Notes to the Interim Financial Statements
Note 1: Basis of preparation and accounting policies
These unaudited condensed consolidated Interim financial statements
for the three months ended 31 March 2023 have been prepared in
accordance with International Accounting Standard 34, 'Interim
Financial Reporting' (IAS 34), as issued by the International
Accounting Standards Board (IASB), IAS 34 as adopted by the
European Union, UK-adopted IAS 34 and the Disclosure Guidance and
Transparency Rules sourcebook of
the United Kingdom's Financial Conduct Authority and with the
requirements of the Companies Act 2006 as
applicable to companies reporting under those
standards.
The unaudited Interim financial statements for the three months
ended 31 March 2023 were approved by
the Board of Directors for publication on 27 April
2023.
This results announcement does not constitute statutory accounts of
the Group within the meaning of sections
434(3) and 435(3) of the Companies Act 2006. The annual financial
statements of the Group for the year ended 31 December 2022 were
prepared in accordance with UK-adopted International Accounting
Standards and with the requirements of the Companies Act 2006. The
annual financial statements also comply fully with IFRSs as issued
by the IASB and International Accounting Standards as adopted by
the European Union. Except for the estimation of the interim income
tax charge, the Interim Financial Statements have been prepared
applying the accounting policies that were applied in the
preparation of the Group's published consolidated financial
statements for the year ended 31 December 2022.
The comparative figures for the financial year ended 31 December
2022 are not the Group's statutory accounts for that financial
year. Those accounts have been reported on by the Group's auditors
and will be delivered to the registrar of companies; their report
was (i) unqualified, (ii) did not include a reference to any
matters to which the auditors drew attention by way of emphasis
without qualifying their report, and (iii) did not contain a
statement under section 498(2) or (3) of the Companies Act
2006.
Alliance and Collaboration Revenues
Effective 1 January 2023, the Group has updated the presentation of
Total Revenue on the face of the Statement of Comprehensive Income
to include Alliance Revenue as a separate element to Collaboration
Revenue. Alliance Revenue, previously reported within Collaboration
Revenue, comprises income related to sales made by collaboration
partners, where AstraZeneca is entitled to a profit share, revenue
share or royalties, which are recurring in nature while the
collaboration arrangement remains in place. Alliance Revenue does
not include Product Sales where AstraZeneca is leading
commercialisation in a territory. Collaboration Revenue arising
from collaborative arrangements where the Group retains a
significant ongoing economic interest and receives upfront amounts
and event-triggered milestones, which arise from the licensing of
intellectual property, will continue to be reported as
Collaboration Revenue. In collaboration arrangements either
AstraZeneca or the collaborator acts as principal in sales to the
end customer. Where AstraZeneca acts as principal, we record 100%
of sales to the end customer within Product Sales. The revised
presentation reflects the increasing importance of income arising
from profit share arrangements where collaboration partners are
responsible for booking revenues in some or all
territories.
The comparative revenue reported in Q1 2023 relating to the quarter
to 31 March 2022 has been retrospectively adjusted to reflect the
new split of Total Revenue, resulting in Alliance Revenue being
reported for the quarter ending 31 March 2022 of $152m, however the
combined total of Alliance Revenue and Collaboration Revenue is
equal to the previously reported Collaboration Revenue total for
the quarter ending 31 March 2022.
Going concern
The Group has considerable financial resources available. As at 31
March 2023, the Group has $13.1bn in financial resources (Cash and
cash equivalent balances of $6.2bn and undrawn committed bank
facilities of $6.9bn available, of which $2.0bn of the facilities
are available until February 2025 and the other $4.9bn are
available until April 2026, with only $3.9bn of borrowings due
within one year). These facilities contain no financial covenants
and were undrawn at 31 March 2023.
The Group's revenues are largely derived from sales of medicines
covered by patents which provide a relatively high level of
resilience and predictability to cash inflows, although government
price interventions in response to budgetary constraints are
expected to continue to adversely affect revenues in some of our
significant markets. The Group, however, anticipates new revenue
streams from both recently launched medicines and those in
development, and the Group has a wide diversity of customers and
suppliers across different geographic areas.
Consequently, the Directors believe that, overall, the Group is
well placed to manage its business risks successfully. Accordingly,
they continue to adopt the going concern basis in preparing the
Interim Financial Statements.
Legal proceedings
The information contained in Note 5 updates the disclosures
concerning legal proceedings and contingent liabilities in the
Group's Annual Report and Form
20-F Information 2022.
Note 2: Intangible assets
In accordance with IAS 36 'Impairment of Assets', reviews for
triggers of impairment or impairment reversals at an individual
asset or cash generating unit level were conducted, and impairment
tests carried out where triggers were identified. As a result,
total net impairment charges of $271m have been recorded against
intangible assets during the three months ended 31 March 2023 (Q1
2022: $94m net reversal). Net impairment charges in respect of
medicines in development were $271m (Q1 2022: $77m reversal)
including the $244m impairment of the ALXN1840 intangible asset,
following decision to discontinue this development programme in
Wilsons disease.
The acquisition of CinCor completed on 24 February 2023, recorded
as an asset acquisition, with consideration and net assets acquired
of $1,268m, which included intangible assets acquired of $780m,
$424m of cash and cash equivalents, and $75m of marketable
securities. Contingent consideration of up to $496m could be
paid on achievement of regulatory milestones, those liabilities
will be recorded when milestones are triggered, or performance
conditions have been satisfied.
Note 3: Net debt
The table below provides an analysis of Net Debt and a
reconciliation of Net Cash Flow to the movement in Net Debt. The
Group monitors Net Debt as part of its capital-management policy as
described in Note 28 of the Annual Report and Form
20-F Information 2022. Net Debt
is a non-GAAP financial measure.
Table 23: Net
debt
|
|
|
At 1 Jan 2023
|
Cash flow
|
Acquisitions
|
Non-cash& other
|
Exchange movements
|
At 31 Mar 2023
|
|
|
|
$m
|
$m
|
$m
|
$m
|
$m
|
$m
|
|
Non-current instalments of loans
|
|
(22,965)
|
(3,826)
|
-
|
(7)
|
(118)
|
(26,916)
|
|
Non-current instalments of leases
|
|
(725)
|
-
|
(6)
|
6
|
(5)
|
(730)
|
|
Total long-term debt
|
|
(23,690)
|
(3,826)
|
(6)
|
(1)
|
(123)
|
(27,646)
|
|
Current instalments of loans
|
|
(4,964)
|
2,004
|
-
|
2
|
-
|
(2,958)
|
|
Current instalments of leases
|
|
(228)
|
72
|
(2)
|
(73)
|
(1)
|
(232)
|
|
Commercial paper
|
|
-
|
(74)
|
-
|
-
|
-
|
(74)
|
|
Bank collateral received
|
|
(89)
|
(10)
|
-
|
-
|
-
|
(99)
|
|
Other short-term borrowings excluding overdrafts
|
|
(78)
|
(13)
|
-
|
-
|
1
|
(90)
|
|
Overdrafts
|
|
(183)
|
(218)
|
-
|
-
|
(3)
|
(404)
|
|
Total current debt
|
|
(5,542)
|
1,761
|
(2)
|
(71)
|
(3)
|
(3,857)
|
|
Gross borrowings
|
|
(29,232)
|
(2,065)
|
(8)
|
(72)
|
(126)
|
(31,503)
|
|
Net derivative financial instruments
|
|
(96)
|
(17)
|
-
|
92
|
-
|
(21)
|
|
Net borrowings
|
|
(29,328)
|
(2,082)
|
(8)
|
20
|
(126)
|
(31,524)
|
|
Cash and cash equivalents
|
|
6,166
|
74
|
-
|
-
|
(8)
|
6,232
|
|
Other investments - current
|
|
239
|
(9)
|
-
|
-
|
-
|
230
|
|
Cash and investments
|
|
6,405
|
65
|
-
|
-
|
(8)
|
6,462
|
|
Net debt
|
|
(22,923)
|
(2,017)
|
(8)
|
20
|
(134)
|
(25,062)
|
Non-cash movements in the period include fair value adjustments
under IFRS 9 Financial Instruments.
The Group has agreements with some bank counterparties whereby the
parties agree to post cash collateral on financial derivatives, for
the benefit of the other, equivalent to the market valuation of the
derivative positions above a predetermined threshold. The carrying
value of such cash collateral held by the Group at 31 March 2023
was $99m (31 December 2022: $89m) and the carrying value of such
cash collateral posted by the Group at 31 March 2023 was $164m (31
December 2022: $162m).
The equivalent GAAP measure to Net debt is 'liabilities arising
from financing activities', which excludes the amounts for cash and
overdrafts, other investments and non-financing derivatives shown
above and includes the Acerta Pharma share purchase liability of
$792m (31 December 2022: $1,646m), which is shown in current other
payables.
Net debt increased by $2,139m in the year to date to $25,062m.
Details of the committed undrawn bank facilities are disclosed
within the going concern section of Note 1.
During the three months ended 31 March 2023, there were no changes
to the Company's solicited credit ratings issued by Standard and
Poor's (long term: A; short term: A-1) and from Moody's (long term:
A3; short term: P-2).
Note 4: Financial Instruments
As detailed in the Group's most recent annual financial statements,
the principal financial instruments consist of derivative financial
instruments, other investments, trade and other receivables, cash
and cash equivalents, trade and other payables, lease liabilities
and interest-bearing loans and borrowings.
The Group has certain equity investments that are categorised as
Level 3 in the fair value hierarchy that are held at $217m at 31
March 2023 (31 December 2022: $186m) and for which fair value gains
of $1m have been recognised in the three months ended 31 March 2023
(31 March 2022: $nil). In the absence of specific market data,
these unlisted investments are held at fair value based on the cost
of investment and adjusting as necessary for impairments and
revaluations on new funding rounds, which are seen to approximate
the fair value. All other fair value gains and/or losses that are
presented in Net gains on equity investments measured at fair value
through other comprehensive income in the Condensed consolidated
statement of comprehensive income for the three months ended 31
March 2023 are Level 1 fair value measurements, valued based on
quoted prices in active markets.
Financial instruments measured at fair value include $1,162m of
other investments, $4,459m held in money-market funds, $291m of
loans designated at fair value through profit or loss and ($21m) of
derivatives as at 31 March 2023. With the exception of derivatives
being Level 2 fair valued, certain equity investments as described
above and an equity warrant of $20m categorised as Level 3, the
aforementioned balances are Level 1 fair valued. Financial
instruments measured at amortised cost include $61m of fixed
deposits and $164m of cash collateral pledged to counterparties.
The total fair value of interest-bearing loans and borrowings at 31
March 2023, which have a carrying value of $31,503m in the
Condensed consolidated statement of financial position, was
$30,576m.
Table 24:
Financial instruments - contingent
consideration
|
|
|
2023
|
2022
|
|
|
|
Diabetes alliance
|
Other
|
Total
|
Total
|
|
|
|
$m
|
$m
|
$m
|
$m
|
|
At 1 January
|
|
2,124
|
98
|
2,222
|
2,865
|
|
Additions through business combinations
|
|
-
|
60
|
60
|
-
|
|
Settlements
|
|
(212)
|
(2)
|
(214)
|
(182)
|
|
Disposals
|
|
-
|
-
|
-
|
(121)
|
|
Discount unwind
|
|
31
|
2
|
33
|
42
|
|
At 31 March
|
|
1,943
|
158
|
2,101
|
2,604
|
|
|
|
|
|
|
|
|
|
|
Contingent consideration arising from business combinations is fair
valued using decision-tree analysis, with key inputs including the
probability of success, consideration of potential delays and the
expected levels of future revenues.
The contingent consideration balance relating to BMS's share of the
global diabetes alliance of $1,943m (31 December 2022:
$2,124m) would increase/decrease by $194m with an increase/decrease
in sales of 10%, as compared with the current
estimates.
Note 5: Legal proceedings and contingent liabilities
AstraZeneca is involved in various legal proceedings considered
typical to its business, including litigation and investigations,
including Government investigations, relating to product liability,
commercial disputes, infringement of intellectual property (IP)
rights, the validity of certain patents, anti-trust law and sales
and marketing practices. The matters discussed below constitute the
more significant developments since publication of the disclosures
concerning legal proceedings in the Company's Annual Report and
Form 20-F Information 2022 (the Disclosures).
As discussed in the Disclosures, the majority of claims involve
highly complex issues. Often these issues are subject to
substantial uncertainties and, therefore, the probability of a
loss, if any, being sustained and/or an estimate of the amount of
any loss is difficult to ascertain.
Unless specifically identified below, AstraZeneca considers each of
the claims to represent a contingent liability or a contingent
asset where the matter is brought by AstraZeneca, and discloses
information with respect to the nature and facts of the cases in
accordance with IAS 37.
There is one matter concerning legal proceedings in the
Disclosures, which is considered probable that an outflow will be
required, but for which we are unable to make an estimate of the
possible loss or range of possible losses at this
stage.
In cases that have been settled or adjudicated, or where
quantifiable fines and penalties have been assessed and which are
not subject to appeal, or where a loss is probable and we are able
to make a reasonable estimate of the loss, AstraZeneca records the
loss absorbed or makes a provision for its best estimate of the
expected loss. The position could change over time and the
estimates that the Company made, and upon which the Company have
relied in calculating these provisions are inherently imprecise.
There can, therefore, be no assurance that any losses that result
from the outcome of any legal proceedings will not exceed the
amount of the provisions that have been booked in the accounts. The
major factors causing this uncertainty are described more fully in
the Disclosures and herein.
AstraZeneca has full confidence in, and will vigorously defend and
enforce, its IP.
Matters disclosed in respect of the first quarter of 2023 and to 27
April 2023
Patent litigation
Enhertu
US patent proceedings
As previously disclosed, in December 2020 and January 2021,
AstraZeneca and Daiichi Sankyo, Inc. filed post-grant review (PGR)
petitions with the US Patent and Trademark Office (USPTO) alleging,
inter alia, that the Seagen patent is invalid for lack of written
description and enablement. The USPTO initially declined to
institute the PGRs, but, in April 2022, the USPTO granted the
rehearing requests, instituting both PGR petitions. Seagen
subsequently disclaimed all patent claims at issue in one of the
PGR proceedings. In July 2022, the USPTO reversed its institution
decision and declined to institute the other PGR petition.
AstraZeneca and Daiichi Sankyo, Inc. requested reconsideration of
the decision not to institute review of the patent. In February
2023, the USPTO reinstituted the PGR proceeding. An oral hearing is
scheduled for August 2023.
Lynparza
US patent proceedings
As previously disclosed, in December 2022, AstraZeneca received a
Paragraph IV notice letter from an abbreviated new drug application
(ANDA) filer relating to patents listed in the FDA Orange Book with
reference to Lynparza. In February 2023, in response to the Paragraph
IV notice, AstraZeneca, MSD International Business GmbH, and the
University of Sheffield initiated ANDA litigation against Natco
Pharma Limited (Natco) in the US District Court for the District of
New Jersey. In the complaint, AstraZeneca alleged that Natco's
generic version of Lynparza, if approved and marketed, would infringe patents
listed in the FDA Orange Book with reference
to Lynparza. No trial date has been
scheduled.
Movantik
US patent proceedings
AstraZeneca has resolved by settlement the previously disclosed
patent infringement lawsuit brought by Aether Therapeutics, Inc. in
the US District Court for the District of Delaware against
AstraZeneca, Nektar Therapeutics and Daiichi Sankyo, Inc., relating
to Movantik. This matter is now
concluded.
Symbicort
US patent proceedings
AstraZeneca has resolved via settlement the previously disclosed
ANDA litigations with Mylan Pharmaceuticals Inc. and Kindeva Drug
Delivery L.P. (together, the Defendants). In those actions,
AstraZeneca alleged that the Defendants' generic versions
of Symbicort, if approved and marketed, would infringe various
AstraZeneca patents. This matter is now
concluded.
Tagrisso
Patent proceedings outside the US
In Russia, in October 2021, AstraZeneca filed a lawsuit in the
Arbitration Court of the Moscow Region (the Court) against
Axelpharm, LLC to prevent it from obtaining authorisation to market
a generic version of Tagrisso prior to the expiration of AstraZeneca's
patents covering Tagrisso. The lawsuit also names the Ministry of Health of
the Russian Federation as a third party. In March 2022, the Court
dismissed the lawsuit. In June 2022, the dismissal was affirmed on
appeal. In January 2023, the dismissal was affirmed on further
appeal. This matter is now concluded.
Product liability litigation
Nexium and Losec/Prilosec
US proceedings
In the US, AstraZeneca is defending various previously disclosed
lawsuits brought in federal and state courts involving multiple
plaintiffs claiming that they have been diagnosed with various
injuries following treatment with proton pump inhibitors (PPIs),
including Nexium and Prilosec. The vast majority of those lawsuits relate to
allegations of kidney injuries. In August 2017, the pending federal
court cases were consolidated in a multidistrict litigation (MDL)
proceeding in the US District Court for the District of New Jersey
for pre-trial purposes. A bellwether trial has been scheduled for
October 2023, with subsequent bellwether trials scheduled for
November 2023 and January 2024. In addition to the MDL cases, there
are cases filed in several state courts around the US; a case that
was previously set to go to trial in Delaware state court was
dismissed in October 2022.
In addition, AstraZeneca has been defending various lawsuits
involving allegations of gastric cancer following treatment with
proton pump inhibitors (PPIs), including Nexium and Prilosec. One such claim is filed in the US District Court
for the Middle District of Louisiana has been scheduled to go to
trial in April 2024.
Onglyza and Kombiglyze
US proceedings
As previously disclosed, in the US, AstraZeneca is defending
various lawsuits alleging heart failure, cardiac injuries, and/or
death from treatment with Onglyza or Kombiglyze. In February 2018, the Judicial Panel on
Multidistrict Litigation ordered the transfer of various pending
federal actions to the US District Court for the Eastern District
of Kentucky (the District Court) for consolidated pre-trial
proceedings with the federal actions pending in the District Court.
The District Court granted AstraZeneca's motion for summary
judgment in August 2022, and plaintiffs are in the process of
appealing that decision. In the California State Court coordinated
proceeding, AstraZeneca's motion for summary judgment was granted
in March 2022. Plaintiffs appealed, and in April 2023, the
California Appellate Court affirmed the lower court's decision to
grant summary judgment.
Commercial Litigation
Viela Bio, Inc. Shareholder Litigation
US proceedings
In February 2023, AstraZeneca was served with a lawsuit filed in
the Delaware State Court against AstraZeneca and certain officers,
on behalf of a putative class of Viela Bio, Inc. (Viela)
shareholders. The complaint alleges that defendants breached their
fiduciary duty to Viela shareholders in the course of Viela's 2021
merger with Horizon Therapeutics, plc. This case remains in the
preliminary stages.
Definiens
In Germany, in July 2020, AstraZeneca received a notice
of arbitration filed with the German Institution of
Arbitration from the sellers of Definiens AG (the Sellers)
regarding the 2014 Share Purchase Agreement (SPA) between
AstraZeneca and the Sellers. The Sellers claim that they are
owed approximately $140m in earn-outs under the SPA. The
arbitration hearing took place in March 2023 and AstraZeneca awaits
a decision.
PARP Inhibitor Royalty Dispute
In October 2012, Tesaro, Inc. (now wholly owned by GlaxoSmithKline
plc, 'GSK') entered into two worldwide, royalty-bearing patent
license agreements with AstraZeneca related to GSK's product
niraparib. In May 2021, AstraZeneca filed a lawsuit against GSK in
the Commercial Court of England and Wales alleging that GSK has
failed to pay all of the royalties due on niraparib sales under the
license agreements. The case was transferred to the Chancery
Division and a trial took place in March 2023. In April 2023, the
court issued a decision in AstraZeneca's favour.
Pay Equity Litigation (US)
AstraZeneca was defending a putative class and collective action
matter in the US District Court for the Northern District of
Illinois brought by three named plaintiffs, who are former
AstraZeneca pharmaceutical sales representatives. The case involved
claims under the federal and Illinois Equal Pay Acts, with the
plaintiffs alleging they were paid less than male employees who
performed substantially similar and/or equal work. The plaintiffs
sought various damages on behalf of themselves and the putative
class and/or collective, including without limitation backpay,
liquidated damages, compensatory and punitive damages, attorneys'
fees, and interest. In January 2023, the District Court granted
AstraZeneca's motion to dismiss plaintiffs' complaint. In March
2023, plaintiffs filed a Second Amended Complaint.
Portola Shareholder Litigation
In the US, in connection with Alexion's July 2020 acquisition of
Portola Pharmaceuticals, Inc (Portola), Alexion assumed litigation
to which Portola is a party. In January 2020, putative securities
class action lawsuits were filed in the US District Court for the
Northern District of California against Portola and certain
officers and directors, on behalf of purchasers of Portola publicly
traded securities during the period 8 January 2019 through 26
February 2020. The operative complaints allege that defendants made
materially false and/or misleading statements or omissions with
regard to Andexxa. In June 2022, the parties reached a settlement
in principle of this matter. In March 2023, the court granted final
approval of the settlement. This matter is now
concluded.
Alexion Shareholder Litigation (US)
In December 2016, putative securities class action lawsuits were
filed in the US District Court for the District of Connecticut (the
District Court) against Alexion and certain officers and directors,
on behalf of purchasers of Alexion publicly traded securities
during the period 30 January 2014 through 26 May 2017. The amended
complaint alleges that defendants engaged in securities fraud,
including by making misrepresentations and omissions in its public
disclosures concerning Alexion's Soliris sales practices, management changes, and
relateds investigations. In August 2021, the District Court issued
a decision denying in part Defendants' motion to dismiss the
matter. The Court granted Plaintiffs' motion for class
certification in April 2023.
Syntimmune
In connection with Alexion's prior acquisition of Syntimmune, Inc.,
(Syntimmune) in December 2020, Alexion was served with a lawsuit
filed by the stockholders' representative for Syntimmune in
Delaware State Court that alleged, among other things, breaches of
contractual obligations relating to the 2018 merger agreement. The
stockholders' representative alleges that Alexion failed to meet
its obligations under the merger agreement to use commercially
reasonable efforts to achieve the milestones. Alexion also filed a
claim for breach of the representations in the 2018 merger
agreement. A trial is scheduled for the matter in July
2023.
Government investigations/proceedings
Brazilian tax assessment
matter (Brazil)
As previously disclosed, in August 2019, the Brazilian Federal
Revenue Service provided a Notice of Tax and Description of the
Facts (the Tax Assessment) to two Alexion subsidiaries (the Brazil
Subsidiaries), as well as to two additional entities, a logistics
provider utilised by Alexion and a distributor. The Tax Assessment
focuses on the importation of Soliris vials pursuant to Alexion's free drug supply
to patients programme in Brazil.
Alexion prevailed in the first level of administrative appeals in
the Brazilian federal administrative proceeding system based on a
deficiency in the Brazil Tax Assessment. The decision was subject
to an automatic (ex officio) appeal to the second level of the
administrative courts. In March 2023, the second level of the
administrative courts issued a decision to remand the matter to the
first level of administrative courts for a determination on the
merits.
Note 6: Subsequent events
In April 2023, the contractual relationship between AstraZeneca and
Sobi relating to future sales of nirsevimab in the US was replaced
by a royalty relationship between Sanofi and Sobi. As a result, a
liability representing AstraZeneca's future obligations to Sobi
will be eliminated from AstraZeneca's Statement of Financial
Position, and AstraZeneca will record a gain of $718m in Core Other
operating income in Q2 2023.
Table 25: Q1 2023 - Product Sales year-on-year
analysis[73]
|
|
World
|
US
|
Emerging Markets
|
Europe
|
Established RoW
|
|
|
|
$m
|
Act % chg
|
CER % chg
|
$m
|
% chg
|
$m
|
Act % chg
|
CER % chg
|
$m
|
Act % chg
|
CER % chg
|
$m
|
Act % chg
|
CER % chg
|
|
Oncology
|
3,920
|
16
|
21
|
1,704
|
24
|
966
|
8
|
16
|
760
|
17
|
24
|
490
|
4
|
19
|
|
Tagrisso
|
1,424
|
9
|
15
|
521
|
19
|
444
|
9
|
17
|
257
|
2
|
8
|
202
|
(2)
|
11
|
|
Imfinzi
|
900
|
50
|
56
|
522
|
66
|
81
|
39
|
47
|
163
|
31
|
38
|
134
|
33
|
52
|
|
Lynparza
|
651
|
5
|
10
|
268
|
(1)
|
137
|
13
|
19
|
178
|
11
|
18
|
68
|
2
|
16
|
|
Calquence
|
532
|
28
|
31
|
384
|
13
|
18
|
n/m
|
n/m
|
108
|
95
|
n/m
|
22
|
76
|
91
|
|
Enhertu
|
37
|
n/m
|
n/m
|
-
|
-
|
24
|
n/m
|
n/m
|
10
|
n/m
|
n/m
|
3
|
n/m
|
n/m
|
|
Orpathys
|
8
|
(33)
|
(27)
|
-
|
-
|
8
|
(33)
|
(27)
|
-
|
-
|
-
|
-
|
-
|
-
|
|
Zoladex
|
227
|
(6)
|
3
|
3
|
(25)
|
167
|
-
|
10
|
33
|
(5)
|
1
|
24
|
(32)
|
(22)
|
|
Faslodex
|
75
|
(19)
|
(11)
|
4
|
(33)
|
37
|
(14)
|
(7)
|
10
|
(39)
|
(35)
|
24
|
(13)
|
1
|
|
Others
|
66
|
(32)
|
(27)
|
2
|
(28)
|
50
|
(31)
|
(27)
|
1
|
(55)
|
(52)
|
13
|
(32)
|
(22)
|
|
BioPharmaceuticals: CVRM
|
2,530
|
15
|
21
|
622
|
19
|
1,165
|
14
|
22
|
557
|
16
|
22
|
186
|
4
|
19
|
|
Farxiga
|
1,299
|
30
|
37
|
296
|
53
|
498
|
27
|
35
|
393
|
24
|
31
|
112
|
15
|
29
|
|
Brilinta
|
334
|
3
|
5
|
179
|
8
|
82
|
19
|
25
|
67
|
(12)
|
(7)
|
6
|
(59)
|
(53)
|
|
Lokelma
|
98
|
56
|
64
|
56
|
45
|
11
|
n/m
|
n/m
|
11
|
98
|
n/m
|
20
|
29
|
50
|
|
roxadustat
|
61
|
49
|
63
|
-
|
-
|
61
|
49
|
63
|
-
|
-
|
-
|
-
|
-
|
-
|
|
Andexxa
|
44
|
34
|
42
|
20
|
(13)
|
-
|
-
|
-
|
15
|
58
|
66
|
9
|
n/m
|
n/m
|
|
Crestor
|
305
|
14
|
23
|
14
|
(22)
|
241
|
22
|
32
|
16
|
48
|
56
|
34
|
(18)
|
(7)
|
|
Seloken/Toprol-XL
|
179
|
(27)
|
(20)
|
-
|
-
|
173
|
(27)
|
(21)
|
4
|
3
|
(3)
|
2
|
(23)
|
(19)
|
|
Onglyza
|
63
|
(8)
|
(3)
|
14
|
(26)
|
37
|
9
|
17
|
9
|
(17)
|
(17)
|
3
|
(32)
|
(17)
|
|
Bydureon
|
45
|
(33)
|
(32)
|
38
|
(32)
|
1
|
44
|
45
|
7
|
(38)
|
(34)
|
(1)
|
n/m
|
n/m
|
|
Others
|
102
|
4
|
9
|
5
|
(25)
|
61
|
19
|
27
|
35
|
(5)
|
(4)
|
1
|
(63)
|
(59)
|
|
BioPharmaceuticals: R&I
|
1,583
|
5
|
10
|
617
|
(4)
|
533
|
22
|
31
|
292
|
5
|
11
|
141
|
(6)
|
3
|
|
Symbicort
|
688
|
2
|
7
|
233
|
(10)
|
229
|
37
|
48
|
147
|
(6)
|
(1)
|
79
|
(14)
|
(7)
|
|
Fasenra
|
338
|
10
|
13
|
201
|
6
|
14
|
n/m
|
n/m
|
88
|
17
|
23
|
35
|
(4)
|
7
|
|
Breztri
|
144
|
67
|
73
|
81
|
53
|
38
|
71
|
85
|
15
|
n/m
|
n/m
|
10
|
52
|
73
|
|
Saphnelo
|
47
|
n/m
|
n/m
|
44
|
n/m
|
-
|
-
|
-
|
1
|
n/m
|
n/m
|
2
|
n/m
|
n/m
|
|
Tezspire
|
11
|
n/m
|
n/m
|
-
|
-
|
-
|
-
|
-
|
7
|
n/m
|
n/m
|
4
|
n/m
|
n/m
|
|
Pulmicort
|
221
|
2
|
9
|
10
|
(54)
|
182
|
11
|
19
|
20
|
12
|
19
|
9
|
(31)
|
(25)
|
|
Bevespi
|
15
|
(1)
|
2
|
9
|
(15)
|
2
|
9
|
21
|
4
|
55
|
64
|
-
|
-
|
-
|
|
Daliresp/Daxas
|
13
|
(75)
|
(75)
|
9
|
(80)
|
1
|
(19)
|
(17)
|
2
|
(6)
|
(2)
|
1
|
35
|
(36)
|
|
Others
|
106
|
(27)
|
(22)
|
30
|
(44)
|
67
|
(9)
|
(1)
|
8
|
(54)
|
(50)
|
1
|
(12)
|
(7)
|
|
BioPharmaceuticals: V&I
|
355
|
(80)
|
(78)
|
-
|
n/m
|
104
|
(84)
|
(83)
|
98
|
(66)
|
(64)
|
153
|
(66)
|
(62)
|
|
COVID-19 mAbs
|
127
|
(73)
|
(70)
|
-
|
n/m
|
8
|
(91)
|
(91)
|
4
|
(94)
|
(93)
|
115
|
n/m
|
n/m
|
|
Vaxzevria
|
28
|
(97)
|
(97)
|
-
|
n/m
|
18
|
(96)
|
(96)
|
10
|
(93)
|
(92)
|
-
|
n/m
|
n/m
|
|
Synagis
|
198
|
(1)
|
5
|
-
|
-
|
78
|
17
|
21
|
82
|
(5)
|
-
|
38
|
(18)
|
(7)
|
|
FluMist
|
2
|
n/m
|
n/m
|
-
|
-
|
-
|
-
|
-
|
2
|
n/m
|
n/m
|
-
|
-
|
-
|
|
Rare Disease
|
1,866
|
10
|
14
|
1,094
|
7
|
173
|
51
|
57
|
387
|
7
|
14
|
212
|
7
|
21
|
|
Soliris
|
834
|
(16)
|
(13)
|
448
|
(24)
|
115
|
63
|
77
|
183
|
(17)
|
(12)
|
88
|
(18)
|
(10)
|
|
Ultomiris
|
651
|
55
|
61
|
381
|
73
|
13
|
(46)
|
(45)
|
159
|
52
|
61
|
98
|
39
|
61
|
|
Strensiq
|
262
|
26
|
28
|
205
|
28
|
15
|
70
|
58
|
21
|
10
|
17
|
21
|
7
|
22
|
|
Koselugo
|
79
|
n/m
|
n/m
|
41
|
34
|
24
|
n/m
|
n/m
|
11
|
n/m
|
n/m
|
3
|
n/m
|
n/m
|
|
Kanuma
|
40
|
4
|
6
|
19
|
3
|
6
|
(1)
|
(6)
|
13
|
5
|
10
|
2
|
31
|
44
|
|
Other medicines
|
312
|
(26)
|
(21)
|
36
|
(8)
|
205
|
-
|
8
|
22
|
(38)
|
(37)
|
49
|
(66)
|
(62)
|
|
Nexium
|
244
|
(27)
|
(20)
|
29
|
(12)
|
156
|
8
|
17
|
12
|
(19)
|
(15)
|
47
|
(67)
|
(62)
|
|
Others
|
68
|
(26)
|
(23)
|
7
|
19
|
49
|
(18)
|
(13)
|
10
|
(52)
|
(52)
|
2
|
(63)
|
(58)
|
|
Total Product Sales
|
10,566
|
(4)
|
1
|
4,073
|
2
|
3,146
|
(5)
|
2
|
2,116
|
1
|
7
|
1,231
|
(23)
|
(13)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Table 26:
Alliance Revenue
|
|
|
Q1 2023
|
Q1 2022
|
|
|
|
$m
|
$m
|
|
Enhertu
|
|
220
|
76
|
|
Tezspire
|
|
43
|
3
|
|
Vaxzevria: royalties
|
|
-
|
56
|
|
Other royalty income
|
|
20
|
16
|
|
Other Alliance Revenue
|
|
3
|
1
|
|
Total
|
|
286
|
152
|
Table 27:
Collaboration Revenue
|
|
|
Q1 2023
|
Q1 2022
|
|
|
|
$m
|
$m
|
|
Lynparza: regulatory
milestones
|
|
-
|
175
|
|
Farxiga: sales
milestones
|
|
24
|
-
|
|
tralokinumab: sales milestones
|
|
-
|
70
|
|
Other Collaboration Revenue
|
|
3
|
13
|
|
Total
|
|
27
|
258
|
Table 28:
Other Operating Income and Expense
|
|
|
Q1 2023
|
Q1 2022
|
|
|
|
$m
|
$m
|
|
brazikumab licence termination funding
|
|
38
|
35
|
|
Divestment of US rights to Pulmicort Flexhaler
|
|
241
|
-
|
|
Other
|
|
100
|
62
|
|
Total
|
|
379
|
97
|
Other shareholder information
Financial calendar
Announcement of half year and second quarter 2023 results:
28 July 2023
Announcement of nine month and third quarter 2023 results: 9
November 2023
Announcement of full year and fourth quarter 2023 results: 8
February 2024
Dividends are normally paid as follows:
First interim: Announced with the half year results and paid
in September
Second interim: Announced with full year results and paid in
March
The record date for the first interim dividend for 2023, payable on
11 September 2023, will be 11 August 2023. The ex-dividend date
will be 10 August 2023.
Contacts
For details on how to contact the
Investor Relations Team, please click
here. For Media
contacts, click
here.
Addresses for correspondence
|
|
|
|
|
|
Registered office
|
Registrar and transfer office
|
Swedish Central Securities Depository
|
US depositary
Deutsche Bank Trust Company Americas
|
|
1 Francis Crick Avenue
Cambridge Biomedical Campus
Cambridge
CB2 0AA
|
Equiniti Limited
Aspect House
Spencer Road
Lancing
West Sussex
BN99 6DA
|
Euroclear Sweden AB PO Box 191
SE-101 23 Stockholm
|
American Stock Transfer
6201 15th Avenue
Brooklyn
NY 11219
|
|
United Kingdom
|
United Kingdom
|
Sweden
|
United States
|
|
|
|
|
|
|
+44 (0) 20 3749 5000
|
0800 389 1580
|
+46 (0) 8 402 9000
|
+1 (888) 697 8018
|
|
|
+44 (0) 121 415 7033
|
|
+1 (718) 921 8137
|
|
|
|
|
db@astfinancial.com
|
Trademarks
Trademarks of the AstraZeneca group of companies appear throughout
this document in italics. Medical publications also appear
throughout the document in italics. AstraZeneca, the AstraZeneca
logotype and the AstraZeneca symbol are all trademarks of the
AstraZeneca group of companies. Trademarks of companies other than
AstraZeneca that appear in this document
include Arimidex and Casodex,
owned by AstraZeneca or Juvisé (depending on
geography); Beyfortus, a trademark of Sanofi Pasteur
Inc.; Enhertu, a trademark of Daiichi Sankyo; Losec,
owned by AstraZeneca or Cheplapharm (depending upon
geography); Seloken, owned by AstraZeneca or Taiyo Pharma Co., Ltd
(depending on geography); Synagis, owned by AstraZeneca or Sobi aka Swedish Orphan
Biovitrum AB (publ). (depending on
geography); and Tezspire, a trademark of Amgen, Inc.
Information on or accessible through AstraZeneca's websites,
including astrazeneca.com,
does not form part of and is not incorporated into this
announcement.
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led
biopharmaceutical company that focuses on the discovery,
development, and commercialisation of prescription medicines in
Oncology, Rare Disease, and BioPharmaceuticals, including
Cardiovascular, Renal & Metabolism, and Respiratory &
Immunology. Based in Cambridge, UK, AstraZeneca operates in over
100 countries and its innovative medicines are used by millions of
patients worldwide. Please visit astrazeneca.com and
follow the Company on Twitter @AstraZeneca.
Cautionary statements regarding forward-looking
statements
In order, among other things, to utilise the 'safe harbour'
provisions of the US Private Securities Litigation Reform Act of
1995, AstraZeneca (hereafter 'the Group') provides the following
cautionary statement:
This document contains certain forward-looking statements with
respect to the operations, performance and financial condition of
the Group, including, among other things, statements about expected
revenues, margins, earnings per share or other financial or other
measures. Although the Group believes its expectations are based on
reasonable assumptions, any forward-looking statements, by their
very nature, involve risks and uncertainties and may be influenced
by factors that could cause actual outcomes and results to be
materially different from those predicted. The forward-looking
statements reflect knowledge and information available at the date
of preparation of this document and the Group undertakes no
obligation to update these forward-looking statements. The Group
identifies the forward-looking statements by using the words
'anticipates', 'believes', 'expects', 'intends' and similar
expressions in such statements. Important factors that could cause
actual results to differ materially from those contained in
forward-looking statements, certain of which are beyond the Group's
control, include, among other things:
-
the risk of failure to meet regulatory or ethical requirements for
medicine development or approval
-
the risk of failures or delays in the quality or execution of the
Group's commercial strategies
-
the risk of pricing, affordability, access and competitive
pressures
-
the risk of failure to maintain supply of compliant, quality
medicines
-
the risk of illegal trade in the Group's medicines
-
the impact of reliance on third-party goods and
services
-
the risk of failure in information technology or
cybersecurity
-
the risk of failure of critical processes
-
the risk of failure to collect and manage data in line with legal
and regulatory requirements and strategic objectives
-
the risk of failure to attract, develop, engage and retain a
diverse, talented and capable workforce
-
the risk of failure to meet regulatory or ethical expectations on
environmental impact, including climate change
-
the risk of the safety and efficacy of marketed medicines being
questioned
-
the risk of adverse outcome of litigation and/or governmental
investigations
-
intellectual property-related risks to our products
-
the risk of failure to achieve strategic plans or meet targets or
expectations
-
the risk of failure in financial control or the occurrence of
fraud
-
the risk of unexpected deterioration in the Group's financial
position
-
the impact that global and/or geopolitical events such as the
COVID-19 pandemic and the Russia-Ukraine war may have or continue
to have on these risks, on the Group's ability to continue to
mitigate these risks, and on the Group's operations, financial
results or financial condition
Nothing in this document, or any related presentation/webcast,
should be construed as a profit forecast.
- End of document -
[1] The COVID-19 medicines
are Vaxzevria, Evusheld, and AZD3152 - the COVID-19 antibody currently in
development.
[2] Constant exchange
rates. The differences between Actual Change and CER Change are due
to foreign exchange movements between periods in 2023 vs 2022. CER
financial measures are not accounted for according to generally
accepted accounting principles (GAAP) because they remove the
effects of currency movements from Reported
results.
[3] Effective 1 January
2023, the Group has updated the presentation of Total Revenue. For
further details of the presentation of Alliance Revenue and
Collaboration Revenue, see the basis of preparation and accounting
policy section of the Notes to the Interim Financial Statements
section.
[4] Reported financial
measures are the financial results presented in accordance with
UK-adopted International Accounting Standards and International
Financial Reporting Standards (IFRSs) as issued by the
International Accounting Standards Board (IASB) and International
Accounting Standards as adopted by the European
Union.
[5] Earnings per
share.
[6] Core financial
measures are adjusted to exclude certain items. The differences
between Reported and Core measures are primarily due to costs
relating to the acquisition of Alexion, amortisation of
intangibles, impairments and restructuring charges. A full
reconciliation between Reported EPS and Core EPS is provided in
Table 13 in the Financial performance section of this
document.
[7] Cardiovascular, Renal
and Metabolism.
[8] Respiratory &
Immunology.
[9] Non-small cell lung
cancer.
[10] Hepatocellular
carcinoma.
[11] Neuromyelitis optica
spectrum disorder.
[12] Human epidermal growth
factor receptor 2.
[13] nirsevimab is approved in
the EU with the Beyfortus trademark.
[14] Vaxzevria is AstraZeneca's trademark for the Company's
supply of the AstraZeneca COVID-19 Vaccine. In the financial tables
in this report, 'Vaxzevria Total Revenue' includes royalties from
sub-licensees that produce and supply the AstraZeneca COVID-19
Vaccine under their own trademarks, recorded in Alliance
Revenue.
[15] Monoclonal antibodies. The
COVID-19 mAbs are Evusheld and AZD3152.
[16] For Alliance Revenue and
Collaboration Revenue, the comparable amounts for FY 2022 are $749m
and $604m respectively.
[17] Vaccines & Immune
Therapies.
[18] In Table 2, the plus and
minus symbols denote the directional impact of the item being
discussed, e.g. a '+' symbol next to an R&D expense comment
indicates that the item increased the R&D expense relative to
the prior year.
[19] The calculation of
Reported and Core Gross Margin excludes the impact of Alliance
Revenue and Collaboration Revenue.
[20] Income from disposals of
assets and businesses, where the Group does not retain a
significant ongoing economic interest, continue to be recorded in
Other Operating Income and Expense in the Company's financial
statements.
[21] Respiratory syncytial
virus.
[22] Hereditary
transthyretin-mediated amyloid polyneuropathy.
[23] Hormone
receptor.
[24] Taskforce on
Climate-related Financial Disclosures.
[25] Product Sales shown
in the Imfinzi line include Product Sales
from Imjudo
[26] National
reimbursement drug list.
[27] France, Germany,
Italy, Spain, UK.
[28] Biliary tract
cancer.
[29] Extensive-stage small
cell lung cancer.
[30] Poly ADP ribose
polymerase.
[31] Platinum sensitive
relapse
[32] Breast cancer gene
mutation.
[33] Germline (hereditary)
breast cancer gene mutation.
[34] Metastatic breast
cancer.
[35] Bruton tyrosine
kinase inhibitor.
[36] Mesenchymal-epithelial
transition.
[37] Sodium-glucose
cotransporter 2.
[38] Heart
failure.
[39] Chronic kidney
disease.
[40] European Society of
Cardiology.
[41] American Heart
Association.
[42] American College of
Cardiology.
[43] Heart Failure Society
of America.
[44] Heart failure with
reduced ejection fraction.
[45] Type-2
diabetes.
[46] Heart failure with
preserved ejection fraction.
[47] Betaloc is the brand name
for Seloken in China.
[48] Inhaled
corticosteroid.
[49] Long-acting
beta-agonist.
[50] Interleukin-5.
[51] The 'dynamic market'
refers to patients who have recently changed their medicine. For
biologic medicines, it captures patients who have adopted a
biologic medicine for the first time, and patients who have
switched from one biologic brand to another.
[52] Fixed dose
combination.
[53] 'New-to-brand' share
represents a medicine's share in the dynamic
market
[54] Asthma COPD
overlap.
[55] Intravenous
injection.
[56] Systemic lupus
erythematosus.
[57] Complement component
5.
[58] Atypical haemolytic
uraemic syndrome.
[59] Generalised
myasthenia gravis.
[60] Other Operating
Income.
[61] Securities Exchange
Commission.
[62] Based on best
prevailing assumptions around currency
profiles.
[63] Based on average
daily spot rates 1 Jan 2022 to 31 Dec 2022.
[64] Based on average
daily spot rates 1 Jan 2023 to 31 Mar 2023.
[65] Based on average
daily spot rates 1 Mar 2023 to 31 Mar 2023.
[66] Change vs the average
spot rate for the previous year
[67] Other currencies
include AUD, BRL, CAD, KRW and RUB.
[68] Overall
survival.
[69] Epidermal growth
factor receptor mutation.
[70] Supplemental new drug
application.
[71] Neutralising
antibody.
[72] Effective 1 January
2023, the Group has updated the presentation of Total Revenue. See
Note 1 for further details of the presentation of Alliance
Revenue.
[73] The table provides an
analysis of year-on-year Product Sales, with Actual and CER growth
rates reflecting year-on-year growth. Due to rounding, the sum of a
number of dollar values and percentages may not agree to
totals.