TIDMAZN
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] $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] EPS [3] $0.48 (70) (66) $0.23 (45) (46)
Core [4] 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] , including
receipt of a milestone payment. Product Sales from Oncology
increased 18%. Total Revenue from R&I [6] increased 3%, CVRM
[7] increased 19% [8] 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]
(DELIVER), Imfinzi in early NSCLC [10] (AEGEAN), eplontersen in
ATTRv-PN [11] (NEURO-TTRansform) and Ultomiris in NMOSD [12]
(CHAMPION-NMOSD). Full results from the Enhertu DESTINY-Breast04
trial in HER2 [13] -low breast cancer, presented at ASCO
-- Key approvals: Enhertu for HER2-positive breast cancer
(DESTINY-Breast03) in the US and EU; positive CHMP [14] opinions in
the EU for Tezspire in severe asthma (NAVIGATOR), Lynparza [15] in
early breast cancer (OlympiA) and Ultomiris in gMG [16]
(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]
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] and VBP [19] 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
----------------------- ------ --------- ---- ---------------------------------------------
$1,776m from medicines acquired
Product Sales 10,630 32 38 with Alexion
$100m for Enhertu (Q2 2021:
$46m)
$13m for Tezspire (Q2 2021:
Collaboration Revenue 141 (20) (20) $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
Farxiga achieved another blockbuster
quarter with $1,104m in revenues
CVRM(8) 2,356 14 19 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
$455m from Vaxzevria [21] ,
$445m from Evusheld
Majority of Vaxzevria revenue
V&I [20] 981 7 12 from initial contracts
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%
Rare Disease(8) 1,801 6 12 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
Pricing pressure associated
with the NRDL and VBP programmes
- China 1,435 (6) (5) 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
------------------------ ------ --------- ---- ---------------------------------------------
Contribution of medicines acquired
Regions exc. Vaxzevria $m Actual CER 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 $1,776m
------------------------ ------ --------- ---- ---------------------------------------------
Table 2 : Key elements of financial performance in Q2 2022
Metric Reported Reported Core Core Comments [22]
($m or change change
%)
---------- -------- ---------- -------- ---------- ------------------------------------------------------------
See Table 1 and the Total
Total 31% Actual 31% Actual Revenue section of this document
Revenue $10,771m 37% CER $10,771m 37% CER for further details
---------- -------- ---------- -------- ---------- ------------------------------------------------------------
Gross 72% (1pp) 83% 10% Actual + Addition of Alexion
Margin Actual 8% CER + Increasing mix of Oncology
[23] (2pp) CER 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
---------- -------- ---------- -------- ---------- ------------------------------------------------------------
+ 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
R&D 39% Actual 35% Actual Core R&D-to-Total Revenue
Expense $2,546m 44% CER $2,431m 40% CER ratio of 23% (Q2 2021: 22%)
---------- -------- ---------- -------- ---------- ------------------------------------------------------------
+ Addition of Alexion
+ Market development activities
for recent launches, including
Evusheld
+ Core SG&A-to-Total Revenue
SG&A 51% Actual 27% Actual ratio of 29%
Expense $4,681m 56% CER $3,137m 33% CER (Q2 2021: 30%)
---------- -------- ---------- -------- ---------- ------------------------------------------------------------
Other $122m (5%) $112m (12%) Includes $61m divestment from
Operating Actual Actual Plendil, and income coming
Income (5%) CER (13%) CER from royalties and prior transactions
[24]
---------- -------- ---------- -------- ---------- ------------------------------------------------------------
(9pp)
Operating Actual 9% Actual See Gross Margin and Expenses
Margin 5% (9pp) CER 31% 8% CER commentary above
---------- -------- ---------- -------- ---------- ------------------------------------------------------------
Net $293m (8%) $223m 1% Actual + Alexion debt financing costs
Finance Actual 26% CER * Reported impacted by lower discount unwind on
Expense 10% CER acquisition-related liabilities
---------- -------- ---------- -------- ---------- ------------------------------------------------------------
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
(8%) quarter to quarter
Actual Full year expectation remains
Tax Rate (46%) n/m 15% (9%) CER 18-22%
---------- -------- ---------- -------- ---------- ------------------------------------------------------------
(45%) Further details of differences
Actual 92% Actual between Reported and Core
EPS $0.23 (46%) CER $1.72 89% CER 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] 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 in June 2022.
Management changes
AstraZeneca PLC today announced the appointment of Michel Demar
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.
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 Regulatory approval (US,
(2nd-line) (DESTINY-Breast03) EU)
Regulatory Lynparza gBRCAm [26] breast cancer CHMP positive opinion
approvals (adjuvant) (OlympiA) (EU)
and other
regulatory
actions
Tezspire Severe asthma (NAVIGATOR) CHMP positive opinion
(EU)
Ultomiris gMG (CHAMPION-MG) CHMP positive opinion
(EU)
Ultomiris Subcutaneous, PNH [27] Regulatory approval (US)
and aHUS [28]
Imfinzi Biliary tract cancer (TOPAZ-1) Priority Review (US),
regulatory submission
(EU)
Enhertu HER2-low breast cancer Priority Review (US),
(3rd-line) (DESTINY-Breast04) regulatory submission
(EU, JP)
Enhertu HER2-positive breast cancer Regulatory submission
(2nd-line) (DESTINY-Breast03) (CN)
Regulatory PT027 Asthma (MANDALA/DENALI) Regulatory submission
submissions (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 camizestrant HR+ [29] /HER2-neg breast Fast Track Designation
III data cancer (SERENA-6) (US)
readouts
and other
developments
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. Data readout
III) (PACIFIC-2)
Imfinzi NSCLC (1st-line) (PEARL) Data readout
Imfinzi Biliary tract cancer (TOPAZ-1) Regulatory decision
Imfinzi Liver cancer (1st-line) Regulatory decision
+/- (HIMALAYA)
tremelimumab
Imfinzi NSCLC (1st-line) (POSEIDON) Regulatory decision
+/-
tremelimumab
Lynparza gBRCAm breast cancer (adjuvant) Regulatory decision (JP)
(OlympiA)
Lynparza Prostate cancer (1st-line) Regulatory submission
(PROpel) (US), regulatory decision
Enhertu HER2-positive breast cancer Data readout, regulatory
(3rd-line) (DESTINY-Breast02) submission
Enhertu HER2-positive breast cancer Regulatory decision
(2nd-line) (DESTINY-Breast03)
Enhertu HER2-low breast cancer (3rd-line) Regulatory decision, regulatory
(DESTINY-Breast04) submission (CN)
Enhertu HER2-positive gastric cancer Regulatory decision (EU)
(2nd-line) (DESTINY-Gastric01)
Enhertu HER2m NCSLC (2nd-line+) Regulatory decision
(DESTINY-Lung01)
Calquence CLL [30] (ELEVATE-TN) Regulatory decision (JP)
capivasertib HR+/HER2-neg breast cancer Data readout
(1st-line) (CAPItello-291)
Farxiga HFpEF (DELIVER) Regulatory submission
Forxiga CKD [31] (DAPA-CKD) Regulatory decision (CN)
eplontersen ATTRv-PN (NEURO-TTRansform) Regulatory submission
(US)
Fasenra EOE [32] (MESSINA) Data readout
Tezspire Severe asthma (NAVIGATOR) Regulatory decision
PT027 Asthma (MANDALA/DENALI) Regulatory decision (US)
nirsevimab RSV [33] (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-Barr 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] NSCLC (1st-line) Data readout
(FLAURA2)
Tagrisso EGFRm NSCLC (unresectable Data readout
Stg. III) (LAURA)
Imfinzi Bladder cancer (muscle invasive) Data readout
(NIAGARA)
Imfinzi Bladder cancer (1st-line) Data readout
(NILE)
Imfinzi NSCLC (neoadjuvant) (AEGEAN) Data readout
Imfinzi NSCLC (unresectable, Stg. Regulatory submission
III) (PACIFIC-2)
Imfinzi Liver cancer (locoregional) Regulatory submission
(EMERALD-1)
Imfinzi Liver cancer (adjuvant) Data readout, regulatory
(EMERALD-2) submission
Imfinzi NSCLC (1st-line) (PEARL) Regulatory submission
Imfinzi SCLC (limited-stage) (ADRIATIC) Data readout
Lynparza gBRCAm [35] breast cancer Regulatory submission
(adjuvant) (OlympiA) (CN)
Lynparza Ovarian cancer (1st-line) Regulatory decision (CN)
(PAOLA-1)
Lynparza Ovarian cancer (1st-line) Data readout
+ Imfinzi (DUO-O)
Enhertu HER2-low breast cancer (2nd-line) Data readout
(DESTINY-Breast06)
capivasertib HR+/HER2-negative breast Regulatory submission
cancer (1st-line) (CAPItello-291)
Dato-DXd NSCLC (3rd-line) (TROPION-Lung01) Data readout, regulatory
submission
roxadustat Anaemia of myelodysplastic Data readout
syndrome
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 Regulatory submission
Stg. III) (LAURA)
Imfinzi Biliary tract cancer (TOPAZ-1) Regulatory submission
(CN)
Imfinzi Bladder cancer (muscle invasive) Regulatory submission
(NIAGARA)
Imfinzi Bladder cancer (1st-line) Regulatory submission
(NILE)
Imfinzi Liver cancer (locoregional) Regulatory submission
(EMERALD-1) (CN)
Imfinzi NSCLC (neoadjuvant) (AEGEAN) Regulatory submission
Imfinzi SCLC (limited-stage) (ADRIATIC) Regulatory submission
Lynparza Endometrial cancer (1st-line) Data readout
+ Imfinzi (DUO-E)
Calquence CLL (ACE-CL-311) Data readout
Calquence MCL [36] (1st-line) (ECHO) Data readout
capivasertib TNBC [37] (locally adv./met.) Data readout, regulatory
submission
(CAPItello-290)
camizestrant HR+/HER2-neg breast cancer Data readout
(SERENA-6)
Farxiga Myocardial infarction (DAPA-MI) Data readout
Fasenra EGPA [38] (MANDARA) Data readout
Fasenra HES [39] (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 .
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 Increased use in 1st-line setting and launch progress
RoW 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] , 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] 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 New reimbursements
RoW
---------------- -------------------------------------------------------------
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]
-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]
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] prostate and gBRCAm
HER2-negative advanced breast cancer
Established New product launches and high levels of HRD [45] testing
RoW in Japan
---------------- ----------------------------------------------------------------
Enhert u
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 $ 397 m 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 In Japan, AstraZeneca receives a mid-single-digit percentage
RoW royalty on sales made by Daiichi Sankyo
---------------- ---------------------------------------------------------------
Calquence
Total Revenue Worldwide Emerging Markets US Europe Established
RoW
-------------- --------- ---------------- --- ------ -----------
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] 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] 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] market in most major regions
Growth in the SGLT2 inhibitor class
Further HF [49] and CKD launches and updated treatment
guidelines including from ESC [50] and AHA [51] /ACC
[52] /HFSA [53]
Emerging Markets uACR [54] and MRF [55] 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] in May 2020, treatment
of CKD in May 2021, and favourable gross-to-net adjustments
Both approvals included patients with and without T2D
[57]
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 In Japan, sales to collaborator Ono Pharmaceutical Co.,
RoW 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] 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] /LABA [60] class
The global ICS/LABA market continues to be eroded as
fixed-dose triple therapies (LAMA [61] /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 Sales in Japan continued to decline due to continued
RoW 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 Increased demand and sustained leadership in new-to-brand
RoW 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 Strong launch performance in Japan
RoW
---------------- ---------------------------------------------------------------
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] 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 Sales in Japan, Canada and Australia
RoW 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] ) 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] & 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 Acquisition Other Core Core
Asset Amortisation of Alexion % Change
& Impairments
$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
1,129
SG&A Expense (9,521) 198 2,081 30 [65] (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 Acquisition Other Core Core
Asset Amortisation of Alexion % Change
& Impairments
$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 combinations 293 82 211
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])
rates versus USD
----------------- -------------------------------------------------------------------------
Currency Primary Relevance FY 2021 [67] 30 Jun 2022 ([68]) % 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]) 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] Health Systems Taskforce, an
editorial 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 . 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] 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] /PD-L1 [73] 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]
date [75] 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] 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] 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] for
Calquence combined with obinutuzumab compared with chlorambucil
combined with obinutuzumab in previously untreated adults with
CLL.
Separately, follow-up data from the ASC 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] 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.
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] 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] .
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] 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] 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 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
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 , 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] , 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 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 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 comprehensive income (12) (27)
Fair value movements related to own credit risk on bonds designated as fair value through
profit or loss 2 2
Tax on items that will not be reclassified to profit or loss (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] 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
comprehensive
income (30) 81
Fair value movements related to own credit risk on bonds designated as fair
value through
profit or loss 2 1
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] 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 Share Other Retained Total Non-controlling Total
capital premium reserves earnings attributable interests equity
account to owners
of the
parent
$m $m $m $m $m $m $m
----------------------- -------- -------- --------- --------- ------------- --------------- -------
At 1 Jan 2021 328 7,971 2,024 5,299 15,622 16 15,638
------------------------ -------- -------- --------- --------- ------------- --------------- -------
Profit for the period - - - 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 combinations 293 82
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 combinations (158) -
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 instruments 9 135
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.
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 .
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 . 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]
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]
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
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please click here . For Media contacts, click here .
Addresses for correspondence
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transfer office Securities Depository Deutsche Bank Trust
Company Americas
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Trademarks
Trademarks of the AstraZeneca group of companies appear
throughout this document in italics. Medical publications also
appear throughout the document in italics. AstraZeneca, the
AstraZeneca logotype and the AstraZeneca symbol are all trademarks
of the AstraZeneca group of companies. Trademarks of companies
other than AstraZeneca that appear in this document include
Arimidex and Casodex, owned by AstraZeneca or Juvis (depending on
geography); 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 , does not form part of and is not
incorporated into this announcement.
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led
biopharmaceutical company that focuses on the discovery,
development, and commercialisation of prescription medicines in
Oncology, Rare Disease, and BioPharmaceuticals, including
Cardiovascular, Renal & Metabolism, and Respiratory &
Immunology. Based in Cambridge, UK, AstraZeneca operates in over
100 countries and its innovative medicines are used by millions of
patients worldwide. Please visit astrazeneca.com and follow the
Company on Twitter @AstraZeneca .
Cautionary statements regarding forward-looking statements
In order, among other things, to utilise the 'safe harbour'
provisions of the US Private Securities Litigation Reform Act of
1995, AstraZeneca (hereafter 'the Group') provides the following
cautionary statement:
This document contains certain forward-looking statements with
respect to the operations, performance and financial condition of
the Group, including, among other things, statements about expected
revenues, margins, earnings per share or other financial or other
measures. Although the Group believes its expectations are based on
reasonable assumptions, any forward-looking statements, by their
very nature, involve risks and uncertainties and may be influenced
by factors that could cause actual outcomes and results to be
materially different from those predicted. The forward-looking
statements reflect knowledge and information available at the date
of preparation of this document and the Group undertakes no
obligation to update these forward-looking statements. The Group
identifies the forward-looking statements by using the words
'anticipates', 'believes', 'expects', 'intends' and similar
expressions in such statements. Important factors that could cause
actual results to differ materially from those contained in
forward-looking statements, certain of which are beyond the Group's
control, include, among other things:
-- the risk of failure or delay in delivery of pipeline or launch of new medicines
-- the risk of failure to meet regulatory or ethical
requirements for medicine development or approval
-- the risk of failures or delays in the quality or execution of
the Group's commercial strategies
-- the risk of pricing, affordability, access and competitive pressures
-- the risk of failure to maintain supply of compliant, quality medicines
-- the risk of illegal trade in the Group's medicines
-- the impact of reliance on third-party goods and services
-- the risk of failure in information technology or cybersecurity
-- the risk of failure of critical processes
-- the risk of failure to collect and manage data in line with
legal and regulatory requirements and strategic objectives
-- the risk of failure to attract, develop, engage and retain a
diverse, talented and capable workforce
-- the risk of failure to meet regulatory or ethical
expectations on environmental impact, including climate change
-- the risk of the safety and efficacy of marketed medicines being questioned
-- the risk of adverse outcome of litigation and/or governmental investigations
-- intellectual property-related risks to our products
-- the risk of failure to achieve strategic plans or meet targets or expectations
-- the risk of failure in financial control or the occurrence of fraud
-- the risk of unexpected deterioration in the Group's financial position
-- the impact that global and/or geopolitical events such as the
COVID-19 pandemic and the Russia-Ukraine war, may have or continue
to have on these risks, on the Group's ability to continue to
mitigate these risks, and on the Group's operations, financial
results or financial condition
Nothing in this document, or any related presentation/webcast,
should be construed as a profit forecast.
- End of document -
[1] Constant exchange rates. The differences between Actual
Change and CER Change are due to foreign exchange movements between
periods in 2022 vs 2021. CER financial measures are not accounted
for according to generally accepted accounting principles (GAAP)
because they remove the effects of currency movements from Reported
results.
[2] Reported financial measures are the financial results
presented in accordance with UK-adopted International Accounting
Standards and International Financial Reporting Standards (IFRSs)
as issued by the International Accounting Standards Board (IASB)
and International Accounting Standards as adopted by the European
Union.
[3] Earnings per share.
[4] Core financial measures are adjusted to exclude certain
items. The differences between Reported and Core measures are
primarily due to items related to the acquisition of Alexion,
amortisation of intangibles, impairments, restructuring charges,
and, as previously disclosed, a charge to provisions relating to a
legal settlement with Chugai Pharmaceutical Co. Ltd (Chugai) that
led to a payment of $775m in Q2 2022. A full reconciliation between
Reported EPS and Core EPS is provided in Tables 12 and 13 in the
Financial performance section of this document.
[5] In FY 2022, Total Revenue from Koselugo is included in Rare
Disease (FY 2021: Oncology) and Total Revenue from Andexxa is
included in BioPharmaceuticals: CVRM (FY 2021: Rare Disease). The
growth rate shown for each disease area has been calculated as
though these changes had been implemented in FY 2021.
[6] Respiratory & Immunology.
[7] Cardiovascular, Renal and Metabolism.
[8] 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] Heart failure with preserved ejection fraction.
[10] Non-small cell lung cancer.
[11] Hereditary transthyretin-mediated amyloid polyneuropathy.
[12] Neuromyelitis optica spectrum disorder.
[13] Human epidermal growth factor receptor 2.
[14] Committee for Medicinal Products for Human Use.
[15] AstraZeneca is collaborating with MSD (Merck & Co.,
Inc. in the US and Canada) to develop and commercialise
Lynparza.
[16] Generalised myasthenia gravis.
[17] Neurofibromatosis type 1 plexiform neurofibromas.
[18] National reimbursement drug list.
[19] Volume-based procurement.
[20] Vaccines & Immune Therapies.
[21] 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] 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] 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] 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] Monoclonal antibodies.
[26] Germline (hereditary) breast cancer gene mutation.
[27] Paroxysmal nocturnal haemoglobinuria.
[28] Atypical haemolytic uraemic syndrome.
[29] Hormone receptor positive.
[30] Chronic lymphocytic leukaemia.
[31] Chronic kidney disease.
[32] Eosinophilic oesophagitis.
[33] Respiratory syncytial virus.
[34] Epidermal growth factor receptor mutation.
[35] Germline (hereditary) breast cancer gene mutation.
[36] Mantle cell lymphoma.
[37] Triple negative breast cancer.
[38] Eosinophilic granulomatosis with polyangiitis.
[39] Hyper-eosinophilic syndrome.
[40] Extensive-stage small cell lung cancer.
[41] Chemoradiation therapy.
[42] Poly ADP ribose polymerase.
[43] US Food and Drug Administration.
[44] Homologous recombination repair gene mutation.
[45] Homologous recombination deficiency.
[46] Mesenchymal-epithelial transition.
[47] Tyrosine kinase inhibitor.
[48] Sodium-glucose cotransporter 2.
[49] Heart failure.
[50] European Society of Cardiology.
[51] American Heart Association.
[52] American College of Cardiology.
[53] Heart Failure Society of America.
[54] Urine albumin creatine ratio.
[55] Measured renal function.
[56] Heart failure with reserved ejection fraction.
[57] Type-2 diabetes.
[58] Betaloc is the brand name for Seloken in China.
[59] Inhaled corticosteroid.
[60] Long-acting beta-agonist.
[61] Long-acting muscarinic-agonist.
[62] Systemic lupus erythematosus.
[63] Intravenous injection.
[64] Other Operating Income.
[65] 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] Based on best prevailing assumptions around currency
profiles.
[67] Based on average daily spot rates in FY 2021.
[68] Spot rates on 30 June 2022.
[69] Other currencies include AUD, BRL, CAD, KRW and RUB.
[70] Sustainable Markets Initiative.
[71] American Society of Clinical Oncology.
[72] Programmed cell death protein 1.
[73] Programmed death-ligand 1.
[74] Prescription Drug User Fee Act.
[75] The PDFUA date is the day the US FDA targets for regulatory
decision.
[76] National Comprehensive Cancer Network.
[77] Progression free survival.
[78] Overall survival.
[79] US Food and Drug Agency
[80] Oestrogen Receptor 1 gene.
[81] Transient ischaemic attack of stroke.
[82] Transthyretin.
[83] Global Initiative for Asthma.
[84] Lower respiratory tract infection.
[85] 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] 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] 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] 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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END
IR UWOWRUBUBUAR
(END) Dow Jones Newswires
July 29, 2022 02:00 ET (06:00 GMT)
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