZeneca is 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 involves 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 seek 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.
The Court has not set a trial date and no class or collective certification
has been sought or granted as of this time.
Government investigations/proceedings
COVID-19 Vaccine Supply and Manufacturing Inquiries
As previously disclosed, in June 2021, Argentina's Federal Criminal
Prosecutor's Office (the Prosecutor) contacted AstraZeneca Argentina seeking
documents and electronic records in connection with a local criminal
investigation relating to the public procurement and supply of Vaxzevria in
that country. In October 2021, the Prosecutor filed a submission with the
presiding court requesting dismissal of the criminal investigation, and that
request was granted by the court in February 2022. This matter is now closed.
In February 2022, a Brazilian Public Prosecutor filed a lawsuit against
several defendants including the Brazilian Federal Government, AstraZeneca,
and other COVID-19 vaccine manufacturers. In April 2022, a Brazilian Court
issued an order dismissing the lawsuit.
US 340B Litigations and Proceedings
As previously disclosed, AstraZeneca is involved in several matters relating
to its contract pharmacy recognition policy under the 340B Drug Pricing
Program in the US. AstraZeneca has sought to intervene in three lawsuits
against several US government agencies and their officials relating to the
appropriate interpretation of the governing statute for the 340B Drug Pricing
Program. Two of the three cases are currently stayed pending further
proceedings and the third case has been dismissed. Administrative Dispute
Resolution proceedings have also been initiated against AstraZeneca before the
US Health Resources and Services Administration.
As previously disclosed, in January 2021, AstraZeneca filed a separate lawsuit
in federal court in Delaware alleging that an Advisory Opinion issued by the
Department of Health and Human Services violates the Administrative Procedure
Act. In June 2021, the Court found in favour of AstraZeneca, invalidating the
Advisory Opinion. Prior to the Court's ruling, however, in May 2021, the US
government issued new and separate letters to AstraZeneca (and other
companies) asserting that our contract pharmacy policy violates the 340B
statute. AstraZeneca amended the complaint to include allegations challenging
the letter sent in May, and in February 2022, the Court ruled in favour of
AstraZeneca invalidating those letters sent by the US Government. The US
government has appealed the decision.
Table 26: H1 2022 - Product Sales year-on-year analysis
87 (#_ftn87)
The CER information in respect of H1 2022 included in the Interim financial
statements has not been reviewed by PricewaterhouseCoopers LLP.
World Emerging Markets US Europe Established RoW
$m Act % chg CER % chg $m Act % chg CER % chg $m % Change $m Act % chg CER % chg $m Act % chg CER % chg
Oncology 7,089 14 18 1,792 10 12 2,979 22 1,341 13 24 977 1 12
Tagrisso 2,704 10 14 805 16 17 951 11 509 9 19 439 1 12
Imfinzi 1,294 12 16 134 1 2 689 15 267 18 29 204 1 12
Lynparza 1,291 14 18 241 30 32 582 11 329 9 20 139 15 27
Calquence 903 84 87 16 n/m n/m 735 65 122 n/m n/m 30 n/m n/m
Enhertu 29 n/m n/m 19 n/m n/m - - 8 n/m n/m 2 n/m n/m
Orpathys 23 n/m n/m 23 n/m n/m - - - - - - - -
Zoladex 477 2 7 332 12 14 7 (14) 68 (8) - 70 (21) (11)
Faslodex 178 (21) (16) 81 1 5 10 (36) 32 (54) (50) 55 (8) 3
Iressa 63 (41) (39) 52 (41) (40) 4 (24) 1 (55) (44) 6 (44) (36)
Arimidex 61 (17) (13) 47 (16) (15) - 1 1 (69) (69) 13 (14) (1)
Casodex 42 (49) (47) 27 (58) (58) - n/m 1 49 21 14 (19) (11)
Others 24 (4) 3 15 4 9 1 n/m 3 6 16 5 (32) (24)
BioPharmaceuticals: CVRM* 4,559 14 18 2,099 9 12 1,151 10 945 28 40 364 21 33
Farxiga 2,103 55 63 814 46 50 468 55 627 69 85 194 55 70
Brilinta 675 (10) (7) 146 (19) (15) 351 (2) 150 (16) (8) 28 (12) (8)
Lokelma 129 79 87 5 n/m n/m 78 58 13 n/m n/m 33 n/m n/m
Roxadustat 91 1 1 91 1 1 - - - - - - - -
Andexxa* 70 9 12 - - - 42 (23) 18 90 n/m 10 n/m n/m
Crestor 547 2 6 414 11 15 35 (15) 21 (36) (30) 77 (18) (10)
Seloken/Toprol-XL 467 (9) (7) 456 (9) (7) - n/m 6 5 2 5 (10) 1
Bydureon 141 (29) (28) 2 1 3 119 (27) 20 (31) (25) - (93) (93)
Onglyza 139 (31) (28) 66 (39) (36) 40 (9) 21 (32) (26) 12 (29) (28)
Others 197 (9) (7) 105 (2) - 18 (35) 69 (6) (4) 5 (27) (20)
BioPharmaceuticals: R&I 2,891 (2) - 731 (17) (16) 1,300 13 551 (11) (3) 309 (1) 6
Symbicort 1,288 (6) (3) 306 - 3 481 (9) 312 (9) (1) 189 (1) 4
Fasenra 662 14 18 17 n/m n/m 419 18 153 12 23 73 (8) 1
Pulmicort 334 (33) (32) 236 (42) (41) 37 5 35 3 13 26 13 20
Breztri 179 n/m n/m 43 61 61 106 n/m 14 n/m n/m 16 46 65
Saphnelo 36 n/m n/m - - - 34 n/m 1 n/m n/m 1 n/m n/m
Daliresp 109 (5) (4) 1 (32) (30) 102 (2) 5 (37) (31) 1 16 18
Bevespi 30 13 16 3 49 47 22 9 5 21 32 - (26) 43
Others 253 (13) (12) 125 (8) (8) 99 65 26 (71) (68) 3 (50) (48)
BioPharmaceuticals: V&I 2,734 n/m n/m 861 89 92 638 n/m 511 (17) (10) 724 n/m n/m
Vaxzevria 1,540 36 41 660 45 45 80 n/m 262 (54) (50) 538 n/m n/m
Evusheld 914 n/m n/m 93 n/m n/m 556 n/m 143 n/m n/m 122 n/m n/m
Synagis 280 n/m n/m 108 n/m n/m 2 (55) 106 n/m n/m 64 n/m n/m
FluMist - n/m n/m - n/m n/m - - - n/m n/m - - -
Rare Disease* 3,495 5 10 206 (24) (8) 2,090 7 733 1 12 466 17 30
Soliris* 2,017 (5) 1 134 (45) (29) 1,165 2 437 (17) (8) 281 34 46
Ultomiris* 853 22 28 30 n/m n/m 456 10 225 65 81 142 (3) 11
Strensiq* 450 11 13 18 24 16 353 12 40 - 9 39 4 18
Koselugo 101 n/m n/m 15 n/m n/m 78 65 8 n/m n/m - - -
Kanuma* 74 9 14 9 4 12 38 11 23 7 18 4 16 20
Other medicines 842 (11) (6) 395 (26) (24) 75 (21) 67 (32) (28) 305 38 54
Nexium 674 (9) (2) 289 (31) (28) 63 (5) 26 (26) (19) 296 36 52
Others 168 (21) (20) 106 (9) (8) 12 (59) 41 (36) (34) 9 n/m n/m
Total Product Sales 21,610 41 47 6,084 12 15 8,233 74 4,148 28 40 3,145 65 81
Table 27: Q2 2022 - Product Sales year-on-year analysis (Unreviewed)
88 (#_ftn88)
The Q2 2022 information in respect of the three months ended 30 June 2022
included in the Interim financial statements has not been reviewed by
PricewaterhouseCoopers LLP.
World Emerging Markets US Europe Established RoW
$m Act % chg CER % chg $m Act % chg CER % chg $m % Change $m Act % chg CER % chg $m Act % chg CER % chg
Oncology 3,701 14 18 897 4 6 1,605 26 691 14 26 508 (1) 12
Tagrisso 1,400 7 12 400 2 4 513 17 256 5 17 231 (1) 12
Imfinzi 695 15 20 75 - 1 374 22 142 21 34 104 (2) 11
Lynparza 673 15 20 120 21 23 312 16 169 11 23 72 8 23
Calquence 489 74 77 8 80 77 396 59 67 n/m n/m 18 n/m n/m
Enhertu 18 n/m n/m 12 n/m n/m - - 4 n/m n/m 2 n/m n/m
Orpathys 11 n/m n/m 11 n/m n/m - - - - - - - -
Zoladex 236 (3) 2 165 3 7 3 (7) 34 (7) 3 34 (23) (14)
Faslodex 86 (18) (11) 37 (1) 3 5 (29) 16 (48) (42) 28 (8) 5
Iressa 32 (32) (29) 26 (28) (26) 2 (32) - (63) (43) 4 (48) (39)
Arimidex 28 (1) 5 22 8 11 - (45) - (93) (93) 6 (19) (4)
Casodex 21 (50) (48) 14 (57) (57) - (99) 1 n/m n/m 6 (29) (19)
Others 12 (8) 1 7 5 11 - - 2 (14) (4) 3 (35) (25)
BioPharmaceuticals: CVRM* 2,352 14 19 1,074 10 14 629 14 463 26 39 186 16 30
Farxiga 1,103 51 59 423 42 47 275 61 309 56 74 96 45 63
Brilinta 350 (7) (4) 78 4 8 185 (5) 73 (19) (10) 14 (17) (14)
Lokelma 66 68 79 2 89 n/m 39 55 7 n/m n/m 18 78 n/m
Roxadustat 50 (2) (1) 50 (2) (1) - - - - - - - -
Andexxa* 37 5 11 - - - 18 (37) 9 49 61 10 n/m n/m
Crestor 280 6 11 217 19 24 16 (14) 10 (14) (4) 37 (30) (22)
Seloken/Toprol-XL 223 (16) (13) 218 (16) (13) - - 3 (3) (4) 2 (13) 1
Bydureon 73 (23) (22) 1 (20) (18) 62 (20) 10 (34) (26) - (95) (95)
Onglyza 71 (28) (25) 32 (36) (32) 22 (15) 10 (33) (26) 7 (8) (7)
Others 99 (1) 1 53 (8) (7) 12 (6) 32 19 22 2 (28) (19)
BioPharmaceuticals: R&I 1,381 (3) 1 294 (14) (12) 654 10 274 (14) (4) 159 (2) 6
Symbicort 614 (10) (6) 139 (1) 2 222 (16) 155 (12) (3) 98 (1) 5
Fasenra 354 11 15 10 94 89 230 15 78 6 18 36 (11) -
Pulmicort 116 (30) (28) 72 (40) (39) 15 (16) 17 (4) 8 12 3 12
Breztri 93 66 72 21 20 21 53 71 9 n/m n/m 10 47 69
Saphnelo 24 n/m n/m - - - 23 n/m - - - 1 n/m n/m
Daliresp 58 7 8 1 (37) (34) 54 11 3 (27) (19) - 34 38
Bevespi 15 12 17 1 46 73 11 8 3 25 39 - (59) 49
Others 107 (18) (17) 50 (14) (14) 46 90 9 (79) (77) 2 (47) (45)
BioPharmaceuticals: V&I 977 10 15 231 (44) (44) 252 n/m 225 (39) (32) 269 n/m n/m
Vaxzevria 451 (48) (44) 185 (55) (55) - - 128 (63) (59) 138 36 50
Evusheld 445 n/m n/m 4 n/m n/m 250 n/m 77 n/m n/m 114 n/m n/m
Synagis 80 n/m n/m 42 n/m n/m 2 (32) 19 (9) (6) 17 n/m n/m
FluMist 1 n/m n/m - - - - - 1 n/m n/m - n/m n/m
Rare Disease* 1,801 6 12 91 (35) (19) 1,070 8 373 2 15 267 33 50
Soliris* 1,027 (5) 2 63 (48) (30) 574 (2) 216 (19) (8) 174 63 81
Ultomiris* 434 23 31 6 21 25 236 14 120 76 98 72 (3) 15
Strensiq* 242 16 18 9 1 (13) 193 21 21 - 12 19 2 17
Koselugo 62 n/m n/m 10 n/m n/m 47 83 5 n/m n/m - - -
Kanuma* 36 9 13 3 (36) (39) 20 15 11 15 30 2 22 24
Other medicines 418 (3) 6 191 (20) (16) 36 (17) 31 (33) (29) 160 60 84
Nexium 343 2 12 145 (22) (17) 30 (13) 12 (35) (28) 156 59 82
Others 75 (19) (17) 46 (14) (13) 6 (32) 19 (32) (30) 4 n/m n/m
Total Product Sales 10,630 32 38 2,778 (2) 1 4,246 72 2,057 21 34 1,549 49 67
Table 28: Collaboration Revenue
H1 2022 H1 2021
$m $m
Lynparza: regulatory milestones 175 -
Enhertu: share of gross profits 173 83
Vaxzevria: royalties 60 33
Tezspire: share of gross profits 16 -
Tralokinumab: sales milestones 70 -
Other royalty income 37 36
Other Collaboration Revenue 20 86
Total 551 238
Table 29: Other Operating Income and Expense
H1 2022 H1 2021
$m $m
Brazikumab licence termination funding 69 51
Divestment of rights to Plendil 61 -
Divestment of Viela Bio, Inc. shareholding - 776
Crestor (Europe ex-UK and Spain) - 309
Other 89 172
Total 219 1,308
Other shareholder information
Financial calendar
Announcement of year to date and third quarter results 10 November
2022
Announcement of full year and fourth quarter
results 9 February 2023
Dividends are normally paid as follows:
First interim: Announced with the half year results and paid
in September
Second interim: Announced with full year results and paid in March
The record date for the first interim dividend for 2022, payable on 12
September 2022, will be 12 August 2022. The ex-dividend date will be 11 August
2022.
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
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Deutsche Bank Trust Company Americas
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db@astfinancial.com
Trademarks
Trademarks of the AstraZeneca group of companies appear throughout this
document in italics. Medical publications also appear throughout the document
in italics. AstraZeneca, the AstraZeneca logotype and the AstraZeneca symbol
are all trademarks of the AstraZeneca group of companies. Trademarks of
companies other than AstraZeneca that appear in this document
include Arimidex and Casodex, owned by AstraZeneca or JuvisŽ (depending on
geography); Enhertu, a trademark of Daiichi Sankyo; Seloken, owned by
AstraZeneca or Taiyo Pharma Co., Ltd (depending on geography); Synagis, owned
by AstraZeneca or AbbVie Inc. (depending on geography); and Tezspire, a
trademark of Amgen, Inc.
Information on or accessible through AstraZeneca's websites, including
astrazeneca.com (https://www.astrazeneca.com/) , does not form part of and is
not incorporated into this announcement.
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical
company that focuses on the discovery, development, and commercialisation of
prescription medicines in Oncology, Rare Disease, and BioPharmaceuticals,
including Cardiovascular, Renal & Metabolism, and Respiratory &
Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries
and its innovative medicines are used by millions of patients worldwide.
Please visit astrazeneca.com (http://www.astrazeneca.com/) and follow the
Company on Twitter @AstraZeneca (http://www.twitter.com/AstraZeneca) .
Cautionary statements regarding forward-looking statements
In order, among other things, to utilise the 'safe harbour' provisions of the
US Private Securities Litigation Reform Act of 1995, AstraZeneca (hereafter
'the Group') provides the following cautionary statement:
This document contains certain forward-looking statements with respect to the
operations, performance and financial condition of the Group, including, among
other things, statements about expected revenues, margins, earnings per share
or other financial or other measures. Although the Group believes its
expectations are based on reasonable assumptions, any forward-looking
statements, by their very nature, involve risks and uncertainties and may be
influenced by factors that could cause actual outcomes and results to be
materially different from those predicted. The forward-looking statements
reflect knowledge and information available at the date of preparation of this
document and the Group undertakes no obligation to update these
forward-looking statements. The Group identifies the forward-looking
statements by using the words 'anticipates', 'believes', 'expects', 'intends'
and similar expressions in such statements. Important factors that could cause
actual results to differ materially from those contained in forward-looking
statements, certain of which are beyond the Group's control, include, among
other things:
‒ the risk of failure or delay in delivery of pipeline or launch of
new medicines
‒ the risk of failure to meet regulatory or ethical requirements for
medicine development or approval
‒ the risk of failures or delays in the quality or execution of the
Group's commercial strategies
‒ the risk of pricing, affordability, access and competitive pressures
‒ the risk of failure to maintain supply of compliant, quality
medicines
‒ the risk of illegal trade in the Group's medicines
‒ the impact of reliance on third-party goods and services
‒ the risk of failure in information technology or cybersecurity
‒ the risk of failure of critical processes
‒ the risk of failure to collect and manage data in line with legal
and regulatory requirements and strategic objectives
‒ the risk of failure to attract, develop, engage and retain a
diverse, talented and capable workforce
‒ the risk of failure to meet regulatory or ethical expectations on
environmental impact, including climate change
‒ the risk of the safety and efficacy of marketed medicines being
questioned
‒ the risk of adverse outcome of litigation and/or governmental
investigations
‒ intellectual property-related risks to our products
‒ the risk of failure to achieve strategic plans or meet targets or
expectations
‒ the risk of failure in financial control or the occurrence of fraud
‒ the risk of unexpected deterioration in the Group's financial
position
‒ the impact that global and/or geopolitical events such as the
COVID-19 pandemic and the Russia-Ukraine war, may have or continue to have on
these risks, on the Group's ability to continue to mitigate these risks, and
on the Group's operations, financial results or financial condition
Nothing in this document, or any related presentation/webcast, should be
construed as a profit forecast.
- End of document -
1 (#_ftnref1) Constant exchange rates. The differences between Actual Change
and CER Change are due to foreign exchange movements between periods in 2022
vs 2021. CER financial measures are not accounted for according to generally
accepted accounting principles (GAAP) because they remove the effects of
currency movements from Reported results.
2 (#_ftnref2) Reported financial measures are the financial results
presented in accordance with UK-adopted International Accounting Standards and
International Financial Reporting Standards (IFRSs) as issued by the
International Accounting Standards Board (IASB) and International Accounting
Standards as adopted by the European Union.
3 (#_ftnref3) Earnings per share.
4 (#_ftnref4) Core financial measures are adjusted to exclude certain items.
The differences between Reported and Core measures are primarily due to items
related to the acquisition of Alexion, amortisation of intangibles,
impairments, restructuring charges, and, as previously disclosed, a charge to
provisions relating to a legal settlement with Chugai Pharmaceutical Co. Ltd
(Chugai) that led to a payment of $775m in Q2 2022. A full reconciliation
between Reported EPS and Core EPS is provided in Tables 12 and 13 in the
Financial performance section of this document.
5 (#_ftnref5) In FY 2022, Total Revenue from Koselugo is included in Rare
Disease (FY 2021: Oncology) and Total Revenue from Andexxa is included in
BioPharmaceuticals: CVRM (FY 2021: Rare Disease). The growth rate shown for
each disease area has been calculated as though these changes had been
implemented in FY 2021.
6 (#_ftnref6) Respiratory & Immunology.
7 (#_ftnref7) Cardiovascular, Renal and Metabolism.
8 (#_ftnref8) H1 2022 and Q2 2022 growth rates on medicines acquired with
Alexion have been calculated on a pro forma basis comparing to the
corresponding period in the prior year, pre-acquisition as previously
published by Alexion. The growth rates shown for the Rare Disease and CVRM
disease areas include these pro forma adjustments.
9 (#_ftnref9) Heart failure with preserved ejection fraction.
10 (#_ftnref10) Non-small cell lung cancer.
11 (#_ftnref11) Hereditary transthyretin-mediated
amyloid polyneuropathy.
12 (#_ftnref12) Neuromyelitis optica spectrum
disorder.
13 (#_ftnref13) Human epidermal growth factor
receptor 2.
14 (#_ftnref14) Committee for Medicinal Products for
Human Use.
15 (#_ftnref15) AstraZeneca is collaborating with MSD
(Merck & Co., Inc. in the US and Canada) to develop and commercialise
Lynparza.
16 (#_ftnref16) Generalised myasthenia gravis.
17 (#_ftnref17) Neurofibromatosis type 1 plexiform
neurofibromas.
18 (#_ftnref18) National reimbursement drug list.
19 (#_ftnref19) Volume-based procurement.
20 (#_ftnref20) Vaccines & Immune Therapies.
21 (#_ftnref21) Vaxzevria is AstraZeneca's trademark
for the Company's supply of the AstraZeneca COVID-19 Vaccine. In the financial
tables in this report, 'Vaxzevria Total Revenue' includes Collaboration
Revenue from sub-licensees that produce and supply the AstraZeneca COVID‑19
Vaccine under their own trademarks.
22 (#_ftnref22) In Table 2, the Ô+ / -Õ symbols
indicate the directional impact of the item being discussed, e.g. a Ô+Õ
symbol next to an item relating to R&D Expenses signifies that the item
increased the R&D Expense relative to the prior year.
23 (#_ftnref23) Gross Profit is defined as Total
Revenue minus Cost of Sales. The calculation of Reported and Core Gross Margin
excludes the impact of Collaboration Revenue and any associated costs, thereby
reflecting the underlying performance of Product Sales.
24 (#_ftnref24) Where AstraZeneca does not retain a
significant ongoing interest in medicines or potential new medicines, income
from divestments is reported within Reported and Core Other Operating Income
and Expense in the CompanyÕs financial statements.
25 (#_ftnref25) Monoclonal antibodies.
26 (#_ftnref26) Germline (hereditary) breast cancer gene mutation.
27 (#_ftnref27) Paroxysmal nocturnal haemoglobinuria.
28 (#_ftnref28) Atypical haemolytic uraemic syndrome.
29 (#_ftnref29) Hormone receptor positive.
30 (#_ftnref30) Chronic lymphocytic leukaemia.
31 (#_ftnref31) Chronic kidney disease.
32 (#_ftnref32) Eosinophilic oesophagitis.
33 (#_ftnref33) Respiratory syncytial virus.
34 (#_ftnref34) Epidermal growth factor receptor mutation.
35 (#_ftnref35) Germline (hereditary) breast cancer gene mutation.
36 (#_ftnref36) Mantle cell lymphoma.
37 (#_ftnref37) Triple negative breast cancer.
38 (#_ftnref38) Eosinophilic granulomatosis with polyangiitis.
39 (#_ftnref39) Hyper-eosinophilic syndrome.
40 (#_ftnref40) Extensive-stage small cell lung cancer.
41 (#_ftnref41) Chemoradiation therapy.
42 (#_ftnref42) Poly ADP ribose polymerase.
43 (#_ftnref43) US Food and Drug Administration.
44 (#_ftnref44) Homologous recombination repair gene mutation.
45 (#_ftnref45) Homologous recombination deficiency.
46 (#_ftnref46) Mesenchymal-epithelial transition.
47 (#_ftnref47) Tyrosine kinase inhibitor.
48 (#_ftnref48) Sodium-glucose cotransporter 2.
49 (#_ftnref49) Heart failure.
50 (#_ftnref50) European Society of Cardiology.
51 (#_ftnref51) American Heart Association.
52 (#_ftnref52) American College of Cardiology.
53 (#_ftnref53) Heart Failure Society of America.
54 (#_ftnref54) Urine albumin creatine ratio.
55 (#_ftnref55) Measured renal function.
56 (#_ftnref56) Heart failure with reserved ejection fraction.
57 (#_ftnref57) Type-2 diabetes.
58 (#_ftnref58) Betaloc is the brand name for Seloken in China.
59 (#_ftnref59) Inhaled corticosteroid.
60 (#_ftnref60) Long-acting beta-agonist.
61 (#_ftnref61) Long-acting muscarinic-agonist.
62 (#_ftnref62) Systemic lupus erythematosus.
63 (#_ftnref63) Intravenous injection.
64 (#_ftnref64) Other Operating Income.
65 (#_ftnref65) Other SG&A expense of $1,129m predominantly includes the
$775m charge to provisions relating to the legal settlement with Chugai and
$293m of fair value movements on contingent consideration arising from
business combinations.
66 (#_ftnref66) Based on best prevailing assumptions around currency
profiles.
67 (#_ftnref67) Based on average daily spot rates in FY 2021.
68 (#_ftnref68) Spot rates on 30 June 2022.
69 (#_ftnref69) Other currencies include AUD, BRL, CAD, KRW and RUB.
70 (#_ftnref70) Sustainable Markets Initiative.
71 (#_ftnref71) American Society of Clinical Oncology.
72 (#_ftnref72) Programmed cell death protein 1.
73 (#_ftnref73) Programmed death-ligand 1.
74 (#_ftnref74) Prescription Drug User Fee Act.
75 (#_ftnref75) The PDFUA date is the day the US FDA targets for regulatory
decision.
76 (#_ftnref76) National Comprehensive Cancer Network.
77 (#_ftnref77) Progression free survival.
78 (#_ftnref78) Overall survival.
79 (#_ftnref79) US Food and Drug Agency
80 (#_ftnref80) Oestrogen Receptor 1 gene.
81 (#_ftnref81) Transient ischaemic attack of stroke.
82 (#_ftnref82) Transthyretin.
83 (#_ftnref83) Global Initiative for Asthma.
84 (#_ftnref84) Lower respiratory tract infection.
85 (#_ftnref85) The Q2 2022 and Q2 2021 information in respect of the
three months ended 30 June 2022 and 30 June 2021 respectively included in the
Interim financial statements has not been reviewed by PricewaterhouseCoopers
LLP.
86 (#_ftnref86) The Condensed consolidated statement of financial position
as at 30 June 2022 and 30 June 2021 has been reviewed by
PricewaterhouseCoopers LLP. The Condensed consolidated statement of financial
position as at 31 December 2021 has been audited by PricewaterhouseCoopers
LLP.
87 (#_ftnref87) 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. * FY 2022 Q2 growth rates on medicines acquired with Alexion have
been calculated on a pro forma basis comparing to the corresponding period in
the prior year, pre-acquisition as previously published by Alexion. The growth
rates shown for Rare Disease and CVRM disease area totals include these pro
forma adjustments.
88 (#_ftnref88) 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. * FY 2022 Q2 growth rates on medicines acquired with Alexion have
been calculated on a pro forma basis comparing to the corresponding period in
the prior year, pre-acquisition as previously published by Alexion. The growth
rates shown for Rare Disease and CVRM disease area totals include these pro
forma adjustments.
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