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| Share Name | Share Symbol | Market | Type | Share ISIN | Share Description |
|---|---|---|---|---|---|
| Astrazeneca Plc | LSE:0A4J | London | Ordinary Share | ASTRAZENECA ADR REPRESENTING 0.5 ORD SHS |
| Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
|---|---|---|---|---|---|---|---|---|---|---|
| 0.00 | 0.00% | 0.00 | - |
| Industry Sector | Turnover | Profit | EPS - Basic | PE Ratio | Market Cap |
|---|---|---|---|---|---|
| 0 | 0 | N/A | 0 |
From Jan 2023 to Jan 2025
TIDMAZN
RNS Number : 8657S
AstraZeneca PLC
09 November 2023
AstraZeneca
9 November 2023
9M and Q3 2023 results
Strong momentum in the year to date leads to increased guidance for Total Revenue ex COVID-19 medicines and Core EPS
Revenue and EPS summary
Hot Features
Premium
9M 2023 Q3 2023
------ --------- --------- ------ ------- ----
% Change % Change
$m Actual CER [1] $m Actual CER
----------------------------- ------ --------- --------- ------ ------- ----
* Product Sales 32,466 1 4 11,018 4 5
* Alliance Revenue [2] 1,004 99 99 377 76 75
* Collaboration Revenue 317 (28) (28) 97 (46) (47)
------------------------------ ------ --------- --------- ------ ------- ----
Total Revenue 33,787 2 5 11,492 5 6
------------------------------ ------ --------- --------- ------ ------- ----
Total Revenue ex
COVID-19 33,453 12 15 11,492 12 13
------------------------------ ------ --------- --------- ------ ------- ----
Reported [3] EPS [4] $3.22 * 2x * 2x $0.89 (16) (6)
Core [5] EPS $5.80 10 17 $1.73 4 9
------------------------------ ------ --------- --------- ------ ------- ----
Financial performance (9M 2023 figures unless otherwise stated , growth numbers at CER)
-- Total Revenue $33,787m, up 5% despite a decline of $2,896m from COVID-19 medicines [6] -- Excluding COVID-19 medicines, both Total Revenue and Product Sales increased 15%
-- Total Revenue from Oncology medicines increased 20%, CVRM [7] 19%, R&I [8] 9%, and Rare Disease 12%
-- Core Product Sales Gross Margin [9] of 82%, up two percentage points, reflecting the decline in sales of lower margin COVID--19 medicines
-- Core Operating Margin of 35% increased by three percentage points including the previously-announced gain from an update to the contractual relationships for Beyfortus, totalling $712m and recorded in Core Other operating income
-- Core EPS increased 17% to $5.80
-- FY 2023 Total Revenue excluding COVID-19 medicines now expected to increase by a low-teens percentage at CER
-- FY 2023 Core EPS now expected to increase by a low double-digit to low-teens percentage at CER
Pascal Soriot, Chief Executive Officer, AstraZeneca, said:
"Our company continued its strong growth trajectory in the third quarter with Total Revenue from our non -- COVID-19 medicines up 13% compared to last year.
We initiated several Phase III trials of high-potential molecules this quarter, including for volrustomig, our PD--1/CTLA-4 [10] bispecific antibody. Our portfolio of bispecifics has the potential to replace the first-generation checkpoint inhibitors across a range of cancers. We also initiated a fixed dose combination study of zibotentan with Farxiga which has the potential to significantly improve outcomes for patients with kidney disease not well controlled on current standard of care.
I am excited about the acceleration of our cardiometabolic and obesity pipeline with today's licensing agreement for ECC5004, a potential best-in-class, oral GLP-1RA [11] . This molecule could offer an important advance, as both a monotherapy and in combinations, for the estimated one billion people living with cardiometabolic diseases such as type-2 diabetes and obesity.
Given the momentum in the year to date we have increased our full-year guidance for Total Revenue excluding COVID medicines as well as for Core EPS."
Key milestones achieved since the prior results announcement
-- Key positive read-outs: datopotamab deruxtecan in metastatic HR [12] -positive breast cancer (TROPION--Breast01); Imfinzi in liver cancer (EMERALD-1); Fasenra in EGPA [13] (MANDARA)
-- Key regulatory approvals: EU approval for Enhertu in HER2 [14] -mutant lung cancer (DESTINY--Lung02); China approvals for Forxiga in heart failure regardless of ejection fraction (DELIVER); Calquence in r/rCLL [15] (ASC); Soliris in NMOSD [16] . Japan approvals for Lynparza in prostate cancer (PROpel); Enhertu in HER2-mutant lung cancer (DESTINY-Lung02)
-- Other milestones: Tagrisso granted US Breakthrough Therapy Designation and US Priority Review in combination with chemotherapy for treatment of patients with locally advanced or metastatic EGFRm [17] NSCLC [18] (FLAURA2); Enhertu granted US Breakthrough Therapy Designations in HER2-positive colorectal
cancer (DESTINY-CRC01, DESTINY-CRC02) and multiple types of HER2--expressing tumours (DESTINY--PanTumor02)
Guidance
The Company updates its Total Revenue and Core EPS guidance for FY 2023 at CER, based on the average foreign exchange rates through 2022.
Total Revenue is expected to increase by a mid single-digit percentage
(previously low-to-mid single-digit).
Excluding COVID-19 medicines, Total Revenue is expected to increase by a low-teens percentage
(previously low double-digit).
Core EPS is expected to increase by a low double-digit to low-teens percentage
(previously high single-digit to low double-digit).
Other elements of the Income Statement are expected to be broadly in line with the indications issued in the Company's H1 2023 results announcement.
The Company is unable to provide guidance on a Reported basis because it cannot reliably forecast material elements of the Reported results, including any fair value adjustments arising on acquisition-related liabilities, intangible asset impairment charges and legal settlement provisions. Please refer to the cautionary statements section regarding forward-looking statements at the end of this announcement.
Currency impact
If foreign exchange rates for October to December 2023 were to remain at the average rates seen in September 2023, it is anticipated that FY 2023 Total Revenue would incur a low single-digit adverse impact versus the performance at CER, and Core EPS would incur a mid single-digit adverse impact (previously a low-to-mid single-digit adverse impact).
The Company's foreign exchange rate sensitivity analysis is provided in Table 19.
Table 1 : Key elements of Total Revenue performance in Q3 2023
% Change
Revenue type $m Actual CER
---------------------- ------ ------ ----- ----------------------------------------------------------
* Double-digit growth at CER
Product Sales 11,018 4 5 in Oncology, CVRM and Rare Disease
* $266m for Enhertu (Q3 2022:
$160m)
* $74m for Tezspire (Q3 2022:
Alliance Revenue 377 76 75 $26m)
* $71m for Beyfortus regulatory
Collaboration Revenue 97 (46) (47) milestone
* Excluding COVID-19 medicines,
Q3 2023 Total Revenue increased
Total Revenue 11,492 5 6 by 12% (13% at CER)
----------------------- ------ ------ ----- ----------------------------------------------------------
Actual
Therapy areas $m % CER %
---------------------- ------ ------ ----- ----------------------------------------------------------
* Strong performance across key
medicines and regions
* No milestones from Lynparza
Oncology 4,664 15 17 in the quarter (Q3 2022: $75m)
* Farxiga up 41%, Lokelma up
30% (31% at CER), roxadustat
up 31% (39% CER), Brilinta declined
CVRM 2,687 14 16 2% (1% at CER)
R&I 1,549 3 5 * Fasenra up 10%, Breztri up
66% (69% CER). Saphnelo and Tezspire
also continue to grow rapidly
during their launch phase, partially
offset by a 12% decline (10%
at CER) in Symbicort following
entry of a generic competitor
in the US during the quarter
V&I [19] 312 (64) (65) * $nil revenue from COVID-19
mAbs and Vaxzevria in the quarter
(Q3 2022: $536m and $180m respectively)
* Beyfortus $138m, including
$50m of Product Sales from product
supplied to Sanofi, $71m of Collaboration
Revenue for a regulatory milestone
and $17m of Alliance Revenue
for AstraZeneca's share of gross
profit outside US
* Ultomiris up 50% (49% at CER),
partially offset by decline in
Soliris of 13% (12% at CER)
* Strensiq up 20% (21% at CER)
and Koselugo up 81% reflecting
Rare Disease 1,974 13 14 strong patient demand
* Nexium generic competition
Other Medicines 306 (36) (32) in Japan
Total Revenue 11,492 5 6
----------------------- ------ ------ ----- ----------------------------------------------------------
Actual
Regions inc. COVID-19 $m % CER %
---------------------- ------ ------ ----- ----------------------------------------------------------
US 4,859 5 4
Emerging Markets 2,964 4 12
----------------------- ------ ------ -----
- China 1,452 (6) 1
- Ex-China Emerging
Markets 1,513 15 25
----------------------- ------ ------ -----
Europe 2,392 16 9
Established RoW 1,276 (10) (6)
Total Revenue inc. 11,492 5 6
COVID-19 * Growth rates impacted by lower sales of COVID--19
medicines (see table below)
---------------------- ------ ------ ----- ----------------------------------------------------------
Actual
Regions ex. COVID-19 $m % CER %
---------------------- ------ ------ ----- ----------------------------------------------------------
US 4,859 12 12
Emerging Markets 2,964 8 16
----------------------- ------ ------ -----
- China 1,452 (6) 1
----------------------- ------ ------ -----
- Ex-China Emerging
Markets 1,513 25 36
----------------------- ------ ------ -----
Europe 2,392 23 16
Established RoW 1,276 5 10
Total Revenue ex.
COVID-19 11,492 12 13
----------------------- ------ ------ ----- ----------------------------------------------------------
Table 2 : Key elements of financial performance in Q3 2023
Metric Reported Reported Core Core Comments [20]
change change
-------------- -------- ----------- -------- ----------- ---------------------------------------------------------
* Excluding COVID-19 medicines,
Q3 2023 Total Revenue increased
by 12% (13% at CER)
* See Table 1 and the Total
5% Actual 5% Actual Revenue section of this document
Total Revenue $11,492m 6% CER $11,492m 6% CER for further details
-------------- -------- ----------- -------- ----------- ---------------------------------------------------------
Product 81% +9pp Actual 81% +1pp Actual + Favourable mix of sales
Sales Gross +10pp CER +1pp CER from Oncology and Rare Disease
Margin medicines
+ No sales of COVID-19 medicines
* Increasing mix of products with profit-sharing
arrangements, where AstraZeneca books Product Sale
s
and records an expense in COGS [21] for the profit
share due to its partner
* Variations in Product Sales
Gross Margin can be expected
between periods due to product
seasonality, foreign exchange
fluctuations and other effects
-------------- -------- ----------- -------- ----------- ---------------------------------------------------------
+ Increased investment in
the pipeline
* Core R&D-to-Total Revenue
ratio of 22%
(Q3 2022: 21%)
* Year-on-year comparisons
can be impacted by differences
5% Actual 5% Actual in cost phasing driven by
R&D expense $2,584m 4% CER $2,485m 5% CER study starts and execution
-------------- -------- ----------- -------- ----------- ---------------------------------------------------------
+ Market development for recent
launches and pre-launch activities
+ Reported SG&A impacted by
increased charges for legal
provisions, including a $425m
charge to provisions relating
to a legal settlement in Q3
2023 (see Note 6)
* Core SG&A-to-Total Revenue
ratio of 29%
(Q3 2022: 29%)
* Year-on-year comparisons
12% Actual 6% Actual can be impacted by differences
SG&A expense $4,800m 12% CER $3,355m 7% CER in cost phasing
-------------- -------- ----------- -------- ----------- ---------------------------------------------------------
Other $70m -34% Actual $70m -35% Actual
operating -33% CER -34% CER * Discontinuation of brazikumab development
income
(and expense)
[22]
-------------- -------- ----------- -------- ----------- ---------------------------------------------------------
* See Product Sales Gross
Stable at Margin, expenses and Other
Operating +6pp Actual Actual operating income and expense
Margin 17% +7pp CER 31% +1pp CER commentary above
-------------- -------- ----------- -------- ----------- ---------------------------------------------------------
+ Higher interest received
on cash and short-term investments,
broadly offset by higher rates
Net finance -9% Actual -12% Actual on floating debt and bond
expense $291m -6% CER $223m -7% CER issuances
-------------- -------- ----------- -------- ----------- ---------------------------------------------------------
n/m Actual +1pp Actual * Variations in the tax rate
Tax rate 17% n/m CER 19% +1pp CER can be expected between periods
-------------- -------- ----------- -------- ----------- ---------------------------------------------------------
* Further details of differences
-16% Actual 4% Actual between Reported and Core
EPS $0.89 -6% CER $1.73 9% CER are shown in Table 14
-------------- -------- ----------- -------- ----------- ---------------------------------------------------------
Table 3 : Pipeline highlights since prior results announcement
Event Medicine Indication / Trial Event
----------------- ------------- ----------------------------------- ---------------------------
Regulatory Lynparza mCRPC [23] (1st-line) Regulatory approval
approvals (PROpel) (JP)
and other
regulatory
actions
Enhertu HER2m [24] NSCLC (2nd-line+) Positive CHMP Opinion
(DESTINY-Lung02) (EU), Regulatory approval
(EU, JP)
Calquence CLL [25] (ASC) Regulatory approval
(CN)
Forxiga HFpEF [26] (DELIVER) Regulatory approval
(CN)
Soliris NMOSD Regulatory approval
(CN)
------------- ----------------------------------- ---------------------------
Regulatory Tagrisso EGFR m NSCLC (1st-line) Regulatory submission
submissions (FLAURA2) (US, EU, CN), Priority
or acceptances* Review (US)
Imfinzi NSCLC (neoadjuvant) Regulatory submission
(AEGEAN) (US)
capivasertib HR+/HER2-negative breast Regulatory submission
cancer (2nd-line) (CAPItello-291) (CN)
roxadustat Chemotherapy-induced Regulatory submission
anaemia (CN)
FluMist Self-administered influenza Regulatory submission
vaccine (US)
----------------- ------------- ----------------------------------- ---------------------------
Major Phase Imfinzi Liver cancer (locoregional) Primary endpoint met
III data (EMERALD-1)
readouts
and other
developments
-----------------
datopotamab HR+/HER2-breast cancer Primary endpoint met
deruxtecan (inoperable and/or metastatic)
(TROPION-Breast01)
-----------------
Fasenra EGPA (MANDARA) Primary endpoint met
----------------- ------------- ----------------------------------- ---------------------------
*US, EU and China regulatory submission denotes filing acceptance
Upcoming pipeline catalysts
For a table of anticipated timings of key trial readouts, please refer to page 2 of the Clinical Trials Appendix, available on www.astrazeneca.com/investor-relations.html.
Other pipeline updates
Ultomiris discontinued plans to deliver subcutaneous administration for adults with aHUS [27] or PNH [28] . This decision follows persistent efforts to reliably secure the availability of the on-body delivery system.
Table 4 : Phase III trials started since 1 January 2023
Medicine Trial name Indication
------------------- ----------------------- -------------------------------------------
datopotamab AVANZAR NSCLC (1st-line)
deruxtecan
TROPION-Lung07 Non-squamous NSCLC (1st-line)
camizestrant CAMBRIA-1 HR-positive/HER2-negative adjuvant
breast cancer
CAMBRIA-2 HR-positive/HER2-negative adjuvant
breast cancer
capivasertib CAPItello-292 HR-positive/HER2-negative advanced
breast cancer
volrustomig eVOLVE-Cervical High-risk locally advanced cervical
cancer
eVOLVE-Lung02 mNSCLC (1st-line) with PD-L1 [29]
<50%
zibo/dapa ZENITH High Proteinuria CKD [30] and high proteinuria
Saphnelo DAISY Systemic sclerosis
Tezspire CROSSING Eosinophilic oesophagitis
Breztri LITHOS Mild to moderate asthma
Breztri ATHLOS COPD [31]
pMDI [32] portfolio HFO1234ze Mucociliary clearance in healthy volunteers
pMDI portfolio HFO1234ze Well-controlled or partially-controlled
asthma
tozorakimab MIRANDA Symptomatic COPD
AZD3152 SUPERNOVA COVID-19 prophylaxis
Ultomiris ARTEMIS Cardiac surgery-associated acute kidney
injury
------------------- ----------------------- -------------------------------------------
Corporate and business development
In September, AstraZeneca and Verge Genomics (Verge) announced a multi-target collaboration to identify novel drug targets for rare neurodegenerative and neuromuscular diseases. Verge is a clinical-stage drug discovery company using artificial intelligence and patient tissue data. Under the terms of the four-year agreement, Verge will receive up to $42 million, consisting of upfront fee, equity, and near-term payments, with potential downstream royalties. AstraZeneca will take an equity position in Verge.
In September, AstraZeneca completed the definitive purchase and licence agreement for a portfolio of preclinical rare disease gene therapy programmes and enabling technologies from Pfizer Inc. The agreement has a total consideration of up to $1bn, plus tiered royalties on sales.
Cellectis
In November, AstraZeneca announced a collaboration and investment agreement with Cellectis, a clinical-stage biotechnology company, to accelerate the development of next generation therapeutics in areas of high unmet need, including oncology, immunology and rare diseases. Under the terms of the collaboration agreement, AstraZeneca will leverage the Cellectis proprietary gene editing technologies and manufacturing capabilities, to design novel cell and gene therapy products, strengthening AstraZeneca's growing offering in this space. As part of the agreement, 25 genetic targets have been exclusively reserved for AstraZeneca, from which up to 10 candidate products could be explored for development.
In Q4 2023, Cellectis will receive an initial payment of $105m from AstraZeneca, which comprises a $25m upfront cash payment under the terms of a research collaboration agreement and an $80m equity investment. A further $140m equity investment is expected to close in early 2024 subject to the signing of a final binding agreement. Post-closing of this second investment, AstraZeneca will hold a total equity stake of approximately 44% in Cellectis. Under the terms of the research collaboration, Cellectis is also eligible to receive an investigational new drug option fee and development, regulatory and sales-related milestone payments, ranging from $70m up to $220m, per each of the 10 candidate products, plus tiered royalties.
Eccogene licence
In November, AstraZeneca and Eccogene entered into an exclusive licence agreement for ECC5004, an investigational oral once-daily glucagon-like peptide 1 receptor agonist (GLP-1RA) for the treatment of obesity, type-2 diabetes and other cardiometabolic conditions . Preliminary results from the Phase I trial have shown a differentiating clinical profile for ECC5004, with good tolerability and encouraging glucose and body weight reduction across the dose levels tested compared to placebo.
Under the terms of the agreement, Eccogene will receive an initial upfront payment of $185m and up to an additional $1.825bn in future clinical, regulatory, and commercial milestones and tiered royalties. AstraZeneca is granted exclusive global rights for the development and commercialisation of ECC5004 for any indication in all territories except China, where Eccogene has the right to co-develop and co-commercialise alongside AstraZeneca.
Sustainability summary
This quarter AstraZeneca entered into long-term renewable energy partnerships in the UK and Sweden. The UK agreement will support the transition away from fossil fuels at Company sites in Macclesfield, Cambridge, Luton and Speke. The Sweden agreement corresponds to approximately 80 percent of total electricity needs at both the Company's Gothenburg site and at Södertälje, one of the world's largest drug manufacturing centres. See the Sustainability section for further details.
Conference call
A conference call and webcast for investors and analysts will begin today, 9 November 2023, at 14:00 UK time. Details can be accessed via astrazeneca.com .
Reporting calendar
The Company intends to publish its full year and fourth quarter results on Thursday 8 February 2024.
Operating and financial review
All narrative on growth and results in this section is based on actual foreign exchange rates, and financial figures are in US$ millions ($m), unless stated otherwise. The performance shown in this announcement covers the nine-month period to 30 September 2023 ('the period' or '9M 2023') compared to the nine-month period to 30 September 2022 ('9M 2022'), or the three-month period to 30 September 2023 ('the quarter' or 'Q3 2023') compared to the three-month period to 30 September 2022 ('Q3 2022'), unless stated otherwise.
Core financial measures, EBITDA, Net debt, Product Sales Gross Margin (formerly termed as Gross Margin), Operating Margin and CER are non-GAAP financial measures because they cannot be derived directly from the Group's Interim financial statements. Management believes that these non-GAAP financial measures, when provided in combination with Reported results, provide investors and analysts with helpful supplementary information to understand better the financial performance and position of the Group on a comparable basis from period to period. These non-GAAP financial measures are not a substitute for, or superior to, financial measures prepared in accordance with GAAP.
Core financial measures are adjusted to exclude certain significant items, such as:
-- Amortisation and impairment of intangible assets, including impairment reversals but excluding any charges relating to IT assets
-- Charges and provisions related to restructuring programmes, which includes charges that relate to the impact of restructuring programmes on capitalised IT assets
-- Alexion acquisition-related items, primarily fair value adjustments on acquired inventories and fair value impact of replacement employee share awards
-- Other specified items, principally the imputed finance charges and fair value movements relating to contingent consideration on business combinations or asset acquisitions, imputed finance charges and remeasurement adjustments on certain Other payables arising from intangible asset acquisitions, legal settlements and remeasurement adjustments relating to Other payables assumed from the Alexion acquisition
-- 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 63 of the Annual Report and Form 20-F Information 2022 .
Reference should be made to the Reconciliation of Reported to Core financial measures table included in the financial performance section in this announcement.
Product Sales Gross Margin (formerly termed Gross Margin) is the percentage by which Product Sales exceeds the Cost of Sales, calculated by dividing the difference between the two by the sales figure. The calculation of Reported and Core Product Sales Gross Margin excludes the impact of Alliance Revenue and Collaboration Revenue and any associated costs, thereby reflecting the underlying performance of Product Sales.
EBITDA is defined as Reported Profit before tax after adding back Net finance expense, results from Joint ventures and associates and charges for Depreciation, amortisation and impairment. Reference should be made to the Reconciliation of Reported Profit before tax to EBITDA included in the financial performance section in this announcement.
Operating Margin is defined as Operating profit as a percentage of Total Revenue.
Net debt is defined as Interest-bearing loans and borrowings and Lease liabilities, net of Cash and cash equivalents, Other investments, and Net derivative financial instruments. Reference should be made to Note 3 'Net debt' included in the Notes to the Interim financial statements in this announcement.
The Company strongly encourages investors and analysts not to rely on any single financial measure, but to review AstraZeneca's financial statements, including the Notes thereto, and other available Company reports, carefully and in their entirety.
Due to rounding, the sum of a number of dollar values and percentages in this announcement may not agree to totals.
Total Revenue
Table 5 : Therapy area and medicine performance - Product Sales and Total Revenue
9M 2023 Q3 2023
----------------------------- -----------------------------
% Change % Change
Product Sales $m % Total Actual CER $m % Total Actual CER
----------------------- ------ ------- ------ ---- ------ ------- ------ ----
Oncology 12,692 38 17 20 4,389 38 16 17
------------------------ ------ ------- ------ ---- ------ ------- ------ ----
- Tagrisso 4,380 13 7 10 1,465 13 5 6
- Imfinzi [33] 3,102 9 53 56 1,126 10 53 54
- Lynparza 2,070 6 6 9 702 6 7 8
- Calquence 1,839 5 25 26 654 6 16 15
- Enhertu 178 1 >3x >3x 73 1 >3x >3x
- Orpathys 33 - (3) 4 12 - 6 13
- Zoladex 699 2 (3) 5 239 2 - 5
- Faslodex 217 1 (16) (10) 64 1 (21) (16)
- Others 174 1 (36) (32) 54 - (33) (30)
------------------------ ------ ------- ------ ---- ------ ------- ------ ----
BioPharmaceuticals:
CVRM 7,887 23 14 18 2,683 23 14 16
------------------------ ------ ------- ------ ---- ------ ------- ------ ----
- Farxiga 4,358 13 36 40 1,554 14 41 41
- Brilinta 996 3 (2) - 331 3 (2) (1)
- Lokelma 300 1 44 49 102 1 30 31
- roxadustat 208 1 41 51 74 1 31 39
- Andexxa 129 - 16 19 40 - (3) (5)
- Crestor 860 3 4 11 275 2 (1) 6
- Seloken/Toprol-XL 496 1 (30) (23) 153 1 (36) (29)
- Onglyza 180 1 (12) (8) 53 - (20) (17)
- Bydureon 123 - (40) (40) 35 - (48) (49)
- Others 237 1 (16) (13) 66 1 (23) (21)
------------------------ ------ ------- ------ ---- ------ ------- ------ ----
BioPharmaceuticals:
R&I 4,517 13 5 8 1,451 13 2 3
------------------------ ------ ------- ------ ---- ------ ------- ------ ----
- Symbicort 1,842 5 (4) (1) 555 5 (12) (10)
- Fasenra 1,134 3 12 13 389 3 10 10
- Breztri 478 1 69 73 171 1 66 69
- Saphnelo 191 1 >2x >2x 76 1 >2x >2x
- Tezspire 51 - >10x >10x 21 - >10x >10x
- Pulmicort 493 1 3 10 148 1 2 7
- Bevespi 42 - (2) (2) 13 - (5) (4)
- Daliresp/Daxas 41 - (74) (74) 11 - (79) (79)
- Others 245 1 (30) (27) 67 1 (31) (28)
------------------------ ------ ------- ------ ---- ------ ------- ------ ----
BioPharmaceuticals:
V&I 667 2 (82) (81) 224 2 (74) (74)
------------------------ ------ ------- ------ ---- ------ ------- ------ ----
- COVID-19 mAbs [34] 126 - (91) (90) - - n/m n/m
- Vaxzevria 28 - (98) (98) - - n/m n/m
- Beyfortus 52 - n/m n/m 50 - n/m n/m
- Synagis 383 1 - 6 99 1 (5) (1)
- FluMist 78 - 32 28 75 1 28 23
------------------------ ------ ------- ------ ---- ------ ------- ------ ----
Rare Disease 5,793 17 11 12 1,974 17 13 14
------------------------ ------ ------- ------ ---- ------ ------- ------ ----
- Soliris 2,429 7 (17) (15) 781 7 (13) (12)
- Ultomiris 2,141 6 56 58 777 7 50 49
- Strensiq 847 3 23 24 285 2 20 21
* Koselugo 246 1 65 65 87 1 81 81
- Kanuma 130 - 17 18 44 - 21 19
------------------------ ------ ------- ------ ---- ------ ------- ------ ----
Other Medicines 910 3 (27) (22) 297 3 (27) (22)
------------------------ ------ ------- ------ ---- ------ ------- ------ ----
- Nexium 735 2 (25) (20) 244 2 (22) (17)
- Others 175 1 (33) (31) 53 - (43) (41)
------------------------ ------ ------- ------ ---- ------ ------- ------ ----
Product Sales 32,466 96 1 4 11,018 96 4 5
Alliance Revenue 1,004 3 99 99 377 3 76 75
Collaboration Revenue 317 1 (28) (28) 97 1 (46) (47)
------------------------ ------ ------- ------ ---- ------ ------- ------ ----
Total Revenue 33,787 100 2 5 11,492 100 5 6 ------------------------ ------ ------- ------ ---- ------ ------- ------ ----
Table 6 : Alliance Revenue
9M 2023 Q3 2023
--------------------------- -------------------------
% Change % Change
$m % Total Actual CER $m % Total Actual CER
----------------------- ----- ------- ------ --- --- ------- ------ ---
Enhertu 741 74 >2x >2x 266 70 66 65
Tezspire 179 18 >4x >4x 74 20 >2x >2x
Vaxzevria : royalties - - n/m n/m - - n/m n/m
Other royalty income 59 6 16 15 18 5 10 9
Other Alliance Revenue 25 2 >2x >2x 19 5 >3x >3x
Total 1,004 100 99 99 377 100 76 75
------------------------ ----- ------- ------ --- --- ------- ------ ---
Table 7 : Collaboration Revenue
9M 2023 Q3 2023
-------------------------- -------------------------
% Change % Change
$m % Total Actual CER $m % Total Actual CER
--------------------------- --- ------- ------ ---- ------- ------ ----
COVID-19 mAbs : licence
fees 180 57 n/m n/m - - n/m n/m
Farxiga : sales milestones 28 9 n/m n/m 3 3 n/m n/m
tralokinumab : sales
milestones 20 6 (82) (82) 20 21 (50) (50)
Lynparza : regulatory - - n/m n/m - - n/m n/m
milestones
Beyfortus : regulatory
milestones 71 22 n/m n/m 71 73 n/m n/m
Other Collaboration
Revenue 18 6 (76) (76) 3 3 (95) (95)
Total 317 100 (28) (28) 97 100 (46) (47)
---------------------------- --- ------- ------ ---- ------- ------ ----
Table 8 : Total Revenue by therapy area
9M 2023 Q3 2023
----------------------------- -----------------------------
% Change % Change
$m % Total Actual CER $m % Total Actual CER
------------------- ------ ------- ------ ---- ------ ------- ------ ----
Oncology 13,458 40 17 20 4,664 41 15 17
BioPharmaceuticals 13,599 40 (10) (7) 4,548 40 (4) (2)
-------------------- ------ ------- ------ ---- ------ ------- ------ ----
- CVRM 7,926 23 14 19 2,687 23 14 16
- R&I 4,729 14 6 9 1,549 13 3 5
- V&I 944 3 (74) (73) 312 3 (64) (65)
-------------------- ------ ------- ------ ---- ------ ------- ------ ----
Rare Disease 5,793 17 11 12 1,974 17 13 14
Other Medicines 937 3 (30) (26) 306 3 (36) (32)
Total 33,787 100 2 5 11,492 100 5 6
-------------------- ------ ------- ------ ---- ------ ------- ------ ----
Table 9 : Total Revenue by region
9M 2023 Q3 2023
----------------------------- -----------------------------
% Change % Change
$m % Total Actual CER $m % Total Actual CER
----------------- ------ ------- ------- --- ------ ------- ------- ---
US 13,940 41 6 6 4,859 42 5 4
------------------ ------ ------- ------- --- ------ ------- ------- ---
Emerging Markets 9,242 27 3 10 2,964 26 4 12
------------------ ------ ------- ------- --- ------ ------- ------- ---
- China 4,495 13 (2) 5 1,452 13 (6) 1
- Ex-China 4,747 14 8 15 1,513 13 15 25
------------------ ------ ------- ------- --- ------ ------- ------- ---
Europe 6,765 20 5 5 2,392 21 16 9
Established RoW 3,840 11 (16) (9) 1,276 11 (10) (6)
Total 33,787 100 2 5 11,492 100 5 6
------------------ ------ ------- ------- --- ------ ------- ------- ---
Table 10 : Total Revenue by region - excluding COVID-19 medicines
9M 2023 Q3 2023
----------------------------- -----------------------------
% Change % Change
$m % Total Actual CER $m % Total Actual CER
----------------- ------ ------- ------- --- ------ ------- ------- ---
US 13,940 42 14 14 4,859 42 12 12
------------------ ------ ------- ------- --- ------ ------- ------- ---
Emerging Markets 9,038 27 12 20 2,964 26 8 16
------------------ ------ ------- ------- --- ------ ------- ------- ---
- China 4,495 13 (1) 6 1,452 13 (6) 1
- Ex-China 4,544 14 28 37 1,513 13 25 36
------------------ ------ ------- ------- --- ------ ------- ------- ---
Europe 6,748 20 14 14 2,392 21 23 16
Established RoW 3,726 11 - 8 1,276 11 5 10
Total 33,453 100 12 15 11,492 100 12 13
------------------ ------ ------- ------- --- ------ ------- ------- ---
Oncology
Oncology Total Revenue of $13,458m in 9M 2023 increased by 17% (20% at CER), representing 40% of overall Total Revenue (9M 2022: 35%). There was no Lynparza Collaboration Revenue in 9M 2023 (9M 2022: $250m), and Enhertu Alliance Revenue was $741m (9M 2022: $335m). Product Sales increased by 17% (20% at CER) in 9M 2023 to $12,692m, reflecting new launches and expanded reimbursement across key brands; partially offset by declines in legacy medicines.
Tagrisso
Total Revenue Worldwide US Emerging Markets Europe Established
RoW
------------- --------- ----- ---------------- ------ -----------
9M 2023 $m 4,380 1,679 1,261 821 619
Actual change 7% 14% 4% 6% (4%)
CER change 10% 14% 11% 6% 5%
------------- --------- ----- ---------------- ------ -----------
Region Drivers and commentary
---------------- --------------------------------------------------------------
Worldwide * Increased global demand for Tagrisso in adjuvant and
1st-line settings combined with expanded reimbursement
in the adjuvant setting
US * Continued growth in demand in 1st-line and adjuvant
settings
Emerging Markets * Growing demand in adjuvant and 1st-line settings offset
by impact of NRDL [35] renewal price in China effective
March 2023, some additional impact in China in the third
quarter resulting from reduced promotional activities
following the government campaign announced at the end
of July 2023
Europe * Increased demand growth in 1st-line and growing adjuvant
demand
Established * Increased demand in 1st-line and adjuvant settings
RoW offset by mandatory price reduction in Japan effective
June 2023
---------------- --------------------------------------------------------------
Imfinzi and Imjudo
Total Revenue Worldwide US Emerging Markets Europe Established
RoW
------------- --------- ----- ---------------- ------ -----------
9M 2023 $m 3,102 1,708 270 547 577
Actual change 53% 55% 20% 36% 90%
CER change 56% 55% 31% 35% >2x
------------- --------- ----- ---------------- ------ -----------
Region Drivers and commentary
---------------- ------------------------------------------------------------------
Worldwide * Includes $161m of Total Revenue from Imjudo, which
launched in Q4 2022 following approvals in the US for
patients with unresectable liver cancer (HIMALAYA) and
Stage IV NSCLC (POSEIDON)
* Growth across all regions, driven by recent launches
(BTC [36] , HCC [37] , Stage IV NSCLC) and established
indications (Stage III NSCLC, SCLC [38] )
US * Continued demand growth for BTC and HCC indications,
increased uptake in SCLC
Emerging Markets * Growth across markets driven by BTC launches and recovery
of diagnosis and treatment rates following the COVID-19
pandemic, slightly offset by decreased promotional activities
in China due to the government campaign announced at
the end of July 2023
Europe * Competitive share gain in SCLC, and expanded reimbursement
for new launch indications (BTC, HCC and Stage IV NSCLC)
Established * Growth driven by launch of HCC and BTC and increased
RoW share across indications in Japan
---------------- ------------------------------------------------------------------
Lynparza
Total Revenue Worldwide US Emerging Markets Europe Established
RoW
------------- --------- --- ---------------- ------ -----------
9M 2023 $m 2,070 902 409 543 216
Actual change (6%) 1% 14% (27%) 7%
CER change (3%) 1% 24% (27%) 16%
------------- --------- --- ---------------- ------ -----------
Product Sales Worldwide US Emerging Markets Europe Established
RoW
------------- --------- --- ---------------- ------ -----------
9M 2023 $m 2,070 902 409 543 216
Actual change 6% 1% 14% 10% 7%
CER change 9% 1% 24% 10% 16%
------------- --------- --- ---------------- ------ -----------
Region Drivers and commentary
---------------- ------------------------------------------------------------------
Worldwide * Lynparza remains the leading medicine in the PARP
[39] inhibitor class globally across four tumour types
(ovarian, breast, prostate, pancreatic), as measured
by total prescription volume
* No regulatory milestones received in the period
US * Continued share growth within the PARP inhibitor class,
offset by declining class use and the label restriction
in 2nd-line ovarian cancer effective September 2023
Emerging Markets * Increased demand, offset by price reduction in China
associated with NRDL renewal that took effect March
2023 for ovarian cancer indications (PSR [40] and BRCAm
[41] 1st-line maintenance) and new NRDL enlistment in
prostate cancer (PROfound) as well as some impact in
the third quarter resulting from reduced promotional
activities following the government campaign announced
end of July 2023
Europe * Demand growth from increased uptake in 1st-line HRD-positive
ovarian cancer, gBRCAm [42] HER2--negative early breast
cancer and mCRPC, offset by reduced use in 2nd-line
ovarian cancer and pricing
* Total Revenue in the prior year period included $250m
of milestones
Established * Growth driven by increased uptake in testing and use
RoW in 1st-line HRD-positive ovarian cancer
---------------- ------------------------------------------------------------------
Enhert u
Total Revenue Worldwide US Emerging Markets Europe Established
RoW
------------- --------- --- ---------------- ------ -----------
9M 2023 $m 919 518 179 204 17
Actual change >2x >2x >3x >2x >3x
CER change >2x >2x >3x >2x >3x
------------- --------- --- ---------------- ------ -----------
Region Drivers and commentary
---------------- --------------------------------------------------------------------
Worldwide * Combined sales of Enhertu, recorded by Daiichi Sankyo
Company Limited (Daiichi Sankyo) and AstraZeneca, amounted
to $1,844m in 9M 2023 (9M 2022: $750m)
* AstraZeneca's Total Revenue of $919m in the period
includes $741m of Alliance Revenue from its share of
gross profit and royalties in territories where Daiichi
Sankyo records product sales
US * US in-market sales, recorded by Daiichi Sankyo, amounted
to $1,087m in 9M 2023 (9M 2022: $532m)
* Increased demand across launched indications. Q3 2023
impacted by HER2-low bolus depletion
Emerging Markets * Continued uptake driven by recent approvals and launches
including strong demand growth in China following HER2-positive
and HER2-low breast cancer launches
Europe * Continued growth driven by increasing adoption in
HER2-positive and HER2-low metastatic breast cancer
Established * In Japan, AstraZeneca receives a mid-single-digit
RoW percentage royalty on sales made by Daiichi Sankyo
---------------- --------------------------------------------------------------------
Calquence
Total Revenue Worldwide US Emerging Markets Europe Established
RoW
------------- --------- ----- ---------------- ------ -----------
9M 2023 $m 1,839 1,337 69 353 80
Actual change 25% 12% >2x 76% 64%
CER change 26% 12% >2x 77% 74%
------------- --------- ----- ---------------- ------ -----------
Region Drivers and commentary
--------- --------------------------------------------------------------
Worldwide * Increased penetration globally; leading BTKi [43]
in key markets
US * Leadership maintained in growing BTKi class, sustained
leading share in the front-line setting, offset by some
competitive impact in relapsed refractory setting and
increased utilisation of free goods program in Q3
EU * Solid growth continued amidst growing competitive
pressure
* Increased new patients starts following expanded access
in key markets
--------- --------------------------------------------------------------
Orpathys
Orpathys Total Revenue of $34m declined 1% (6% increase at CER), (9M 2022: $35m), following its inclusion in the updated NRDL in China from March 2023, for the treatment of patients with NSCLC with MET exon 14 skipping alterations.
Other Oncology medicines
9M 2023 Change
Total Revenue $m Actual CER
--------------- --- ------ ----- -------------------------------------------------
Zoladex 723 (2%) 5% * Underlying growth due to continued demand
growth in Emerging Markets, partially
offset by price reduction in China following
NRDL renewal
Faslodex 217 (16%) (10%) * Generic competition
Other Oncology 174 (36%) (32%) * Generic competition
---------------- --- ------ ----- -------------------------------------------------
BioPharmaceuticals
BioPharmaceuticals Total Revenue decreased by 10% (7% at CER) in 9M 2023 to $13,599m, representing 40% of overall Total Revenue (9M 2022: 45%). The decline was driven by COVID-19 medicines, partially offset by strong growth from Farxiga and newer R&I medicines.
BioPharmaceuticals - CVRM
CVRM Total Revenue increased by 14% (19% at CER) to $7,926m in 9M 2023, driven by the strong Farxiga performance, and represented 23% of overall Total Revenue (9M 2022: 21%).
Farxiga
Total Revenue Worldwide US Emerging Markets Europe Established
RoW
------------- --------- ----- ---------------- ------ -----------
9M 2023 $m 4,389 1,000 1,655 1,356 378
Actual change 37% 34% 35% 42% 35%
CER change 41% 34% 43% 41% 45%
------------- --------- ----- ---------------- ------ -----------
Region Drivers and commentary
---------------- --------------------------------------------------------------------
Worldwide * Farxiga volume is growing faster than the overall
SGLT2 [44] market in most major regions, fuelled by
launches in heart failure and CKD
* Additional benefit from continued growth in the overall
SGLT2 inhibitor class
US * Growth driven by heart failure and CKD for patients
with and without T2D [45] resulting in an increasing
market share
Emerging Markets * Solid growth despite generic competition in some markets
Europe * Benefited from the addition of cardiovascular outcomes
trial data to the label and growth in HFrEF [46] , CKD
and the HFpEF approval in February 2023. ESC [47] guidelines
updated in August 2023 to also include treatment of
patients with HFpEF
* Continued strong volume growth in the quarter and
expanded class leadership in several key markets
Established * In Japan, AstraZeneca sells to collaborator Ono Pharmaceutical
RoW Co., Ltd, which records in-market sales. Continued volume
growth driven by HF and CKD launches. Generics launched
in Canada in the third quarter
---------------- --------------------------------------------------------------------
Brilinta
Total Revenue Worldwide US Emerging Markets Europe Established
RoW
------------- --------- --- ---------------- ------ -----------
9M 2023 $m 996 551 224 203 18
Actual change (2%) 2% 1% (5%) (54%)
CER change - 2% 10% (5%) (51%)
------------- --------- --- ---------------- ------ -----------
Region Drivers and commentary
---------------- ------------------------------------------------------------
US * Sales in the third quarter benefitted from channel
inventory movements
Emerging Markets * Sales declined by 16% (4% at CER) in the third quarter
driven by tender phasing
Europe * Sales partly impacted by clawbacks
Established * Sales decline driven by generic entry in Canada
RoW
---------------- ------------------------------------------------------------
Lokelma
Lokelma Total Revenue increased 44% (49% at CER) to $300m with strong demand growth in all regions.
Roxadustat
Total Revenue increased 40% (50% at CER) to $212m, benefitting from increased demand in both the dialysis- and non-dialysis-dependent populations
Andexxa
Andexxa Total Revenue increased 7% (9% at CER) to $129m.
Other CVRM medicines
9M 2023 Change
Total Revenue $m Actual CER
-------------- --- ------ ----- -------------------------------------------------
Crestor 862 4% 11% * Continued sales growth in Emerging Markets,
partly offset by declines in the US and
Established RoW
Seloken 496 (30%) (23%) * Ongoing impact of China VBP implementation
Onglyza 180 (12%) (8%) * Continued decline for DPP-IV class
Bydureon 123 (40%) (40%) * Continued competitive pressures
Other CVRM 237 (16%) (13%)
--------------- --- ------ ----- -------------------------------------------------
BioPharmaceuticals - R&I
Total Revenue of $4,729m from R&I medicines in 9M 2023 increased 6% (9% at CER) and represented 14% of overall Total Revenue (9M 2022: 14%). This reflected growth in Fasenra, Tezspire, Breztri and Saphnelo, offsetting a decline in Symbicort and other mature brands.
Fasenra
Total Revenue Worldwide US Emerging Markets Europe Established
RoW
------------- --------- --- ---------------- ------ -----------
9M 2023 $m 1,134 718 48 262 106
Actual change 12% 11% 62% 14% (1%)
CER change 13% 11% 69% 14% 6%
------------- --------- --- ---------------- ------ -----------
Region Drivers and commentary
---------------- ------------------------------------------------------------------
Worldwide * Retained market share leadership in severe eosinophilic
asthma across major markets
US * Expanded leadership in eosinophilic asthma and maintained
total share in a growing market, leading to double-digit
volume growth , partially offset by managed market price
difference
Emerging Markets * Continued strong volume growth driven by launch acceleration
across key markets
Europe * Expanded leadership in severe eosinophilic asthma,
with strong volume growth partially offset by price
in some markets
Established * Maintained class leadership in Japan while market
RoW growth remained stable
---------------- ------------------------------------------------------------------
Breztri
Total Revenue Worldwide US Emerging Markets Europe Established
RoW
------------- --------- --- ---------------- ------ -----------
9M 2023 $m 478 263 123 55 37
Actual change 69% 60% 73% >2x 48%
CER change 73% 60% 86% >2x 58%
------------- --------- --- ---------------- ------ -----------
Region Drivers and commentary
---------------- --------------------------------------------------------------
Worldwide * Continued to gain market share within the growing
FDC [48] triple class across major markets
US * Consistent share growth within the FDC triple class
in new-to-brand [49] and the total market
Emerging Markets * Maintained market share leadership in China with strong
triple FDC class penetration
Europe * Sustained growth across markets as new launches continue
to progress
Established * Increased market share gains within COPD in Japan
RoW and strong launch performance in Canada
---------------- --------------------------------------------------------------
Tezspire
Total Revenue Worldwide US Emerging Markets Europe Established
RoW
------------- --------- --- ---------------- ------ -----------
9M 2023 $m 230 179 - 28 23
Actual change >5x >4x - n/m n/m
CER change >5x >4x - n/m n/m
------------- --------- --- ---------------- ------ -----------
Region Drivers and commentary
----------- -------------------------------------------------------------------
Worldwide * Tezspire is approved in the US, EU and Japan (as well
as other countries) for the treatment of severe asthma
without biomarker or phenotypic limitation
* Amgen records sales in the US, and AstraZeneca records
its share of US gross profits as Alliance Revenue. AstraZeneca
books Product Sales in markets outside the US
* Combined sales of Tezspire by AstraZeneca and Amgen
were $438m in 9M 2023
US * Increased new-to-brand market share with majority
of patients new to biologics
* Pre-filled pen approved in February 2023
Europe * Achieved and maintained new-to-brand leadership in
key markets
* Pre-filled pen approved in January 2023
Established * Japan maintained new-to-brand leadership
RoW
----------- -------------------------------------------------------------------
Saphnelo
Total Revenue Worldwide US Emerging Markets Europe Established
RoW
------------- --------- --- ---------------- ------ -----------
9M 2023 $m 191 178 1 5 7
Actual change >2x >2x n/m >4x >3x
CER change >2x >2x n/m >4x >3x
------------- --------- --- ---------------- ------ -----------
Region Drivers and commentary
--------- -----------------------------------------------------------
Worldwide * D emand acceleration in the US, and additional growth
driven by ongoing launches in Europe and Japan
--------- -----------------------------------------------------------
Symbicort
Total Revenue Worldwide US Emerging Markets Europe Established
RoW
------------- --------- ----- ---------------- ------ -----------
9M 2023 $m 1,842 589 600 408 245
Actual change (4%) (18%) 26% (8%) (12%)
CER change (1%) (18%) 36% (8%) (7%)
------------- --------- ----- ---------------- ------ -----------
Region Drivers and commentary
---------------- ------------------------------------------------------------
Worldwide * Symbicort remained the global market leader within
a stable ICS [50] /LABA [51] class
US * Generic competition entered the US market in the third
quarter, leading to price and volume share declines
Emerging Markets * Strong underlying demand. Growth in China benefitted
from the post-COVID-19 recovery at the start of the
year
Europe * Continued price and volume erosion from generics and
a slowing overall market
Established * Generic erosion in Japan
RoW
---------------- ------------------------------------------------------------
Other R&I medicines
9M 2023 Change
Total Revenue $m Actual CER
-------------- --- ------ ----- ----------------------------------------------
Pulmicort 493 3% 10% * 80% of revenues from Emerging Markets
* China market share has stabilised, with
VBP having been in effect for over 12
months
Bevespi 42 (2%) (2%)
Daliresp 41 (74%) (74%) * Impacted by uptake of multiple generics
following loss of exclusivity in the US
Other R&I 278 (41%) (38%) * Collaboration Revenue of $20m (9M 2022:
$110m)
* Product Sales of $245m decreased 30%
(27% at CER) due to generic competition
--------------- --- ------ ----- ----------------------------------------------
BioPharmaceuticals - V&I
Total Revenue from V&I medicines declined by 74% (73% at CER) to $944m (9M 2022: $3,673m) and represented 3% of overall Total Revenue (9M 2022: 11%). In Q3 2023, no revenue was generated from COVID--19 medicines.
COVID-19 mAbs
Total Revenue Worldwide US Emerging Markets Europe Established
RoW
------------- --------- --- ---------------- ------ -----------
9M 2023 $m 306 - 185 7 114
Actual change (79%) n/m 11% (97%) (51%)
CER change (78%) n/m 11% (96%) (45%)
------------- --------- --- ---------------- ------ -----------
Region Drivers and commentary
---------------- ----------------------------------------------------------
Worldwide * All Product Sales in 9M 2023 were derived from sales
of Evusheld in the first quarter
Emerging Markets * $180m license fee from Serum Institute of India in
Q2 2023 recorded as Collaboration Revenue
---------------- ----------------------------------------------------------
Vaxzevria
Total Revenue Worldwide US Emerging Markets Europe Established
RoW
------------- --------- --- ---------------- ------ -----------
9M 2023 $m 28 - 18 10 -
Actual change (98%) n/m (98%) (97%) n/m
CER change (98%) n/m (98%) (97%) n/m
------------- --------- --- ---------------- ------ -----------
Region Drivers and commentary
--------- -------------------------------------------------------
Worldwide * Revenue in the period decreased by 98% due to the
conclusion of Vaxzevria contracts
--------- -------------------------------------------------------
Other V&I medicines
9M 2023 Change
Total Revenue $m Actual CER
------------- --- ------ --- -----------------------------------------------------
Beyfortus 139 n/m n/m * In Q3 2023 AstraZeneca reported $50m
of Product Sales, $17m of Alliance Revenue,
and also $71m of Collaboration Revenue
relating to a regulatory milestone
* The Product Sales relates to sales to
Sanofi of Beyfortus product manufactured
by AstraZeneca. In Q3 Product Sales benefitted
from stock building for the 2023-2024
RSV [52] season
* The Alliance Revenue consists of AstraZeneca's
50% share of gross profits on sales of
Beyfortus in major markets outside the
US. AstraZeneca will also book 25% of
revenues in rest of world markets. AstraZeneca
has no participation in US profits or
losses
Synagis 383 - 6% * Performance broadly in-line with prior
year
FluMist 88 49% 45% * $10m milestone received from Daiichi
Sankyo in the second quarter following
FluMist approval in Japan
------------- --- ------ --- -----------------------------------------------------
Rare Disease
Total Revenue from Rare Disease medicines increased by 11% (12% at CER) in 9M 2023 to $5,793m, representing 17% of overall Total Revenue (9M 2022: 16%).
Performance was driven by the continued growth and durability of the C5 [53] franchise, and also the strength of Strensiq and Koselugo patient demand.
Ultomiris
Total Revenue Worldwide US Emerging Markets Europe Established
RoW
------------- --------- ----- ---------------- ------ -----------
9M 2023 $m 2,141 1,260 47 495 339
Actual change 56% 63% 38% 43% 54%
CER change 58% 63% 39% 42% 68%
------------- --------- ----- ---------------- ------ -----------
Region Drivers and commentary
---------------- ------------------------------------------------------------
Worldwide * Growth in neurology indications, expansion into new
markets and continued conversion from Soliris
* Quarter-on-quarter variability in revenue growth can
be expected due to Ultomiris every eight-week dosing
schedule and lower average annual treatment cost per
patient compared to Soliris
US * Growth in naïve patients in gMG [54] and NMOSD
as well as successful conversion from Soliris across
shared indications
Emerging Markets * Continued progress following launches in new markets
Europe * Strong demand generation following launches in new
markets, particularly in neurology indications, as well
as accelerated conversion from Soliris in key markets
Established * Continued conversion from Soliris and strong demand
RoW following new launches, particularly NMOSD in Japan
---------------- ------------------------------------------------------------
Soliris
Total Revenue Worldwide US Emerging Markets Europe Established
RoW
------------- --------- ----- ---------------- ------ -----------
9M 2023 $m 2,429 1,313 338 530 248
Actual change (17%) (22%) 55% (15%) (36%)
CER change (15%) (22%) 74% (15%) (31%)
------------- --------- ----- ---------------- ------ -----------
Region Drivers and commentary
---------------- ----------------------------------------------------------
US * Decline driven by successful conversion of Soliris
patients to Ultomiris in PNH, aHUS and gMG, partially
offset by Soliris growth in NMOSD
Emerging Markets * Continued progress, launching in new markets
Europe, * Decline driven by successful conversion from Soliris
Established to Ultomiris, partially offset by growth in NMOSD
RoW
---------------- ----------------------------------------------------------
Strensiq
Total Revenue Worldwide US Emerging Markets Europe Established
RoW
------------- --------- --- ---------------- ------ -----------
9M 2023 $m 847 690 29 64 64
Actual change 23% 26% 14% 9% 12%
CER change 24% 26% 16% 8% 22%
------------- --------- --- ---------------- ------ -----------
Region Drivers and commentary
--------- ------------------------------------------------------------
Worldwide * Strong patient demand particularly in the US and Japan
--------- ------------------------------------------------------------
Other Rare Disease medicines
9M 2023 Change
Total Revenue $m Actual CER Commentary
------------- --- ------ --- ----------------------------------------------
Koselugo 246 65% 65% * Driven by patient demand and expansion
in new markets
Kanuma 130 17% 18% * Continued demand growth in ex-US markets
------------- --- ------ --- ----------------------------------------------
Other medicines (outside the main therapy areas)
9M 2023 Change
Total Revenue $m Actual CER Commentary
------------- --- ------ ----- ---------------------------------------------
Nexium 748 (30%) (25%) * Generic launches in Japan in the latter
part of 2022
Others 189 (31%) (29%) * Continued impact of generic competition
------------- --- ------ ----- ---------------------------------------------
Financial performance
Table 11 : Reported Profit and Loss
9M 2023 9M 2022 % Change Q3 2023 Q3 2022 % Change
$m $m Actual CER $m $m Actual CER
------------------------ -------- -------- ------ ----- ------- ------- ------ -----
Total Revenue 33,787 33,144 2 5 11,492 10,982 5 6
- Product Sales 32,466 32,200 1 4 11,018 10,590 4 5
- Alliance Revenue 1,004 504 99 99 377 214 76 75
- Collaboration Revenue 317 440 (28) (28) 97 178 (46) (47)
------------------------- -------- -------- ------ ----- ------- ------- ------ -----
Cost of sales (5,960) (9,491) (37) (38) (2,095) (2,982) (30) (31)
------------------------- -------- -------- ------ ----- ------- ------- ------ -----
Gross profit 27,827 23,653 18 22 9,397 8,000 17 20
Product Sales Gross
Margin 81.6% 70.5% +11pp +12pp 81.0% 71.8% +9pp +10pp
------------------------- -------- -------- ------ ----- ------- ------- ------ -----
Distribution expense (394) (380) 4 6 (129) (126) 2 2
% Total Revenue 1.2% 1.1% - - 1.1% 1.1% - -
R&D expense (7,862) (7,137) 10 12 (2,584) (2,458) 5 4
% Total Revenue 23.3% 21.5% -2pp -2pp 22.5% 22.4% - -
SG&A expense (13,845) (13,798) - 2 (4,800) (4,277) 12 12
% Total Revenue 41.0% 41.6% +1pp +1pp 41.8% 38.9% -3pp -2pp
OOI [55] & expense 1,233 325 >3x >3x 70 106 (34) (33)
% Total Revenue 3.6% 1.0% +3pp +3pp 0.6% 1.0% - -
------------------------- -------- -------- ------ ----- ------- ------- ------ -----
Operating profit 6,959 2,663 >2x >2x 1,954 1,245 57 69
Operating Margin 20.6% 8.0% +13pp +14pp 17.0% 11.3% +6pp +7pp
------------------------- -------- -------- ------ ----- ------- ------- ------ -----
Net finance expense (945) (936) 1 1 (291) (324) (9) (6)
Joint ventures and
associates (12) (4) >2x >2x (11) 1 n/m n/m
------------------------- -------- -------- ------ ----- ------- ------- ------ -----
Profit before tax 6,002 1,723 >3x >3x 1,652 922 79 91
------------------------- -------- -------- ------ ----- ------- ------- ------ -----
Taxation (1,000) 668 n/m n/m (274) 720 n/m n/m
Tax rate 17% -39% 17% -78%
------------------------- -------- -------- ------ ----- ------- ------- ------ -----
Profit after tax 5,002 2,391 >2x >2x 1,378 1,642 (16) (6)
Earnings per share $3.22 $1.54 >2x >2x $0.89 $1.06 (16) (6)
------------------------- -------- -------- ------ ----- ------- ------- ------ -----
Table 12 : Reconciliation of Reported Profit before tax to EBITDA
9M 2023 9M 2022 % Change Q3 2023 Q3 2022 % Change
$m $m Actual CER $m $m Actual CER
--------------------------- ------ ----- ------ --- ----- ----- ------ ---
Reported Profit before
tax 6,002 1,723 >3x >3x 1,652 922 79 91
Net finance expense 945 936 1 1 291 324 (9) (6)
Joint ventures and
associates 12 4 >2x >2x 11 (1) n/m n/m
Depreciation, amortisation
and impairment 4,060 4,000 2 3 1,282 1,334 (4) (4)
EBITDA 11,019 6,663 65 77 3,236 2,579 25 32
---------------------------- ------ ----- ------ --- ----- ----- ------ ---
EBITDA for the comparative 9M 2022 was negatively impacted by $3,175m unwind of inventory fair value uplift recognised on the acquisition of Alexion. EBITDA for the comparative Q3 2022 was negatively impacted by $857m unwind of inventory fair value uplift recognised on the acquisition of Alexion. This unwind had a $78m negative impact on 9M 2023 and a $23m negative impact on Q3 2023. It will continue to be minimal and will unwind fully over the next quarter.
Table 13 : Reconciliation of Reported to Core financial measures: 9M 2023
9M 2023 Reported Restructuring Intangible Acquisition Other Core Core
Asset Amortisation of Alexion [56] % Change
& Impairments
$m $m $m $m $m $m Actual CER
------------------ -------- ----- ----- ----- ----- -------- ------ ----
Gross profit 27,827 133 24 82 (4) 28,062 4 8
Product Sales
Gross Margin 81.6% 82.4% +1pp +2pp
------------------- -------- ----- ----- ----- ----- -------- ------ ----
Distribution
expense (394) - - - - (394) 4 6
R&D expense (7,862) 117 386 5 1 (7,353) 5 7
SG&A expense (13,845) 163 2,863 7 1,107 (9,705) 5 8
------------------- -------- ----- ----- ----- ----- -------- ------ ----
Total operating
expense (22,101) 280 3,249 12 1,108 (17,452) 5 7
------------------- -------- ----- ----- ----- ----- -------- ------ ----
Other operating
income & expense 1,233 (61) - - - 1,172 >3x >3x
------------------- -------- ----- ----- ----- ----- -------- ------ ----
Operating
profit 6,959 352 3,273 94 1,104 11,782 10 16
Operating
Margin 20.6% 34.9% +2pp +3pp
------------------- -------- ----- ----- ----- ----- -------- ------ ----
Net finance
expense (945) - - - 220 (725) (1) (2)
Taxation (1,000) (81) (617) (22) (329) (2,049) 12 19
EPS $3.22 $0.17 $1.72 $0.05 $0.64 $5.80 10 17
------------------- -------- ----- ----- ----- ----- -------- ------ ----
Table 14 : Reconciliation of Reported to Core financial measures: Q3 2023
Q3 2023 Reported Restructuring Intangible Acquisition Other Core Core
Asset Amortisation of Alexion [57] % Change
& Impairments
$m $m $m $m $m $m Actual CER
------------------ ------- ----- ----- ----- ----- ------- ------ ----
Gross profit 9,397 15 8 25 (1) 9,444 6 7
Product Sales
Gross Margin 81.0% 81.4% +1pp +1pp
------------------- ------- ----- ----- ----- ----- ------- ------ ----
Distribution
expense (129) - - - - (129) 3 2
R&D expense (2,584) 48 49 2 - (2,485) 5 5
SG&A expense (4,800) 61 957 3 424 (3,355) 6 7
------------------- ------- ----- ----- ----- ----- ------- ------ ----
Total operating
expense (7,513) 109 1,006 5 424 (5,969) 6 6
------------------- ------- ----- ----- ----- ----- ------- ------ ----
Other operating
income & expense 70 - - - - 70 (35) (34)
------------------- ------- ----- ----- ----- ----- ------- ------ ----
Operating
profit 1,954 124 1,014 30 423 3,545 4 9
Operating
Margin 17.0% 30.8% - +1pp
------------------- ------- ----- ----- ----- ----- ------- ------ ----
Net finance
expense (291) - - - 68 (223) (12) (7)
Taxation (274) (29) (189) (7) (125) (624) 8 13
EPS $0.89 $0.06 $0.53 $0.01 $0.24 $1.73 4 9
------------------- ------- ----- ----- ----- ----- ------- ------ ----
Profit and Loss drivers
Gross profit
-- The calculation of Reported and Core Product Sales Gross Margin excludes the impact of Alliance Revenue and Collaboration Revenue. The change in Product Sales Gross Margin (Reported and Core) in the nine months was impacted by:
-- Positive effects from product mix. The increased contribution from Rare Disease and Oncology medicines had a positive impact on the Product Sales Gross Margin. Vaxzevria sales, which are dilutive to Product Sales Gross Margin, declined substantially
-- Dilutive effects from product mix. The rising contribution of Product Sales with profit sharing arrangements (Lynparza, Enhertu and Tezspire) has a negative impact on Product Sales Gross Margin because AstraZeneca records product revenues in certain markets but pays away a share of the gross profit to its collaboration partners
-- Dilutive effects from geographic mix. Emerging Markets, where Product Sales Gross Margin tends to be below the Company average, grew as a proportion of Total Revenue excluding COVID-19 medicines
-- Variations in Product Sales Gross Margin performance between periods can continue to be expected due to product seasonality, foreign exchange fluctuations and other effects.
R&D expense
-- The change in R&D expense (Reported and Core) in the period was impacted by:
-- Recent positive data read-outs for several high priority medicines that have ungated late-stage trials
-- Investment in platforms, new technology and capabilities to enhance R&D productivity -- Reported R&D expense was also impacted by intangible asset impairments
SG&A expense
-- The change in SG&A expense (Reported and Core) in the period was driven primarily by market development activities for launches
-- Reported SG&A expense was also impacted by amortisation of intangible assets related to the Alexion acquisition and other acquisitions and collaborations
-- Reported SG&A expense was also impacted by a $510m charge to provisions relating to a legal settlement in Q2 2023 with Bristol-Myers Squibb and Ono Pharmaceutical, and a $425m charge to provisions in Q3 2023 for product liability litigations related to Nexium and Prilosec. The prior nine month period was impacted by a $775m legal settlement with Chugai Pharmaceutical Co. Ltd
Other operating income and expense
-- Reported and Core Other operating income and expense in the period included a $712m gain resulting from an update to the contractual relationships for Beyfortus (nirsevimab), a $241m gain on the disposal of the US rights to Pulmicort Flexhaler, and other disposal proceeds on the sale of tangible assets, and royalties on certain medicines
-- In the third quarter Reported and Core Other operating income decreased by $36m and $37m respectively, principally due to the discontinuation of brazikumab development. Prior to this, AstraZeneca received quarterly development contributions for brazikumab development from AbbVie, which were recognised as Other operating income
Net finance expense
-- Reported Net finance expense was impacted by the discount unwind on acquisition-related liabilities. Core Net finance expense reduced by 1% (2% at CER) with higher interest received on cash and short-term investments, broadly offset by higher rates on floating debt and bond issuances
Taxation
-- The effective Reported Tax rate for the nine months to 30 September 2023 was 17% (9M 2022: (39%)) and the effective Core Tax rate was 19% (9M 2022: 18%). The Q3 2022 effective Reported Tax rate was lower as it included a one-time favourable adjustment of $883m relating to deferred taxes arising from an internal reorganisation to integrate the Alexion business
-- The cash tax paid for the nine months to 30 September 2023 was $1,710m (9M 2022: $1,335m), representing 28% of Reported Profit before tax (9M 2022: 77%)
-- On 20 June 2023, Finance (No.2) Act 2023 was substantively enacted in the UK, introducing a global minimum effective tax rate of 15%. The legislation implements a domestic top-up tax and a multinational top-up tax, effective for accounting periods starting on or after 31 December 2023. The Company is currently assessing the impact of these rules upon its financial statements. The Company has applied the exception under the IAS 12 'Income Taxes' amendment for recognising and disclosing information about deferred tax assets and liabilities related to top-up income taxes
Table 15 : Cash Flow summary
9M 2023 9M 2022 Change
$m $m $m
------- ------- -------
Reported Operating profit 6,959 2,663 4,296
Depreciation, amortisation and impairment 4,060 4,000 60
Decrease in working capital and short-term
provisions 150 3,458 (3,308)
Gains on disposal of intangible assets (247) (88) (159)
Fair value movements on contingent consideration
arising from
business combinations 202 293 (91)
Non-cash and other movements (623) (973) 350
Interest paid (826) (608) (218)
Taxation paid (1,710) (1,335) (375)
-------------------------------------------------- ------- ------- -------
Net cash inflow from operating activities 7,965 7,410 555
-------------------------------------------------- ------- ------- -------
Net cash inflow before financing activities 4,978 4,699 279
-------------------------------------------------- ------- ------- -------
Net cash outflow from financing activities (6,276) (6,465) 189
-------------------------------------------------- ------- ------- -------
In 9M 2022, the Reported Operating profit of $2,663m included a negative impact of $3,175m relating to the unwind of the inventory fair value uplift recognised on the acquisition of Alexion. This was offset by a corresponding item (positive impact of $3,175m) in Decrease in working capital and short-term provisions. Overall, the unwind of the fair value uplift had no impact on Net cash inflow from operating activities. This unwind had $78m negative impact on 9M 2023 Reported Operating profit and offsetting positive impact on Working capital movements, and will continue to be minimal in the next quarter. As a result of the update to the contractual relationships between AstraZeneca, Sobi and Sanofi relating to the future sales of Beyfortus (nirsevimab) in the US, a gain of $712m has been recorded in non-cash and other movements, with no overall net impact on the Net cash inflow from operating activities.
Included within Net cash inflow before financing activities is a movement in the profit-participation liability of $190m, including a cash receipt from Sobi in Q1 2023 after achievement of a regulatory milestone. The associated cash flow is presented within investing activities.
The decrease in Net cash outflow from financing activities of $189m is primarily driven by the Issue of loans and borrowings of $3,816m, offset by the increase in Repayment of loans and borrowings of $3,394m.
Capital expenditure
Capital expenditure amounted to $836m in the nine months to 30 September 2023 (9M 2022: $719m).
Table 16 : Net debt summary
At 30 At 31 At 30
Sep 2023 Dec 2022 Sep 2022
$m $m $m
--------------------------------------------------- --------- --------- ---------
Cash and cash equivalents 4,871 6,166 4,458
Other investments 244 239 440
---------------------------------------------------- --------- --------- ---------
Cash and investments 5,115 6,405 4,898
---------------------------------------------------- --------- --------- ---------
Overdrafts and short-term borrowings (515) (350) (743)
Lease liabilities (979) (953) (878)
Current instalments of loans (4,857) (4,964) (4,665)
Non-current instalments of loans (22,225) (22,965) (23,013)
---------------------------------------------------- --------- --------- ---------
Interest-bearing loans and borrowings (Gross debt) (28,576) (29,232) (29,299)
---------------------------------------------------- --------- --------- ---------
Net derivatives 90 (96) (141)
Net debt (23,371) (22,923) (24,542)
---------------------------------------------------- --------- --------- ---------
Net debt increased by $448m in the nine months to 30 September 2023 to $23,371m. 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 and further details on Net Debt 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, 4.875% Notes due 2028, 1.750% Notes due 2028, 4.900% Notes due 2030, 2.250% Notes due 2031 and 4.875% Notes due 2033 (the "AstraZeneca Finance Notes"). Each series of AstraZeneca Finance Notes has been fully and unconditionally guaranteed by AstraZeneca PLC. AstraZeneca Finance is 100% owned by AstraZeneca PLC and each of the guarantees by AstraZeneca PLC is full and unconditional and joint and several.
The AstraZeneca Finance Notes are senior unsecured obligations of AstraZeneca Finance and rank equally with all of AstraZeneca Finance's existing and future senior unsecured and unsubordinated indebtedness. The guarantee by AstraZeneca PLC of the AstraZeneca Finance Notes is the senior unsecured obligation of AstraZeneca PLC and ranks equally with all of AstraZeneca PLC's existing and future senior unsecured and unsubordinated indebtedness. Each guarantee by AstraZeneca PLC is effectively subordinated to any secured indebtedness of AstraZeneca PLC to the extent of the value of the assets securing such indebtedness. The AstraZeneca Finance Notes are structurally subordinated to indebtedness and other liabilities of the subsidiaries of AstraZeneca PLC, none of which guarantee the AstraZeneca Finance Notes.
AstraZeneca PLC manages substantially all of its operations through divisions, branches and/or investments in subsidiaries and affiliates. Accordingly, the ability of AstraZeneca PLC to service its debt and guarantee obligations is also dependent upon the earnings of its subsidiaries, affiliates, branches and divisions, whether by dividends, distributions, loans or otherwise.
Please refer to the consolidated financial statements of AstraZeneca PLC in our Annual Report on Form 20-F and reports on Form 6-K with our quarterly financial results as filed or furnished with the SEC [58] for further financial information regarding AstraZeneca PLC and its consolidated subsidiaries. For further details, terms and conditions of the AstraZeneca Finance Notes please refer to AstraZeneca PLC's reports on Form 6-K furnished to the SEC on 3 March 2023 and 28 May 2021.
Pursuant to Rule 13-01 and Rule 3-10 of Regulation S-X under the Securities Act of 1933, as amended (the "Securities Act"), we present below the summary financial information for AstraZeneca PLC, as Guarantor, excluding its consolidated subsidiaries, and AstraZeneca Finance, as the issuer, excluding its consolidated subsidiaries. The following summary financial information of AstraZeneca PLC and AstraZeneca Finance is presented on a combined basis and transactions between the combining entities have been eliminated. Financial information for non-guarantor entities has been excluded. Intercompany balances and transactions between the obligor group and the non-obligor subsidiaries are presented on separate lines.
Table 17 : Obligor group summarised Statement of comprehensive income
9M 2023 9M 2022
$m $m
------- -------
Total Revenue - -
Gross profit - -
Operating loss (2) (3)
Loss for the period (695) (404)
Transactions with subsidiaries that are not issuers or guarantors 9,758 502
------------------------------------------------------------------- ------- -------
Table 18 : Obligor group summarised Statement of financial position
At 30 Sep 2023 At 30 Sep 2022
$m $m
----------------------------------------------------------------- -------------- --------------
Current assets 6 5
Non-current assets - -
Current liabilities (4,760) (3,067)
Non-current liabilities (22,077) (22,556)
Amounts due from subsidiaries that are not issuers or guarantors 12,921 7,349
Amounts due to subsidiaries that are not issuers or guarantors (295) (301)
------------------------------------------------------------------ -------------- --------------
Foreign exchange
The Company's transactional currency exposures on working-capital balances, which typically extend for up to three months, are hedged where practicable using forward foreign exchange contracts against the individual companies' reporting currency. Foreign exchange gains and losses on forward contracts for transactional hedging are taken to profit or loss. In addition, the Company's external dividend payments, paid principally in pounds sterling and Swedish krona, are fully hedged from announcement to payment date.
Table 19 : Currency sensitivities
The Company provides the following currency-sensitivity information:
Average Annual impact ($m) of 5% strengthening (FY2023 average rate vs. FY 2022 average) ([59])
rates vs. USD
-------------- ---------------------------------------------------------------------------------------
Currency Primary FY YTD Change Sep 2023 Change [63] Total Core
Relevance 2022 [60] 2023 [61] (%) [62] (%) Revenue Operating
Profit
EUR Total Revenue 0.95 0.92 3 0.94 1 323 159
CNY Total Revenue 6.74 7.04 (4) 7.30 (8) 309 174
JPY Total Revenue 131.59 138.18 (5) 147.71 (11) 181 122
Other ([64]) 385 202
---------------------------- ---------- ---------- ------ ------------ ----------- ------------ -----------
Operating
GBP expense 0.81 0.80 1 0.81 0 46 (92)
Operating
SEK expense 10.12 10.59 (4) 11.08 (9) 7 (55)
Sustainability
Since the last quarterly report, AstraZeneca:
Access to healthcare
-- Hosted the first dedicated side-event on Chronic Kidney Disease (CKD) "How improving kidney health can transform health systems for all" during the 78th United Nations General Assembly (UNGA) meeting in New York, with public, private and patient voices represented. During UNGA, the Company also engaged with the cancer community on access, services within universal health coverage (UHC) and the need for investment in cancer and non-communicable diseases (NCDs)
-- Continued to make a high-level contribution to the work of the Partnership for Health System Sustainability and Resilience (PHSSR), which provides a valuable platform for dialogue with policymakers, the Company and other stakeholders. In Canada, a workshop with participation from the Minister of Health of Quebec fed into the discussions on transformation of Quebec's health system. In Japan, AstraZeneca's Chair Michel Demaré participated in a PHSSR roundtable co-hosted by the British Embassy, which focused on health equity and digital healthcare. PHSSR also engaged at leading global and regional healthcare events, including the European Health Forum Gastein, the Global Congress on Population, Health and Development, ICHOM 2023 and the World Health Summit in Berlin
-- Ruud Dobber, EVP BioPharmaceuticals Business Unit, delivered the opening keynote address at the POLITICO EU Healthcare Summit in Brussels where he called for bold action and collaboration across the healthcare ecosystem to support early diagnosis and treatment. He highlighted the need for regulatory frameworks that accelerate access to medical innovation, as well as the urgency to combat the effects of the climate crisis on health
-- Marked World Heart Day and the ninth anniversary of Healthy Heart Africa (HHA)'s launch, by convening African health stakeholders to take stock of the programme's achievements and share insights on the critical role of public-private partnerships in supporting primary healthcare. Speakers included representatives of Ministries of Health from nine countries and HHA implementing partners, with more than 70 attendees. HHA has trained more than 11,000 healthcare workers and conducted over 43 million blood pressure screenings, identifying 8.6 million with elevated blood pressure since launch, moving closer to the programme ambition of 10 million by 2025, and achieving one million screenings per month since February 2023 (data as at end of September 2023)
-- Young Health Programme is now active in 40 countries, with new programmes launched in Costa Rica and Taiwan. Through the Young Health Programme Impact Fellowship, the Company supported a delegation of 17 young health leaders from 13 countries to attend One Young World 2023 in Belfast. Three of these changemakers joined AstraZeneca leadership in on-stage appearances, discussing their impact on NCD prevention for young people in their communities. AstraZeneca and Plan International UK were awarded 'Highly Commended' at the Corporate Engagement Awards for Best Educational Programme
Environmental protection
-- Entered into an agreement in Sweden with Statkraft, Europe's largest renewable energy producer, on wind power deliveries that will increase the supply of renewable electricity in Sweden. The agreement is based on the commissioning of new wind farms. Under the agreement, AstraZeneca commits to purchasing 200 gigawatt-hours per year for 10 years, equivalent to two terawatt-hours. This corresponds to approximately 80 percent of total electricity needs at both the Company's Gothenburg site and at Södertälje, the largest manufacturing centre and one of the world's largest drug manufacturing centres
-- Agreed a 15-year partnership with Future Biogas to establish the first unsubsidised industrial-scale supply of biomethane in the UK. This biomethane will support the transition away from fossil fuels at Company sites in Macclesfield, Cambridge, Luton and Speke. A new biomethane plant will add renewable energy capacity to existing UK infrastructure and supply more than 100 gigawatt hours of biomethane, equivalent to the heat needs of more than 8,000 homes. Using crops grown locally as part of diverse crop rotations, the plant will also contribute to the development of a circular economy, supporting UK farms with sustainable land management practices
-- In China, CEO Pascal Soriot and EVP and China President Leon Wang witnessed the launch of the Sustainable Markets Initiative (SMI) China Council Health Working Group. Inspired by the SMI Health Systems Task Force, members of this new partnership will collaborate to accelerate the delivery of a net zero health system, for domestic and global impact. AstraZeneca China will co-chair this Working Group, which comprises China-based organisations and Chinese affiliates of global pharmaceutical companies
-- In the U.S., advocated for climate action and sustainable healthcare reform during Climate Week NYC by convening high-level representatives from the US government, WHO, civil society and philanthropy at a plenary event with Climate Group on "Addressing the climate-health-equity nexus: The path to a sustainable future". The Company also discussed accelerating health sector decarbonisation at the Forbes Sustainability Leaders Summit in a session on "How the healthcare industry is responding to climate change" alongside US National Academy of Medicine President Dr. Victor J. Dzau. Furthermore, the Company participated in an event on water stewardship
-- Contributed to a joint report on Advancing water stewardship through supplier collaboration in partnership with the World Wide Fund for Nature
-- Ranked in first position for climate action in a new STAT Report "Climate rankings: How top drug companies measure up in combating climate change", which noted that "Companies like AstraZeneca are the exception in an industry that, as a whole, could be doing much more to measure and report its climate impacts, according to organizations that pool data on this topic"
-- Received the EcoVadis Gold Medal for 2023, improving on the 2022 Silver rating. AstraZeneca was scored in four areas: Environment, Ethics, Labor and Human Rights, and Sustainable Procurement, and received an Advanced rating in the Environment and Human Rights categories
-- Recognised with two awards from My Green Lab and the International Institute for Sustainable Laboratories' in the 2023 Freezer Challenge: the Top Organization Award and the Small Size Lab Award for our site in Gothenburg, Sweden
Ethics and transparency
-- Received three supplier diversity awards from the Diversity for Science Alliance including 2023 Company of the year
-- Launched Global Ethics training ahead of Global Ethics Day in October, an annual reminder to employees of the Company's commitment to high ethical standards in all areas of AstraZeneca's business, marking the day with local and virtual events and an #EmpoweringEthics employee social campaign
-- Held an internal Power of Diversity panel discussion with members of the Company's Global Inclusion & Diversity (I&D) Council on the topic of putting an I&D lens over our AZ Values. This focused on building a sense of belonging through allyship, mutual support and the sharing of diverse perspectives. Supporting materials were made available through employee communication channels
Research and development
This section covers R&D events and milestones that have occurred since the prior results announcement on 28 July 2023, up to and including events on 8 November 2023.
A comprehensive view of AstraZeneca's pipeline of medicines in human trials can be found in the latest Clinical Trials Appendix, available on www.astrazeneca.com/investor-relations . The Clinical Trials Appendix includes tables with details of the ongoing clinical trials for AstraZeneca medicines and new molecular entities in the pipeline.
Oncology
AstraZeneca presented new data across its diverse portfolio of cancer medicines at two major medical congresses during the quarter: the 2023 World Conference on Lung Cancer (WCLC) in September and the 2023 European Society of Medical Oncology (ESMO) in October. At WCLC, AstraZeneca presented more than 40 abstracts featuring eight approved and potential new medicines, including nine oral presentations and a late-breaking plenary Presidential Symposium presentation of results from the FLAURA2 Phase III trial of Tagrisso plus chemotherapy in 1st-line EGFRm NSCLC. At ESMO, AstraZeneca presented nearly 100 abstracts featuring 19 approved and potential new medicines including 26 oral presentations and two late-breaking Presidential Symposia of the TROPION-Lung01 and TROPION-Breast 01 Phase III trials of monotherapy Dato-DXd versus conventional chemotherapy in lung and breast cancers.
Tagrisso
Event Commentary
------------- ----------- --------------------------------------------------------
Breakthrough US Tagrisso in combination with chemotherapy for
Designation the treatment of adult patients with locally
advanced or metastatic EGFRm lung cancer. (FLAURA2,
August 2023)
Presentation: FLAURA2 Interim analysis of the Phase III FLAURA2 trial,
WCLC presented at WCLC, demonstrated Tagrisso plus
chemotherapy extended median PFS [65] by nearly
nine months and reduced the risk of disease progression
by 38% in EGFRm advanced lung cancer vs. Tagrisso
monotherapy. (September 2023)
Priority US Tagrisso in combination with chemotherapy for
Review the treatment of adult patients with locally
advanced or metastatic EGFRm lung cancer. (FLAURA2,
October 2023)
Presentation: FLAURA2 CNS Prespecified exploratory analysis of the Phase
ESMO analysis III FLAURA2 trial, presented at ESMO, showed
Tagrisso plus chemotherapy demonstrated a 42%
improvement in CNS [66] PFS vs. Tagrisso monotherapy
in patients with EGFRm advanced lung cancer and
brain metastases at baseline, representing 40%
of patients in the trial, as assessed by blinded
independent central review. (October 2023)
------------- ----------- --------------------------------------------------------
Imfinzi and Imjudo
Event Commentary
------------- ---------- ------------------------------------------------------
Positive EU The Committee for Medicinal Products for Human
Opinion Use (CHMP) issued a positive opinion for Type
II Extension of Indication Variation for Imfinzi
as monotherapy for the first line treatment of
adults with advanced or unresectable HCC. (HIIMALAYA,
July 2023)
Presentation: MATTERHORN Interim analysis of the Phase III MATTERHORN
ESMO III trial, presented at ESMO, showed that Imfinzi
in combination with standard-of-care FLOT [67]
neoadjuvant chemotherapy demonstrated a statistically
significant and clinically meaningful 12% improvement
in the key secondary endpoint of pCR [68] vs.
neoadjuvant chemotherapy alone for patients with
resectable, early-stage and locally gastric and
GEJ [69] cancers. (October 2023)
Phase III EMERALD-1 Positive high-level results from the EMERALD-1
data readout Phase III trial showed Imfinzi in combination
with TACE [70] and bevacizumab demonstrated a
statistically significant and clinically meaningful
improvement in the primary endpoint of PFS versus
TACE alone in patients with HCC eligible for
embolisation. The trial continues to follow the
secondary endpoint of OS [71] . (November 2023)
------------- ---------- ------------------------------------------------------
Lynparza
Event Commentary
----------------- ------------- ------------------------------------------------------
Approval Japan Lynparza in combination with abiraterone and
prednisolone for the treatment of adult patients
with BRCAm mCRPC. (August 2023)
Label restriction US Restriction of the Lynparza indication for the
maintenance treatment of adult patients with
recurrent epithelial ovarian, fallopian tube,
or primary peritoneal cancer who are in a complete
or partial response to platinum-based chemotherapy
to the BRCAm (germline or somatic) patient population
only. (September 2023)
Presentation: DUO-E Primary analysis of the Phase III DUO-E Phase
ESMO (Lynparza III trial, presented at ESMO, showed that treatment
and Imfinzi) with Imfinzi plus chemotherapy followed by either
Imfinzi monotherapy or Imfinzi plus Lynparza
demonstrated a reduction in the risk of disease
progression or death, by 45% and 29%, respectively,
vs. chemotherapy alone in patients with advanced
or recurrent endometrial cancer. (October 2023)
----------------- ------------- ------------------------------------------------------
Enhertu
Event Commentary
------------- -------------- -------------------------------------------------------
Approval Japan For the treatment of adult patients with unresectable
advanced or recurrent NSCLC with HER2 (ERBB2)
mutations that has progressed after chemotherapy.
(DESTINY-Lung02, August 2023)
Breakthrough US For the treatment of adult patients with unresectable
Designation or metastatic HER2-positive (IHC [72] 3+) solid
tumours that have progressed following prior
treatment and who have no alternative treatment
options. (DESTINY-PanTumor02, August 2023)
For the treatment of patients with HER2-positive
(IHC 3+) metastatic colorectal cancer who have
received two or more prior regimens. (DESTINY-CRC01,
DESTINY-CRC02, August 2023)
Presentation: DESTINY-Lung02 Results from the primary analysis of the DESTINY-Lung02
WCLC Phase II trial, presented at WCLC, showed Enhertu
provided a median PFS of 9.9 months at a dose
of 5.4mg/kg, and 15.4 months at a dose of 6.4mg/kg,
with a favourable safety profile that confirm
5.4mg/kg is the optimal dose in this tumour type.
(September 2023)
Approval EU As monotherapy for the treatment of adult patients
with advanced NSCLC whose tumours have an activating
HER2 (ERBB2 [73] ) mutation and who require systemic
therapy following platinum-based chemotherapy
with or without immunotherapy. (DESTINY-Lung02,
October 2023)
Presentation: DESTINY-PanTumor02 Primary analysis of the Phase II DESTINY-PanTumor02
ESMO trial, presented at ESMO, showed that treatment
with Enhertu resulted in confirmed ORR [74] of
37.1%, a median PFS of 6.9 months and median
OS of 13.4 months in previously treated patients
across multiple HER2-expressing advanced solid
tumours. (October 2023)
------------- ------------------ ---------------------------------------------------
Calquence
Event Commentary
-------- ----- -------------------------------------------------
Approval China For the treatment of adult patients with CLL
or SLL [75] who have received at least one prior
therapy. (ASC, September 2023)
-------- ----- -------------------------------------------------
datopotamab deruxtecan (Dato-Dxd)
Event Commentary
------------- ---------------- -------------------------------------------------------
Presentation: TROPION-Lung04 Results from a planned interim analysis of the
WCLC Phase Ib TROPION-Lung04 trial, presented at WCLC,
showed that Dato-DXd in combination with Imfinzi,
with or without carboplatin demonstrated objective
response rates of 77% and 50% and disease control
rates of 92% and 93% respectively, with no new
safety signals in patients with previously untreated
advanced or metastatic NSCLC without actionable
genomic alterations. (September 2023)
Presentation: BEGONIA Updated results from the Phase Ib/II BEGONIA
ESMO trial, presented at ESMO, showed Dato-DXd plus
Imfinzi demonstrated a confirmed objective response
rate of 79% and a median PFS of 13.8 months in
patients with previously untreated advanced or
metastatic triple-negative breast cancer. (October
2023)
Presentation: TROPION-Lung01 Primary analysis for the Phase III TROPION-Lung01
ESMO trial, presented at ESMO, showed that Dato-DXd
reduced the risk of disease progression or death
by 25% in the overall population and by 37% in
non-squamous tumours vs. docetaxel in patients
with previously treated NSCLC. (October 2023)
Presentation: TROPION-Breast01 Primary analysis for the Phase III TROPION-Breast01
ESMO trial, presented at ESMO, showed that Dato-DXd
reduced the risk of disease progression or death
by 37%, providing a two-month median PFS benefit,
and was well tolerated in the post-endocrine
therapy setting vs. investigator's choice of
chemotherapy in patients with inoperable or metastatic
HR-positive, HER2-low or HER2-negative breast
cancer previously treated with endocrine-based
therapy and at least one systemic therapy. (October
2023)
------------- ---------------- -------------------------------------------------------
Other oncology pipeline
Event Commentary
------------- ----------- --------------------------------------------------------
Trial update MONETTE Phase II trial of ceralasertib + Imfinzi in unresectable
or advanced melanoma and resistance to PD-(L)1
inhibition stopped enrolment following a pre-specified
futility (efficacy) assessment. There were no
concerning safety signals identified at this
interim analysis or during the two prior data
review meetings.
Presentation: NCT04805307 Interim analysis for the Phase I trial (NCT04805307)
ASCO Virtual of CMG901 (Claudin 18.2 ADC [76] ) demonstrated
Plenary promising clinical efficacy in patients with
heavily pre-treated CLDN18.2-positive gastric/GEJ
cancer, with a manageable safety profile. (November
2023)
------------- ----------- --------------------------------------------------------
BioPharmaceuticals - CVRM
AstraZeneca presented 19 abstracts, including 10 oral presentations and five late-breaking presentations, at the European Society of Cardiology (ESC) Congress in August, including data highlighting the opportunities for improved management in heart failure, and AstraZeneca's leadership across the interconnectedness of chronic diseases. At the American Society of Nephrology's (ASN) Kidney Week in November, AstraZeneca presented 53 abstracts showcasing the strength of its portfolio, including new ZORA and REVOLUTIONIZE real-world evidence data for Lokelma and compelling next-wave pipeline innovation with results from the ZENITH-CKD Phase IIb trial for zibotentan/dapagliflozin.
Farxiga
Event Commentary
-------- ------- ------------------------------------------------------
Approval China Approved in China to reduce the risk of cardiovascular
death, hospitalisation for HF [77] or urgent
HF visits in adults with symptomatic chronic
HF. (June 2023)
Data T2NOW P ositive data from the Phase III T2NOW trial,
demonstrating a significant reduction in A1C
in patients aged 10-17 years compared to patients
receiving placebo. (October 2023)
Data DAPA-MI Pr imary endpoint met, non-registrational trial.
(August 2023)
-------- ------- ------------------------------------------------------
zibotentan/dapagliflozin
Event Commentary
------------- ---------- --------------------------------------------------------------
Presentation: ZENITH-CKD Phase IIb data showed statistically significant
ASN and clinically meaningful reductions in urinary
albumin-to-creatinine ratio (UACR), used to assess
albuminuria, at 12 weeks compared with the standard
of care of dapagliflozin alone. After 12 weeks
of treatment, the UACR difference of zibotentan/dapagliflozin
versus dapagliflozin alone was -33.7% (90% CI
-42.5 to -23.5; p<0.001) for high-dose (1.5 mg
zibotentan / 10 mg dapagliflozin ) and -27.0%
(90% CI -38.4 to -13.6; p=0.002) for low dose
( 0.25 mg/10mg ) . (November 2023)
------------- ---------- --------------------------------------------------------------
Eplontersen
Event Commentary ------------ --------------------------------------------------- Orphan Drug EU Orphan drug d esignation received for the treatment Designation of ATTR [78] . (October 2023) ------------ ---------------------------------------------------
BioPharmaceuticals - R&I
AstraZeneca presented new data across its inhaled, biologic and early science respiratory portfolio at the European Respiratory Society (ERS) International Congress 2023. The company presented over 90 abstracts, including 18 oral presentations, which focused on unmet needs in severe asthma, chronic obstructive pulmonary disease and other acute respiratory diseases. Data from Fasenra and Tezspire advanced clinical remission as a treatment target to change the trajectory of severe asthma care.
Fasenra
Event Commentary
------------- ------- -----------------------------------------------------------
Phase III MANDARA Positive high-level results from the MANDARA
data readout Phase III trial for Fasenra demonstrated non-inferior
rates of remission compared to mepolizumab in
patients with EGPA who were receiving oral corticosteroids
with or without stable immunosuppressive therapy.
MANDARA was the first head-to-head trial of biologics
in EGPA, comparing a single monthly injection
of Fasenra to three injections per month of mepolizumab,
the only currently approved treatment. (September
2023)
Presentation: SHAMAL SHAMAL assessed the ability of Fasenra to permit
ERS a progressive reduction from high-dose ICS/LABA
down to anti-inflammatory reliever whilst maintaining
control in SEA [79] pts who were well-controlled
on Fasenra. Fasenra enabled the majority of SEA
patients to maintain disease control and remain
exacerbation-free despite a reduction in background
therapy to anti-inflammatory reliever only. (September
2023)
Presentation: MIRACLE The positive MIRACLE Phase III trial demonstrated
ERS a reduction in annual asthma exacerbation rate
of 74% among patients in China with uncontrolled
SEA vs. placebo. A filing for regulatory approval
in China has been submitted, with a decision
expected in H2 2024. (September 2023)
------------- ------- -----------------------------------------------------------
Tezspire
Event Commentary
------------- ----------- -------------------------------------------------------
Presentation: DESTINATION In a post-hoc exploratory analysis of the DESTINATION
ERS Phase III trial of patients with severe, uncontrolled
asthma, a numerically greater proportion of patients
who received tezepelumab than placebo achieved
remission during the time periods assessed. (September
2023)
----------- -------------------------------------------------------
BioPharmaceuticals - V&I
AZD3152
Event Commentary
------------- --------------- ----------------------------------------------------
Presentation: In-vitro In vitro neutralisation data presented at ID
ID Week neutralisation Week showed that AZD3152 potently neutralises
data across a broad range of historical and contemporary
SARS-CoV-2 variants, including the newly emerging
BA.2.86 variant. AZD3152 loses activity against
XBB variants with the F456L mutation. (October
2023)
The SUPERNOVA Phase III efficacy trial, which
is now fully enrolled, will assess the potential
benefit of AZD3152 in protecting immunocompromised
patients in an environment with many variants
in circulation.
--------------- ----------------------------------------------------
FluMist
Event Commentary
----------- ------------------- -----------------------------------------------------------
sBLA Self administration The FDA has accepted for review a sBLA for the
submission approval of a self- or caregiver-administered
option for FluMist. If approved, FluMist will
be the first flu vaccine available to be self-administered
by eligible patients or administered by caregivers.
The sBLA is supported by a usability study which
confirmed that individuals over 18 years of age
could self-administer or administer FluMist to
eligible patients 2-49 years of age when given
instructions for use without any additional guidance.
(October 2023)
----------- ------------------- -----------------------------------------------------------
Rare Disease
Alexion, AstraZeneca Rare Disease presented new real-world and clinical data at the European Committee for Treatment and Research in Multiple Sclerosis and Americas Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS-ACTRIMS), offering further evidence to support the established safety and efficacy of Soliris and Ultomiris in treating NMOSD.
Alexion, AstraZeneca Rare Disease presented new clinical data at the American Society of Nephrology (ASN) for Ultomiris in IgAN [80] as well as real-world data in aHUS.
Alexion, AstraZeneca Rare Disease presented new real-world and clinical data at the American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting and Myasthenia Gravis Foundation of America Scientific Session (MGFA SS). Data shared across 13 abstracts, reinforcing the safety and efficacy of C5 inhibition in treating generalized myasthenia gravis (gMG).
Soliris
Event Commentary
-------- ----- -----------------------------------------------
Approval Japan Paediatric patients with gMG. (August 2023)
Approval China Adults with anti- aquaporin-4 antibody-positive
NMOSD. (October 2023)
-------- ----- -----------------------------------------------
Ultomiris
Event Commentary
------------- --------- -----------------------------------------------------------
CRL US The US FDA issued a CRL [81] regarding the sBLA
[82] for Ultomiris for the treatment of adults
with NMOSD. The sBLA included data from the CHAMPION-NMOSD
Phase III trial, which met the primary endpoint
with a safety profile consistent with the known
profile of the medicine. The CRL requested modifications
to enhance the Ultomiris Risk Evaluation and
Mitigation Strategy to further validate patients'
meningococcal vaccination status or prophylactic
administration of antibiotics prior to treatment.
(September 2023)
Presentation: SANCTUARY Ultomiris demonstrated c linically meaningful
ASN Phase II efficacy and proof-of-concept as a potential
treatment for IgAN, based on rapid and sustained
proteinuria reduction. (November 2023)
------------- --------- -----------------------------------------------------------
vemircopan
Event Commentary
----------- ---------- -----------------------------------------------------
Termination ACH228-110 Trial discontinued due to lack of efficacy. Following
Phase II an interim analysis, vemircopan's ability to
appropriately control intravascular haemolysis
was not adequately shown, due to significantly
increased rates of breakthrough haemolysis and
high levels of LDH [83] . No new safety findings
were observed, and the safety profile of vemircopan
has been favourable to date. This decision does
not impact ongoing Phase II trials. (September
2023)
----------- ---------- -----------------------------------------------------
gefurulimab
Event Commentary
------------ -----------------------------------------------
Orphan Drug US gefurulimab was granted orphan drug designation
Designation by the FDA for the treatment of patients with
gMG. (September 2023)
------------ -----------------------------------------------
ALXN2220
Event Commentary
------------ ----------------------------------------------
Orphan Drug US ALXN2220 was granted orphan drug designation
Designation by the FDA for the treatment of patients with
ATTR-CM [84] . (September 2023)
------------ ----------------------------------------------
Interim financial statements
Table 20 : Condensed consolidated statement of comprehensive income: 9M 2023
For the nine months ended 30 September 2023 2022
$m $m
-------- --------
Total Revenue [85] 33,787 33,144
Product Sales 32,466 32,200
Alliance Revenue 1,004 504
Collaboration Revenue 317 440
--------------------------------------------------------------------------------------------- -------- --------
Cost of sales (5,960) (9,491)
--------------------------------------------------------------------------------------------- -------- --------
Gross profit 27,827 23,653
--------------------------------------------------------------------------------------------- -------- --------
Distribution expense (394) (380)
Research and development expense (7,862) (7,137)
Selling, general and administrative expense (13,845) (13,798)
Other operating income and expense 1,233 325
--------------------------------------------------------------------------------------------- -------- --------
Operating profit 6,959 2,663
--------------------------------------------------------------------------------------------- -------- --------
Finance income 236 50
Finance expense (1,181) (986)
Share of after tax losses in associates and joint ventures (12) (4)
--------------------------------------------------------------------------------------------- -------- --------
Profit before tax 6,002 1,723
--------------------------------------------------------------------------------------------- -------- --------
Taxation (1,000) 668
--------------------------------------------------------------------------------------------- -------- --------
Profit for the period 5,002 2,391
--------------------------------------------------------------------------------------------- -------- --------
Other comprehensive income
Items that will not be reclassified to profit or loss
Remeasurement of the defined benefit pension liability (1) 1,283
Net gains/(losses) on equity investments measured at fair value through other comprehensive
income 45 (21)
Fair value movements related to own credit risk on bonds designated as fair value through
profit or loss 5 1
Tax on items that will not be reclassified to profit or loss - (291)
--------------------------------------------------------------------------------------------- -------- --------
49 972
-------- --------
Items that may be reclassified subsequently to profit or loss
Foreign exchange arising on consolidation (201) (2,493)
Foreign exchange arising on designated liabilities in net investment hedges (63) (321)
Fair value movements on cash flow hedges 62 (214)
Fair value movements on cash flow hedges transferred to profit and loss 28 250
Fair value movements on derivatives designated in net investment hedges 47 33
Costs of hedging (3) (11)
Tax on items that may be reclassified subsequently to profit or loss (7) 95
--------------------------------------------------------------------------------------------- -------- --------
(137) (2,661)
-------- --------
Other comprehensive loss, net of tax (88) (1,689)
--------------------------------------------------------------------------------------------- -------- --------
Total comprehensive income for the period 4,914 702
--------------------------------------------------------------------------------------------- -------- --------
Profit attributable to:
--------------------------------------------------------------------------------------------- -------- --------
Owners of the Parent 4,995 2,387
Non-controlling interests 7 4
--------------------------------------------------------------------------------------------- -------- --------
5,002 2,391
-------- --------
Total comprehensive income attributable to:
--------------------------------------------------------------------------------------------- -------- --------
Owners of the Parent 4,907 701
Non-controlling interests 7 1
--------------------------------------------------------------------------------------------- -------- --------
4,914 702
-------- --------
Basic earnings per $0.25 Ordinary Share $3.22 $1.54
Diluted earnings per $0.25 Ordinary Share $3.20 $1.53
Weighted average number of Ordinary Shares in issue (millions) 1,549 1,548
Diluted weighted average number of Ordinary Shares in issue (millions) 1,560 1,560
--------------------------------------------------------------------------------------------- -------- --------
Table 21 : Condensed consolidated statement of comprehensive income: Q3 2023
For the quarter ended 30 September 2023 2022
$m $m
------- -------
Total Revenue (85) 11,492 10,982
Product Sales 11,018 10,590
Alliance Revenue 377 214
Collaboration Revenue 97 178
--------------------------------------------------------------------------------------------- ------- -------
Cost of sales (2,095) (2,982)
--------------------------------------------------------------------------------------------- ------- -------
Gross profit 9,397 8,000
--------------------------------------------------------------------------------------------- ------- -------
Distribution expense (129) (126)
Research and development expense (2,584) (2,458)
Selling, general and administrative expense (4,800) (4,277)
Other operating income and expense 70 106
--------------------------------------------------------------------------------------------- ------- -------
Operating profit 1,954 1,245
--------------------------------------------------------------------------------------------- ------- -------
Finance income 101 15
Finance expense (392) (339)
Share of after tax (losses)/profits in associates and joint ventures (11) 1
--------------------------------------------------------------------------------------------- ------- -------
Profit before tax 1,652 922
--------------------------------------------------------------------------------------------- ------- -------
Taxation (274) 720
--------------------------------------------------------------------------------------------- ------- -------
Profit for the period 1,378 1,642
--------------------------------------------------------------------------------------------- ------- -------
Other comprehensive income
Items that will not be reclassified to profit or loss
Remeasurement of the defined benefit pension liability (8) 252
Net gains/(losses) on equity investments measured at fair value through other comprehensive
income 93 (9)
Fair value movements related to own credit risk on bonds designated as fair value through
profit or loss 1 (1)
Tax on items that will not be reclassified to profit or loss 5 (16)
--------------------------------------------------------------------------------------------- ------- -------
91 226
------- -------
Items that may be reclassified subsequently to profit or loss
Foreign exchange arising on consolidation (306) (1,167)
Foreign exchange arising on designated liabilities in net investment hedges 38 (126)
Fair value movements on cash flow hedges (27) (76)
Fair value movements on cash flow hedges transferred to profit and loss 99 119
Fair value movements on derivatives designated in net investment hedges 7 (1)
Costs of hedging (2) 2
Tax on items that may be reclassified subsequently to profit or loss (19) 49
--------------------------------------------------------------------------------------------- ------- -------
(210) (1,200)
------- -------
Other comprehensive loss, net of tax (119) (974)
--------------------------------------------------------------------------------------------- ------- -------
Total comprehensive income for the period 1,259 668
--------------------------------------------------------------------------------------------- ------- -------
Profit attributable to:
--------------------------------------------------------------------------------------------- ------- -------
Owners of the Parent 1,374 1,640
Non-controlling interests 4 2
--------------------------------------------------------------------------------------------- ------- -------
1,378 1,642
------- -------
Total comprehensive income attributable to:
--------------------------------------------------------------------------------------------- ------- -------
Owners of the Parent 1,255 667
Non-controlling interests 4 1
--------------------------------------------------------------------------------------------- ------- -------
1,259 668
------- -------
Basic earnings per $0.25 Ordinary Share $0.89 $1.06
Diluted earnings per $0.25 Ordinary Share $0.88 $1.05
Weighted average number of Ordinary Shares in issue (millions) 1,549 1,548
Diluted weighted average number of Ordinary Shares in issue (millions) 1,560 1,559
--------------------------------------------------------------------------------------------- ------- -------
Table 22 : Condensed consolidated statement of financial position
At 30 Sep At 31 Dec At 30 Sep
2023 2022 2022
$m $m $m
------------------------------------------------------------------ --------- --------- ---------
Assets
Non-current assets
Property, plant and equipment 8,723 8,507 8,352
Right-of-use assets 977 942 875
Goodwill 19,939 19,820 19,707
Intangible assets 37,687 39,307 39,585
Investments in associates and joint ventures 62 76 53
Other investments 1,228 1,066 1,049
Derivative financial instruments 151 74 112
Other receivables 761 835 792
Deferred tax assets 4,057 3,263 3,436
------------------------------------------------------------------- --------- --------- ---------
73,585 73,890 73,961
--------- --------- ---------
Current assets
Inventories 5,292 4,699 5,078
Trade and other receivables 11,300 10,521 9,336
Other investments 244 239 440
Derivative financial instruments 97 87 105
Intangible assets - - 82
Income tax receivable 697 731 725
Cash and cash equivalents 4,871 6,166 4,458
Assets held for sale - 150 -
------------------------------------------------------------------- --------- --------- ---------
22,501 22,593 20,224
--------- --------- ---------
Total assets 96,086 96,483 94,185
------------------------------------------------------------------- --------- --------- ---------
Liabilities
Current liabilities
Interest-bearing loans and borrowings (5,372) (5,314) (5,408)
Lease liabilities (235) (228) (210)
Trade and other payables (20,542) (19,040) (17,694)
Derivative financial instruments (83) (93) (68)
Provisions (1,193) (722) (377)
Income tax payable (1,163) (896) (1,093)
------------------------------------------------------------------- --------- --------- ---------
(28,588) (26,293) (24,850)
--------- --------- ---------
Non-current liabilities
Interest-bearing loans and borrowings (22,225) (22,965) (23,013)
Lease liabilities (744) (725) (668)
Derivative financial instruments (75) (164) (290)
Deferred tax liabilities (2,752) (2,944) (3,479)
Retirement benefit obligations (1,048) (1,168) (919)
Provisions (1,189) (896) (930)
Other payables (2,244) (4,270) (4,882)
------------------------------------------------------------------- --------- --------- ---------
(30,277) (33,132) (34,181)
--------- --------- ---------
Total liabilities (58,865) (59,425) (59,031)
------------------------------------------------------------------- --------- --------- ---------
Net assets 37,221 37,058 35,154
------------------------------------------------------------------- --------- --------- ---------
Equity
Capital and reserves attributable to equity holders of the Parent
Share capital 387 387 387
Share premium account 35,166 35,155 35,137
Other reserves 2,078 2,069 2,081
Retained earnings (434) (574) (2,471)
------------------------------------------------------------------- --------- --------- ---------
37,197 37,037 35,134
Non-controlling interests 24 21 20
Total equity 37,221 37,058 35,154
------------------------------------------------------------------- --------- --------- ---------
Table 23 : Condensed consolidated statement of changes in equity
Share Share Other Retained Total Non-controlling Total
capital premium reserves earnings attributable interests equity
account to owners
of the
parent
$m $m $m $m $m $m $m
--------------------------- -------- -------- --------- --------- ------------- --------------- -------
At 1 Jan 2022 387 35,126 2,045 1,710 39,268 19 39,287
---------------------------- -------- -------- --------- --------- ------------- --------------- -------
Profit for the period - - - 2,387 2,387 4 2,391
Other comprehensive
loss - - - (1,686) (1,686) (3) (1,689)
Transfer to other
reserves - - 36 (36) - - -
Transactions with
owners:
Dividends - - - (4,486) (4,486) - (4,486)
Issue of Ordinary
Shares - 11 - - 11 - 11
Share-based payments
charge for the period - - - 471 471 - 471
Settlement of share
plan awards - - - (831) (831) - (831)
---------------------------- -------- -------- --------- --------- ------------- --------------- -------
Net movement - 11 36 (4,181) (4,134) 1 (4,133)
---------------------------- -------- -------- --------- --------- ------------- --------------- -------
At 30 Sep 2022 387 35,137 2,081 (2,471) 35,134 20 35,154
---------------------------- -------- -------- --------- --------- ------------- --------------- -------
At 1 Jan 2023 387 35,155 2,069 (574) 37,037 21 37,058
---------------------------- -------- -------- --------- --------- ------------- --------------- -------
Profit for the period - - - 4,995 4,995 7 5,002
Other comprehensive
loss - - - (88) (88) - (88)
Transfer to other
reserves - - 9 (9) - - -
Transactions with
owners:
Dividends - - - (4,487) (4,487) - (4,487)
Dividends paid to
non-controlling interests - - - - - (4) (4)
Issue of Ordinary
Shares - 11 - - 11 - 11
Share-based payments
charge for the period - - - 429 429 - 429
Settlement of share
plan awards - - - (700) (700) - (700) ---------------------------- -------- -------- --------- --------- ------------- --------------- ------- Net movement - 11 9 140 160 3 163 ---------------------------- -------- -------- --------- --------- ------------- --------------- ------- At 30 Sep 2023 387 35,166 2,078 (434) 37,197 24 37,221 ---------------------------- -------- -------- --------- --------- ------------- --------------- -------
Table 24 : Condensed consolidated statement of cash flows
For the nine months ended 30 September 2023 2022
----------------------------------------
$m $m
---- ----
Cash flows from operating activities
Profit before tax 6,002 1,723
Finance income and expense 945 936
Share of after tax losses of associates and
joint ventures 12 4
Depreciation, amortisation and impairment 4,060 4,000
Decrease in working capital and short-term provisions 150 3,458
Gains on disposal of intangible assets (247) (88)
Fair value movements on contingent consideration
arising from business combinations 202 293
Non-cash and other movements (623) (973)
------------------------------------------------------- ------- -------
Cash generated from operations 10,501 9,353
------------------------------------------------------- ------- -------
Interest paid (826) (608)
Tax paid (1,710) (1,335)
------------------------------------------------------- ------- -------
Net cash inflow from operating activities 7,965 7,410
------------------------------------------------------- ------- -------
Cash flows from investing activities
Acquisition of subsidiaries, net of cash acquired (189) -
Payments upon vesting of employee share awards
attributable to business combinations (84) (297)
Payment of contingent consideration from business
combinations (610) (570)
Purchase of property, plant and equipment (836) (719)
Disposal of property, plant and equipment 131 17
Purchase of intangible assets (1,996) (1,298)
Disposal of intangible assets 288 442
Movement in profit-participation liability 190 -
Purchase of non-current asset investments (109) (28)
Disposal of non-current asset investments 32 42
Movement in short-term investments, fixed deposits
and other investing instruments (12) (321)
Payments to associates and joint ventures - (5)
Interest received 208 26
------------------------------------------------------- ------- -------
Net cash outflow from investing activities (2,987) (2,711)
------------------------------------------------------- ------- -------
Net cash inflow before financing activities 4,978 4,699
------------------------------------------------------- ------- -------
Cash flows from financing activities
Proceeds from issue of share capital 12 11
Issue of loans and borrowings 3,816 -
Repayment of loans and borrowings (4,655) (1,261)
Dividends paid (4,479) (4,364)
Hedge contracts relating to dividend payments (19) (127)
Repayment of obligations under leases (194) (182)
Movement in short-term borrowings 110 378
Payment of Acerta Pharma share purchase liability (867) (920)
------------------------------------------------------- ------- -------
Net cash outflow from financing activities (6,276) (6,465)
------------------------------------------------------- ------- -------
Net decrease in Cash and cash equivalents in
the period (1,298) (1,766)
Cash and cash equivalents at the beginning of
the period 5,983 6,038
Exchange rate effects (66) (86)
------------------------------------------------------- ------- -------
Cash and cash equivalents at the end of the
period 4,619 4,186
------------------------------------------------------- ------- -------
Cash and cash equivalents consist of:
Cash and cash equivalents 4,871 4,458
Overdrafts (252) (272)
------------------------------------------------------- ------- -------
4,619 4,186
------- -------
Notes to the Interim financial statements
Note 1: Basis of preparation and accounting policies
These unaudited condensed consolidated Interim financial statements for the nine months ended 30 September 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 nine months ended 30 September 2023 were approved by the Board of Directors for publication on 9 November 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 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.
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 9M 2023 relating to the nine months to 30 September 2022 has been retrospectively adjusted to reflect the new split of Total Revenue, resulting in Alliance Revenue of $504m being reported for the nine months to 30 September 2022, however the combined total of Alliance Revenue and Collaboration Revenue is equal to the previously reported Collaboration Revenue total for the nine months to 30 September 2022.
Going concern
The Group has considerable financial resources available. As at 30 September 2023, the Group has $11.8bn in financial resources (Cash and cash equivalent balances of $4.9bn 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 $5.6bn of borrowings due within one year). These facilities contain no financial covenants and were undrawn at 30 September 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 6 updates the disclosures concerning legal proceedings and contingent liabilities in the Group's Annual Report and Form 20-F Information 2022 .
IAS 12 'Income Taxes'
On 25 May 2023, the IASB issued an amendment to IAS 12 'Income Taxes' to clarify how the effects of the global minimum tax framework should be accounted for and disclosed effective 1 January 2023. This was endorsed by the UK Endorsement Board on 19 July 2023 and has been adopted by the Company for 2023 reporting. The Company is currently assessing the potential impact of these rules upon its financial statements. The Company has applied the exception to recognising and disclosing information about deferred tax assets and liabilities related to Pillar 2 income taxes.
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 impairment charges of $376m have been recorded against intangible assets during the nine months ended 30 September 2023 (9M 2022: $44m net charge). Impairment charges in respect of medicines in development were $359m (9M 2022: $61m net charge) including the $244m impairment of the ALXN1840 intangible asset, following decision to discontinue this development programme in Wilson's disease. Impairment charges in respect of launched medicines were $17m (9M 2022: $nil).
As previously disclosed, on 16 January 2023 AstraZeneca completed the acquisition of Neogene Therapeutics Inc. (Neogene), a global clinical-stage biotechnology company pioneering the discovery, development and manufacturing of next-generation T-cell receptor therapies (TCR-Ts). The purchase price allocation exercise has completed, with the fair value of total consideration determined at $267m. Intangible assets of $100m and goodwill of $158m were recognised in the acquisition balance sheet, as well as a cash outflow of $189m net of cash acquired. Future contingent milestones-based and non-contingent consideration is payable to a maximum of $120m. Neogene's results have been consolidated into the Group's results from 16 January 2023.
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. The Condensed consolidated statement of cash flows includes a $1,204m payment for the intangible assets which is presented net of the $424m cash and cash equivalents acquired within Purchase of intangible assets, whilst the $75m increase in marketable securities is presented within Movement in short-term investments, fixed deposits and other investing instruments. Contingent consideration of up to $496m could be paid on achievement of regulatory milestones, and will be recognised when the associated milestones are triggered.
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 25 : Net debt
At 1 Jan 2023 Cash flow Acquisitions Non-cash Exchange movements At 30 Sep 2023
& other
$m $m $m $m $m $m
----------------------------- ------------- --------- ------------ -------- ------------------ --------------
Non-current instalments of
loans (22,965) (3,826) - 4,592 (26) (22,225)
Non-current instalments of
leases (725) (1) (6) (23) 11 (744)
------------------------------ ------------- --------- ------------ -------- ------------------ --------------
Total long-term debt (23,690) (3,827) (6) 4,569 (15) (22,969)
Current instalments of loans (4,964) 4,655 - (4,587) 39 (4,857)
Current instalments of leases (228) 215 (2) (230) 10 (235)
Bank collateral received (89) (95) - - - (184)
Other short-term borrowings
excluding overdrafts (78) (15) - - 14 (79)
Overdrafts (183) (69) - - - (252)
------------------------------ ------------- --------- ------------ -------- ------------------ --------------
Total current debt (5,542) 4,691 (2) (4,817) 63 (5,607)
------------------------------ ------------- --------- ------------ -------- ------------------ --------------
Gross borrowings (29,232) 864 (8) (248) 48 (28,576)
Net derivative financial
instruments (96) 19 - 167 - 90
------------------------------ ------------- --------- ------------ -------- ------------------ --------------
Net borrowings (29,328) 883 (8) (81) 48 (28,486)
Cash and cash equivalents 6,166 (1,229) - - (66) 4,871
Other investments - current 239 12 - - (7) 244
------------------------------ ------------- --------- ------------ -------- ------------------ --------------
Cash and investments 6,405 (1,217) - - (73) 5,115
------------------------------ ------------- --------- ------------ -------- ------------------ --------------
Net debt (22,923) (334) (8) (81) (25) (23,371)
------------------------------ ------------- --------- ------------ -------- ------------------ --------------
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 30 September 2023 was $184m (31 December 2022: $89m) and the carrying value of such cash collateral posted by the Group at 30 September 2023 was $175m (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 $819m (31 December 2022: $1,646m), which is shown in current other payables.
Net debt increased by $448m in the nine months to 30 September 2023 to $23,371m. Details of the committed undrawn bank facilities are disclosed within the going concern section of Note 1.
During the quarter to 30 September 2023, Moody's upgraded the Company's solicited long term credit rating from A3 to A2 and its short term rating from P-2 to P-1. Standard and Poor's credit ratings were unchanged (long term: A; short term: A-1).
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 $281m at 30 September 2023 (31 December 2022: $186m) and for which fair value gains of $17m have been recognised in the nine months ended 30 September 2023 (9M 2022: $50m). 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/(losses) on equity investments measured at fair value through other comprehensive income in the Condensed consolidated statement of comprehensive income for the nine months ended 30 September 2023 are Level 1 fair value measurements, valued based on quoted prices in active markets.
Financial instruments measured at fair value include $1,296m of other investments, $3,551m held in money-market funds, $289m of loans designated at fair value through profit or loss and $90m of derivatives as at 30 September 2023. With the exception of derivatives being Level 2 fair valued, certain equity investments as described above and an equity warrant of $14m categorised as Level 3, the aforementioned balances are Level 1 fair valued. Financial instruments measured at amortised cost include $175m of cash collateral pledged to counterparties. The total fair value of interest-bearing loans and borrowings at 30 September 2023, which have a carrying value of $28,576m in the Condensed consolidated statement of financial position, was $26,576m.
As announced in April 2023, the contractual relationship between AstraZeneca and Swedish Orphan Biovitrum AB (Sobi) relating to future sales of Beyfortus (nirsevimab) in the US has been replaced by a royalty relationship between Sanofi and Sobi. As a result, a non-current other payable representing AstraZeneca's future obligations to Sobi was eliminated from AstraZeneca's Statement of Financial Position in the quarter to 30 June 2023, and AstraZeneca recorded a gain of $712m in Core Other operating income.
Table 26 : 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 (608) (2) (610) (570)
Disposals - - - (121)
Revaluations 229 (27) 202 293
Discount unwind 93 6 99 126
----------------------------------------- ----------------- ----- ----- -----
At 30 September 1,838 135 1,973 2,593
----------------------------------------- ----------------- ----- ----- -----
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 $1,838m (31 December 2022: $2,124m) would increase/decrease by $184m with an increase/decrease in sales of 10%, as compared with the current estimates.
Note 5: Pensions and other post-retirement benefit obligations
During the nine months ended 30 September 2023, AstraZeneca Pharmaceuticals PLP terminated its main defined benefit pension plan. A total of $839m of pension obligations were discharged, $142m of which was settled via a cash payment to the participants and the remaining $697m was transferred to an external insurer via a buy-out. At 30 September 2023, the plan contained immaterial residual assets and obligations which are expected to be discharged by the end of 2023, with minimal impact to the income statement.
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 2022 and the Interim Financial Statements for the six months ended 30 June 2023 (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.
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 third quarter of 2023 and to 9 November 2023
Patent litigation
Legal proceedings brought against AZ considered to be contingent liabilities
Enhertu
US patent proceedings
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 (District Court) alleging that Enhertu infringes a Seagen patent. AstraZeneca Pharmaceuticals LP co-commercialises Enhertu with Daiichi Sankyo, Inc. in the US. After trial in April 2022, the jury found that the patent was infringed and awarded Seagen $41.82m in past damages. In July 2022, the District Court entered final judgment and declined to enhance damages on the basis of willfulness. In October 2023, the District Court entered an amended final judgment that requires Daiichi Sankyo to pay Seagen a royalty of 8% on US sales of Enhertu from April 1, 2022 through November 4, 2024, in addition to the past damages previously awarded by the Court.
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 requested reconsideration of the decision not to institute review of the patent. In February 2023, the USPTO reinstituted the PGR proceeding. An oral hearing took place in August 2023. The parties await a decision.
Legal proceedings brought by AZ considered to be contingent assets
Faslodex
Patent proceedings outside the US
In 2021 in Japan, AstraZeneca received notice from the Japan Patent Office (JPO) that Sandoz K.K. (Sandoz) and Sun Pharma Japan Ltd. (Sun) were seeking to invalidate the Faslodex formulation patent. AstraZeneca defended the challenged patent, and Sun withdrew from the JPO patent challenge. In July 2023, the JPO issued a final decision upholding various claims of the challenged patent and determining that other patent claims were invalid. In August 2023, Sandoz appealed the JPO decision to the Japan IP High Court.
Calquence
US patent proceedings
In February 2022, 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 alleges that a generic version of Calquence, if approved and marketed, would infringe patents listed in the US FDA Orange Book with reference to Calquence that are owned or licensed by AstraZeneca. Trial has been scheduled for March 2025.
In February 2023, Sandoz Inc. filed a petition for inter partes review with the US Patent and Trademark Office (USPTO) of certain Calquence patent claims. AstraZeneca has asserted claims for patent infringement against Sandoz and other defendants in the US ANDA litigation. In August 2023, the Patent Trial and Appeal Board issued a decision denying institution of inter partes review.
Product liability litigation
Legal proceedings brought against AZ for which a provision has been taken
Nexium and Losec/Prilosec
US proceedings
In the US, AstraZeneca is defending various 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 related 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 had been scheduled for October 2023, with subsequent bellwether trials scheduled for November 2023 and January 2024. In addition to the MDL cases, there were cases filed in Delaware and New Jersey state courts.
In addition, AstraZeneca has been defending lawsuits involving allegations of gastric cancer following treatment with PPIs. One such claim was filed in the US District Court for the Middle District of Louisiana and is scheduled to go to trial in April 2024.
In October 2023, AstraZeneca resolved all pending claims in the MDL, as well as all of the pending claims in Delaware and New Jersey state courts, for $425m, for which a current provision has been taken. A single case remains pending in the US District Court for the Middle District of Louisiana.
Legal proceedings brought against AZ considered to be contingent liabilities
Farxiga and Xigduo XR
US proceedings
In several jurisdictions in the US, AstraZeneca has been named as a defendant in lawsuits involving plaintiffs claiming physical injury, including Fournier's Gangrene and necrotising fasciitis, from treatment with Farxiga and/or Xigduo XR. A majority of these claims are filed in Delaware state court and remain pending. In September of 2023, the parties resolved by settlement one case, filed in state court in Minnesota, previously scheduled for trial in October 2023.
Commercial litigation
Legal proceedings brought against AZ for which a provision has been taken
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 related 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. In August 2023, the parties reached a settlement in principle of this matter. In September 2023, the court granted preliminary approval of the class settlement. The court scheduled a hearing in December 2023 to rule on final approval. A provision has been recognised in the quarter.
Legal proceedings brought by AZ considered to be contingent assets
US 340B litigations and proceedings
US proceedings
AstraZeneca has been involved in several matters relating to its contract pharmacy recognition policy under the 340B Drug Pricing Program in the US.
In August 2023, AstraZeneca filed a lawsuit against the Attorney General of the State of Louisiana alleging that the Louisiana's 340B statute, which requires manufacturers to recognize an unlimited number of contract pharmacies, is preempted on several grounds and violates the Contracts Clause of the U.S. Constitution.
In September 2023, the Arkansas Insurance Department sent AstraZeneca an administrative complaint concerning compliance with Arkansas's 340B Statute, which requires manufacturers to recognize an unlimited number of contract pharmacies. AstraZeneca response is due in November 2023.
Inflation Reduction Act Litigation
US proceedings
In August 2023, AstraZeneca filed a lawsuit in the US District Court for the District of Delaware challenging aspects of the drug price negotiation provisions of the Inflation Reduction Act and the implementing guidance and regulations promulgated by the Department of Health and Human Services.
Government investigations/proceedings
Legal proceedings brought against AZ considered to be contingent liabilities
340B Qui Tam
US Proceedings
In July 2023, AstraZeneca was served with an unsealed civil lawsuit brought by a qui tam relator on behalf of the United States, several states, and the District of Columbia in the United States District Court for Central District of California. The complaint alleges that AstraZeneca violated the False Claims Act and State-Law Counterparts. In September 2023, AstraZeneca filed a motion to dismiss the relator's claims.
Subsequent events
In November, AstraZeneca announced a collaboration and investment agreement with Cellectis, a clinical-stage biotechnology company, to accelerate the development of next generation therapeutics in areas of high unmet need, including oncology, immunology and rare diseases. In Q4 2023, under the terms of the collaboration agreement, Cellectis will receive an initial payment of $105m from AstraZeneca, which comprises a $25m upfront cash payment and an $80m equity investment. AstraZeneca expects to treat its investment in Cellectis as an associate.
In November, AstraZeneca and Eccogene entered into an exclusive licence agreement for ECC5004, an investigational oral once-daily GLP-1RA for the treatment of obesity, type-2 diabetes and other cardiometabolic conditions. Under the terms of the agreement, AstraZeneca obtained exclusive global rights for development and commercialisation in all territories except China where Eccogene has the right to co-develop and co-commercialise alongside AstraZeneca. Eccogene will receive an initial upfront payment of $185m and up to an additional $1.825bn in future clinical, regulatory, and commercial milestones and tiered royalties.
Note 7
Table 27 : 9M 2023 - Product Sales year-on-year analysis [86]
World US Emerging Markets Europe Established RoW
$m Act CER $m % chg $m Act CER $m Act CER $m Act CER
% chg % chg % chg % chg % chg % chg % chg % chg
-------------------- ------ ----- ----- ------ ----- ----- ----- ----- ----- ----- ----- ----- ----- -----
Oncology 12,692 17 20 5,652 20 2,925 7 15 2,428 19 19 1,687 18 28
Tagrisso 4,380 7 10 1,679 14 1,261 4 11 821 6 6 619 (4) 5
Imfinzi 3,102 53 56 1,708 55 270 20 31 547 36 35 577 90 n/m
Lynparza 2,070 6 9 902 1 409 14 24 543 10 10 216 7 16
Calquence 1,839 25 26 1,337 12 69 n/m n/m 353 76 77 80 64 74
Enhertu 178 n/m n/m - - 121 n/m n/m 40 n/m n/m 17 n/m n/m
Orpathys 33 (3) 4 - - 33 (3) 4 - - - - - -
Zoladex 699 (3) 5 12 9 521 3 11 98 (2) (1) 68 (31) (24)
Faslodex 217 (16) (10) 9 (38) 113 (6) - 22 (50) (50) 73 (8) -
Others 174 (36) (32) 5 (36) 128 (38) (34) 4 (41) (40) 37 (29) (22)
-------------------- ------ ----- ----- ------ ----- ----- ----- ----- ----- ----- ----- ----- ----- -----
BioPharmaceuticals:
CVRM 7,887 14 18 1,972 11 3,507 10 18 1,825 29 29 583 10 19
Farxiga 4,358 36 40 1,000 34 1,653 35 43 1,356 42 41 349 26 36
Brilinta 996 (2) - 551 2 224 1 10 203 (5) (5) 18 (54) (51)
Lokelma 300 44 49 156 28 37 n/m n/m 41 98 99 66 32 44
roxadustat 208 41 51 - - 208 41 51 - - - - - -
Andexxa 129 16 19 57 (8) - - - 44 51 51 28 40 54
Crestor 860 4 11 40 (19) 678 8 15 41 38 38 101 (11) (4)
Seloken /Toprol-XL 496 (30) (23) - - 482 (30) (24) 8 (19) (19) 6 (18) (13)
Onglyza 180 (12) (8) 44 (26) 99 1 9 25 (17) (17) 12 (30) (27)
Bydureon 123 (40) (40) 101 (43) 2 15 14 20 (30) (30) - - -
Others 237 (16) (13) 23 (13) 124 (19) (13) 87 (10) (10) 3 (52) (49)
-------------------- ------ ----- ----- ------ ----- ----- ----- ----- ----- ----- ----- ----- ----- -----
BioPharmaceuticals:
R&I 4,517 5 8 1,900 (3) 1,315 19 29 847 7 7 455 (1) 6
Symbicort 1,842 (4) (1) 589 (18) 600 26 36 408 (8) (8) 245 (12) (7)
Fasenra 1,134 12 13 718 11 48 62 69 262 14 14 106 (1) 6
Breztri 478 69 73 263 60 123 73 86 55 n/m n/m 37 48 58
Saphnelo 191 n/m n/m 178 n/m 1 n/m n/m 5 n/m n/m 7 n/m n/m
Tezspire 51 n/m n/m - - - - - 28 n/m n/m 23 n/m n/m Pulmicort 493 3 10 22 (58) 392 16 24 49 (1) - 30 (18) (13) Bevespi 42 (2) (2) 24 (23) 5 21 32 12 70 70 1 59 10 Daliresp /Daxas 41 (74) (74) 32 (79) 2 (23) (10) 6 (9) (9) 1 3 (25) Others 245 (30) (27) 74 (44) 144 (20) (14) 22 (35) (34) 5 (4) 2 -------------------- ------ ----- ----- ------ ----- ----- ----- ----- ----- ----- ----- ----- ----- ----- BioPharmaceuticals: V&I 667 (82) (81) 15 (98) 181 (82) (81) 236 (66) (66) 235 (76) (73) COVID-19 mAbs 126 (91) (90) - n/m 5 (97) (97) 7 (97) (96) 114 (51) (45) Vaxzevria 28 (98) (98) - n/m 18 (97) (97) 10 (97) (97) - n/m n/m Beyfortus 52 n/m n/m - - - - - 52 - - - - - Synagis 383 - 6 (1) n/m 158 9 15 109 (12) (9) 117 2 11 FluMist 78 32 28 16 44 - n/m n/m 58 28 22 4 79 71 -------------------- ------ ----- ----- ------ ----- ----- ----- ----- ----- ----- ----- ----- ----- ----- Rare Disease 5,793 11 12 3,469 9 487 54 68 1,165 8 8 672 1 9 Soliris 2,429 (17) (15) 1,313 (22) 338 55 74 530 (15) (15) 248 (36) (31) Ultomiris 2,141 56 58 1,260 63 47 38 39 495 43 42 339 54 68 Strensiq 847 23 24 690 26 29 14 16 64 9 8 64 12 22 Koselugo 246 65 65 144 26 49 n/m n/m 38 n/m n/m 15 n/m n/m Kanuma 130 17 18 62 11 24 53 55 38 13 12 6 4 12 -------------------- ------ ----- ----- ------ ----- ----- ----- ----- ----- ----- ----- ----- ----- ----- Other medicines 910 (27) (22) 104 (7) 580 (5) 3 67 (29) (29) 159 (63) (60) Nexium 735 (25) (20) 88 (6) 458 5 14 36 (1) (2) 153 (63) (60) Others 175 (33) (31) 16 (13) 122 (29) (25) 31 (47) (47) 6 (54) (50) -------------------- ------ ----- ----- ------ ----- ----- ----- ----- ----- ----- ----- ----- ----- ----- Total Product Sales 32,466 1 4 13,112 3 8,995 1 8 6,568 7 7 3,791 (16) (9) -------------------- ------ ----- ----- ------ ----- ----- ----- ----- ----- ----- ----- ----- ----- -----
Table 28 : Q3 2023 - Product Sales year-on-year analysis [87]
World US Emerging Markets Europe Established RoW
$m Act CER $m % chg $m Act CER $m Act CER $m Act CER
% chg % chg % chg % chg % chg % chg % chg % chg
-------------------- ------ ----- ----- ----- ----- ----- ----- ----- ----- ----- ----- ----- ----- -----
Oncology 4,389 16 17 1,986 16 971 4 13 849 22 15 583 28 35
Tagrisso 1,465 5 6 577 11 409 1 8 281 5 (1) 198 (3) 2
Imfinzi 1,126 53 54 610 48 87 (4) 7 208 54 45 221 n/m n/m
Lynparza 702 7 8 322 3 131 12 26 178 8 2 71 11 16
Calquence 654 16 15 468 2 28 n/m n/m 128 63 54 30 65 72
Enhertu 73 n/m n/m - - 48 n/m n/m 16 n/m n/m 9 n/m n/m
Orpathys 12 6 13 - - 12 6 13 - - - - - -
Zoladex 239 - 5 5 29 182 4 11 31 (1) (6) 21 (29) (25)
Faslodex 64 (21) (16) 3 (41) 32 (19) (13) 6 (53) (55) 23 (5) -
Others 54 (33) (30) 1 (59) 42 (34) (32) 1 11 11 10 (30) (22)
-------------------- ------ ----- ----- ----- ----- ----- ----- ----- ----- ----- ----- ----- ----- -----
BioPharmaceuticals:
CVRM 2,683 14 16 690 9 1,161 7 15 657 40 32 175 6 10
Farxiga 1,554 41 41 366 31 579 41 48 506 54 45 103 24 29
Brilinta 331 (2) (1) 193 4 64 (16) (4) 68 4 (2) 6 (45) (46)
Lokelma 102 30 31 51 15 13 39 48 16 97 87 22 31 38
roxadustat 74 31 39 - - 74 30 39 - - - - - -
Andexxa 40 (3) (5) 20 - - - - 15 32 20 5 (50) (47)
Crestor 275 (1) 6 14 (10) 219 2 9 9 6 3 33 (11) (7)
Seloken /Toprol-XL 153 (36) (29) - - 149 (36) (29) 2 (45) (45) 2 (4) (18)
Onglyza 53 (20) (17) 9 (57) 33 - 9 8 (9) (16) 3 (27) (25)
Bydureon 35 (48) (49) 28 (52) 1 97 90 6 (25) (30) - - -
Others 66 (23) (21) 9 15 29 (40) (37) 27 (1) (2) 1 (42) (39)
-------------------- ------ ----- ----- ----- ----- ----- ----- ----- ----- ----- ----- ----- ----- -----
BioPharmaceuticals:
R&I 1,451 2 3 609 (8) 422 14 23 266 9 2 154 3 7
Symbicort 555 (12) (10) 156 (34) 195 15 24 123 (7) (13) 81 (11) (8)
Fasenra 389 10 10 249 9 19 56 67 86 12 5 35 1 4
Breztri 171 66 69 98 69 42 51 62 19 n/m n/m 12 37 46
Saphnelo 76 n/m n/m 71 n/m - - - 2 n/m n/m 3 n/m n/m
Tezspire 21 n/m n/m - - - - - 11 n/m n/m 10 n/m n/m
Pulmicort 148 2 7 5 (69) 119 16 24 13 (11) (16) 11 (8) (5)
Bevespi 13 (5) (4) 8 (23) 2 (2) 7 3 77 72 - - -
Daliresp /Daxas 11 (79) (79) 8 (83) - (36) (2) 2 (2) (18) 1 n/m -
Others 67 (31) (28) 14 (55) 45 (20) (14) 7 (14) (19) 1 (7) 7
-------------------- ------ ----- ----- ----- ----- ----- ----- ----- ----- ----- ----- ----- ----- -----
BioPharmaceuticals:
V&I 224 (74) (74) 15 (95) 32 (76) (75) 122 (33) (35) 55 (78) (77)
COVID-19 mAbs - n/m n/m - n/m - n/m n/m - n/m n/m - n/m n/m
Vaxzevria - n/m n/m - - - n/m n/m - n/m n/m - n/m n/m
Beyfortus 50 n/m n/m - - - - - 50 - - - - -
Synagis 99 (5) (1) - - 32 (13) (7) 16 (4) (10) 51 1 6
FluMist 75 28 23 15 41 - - - 56 22 16 4 81 76
-------------------- ------ ----- ----- ----- ----- ----- ----- ----- ----- ----- ----- ----- ----- -----
Rare Disease 1,974 13 14 1,179 9 163 49 70 397 15 8 235 16 22
Soliris 781 (13) (12) 420 (20) 124 47 71 163 (14) (19) 74 (28) (26)
Ultomiris 777 50 49 445 41 17 n/m n/m 184 51 41 131 70 78
Strensiq 285 20 21 237 23 5 (32) (10) 22 17 8 21 13 19
Koselugo 87 81 81 54 51 11 51 69 15 n/m n/m 7 n/m n/m
Kanuma 44 21 19 23 27 6 (4) (2) 13 31 23 2 (10) (5)
-------------------- ------ ----- ----- ----- ----- ----- ----- ----- ----- ----- ----- ----- ----- -----
Other medicines 297 (27) (22) 36 (3) 190 (11) (4) 19 (32) (34) 52 (59) (56)
Nexium 244 (22) (17) 29 (6) 153 3 13 11 5 (2) 51 (59) (56)
Others 53 (43) (41) 7 10 37 (44) (41) 8 (54) (53) 1 (66) (57)
-------------------- ------ ----- ----- ----- ----- ----- ----- ----- ----- ----- ----- ----- ----- -----
Total Product Sales 11,018 4 5 4,515 2 2,939 3 12 2,310 18 11 1,254 (7) (3)
-------------------- ------ ----- ----- ----- ----- ----- ----- ----- ----- ----- ----- ----- ----- -----
Table 29 : Alliance Revenue
9M 2023 9M 2022
$m $m
------- -------
Enhertu 741 335
Tezspire 179 42
Vaxzevria: royalties - 67
Other royalty income 59 51
Other Alliance Revenue 25 9
------------------------ ------- -------
Total 1,004 504
------------------------ ------- -------
Table 30 : Collaboration Revenue
9M 2023 9M 2022
$m $m
------- -------
Lynparza : regulatory milestones - 250
COVID-19 mAbs: licence fees 180 -
Farxiga : sales milestones 28 -
tralokinumab: sales milestones 20 110
Beyfortus : regulatory milestones 71 -
Other Collaboration Revenue 18 80
----------------------------------- ------- -------
Total 317 440
----------------------------------- ------- -------
Table 31 : Other operating income and expense
9M 2023 9M 2022
$m $m
------- -------
brazikumab licence termination funding 75 104
Divestment of rights to Plendil - 61
Divestment of US rights to Pulmicort Flexhaler 241 -
Update to the contractual relationships for Beyfortus (nirsevimab) 712 -
Other 205 160
-------------------------------------------------------------------- ------- -------
Total 1,233 325
-------------------------------------------------------------------- ------- -------
Other shareholder information
Financial calendar
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
Contacts
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Addresses for correspondence
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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 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 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 impact that global and/or geopolitical events 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
-- the risk of failure in financial control or the occurrence of fraud -- the risk of unexpected deterioration in the Group's financial position
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 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.
[2] 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 policies section of the Notes to the Interim financial statements section.
[3] 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.
[4] Earnings per share.
[5] 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, legal settlements and restructuring charges. A full reconciliation between Reported EPS and Core EPS is provided in Table 13 and Table 14 in the Financial performance section of this document.
[6] The COVID-19 medicines are Vaxzevria, Evusheld, and AZD3152 - the COVID-19 antibody currently in development.
[7] Cardiovascular, Renal and Metabolism.
[8] Respiratory & Immunology.
[9] The calculation of Reported and Core Product Sales Gross Margin (formerly termed as Gross Margin) excludes the impact of Alliance Revenue and Collaboration Revenue.
[10] Programmed cell death protein 1/cytotoxic T-lymphocyte-associated protein 4. [11] Glucagon-like peptide 1 receptor agonist. [12] Hormone receptor. [13] Eosinophilic granulomatosis with polyangiitis. [14] Human epidermal growth factor receptor 2. [15] Relapsed or refractory chronic lymphocytic leukaemia. [16] Neuromyelitis optica spectrum disorder. [17] Epidermal growth factor receptor mutation. [18] Non-small cell lung cancer. [19] Vaccines & Immune Therapies.
[20] 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.
[21] Cost of goods sold.
[22] 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.
[23] Metastatic castration-resistant prostate cancer. [24] Human epidermal growth factor receptor mutant. [25] Chronic lymphocytic leukaemia. [26] Heart failure with preserved ejection fraction. [27] Atypical haemolytic uraemic syndrome. [28] Paroxysmal nocturnal haemoglobinuria. [29] Programmed death-ligand 1. [30] Chronic kidney disease. [31] Chronic obstructive pulmonary disease. [32] Pressure metered dose inhaler.
[33] Product Sales shown in the Imfinzi line include Product Sales from Imjudo.
[34] COVID-19 monoclonal antibodies.
[35] National reimbursement drug list.
[36] Biliary tract cancer.
[37] Hepatocellular carcinoma.
[38] Small cell lung cancer.
[39] Poly ADP ribose polymerase.
[40] Platinum sensitive relapse.
[41] Breast cancer gene mutation.
[42] Germline (hereditary) breast cancer gene mutation.
[43] Bruton tyrosine kinase inhibitor.
[44] Sodium-glucose cotransporter 2.
[45] Type-2 diabetes.
[46] Heart failure with reserved ejection fraction.
[47] European Society of Cardiology.
[48] Fixed dose combination.
[49] 'New-to-brand' share represents a medicine's share in the dynamic market.
[50] Inhaled corticosteroid.
[51] Long-acting beta-agonist.
[52] Respiratory syncytial virus.
[53] Complement component 5.
[54] Generalised myasthenia gravis.
[55] Other Operating Income.
[56] Other adjustments include fair-value adjustments relating to contingent consideration on business combinations and other acquisition-related liabilities, discount unwind on acquisition-related liabilities (see Note 4) and provision movements related to certain legal matters, including a $510m charge to provisions relating to a legal settlement with BMS and Ono and a $425m charge to provisions relating to a multidistrict litigation proceeding legal settlement in 9M 2023 (see Note 6).
[57] Other adjustments include fair-value adjustments relating to contingent consideration on business combinations and other acquisition-related liabilities, discount unwind on acquisition-related liabilities (see Note 4) and provision movements related to certain legal matters, including a $425m charge to provisions relating to a multidistrict litigation proceeding legal settlement in Q3 2023 (see Note 6).
[58] Securities Exchange Commission.
[59] Based on best prevailing assumptions around currency profiles.
[60] Based on average daily spot rates 1 Jan 2022 to 31 Dec 2022.
[61] Based on average daily spot rates 1 Jan 2023 to 30 Sep 2023.
[62] Based on average daily spot rates 1 Sep 2023 to 30 Sep 2023.
[63] Change vs. the average spot rate for the previous year
[64] Other currencies include AUD, BRL, CAD, KRW and RUB.
[65] Progression free survival.
[66] Central nervous system.
[67] Fluorouracil, oxaliplatin and docetaxel .
[68] Pathologic complete response.
[69] Gastro oesophageal junction.
[70] Transarterial chemoembolisation.
[71] Overall survival.
[72] Immunohistochemistry.
[73] v-erb-b2 avian erythroblastic leukemia viral oncogene homolog 2.
[74] Overall response rate.
[75] Small lymphocytic lymphoma.
[76] Antibody drug conjugate.
[77] Heart failure.
[78] Transthyretin-mediated amyloid cardiomyopathy and transthyretin-mediated amyloid polyneuropathy
[79] Severe eosinophilic asthma.
[80] Immunoglobulin A neuropathy.
[81] Compete Response Letter.
[82] Supplemental biologics license application.
[83] Lactic dehydrogenase.
[84] Transthyretin-mediated amyloid cardiomyopathy.
[85] 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.
[86] 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.
[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.
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