FORM 6-K
 
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
Report of Foreign Issuer
 
Pursuant to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934
 
For the month of November 2022
 
Commission File Number: 001-11960
 
AstraZeneca PLC
 
1 Francis Crick Avenue
Cambridge Biomedical Campus
Cambridge CB2 0AA
United Kingdom
 
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
 
Form 20-F X               Form 40-F __
 
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
 
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ______
 
Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
 
Yes __                  No X
 
If “Yes” is marked, indicate below the file number assigned to the Registrant in connection with Rule 12g3-2(b): 82-_____________
 
 
 
 
 
AstraZeneca PLC
 
INDEX TO EXHIBITS
 
 
1.  YTD and Q3 2022 Results
 
 
 
 
AstraZeneca PLC
10 November 2022 07:00 GMT 
YTD and Q3 2022 results
 
Record number of regulatory approvals and guidance uplift underpinned by strong business performance
 
Revenue and EPS summary
 
 
 
 
YTD 2022 
 
 
Q3 2022 
 
 
 
 
    % Change
 
    % Change 
 
 
$m 
Actual 
CER[1]
$m 
Actual 
CER 
- Product Sales 
 
32,200 
    29 
35 
10,590 
16 
- Collaboration Revenue 
 
944 
>2x 
>2x 
392 
>3x 
>3x 
Total Revenue 
 
33,144 
30 
37 
10,982 
11 
19 
Reported [2] EPS[3]
 
$1.54 
>4x 
>4x 
$1.06 
n/m 
n/m 
Core[4] EPS 
 
$5.28 
47 
52 
$1.67 
55 
70 
 
YTD 2022 Financial performance (growth numbers and commentary at CER[5])
‒    Total Revenue increased 37% to $33,144m, with growth coming from all disease areas, and from the addition of Alexion, which was incorporated into the Group's results from 21 July 2021
 
‒    Oncology Total Revenue increased 24%, inclusive of milestone payments from MSD[6] for Lynparza.  Oncology Product Sales increased 20%. Total Revenue from R&I[7] increased 4%, CVRM[8] increased 19%[9] and Rare Disease increased 10%
 
‒    Core Gross Margin of 81%, up six percentage points at CER, reflecting the lower revenue from initial Vaxzevria contracts and the increased share of specialty care medicines
 
‒    Core Total Operating Expense increased 26%, reflecting the addition of Alexion, continued investment in new launches and the pipeline, to deliver sustainable long-term growth
 
‒    Core Operating Margin of 32%, up six percentage points at CER, benefitting from favourable phasing and product mix
 
‒    Core EPS increased 52% to $5.28
 
‒    FY 2022 Core EPS at constant exchange rates now expected to increase by a high twenties to low thirties percentage, vs previous guidance of a mid-to-high twenties increase. At actual exchange rates, FY 2022 Core EPS growth is anticipated to be impacted by a currency headwind[10] of a mid-to-high single-digit percentage, versus previous guidance of a mid single-digit headwind
 
Key milestones achieved since the prior results
‒    Key data: Positive Phase III read-outs for danicopan in PNH-EVH[11] (ALPHA) and for capivasertib in 2nd-line HR-positive, metastatic breast cancer (CAPItello-291)
 
‒    Key regulatory approvals: 19 approvals in major markets since H1 2022 results, including US approvals for Enhertu in HER2[12]-low breast cancer (DESTINY-Breast04) and advanced NSCLC[13] (DESTINY-Lung02), Imjudo and Imfinzi in advanced liver cancer (HIMALAYA), Imfinzi in advanced biliary tract cancer (TOPAZ-1); EU approval for Beyfortus for the prevention of RSV[14] lower respiratory tract disease (MELODY/MEDLEY); EU and Japan approvals for Ultomiris in gMG[15] (CHAMPION-MG), Tezspire in severe asthma (NAVIGATOR) and Lynparza in early breast cancer (OlympiA)
 
‒    Other regulatory milestones: US Priority Review for Lynparza for 1st-line metastatic castration-resistant prostate cancer (PROpel)
 
Pascal Soriot, Chief Executive Officer, AstraZeneca, said:
"AstraZeneca continues to see the benefit of our sustained investment in R&D, with 19 major regulatory approvals since our last earnings call.
 
After a strong performance in the year to date, we have increased our Core EPS guidance for the full year 2022. Additionally, recent encouraging data for several of our pipeline programmes have given us the confidence to proceed with additional late-stage clinical trials as we maintain our focus on delivery of our growth ambitions.
 
I would also like to highlight the announcement at COP27 to accelerate the delivery of our net zero strategy. Our company intends to lead by example on this increasingly important objective for the world."
 
Guidance
The Company updates its FY 2022 guidance at CER, due to the strong performance in the year to date. The guided range for FY 2022 Core EPS has been increased to a high twenties to low thirties percentage; the final outcome within that range will depend on the timing of Evusheld deliveries and collaboration milestones linked to regulatory events.
 
At actual exchange rates, it is anticipated that FY 2022 Total Revenue growth will also be impacted by a currency headwind of a mid single-digit percentage, and that FY 2022 Core EPS growth will be impacted by a currency headwind of a mid-to-high single-digit percentage (see 'Currency impact', below).
 
 

 
Total Revenue is expected to increase by a low twenties percentage (unchanged)
Core EPS is expected to increase by a high twenties to low thirties percentage
(previously mid-to-high twenties percentage)
 
 

 
Other elements of the Income Statement are expected to be broadly in line with the indications issued in the Company's H1 2022 results announcement (29 July 2022).
 
AstraZeneca continues to recognise geopolitical and supply chain uncertainties on overall business performance. Variations in performance between quarters can be expected to continue.
 
The Company is unable to provide guidance on a Reported basis because AstraZeneca cannot reliably forecast material elements of the Reported result, including any fair value adjustments arising on acquisition-related liabilities, intangible asset impairment charges and legal settlement provisions. Please refer to the cautionary statements section regarding forward-looking statements at the end of this announcement.
 
Currency impact
The growth numbers in the guidance above are provided at CER, based on the average exchange rates through 2021.
 
If foreign-exchange rates for November to December 2022 were to remain at the spot rates seen on 31 October 2022, it is anticipated that FY 2022 Total Revenue would incur a mid single-digit adverse impact versus the performance at CER, and FY 2022 Core EPS would incur a mid-to-high single-digit adverse impact (previously a mid single-digit adverse impact).
 
The Company's foreign-exchange rate sensitivity analysis is provided in Table 17.
 
Table 1: Key elements of Total Revenue performance in Q3 2022
 
 
% Change 
 
 
 
Revenue type 
 
$m 
Actual 
CER 
 
 
Product Sales 
 
10,590 
16 
 
Strong Oncology and BioPharmaceuticals sales
$1,734m from medicines acquired with Alexion 
Collaboration Revenue 
 
392 
>3x 
>3x 
 
$160m for Enhertu (Q3 2021: $52m)
$26m for Tezspire (Q3 2021: $nil)
Milestones of $75m for Lynparza, $62m for Nexium and $40m for tralokinumab
 
Total Revenue 
 
10,982 
11 
19 
 
 
 
Disease areas
 
$m 
Actual 
CER 
 
 
Oncology 
 
4,039 
20 
27 
 
Good performance across key medicines and regions
 
CVRM
 
2,351 
11 
18 
 
Farxiga achieved its third consecutive blockbuster quarter with $1,103m in revenues
 
R&I 
 
1,499 
 
Growth across Breztri and Fasenra offsetting a decline in Pulmicort of 33% (31% at CER) primarily due to the impact of VBP[16] implementation and COVID-19 lockdowns in China 
 
V&I[17]
 
878 
(29)
(24)
 
$180m from Vaxzevria[18] (Q3 2021: $1,050m)
$536m from Evusheld (Q3 2021: $nil)
 
Rare Disease
 
1,741 
11 
 
$518m from Ultomiris which was up 37% (47% at CER)
 
Other Medicines 
 
474 
34 
50 
 
Includes a Collaboration Revenue milestone of $62m for Nexium. Nexium revenue in Q3 2021 was negatively impacted by a transition in distribution partners
 
Total Revenue 
 
10,982 
11 
19 
 
 
 
Regions inc. Vaxzevria 
 
$m 
Actual 
CER 
 
 
Emerging Markets 
 
2,856 
(10)
(4)
 
Decline due to lower sales of Vaxzevria (growth rates excluding Vaxzevria shown below)
 
- China 
 
1,541 
 
Q3 2021 was negatively impacted by Tagrisso inventory phasing and stock compensation following NRDL[19] changes
 
- Ex-China Emerging Markets 
 
1,316 
(21)
(15)
 
Decline due to lower sales of Vaxzevria
US 
 
4,650 
34 
34 
 
 
Europe 
 
2,065 
23 
 
 
Established RoW 
 
1,412 
26 
 
 
Total Revenue inc. Vaxzevria
 
10,982 
11 
19 
 
 
 
Regions exc. Vaxzevria 
 
$m 
Actual 
CER 
 
 
Contribution of medicines acquired with Alexion
Emerging Markets 
 
2,826 
13 
20 
 
$102m 
- China 
 
1,541 
 
 
- Ex-China Emerging Markets 
 
1,285 
26 
37 
 
$102m 
 
US 
 
4,650 
34 
34 
 
$1,069m 
 
Europe 
 
2,002 
14 
30 
 
$351m 
 
Established RoW 
 
1,325 
22 
45 
 
$212m 
 
Total Revenue exc. Vaxzevria
 
10,803 
23 
31 
 
$1,734m 
 
 
 
 
 
 
 
 
Table 2: Key elements of financial performance in Q3 2022
 
Metric
 
Reported
Reported change
Core
Corechange
 
Comments[20]
Total Revenue
$10,982m
11% Actual      19% CER
$10,982m
11% Actual      19% CER
 
See Table 1 and the Total Revenue section of this document for further details
 
Gross Margin[21]
72%
10pp Actual      11pp CER
81%
6pp Actual      7pp CER
 
+  Addition of Alexion
+  Increasing mix of Oncology sales
‒   Impact from profit-sharing arrangements(e.g. Lynparza)
‒   Reported Gross Margin impacted by unwind of Alexion inventory fair value adjustment
R&D Expense
$2,458m
-32% Actual      -28% CER
$2,357m
10% Actual      16% CER
 
+  Addition of Alexion
+  Increased investment in the pipeline following ungating of additional late-stage trials
Reported R&D Expense in Q3 2021 included a $1,172m impairment charge
Core R&D-to-Total Revenue ratio of 21%(Q3 2021: 22%)
SG&A Expense
$4,277m
5% Actual      9% CER
$3,160m
10% Actual      16% CER
 
+  Addition of Alexion
+  Market development activities for recent launches, including Evusheld
+  Core SG&A-to-Total Revenue ratio of 29%(Q3 2021: 29%)
Other Operating Income[22]
$106m
>2x Actual      >2x CER
$107m
>2x Actual      >3x CER
 
Includes income from royalties and prior transactions
Operating Margin
11%
28pp Actual      30pp CER
31%
8pp Actual      9pp CER
 
See Gross Margin and Expensescommentary above
Net Finance Expense
$324m
1% Actual      2% CER
$254m
16% Actual      14% CER
 
+  Foreign exchange movements
+  Interest rate increase on floating rate liabilities
Reported impacted by discount unwind on acquisition-related liabilities
Tax Rate
-78%
n/m
18%
-3pp Actual      -3pp CER
 
18% Core Tax Rate in the quarter reflected geographical mix of profits and favourable adjustments to prior year tax liabilities in a number of major jurisdictions
Reported affected by a $883m deferred tax credit arising from a legal entity  reorganisation to integrate Alexion
Variations in the tax rate can be expected to continue quarter to quarter
EPS
$1.06
n/m
$1.67
55% Actual      70% CER
 
Further details of differences between Reported and Core are shown in Table 12
 
Table 3: Pipeline highlights since prior results announcement
 
Event
Medicine
Indication / Trial
Event
Regulatory approvals and other regulatory actions
Tagrisso
NSCLC (adjuvant) (ADAURA)
Regulatory approval (JP)
Imfinzi
Biliary tract cancer (TOPAZ-1)
Regulatory approval (US)
Imfinzi
Liver cancer (1st-line) (HIMALAYA)
Regulatory approval (US)
Lynparza
gBRCA[23] breast cancer (adjuvant) (OlympiA)
Regulatory approval (EU, JP)
Lynparza
HRD[24]-positive advanced ovarian cancer (1st-line maint.) (PAOLA-1)
Regulatory approval (CN)
Enhertu
HER2-low breast cancer (3rd-line) (DESTINY-Breast04)
Regulatory approval (US)
Enhertu
HER2m[25] NSCLC (2nd-line+) (DESTINY-Lung02)
Regulatory approval (US)
Calquence
Maleate tablet formulation
Regulatory approval (US)
Forxiga
CKD[26] (DAPA-CKD)
Regulatory approval (CN)
Tezspire
Severe asthma (NAVIGATOR)
Regulatory approval (EU, JP)
Beyfortus
RSV (MELODY/MEDLEY)
Regulatory approval (EU)
Evusheld
COVID-19 (PROVENT/TACKLE)
Regulatory approval (JP)
Evusheld
COVID-19 (TACKLE)
Regulatory approval (EU)
Soliris
PNH and aHUS[27]
Regulatory approval (CN)
Ultomiris
gMG (CHAMPION-MG)
Regulatory approval (EU, JP)
Koselugo
NF1-PN[28] (SPRINT)
Regulatory approval (JP)
Regulatory submissionsor acceptances
 
Lynparza
Prostate cancer (1st-line) (PROpel)
Priority Review (US)
Enhertu
HER2-low breast cancer (3rd-line) (DESTINY-Breast04)
Regulatory submission (CN)
Farxiga/Forxiga
HFpEF[29] (DELIVER)
Regulatory submission (US, EU, JP, CN)
Ultomiris
NMOSD[30] (CHAMPION-NMOSD)
Regulatory submission (US, EU, JP)
Major Phase III data readouts and other developments
capivasertib
HR+/HER2-neg breast cancer (1st-line)
(CAPItello-291)
Primary endpoint met
monalizumab
Recurrent or metastatic HNSCC[31](2nd-line) (INTERLINK-1)
Efficacy threshold not met
Fasenra
EoE[32] (MESSINA)
One of two dual-primary endpoints not met
Soliris
Guillain-Barré syndrome
Primary endpoint not met
danicopan
PNH with extravascular haemolysis
Primary endpoint met
 
Corporate and business development
In October 2022, AstraZeneca entered a definitive agreement to acquire LogicBio Therapeutics, Inc. (NASDAQ: LOGC), a pioneering genomic medicine company. The proposed acquisition aims to rapidly accelerate Alexion's growth in genomic medicines through LogicBio's unique technology, experienced rare disease R&D team, and expertise in pre-clinical development.
 
Sustainability summary
AstraZeneca attended COP27, where the Sustainable Markets Initiative Health Systems Task Force collectively made significant commitments to tackle the climate crisis, setting a benchmark for others to drive action at scale. Some commitment highlights include supply chain emissions, which drive approximately 50% of healthcare emissions: the Task Force members have committed to align on a set of common supplier standards and jointly explore green transportation corridors. The patient care pathway drives approximately 45% of healthcare emissions, and the Task Force has committed to build an end-to-end care pathway emissions standard to measure emissions across the care pathway, as well as align and publish product-level lifecycle management assessment data to increase transparency on emissions. The Task Force has also committed to leverage digital health solutions to decarbonise clinical trials.
 
Conference call
A conference call and webcast for investors and analysts will begin today, 10 November 2022, at 11:45 GMT. Details can be accessed via astrazeneca.com.
 
Reporting calendar
The Company intends to publish its full year and fourth quarter results on Thursday 9 February 2022.
 
Operating and financial review

 
All narrative on growth and results in this section is based on actual exchange rates, and financial figures are in US$ millions ($m), unless stated otherwise. Unless stated otherwise, the performance shown in this announcement covers the nine-month period to 30 September 2022 ('the year to date' or 'YTD 2022') compared to the nine-month period to 30 September 2021 (YTD 2021), or the three-month period to 30 September 2022 ('the quarter' or 'Q3 2022') compared to the three-month period to 30 September 2021 (Q3 2021).
 
Core financial measures, EBITDA, Net Debt, CER, Initial Collaboration Revenue and Ongoing Collaboration Revenue are non-GAAP financial measures because they cannot be derived directly from the Group's Interim financial statements. Management believes that these non-GAAP financial measures, when provided in combination with Reported results, provide investors and analysts with helpful supplementary information to understand better the financial performance and position of the Group on a comparable basis from period to period. These non-GAAP financial measures are not a substitute for, or superior to, financial measures prepared in accordance with GAAP.
 
Core financial measures are adjusted to exclude certain significant items, such as:
 
‒    Amortisation and impairment of intangible assets, including impairment reversals but excluding any charges relating to IT assets
 
‒    Charges and provisions related to restructuring programmes, which includes charges that relate to the impact of restructuring programmes on capitalised IT assets as well as Post Alexion Acquisition Group Review items
 
‒    Alexion acquisition-related items, primarily fair value adjustments on acquired inventories and fair value impact of replacement employee share awards
 
‒    Other specified items, principally the imputed finance charge relating to contingent consideration on business combinations, legal settlements and the one off deferred tax credit arising from the internal reorganisation to integrate Alexion
 
‒    The tax effects of the adjustments above are excluded from the Core Tax charge
 
Details on the nature of Core financial measures are provided on page 54 of the Annual Report and Form 20-F Information 2021.
 
Reference should be made to the Reconciliation of Reported to Core financial measures table included in the financial performance section in this announcement.
 
Gross Margin, previously termed Gross Profit Margin, is the percentage by which Product Sales exceeds the Cost of sales, calculated by dividing the difference between the two by the sales figure. The calculation of Reported and Core Gross Margin excludes the impact of Collaboration Revenue and any associated costs, thereby reflecting the underlying performance of Product Sales.
 
EBITDA is defined as Reported Profit before tax after adding back Net Finance Expense, results from Joint Ventures and Associates and charges for Depreciation, Amortisation and Impairment. Reference should be made to the Reconciliation of Reported Profit before tax to EBITDA included in the financial performance section in this announcement.
 
Net Debt is defined as Interest-bearing loans and borrowings and Lease liabilities, net of Cash and cash equivalents, Other investments, and net derivative financial instruments. Reference should be made to Note 3 'Net Debt' included in the Notes to the Interim financial statements in this announcement.
 
Ongoing Collaboration Revenue is defined as Collaboration Revenue excluding Initial Collaboration Revenue (which is defined as Collaboration Revenue that is recognised at the date of completion of an agreement or transaction, in respect of upfront consideration). Ongoing Collaboration Revenue comprises, among other items, royalties, milestone revenue and profit-sharing income. Reference should be made to the Collaboration Revenue table in this Operating and financial review.
 
The Company strongly encourages investors and analysts not to rely on any single financial measure, but to review AstraZeneca's financial statements, including the Notes thereto, and other available Company reports, carefully and in their entirety.
 
Due to rounding, the sum of a number of dollar values and percentages in this announcement may not agree to totals.
 
Total Revenue

Table 4: Disease area and medicine performance
 
 
 
YTD 2022
Q3 2022
 
 
 
 
% Change 
 
 
% Change 
Product Sales 
 
$m 
% Total 
Actual 
CER 
$m 
% Total 
Actual 
CER 
Oncology 
 
10,885 
33 
14 
20 
3,797 
35 
15 
22 
Tagrisso 
 
4,102 
12 
11 
16 
1,398 
13 
12 
20 
Imfinzi 
 
2,031 
14 
19 
737 
19 
26 
Lynparza 
 
1,949 
13 
19 
659 
12 
19 
Calquence 
 
1,469 
74 
77 
566 
60 
63 
Enhertu 
 
52 
>5x 
>5x 
23 
>4x 
>4x 
Orpathys 
 
34 
>3x 
>3x 
11 
11 
16 
Zoladex 
 
717 
-
240 
(4)
Faslodex 
 
259 
(21)
(14)
81 
(21)
(10)
Iressa 
 
90 
(39)
(37)
27 
(35)
(31)
Arimidex 
 
85 
(20)
(16)
24 
(28)
(23)
Casodex 
 
63 
(48)
(45)
21 
(46)
(40)
- Others 
 
34 
(9)
(1)
10 
(18)
(10)
BioPharmaceuticals: CVRM
 
6,907 
21 
13 
18 
2,348 
21 
11 
19 
Farxiga 
 
3,204 
10 
49 
58 
1,101 
10 
38 
50 
Brilinta 
 
1,013 
(10)
(7)
338 
(10)
(7)
Lokelma 
 
208 
71 
80 
79 
59 
69 
- Roxadustat 
 
148 
57 
Andexxa
 
111 
14 
41 
17 
Crestor 
 
824 
(2)
277 
(7)
-
Seloken/Toprol-XL 
 
705 
(6)
(2)
238 
10 
Bydureon
 
207 
(29)
(28)
66 
(30)
(29)
Onglyza
 
205 
(28)
(25)
66 
(21)
(17)
- Others 
 
282 
(9)
(7)
85 
(11)
(8)
BioPharmaceuticals: R&I 
 
4,318 
13 
(3)
-
1,427 
13 
(4)
Symbicort 
 
1,919 
(6)
(2)
630 
(7)
(1)
Fasenra
 
1,015 
13 
17 
353 
10 
15 
Breztri  
 
282 
>2x 
>2x 
103 
>2x 
>2x 
Saphnelo 
 
69 
>10x 
>10x 
33 
>10x 
>10x 
Pulmicort 
 
479 
(33)
(31)
145 
(33)
(31)
Daliresp 
 
161 
(5)
(4)
52 
(4)
(3)
Bevespi
 
43 
11 
13 
14 
- Others 
 
350 
(21)
(20)
97 
(36)
(33)
BioPharmaceuticals: V&I 
 
3,607 
11 
51 
59 
873 
(27)
(21)
Vaxzevria 
 
1,713 
(20)
(16)
173 
(83)
(81)
Evusheld 
 
1,451 
n/m 
n/m 
537 
n/m 
n/m 
Synagis
 
384 
>2x 
>2x 
104 
(15)
(1)
FluMist
 
59 
(22)
(13)
59 
(19)
(10)
Rare Disease
 
5,236 
16 
10 
1,741 
16 
11 
- Soliris
 
2,918 
(7)
(2)
901 
(13)
(6)
- Ultomiris
 
1,371 
27 
35 
518 
37 
47 
- Strensiq
 
687 
13 
15 
237 
17 
20 
Koselugo 
 
149 
>2x 
>2x 
48 
82 
81 
Kanuma
 
111 
11 
37 
Other Medicines 
 
1,247 
(4)
404 
17 
30 
Nexium 
 
986 
(1)
311 
20 
36 
- Others 
 
261 
(12)
(10)
93 
13 
Product Sales 
 
32,200 
97 
29 
35 
10,590 
96 
16 
Collaboration Revenue 
 
944 
>2x 
>2x 
392 
>3x 
>3x 
Total Revenue 
 
33,144 
100 
30 
37 
10,982 
100 
11 
19 
 
Table 5: Collaboration Revenue
 
 
 
YTD 2022
Q3 2022
 
 
 
 
% Change
 
 
% Change
 
 
$m 
% Total 
Actual 
CER 
$m 
% Total 
Actual 
CER 
Enhertu: alliance revenue[33] 
 
332 
35
>2x 
>2x 
159
41
>3x 
>3x 
Tezspire: alliance revenue
 
42 
4
n/m 
n/m 
26
7
n/m 
n/m 
Lynparza: regulatory milestones 
 
250 
26
n/m 
n/m 
75
19
n/m 
n/m 
Tralokinumab: sales milestone
 
110 
12
n/m 
n/m 
40
10
n/m 
n/m 
Vaxzevria: royalties  
 
67 
7
(19)
(22)
6
2
(87)
(87)
Other royalty income 
 
54 
6
18
5
(4)
(3)
Other Collaboration Revenue 
 
89 
9
(4)
12 
68
17
>10x 
>10x 
Total 
 
944 
100
>2x 
>2x 
392
100
>3x 
>3x 
 
Table 6: Total Revenue by disease area
 
 
 
YTD 2022 
Q3 2022 
 
 
 
 
% Change 
 
 
% Change 
 
 
$m 
% Total 
 Actual 
CER 
$m 
% Total 
 Actual 
CER 
Oncology 
 
11,493 
35 
19 
24 
4,039 
37 
20 
27 
BioPharmaceuticals9 
 
15,078 
45 
16 
21 
4,728 
43 
(2)
- CVRM9 
 
6,927 
21 
13 
19 
2,351 
21 
11 
18 
- R&I 
 
4,478 
14 
1,499 
14 
- V&I 
 
3,673 
11 
49 
56 
878 
(29)
(24)
Rare Disease9
 
5,236 
16 
10 
1,741 
16 
11 
Other Medicines 
 
1,337 
(5)
474 
34 
50 
Total
 
33,144 
100 
30 
37 
10,982 
100 
11 
19 
 
Table 7: Total Revenue by region
 
 
 
YTD 2022 
Q3 2022 
 
 
 
 
% Change 
 
 
% Change 
 
 
$m 
% Total 
 Actual 
CER 
$m 
% Total 
 Actual 
CER 
Emerging Markets 
 
9,013 
27 
2,856 
26 
(10)
(4)
- China 
 
4,597 
14 
(2)
(1)
1,541 
14 
- Ex-China 
 
4,415 
13 
13 
20 
1,316 
12 
(21)
(15)
US 
 
13,132 
40 
58 
58 
4,650 
42 
34 
34 
Europe 
 
6,429 
19 
24 
37 
2,065 
19 
23 
Established RoW 
 
4,570 
14 
38 
55 
1,412 
13 
26 
Total 
 
33,144 
100 
30 
37 
10,982 
100 
11 
19 
 
Table 8: Total Revenue by region - excluding Vaxzevria
 
 
 
YTD 2022 
Q3 2022 
 
 
 
 
% Change 
 
 
% Change 
 
 
$m 
% Total 
 Actual 
CER 
$m 
% Total 
 Actual 
CER 
Emerging Markets 
 
8,262 
25 
10 
15 
2,826 
26 
13 
20 
- China 
 
4,551 
14 
(3)
(2)
1,541 
14 
- Ex-China 
 
3,711 
11 
33 
44 
1,285 
12 
26 
37 
US 
 
13,053 
39 
57 
57 
4,650 
42 
34 
34 
Europe 
 
6,104 
18 
37 
52 
2,002 
18 
14 
30 
Established RoW 
 
3,945 
12 
33 
50 
1,325 
12 
22 
45 
Total 
 
31,364 
95 
35 
42 
10,803 
98 
23 
31 
 
Oncology
Oncology Total Revenue increased by 19% (24% at CER) in YTD 2022 to $11,493m and represented 35% of overall Total Revenue (YTD 2021: 38%). This included Lynparza Collaboration Revenue of $250m (YTD 2021: $nil) and Enhertu Collaboration Revenue of $335m (YTD 2021: $137m). Product Sales increased by 14% (20% at CER) in YTD 2022 to $10,885m, reflecting new launches and increased patient access for TagrissoImfinziLynparza and Calquence partially offset by declines in some older medicines. Oncology Total Revenue grew 20% (27% at CER) in Q3 benefiting from new launches for ImfinziCalquence and Enhertu and improvement in rates of lung cancer diagnosis and treatment.
 
Tagrisso
 
Total Revenue
 
Worldwide
 
Emerging Markets
US
Europe
Established RoW
YTD 2022  $m
 
4,102
 
1,211
1,472
777
642
Actual change
 
11%
 
20%
14%
7%
(4%)
CER change
 
16%
 
22%
14%
19%
10%
 
Region
 
 Drivers and commentary
Worldwide
 
Increased use of Tagrisso in adjuvant and 1st-line setting
 
Emerging Markets
 
Increased 1st-line use in China and continued growth in other Emerging Markets
Rising demand from increased patient access in China continues to offset the impact of the March 2021 NRDL price reduction
Q3 2022 growth of 29% (35% at CER) benefited from the comparison to Q3 2021, which was negatively impacted by inventory phasing and stock compensation relating to NRDL changes in March 2021
In China, COVID-19 related lockdowns continued to have an adverse impact in Q3, though at a lower level than Q2
 
US
 
Increased EGFR[34] testing rates
Greater use in 1st-line with longer duration of treatment and increasing adjuvant penetration, partially offset by lower 2nd-line use
 
Europe
 
Greater use in 1st-line and adjuvant settings, with longer duration of treatment, partially offset by lower 2nd-line use
 
Established RoW
 
Increased use in 1st-line setting and launch progress in adjuvant including Japan
Q3 Total Revenue decline of 12% (growth of 5% at CER) impacted by a COVID-19 wave in Japan
 
 
Imfinzi
 
Total Revenue
 
Worldwide
 
Emerging Markets
US
Europe
Established RoW
YTD 2022  $m
 
2,031
 
224
1,102
402
303
Actual change
 
14%
 
6%
20%
16%
-
CER change
 
19%
 
9%
20%
29%
14%
 
Region
 
 Drivers and commentary
Worldwide
 
Increased use of Imfinzi to treat patients with ES-SCLC[35]
Recovery in rates of diagnosis and treatment following the COVID-19 pandemic
Q3 Worldwide Total Revenue growth of 19% (26% at CER)  
Emerging Markets
 
Growth in ex-China, offset by an adverse impact in CRT[36] rates and hospital use of infused oncology medicines due to COVID-19 lockdowns in several major cities in China
US
 
New patient starts across Stage III NSCLC and ES-SCLC
A strong launch in biliary tract cancer after approval by the US FDA in September based on the TOPAZ-1 Phase III trial
Europe
 
Increased market penetration in ES-SCLC, growth in the number of reimbursed markets, an ongoing recovery in rates of diagnosis and treatment
Established RoW
 
New reimbursements
 
 
Lynparza
 
Total Revenue
 
Worldwide
 
Emerging Markets
US
Europe
Established RoW
YTD 2022  $m
 
2,199
 
358
896
743
202
Actual change
 
28%
 
27%
13%
63%
8%
CER change
 
33%
 
30%
13%
75%
22%
 
Product Sales
 
Worldwide
 
Emerging Markets
US
Europe
Established RoW
YTD 2022  $m
 
1,949
 
358
896
493
202
Actual change
 
13%
 
27%
13%
8%
8%
CER change
 
19%
 
30%
13%
20%
22%
 
Region
 
 Drivers and commentary
Worldwide
 
Lynparza remains the leading medicine in the PARP[37]-inhibitor class globally across four tumour types, as measured by total prescription volume
Total Revenue includes $250m in regulatory milestones received from MSD and recognised in Europe, in respect of the approval in the US and EU for the adjuvant treatment of patients with gBRCAm[38] breast cancer, based on the data from the OlympiA Phase III trial
Q3 Product Sales growth of 12% (19% at CER)
 
Emerging Markets
 
Increased patient access following admission to China's NRDL as a 1st-line maintenance treatment for BRCAm[39] ovarian cancer patients, with effect from March 2021; also launches in other markets
 
US
 
US launch in early breast cancer following US FDA[40] approval in March based on data from the OlympiA Phase III trial
Growth in use in breast, ovarian and prostate cancers
 
Europe
 
Increasing HRD testing rates and use in 1st-line HRD-positive ovarian cancer, increased Lynparza uptake in BRCAm mCRPC[41] and gBRCAm HER2-negative advanced breast cancer and the EU launch in gBRCAm early breast cancer following EMA[42] approval in August based on data from the OlympiA Phase III trial
 
Established RoW
 
New product launches and high levels of HRD testing in Japan
 
 
Enhertu
 
Total Revenue
 
Worldwide
 
Emerging Markets
US
Europe
Established RoW
YTD 2022  $m
 
387
 
51
254
77
4
Actual change
 
>2x
 
>6x
>2x
>4x
>10x
CER change
 
>2x
 
>6x
>2x
>4x
>10x
 
Region
 
 Drivers and commentary
Worldwide
 
Excluding Japan, Enhertu global in-market sales recorded by Daiichi Sankyo Company Limited (Daiichi Sankyo) and AstraZeneca, amounted to $750m in the year to date (YTD 2021: $293m)
AstraZeneca's Total Revenue of $387m includes $335m of Collaboration Revenue from its share of gross profit in territories where Daiichi Sankyo records product sales and royalties on sales in Japan
Q3 Worldwide Total Revenue growth of >3x
 
Emerging Markets
 
Strong uptake in early launch markets
 
US
 
US in-market sales, recorded by Daiichi Sankyo, amounted to $532m in the year to date (YTD 2021: $253m)
US launches in 2nd-line HER2-positive metastatic breast cancer after US FDA approval in May based on data from the DESTINY-Breast03 Phase III trial; and in 3rd-line+ HER2-low metastatic breast cancer after US FDA approval in August based on the DESTINY-Breast04 Phase III trial
 
Europe
 
Growth in 3rd-line+ HER2-positive metastatic breast and launch in 2nd-line HER2-positive metastatic breast cancer after EMA approval in July based on data from the DESTINY-Breast03 Phase III trial
 
Established RoW
 
In Japan, AstraZeneca receives a mid-single-digit percentage royalty on sales made by Daiichi Sankyo
 
 
Calquence
 
Total Revenue
 
Worldwide
 
Emerging Markets
US
Europe
Established RoW
YTD 2022  $m
 
1,469
 
28
1,192
200
49
Actual change
 
74%
 
>2x
58%
>2x
>4x
CER change
 
77%
 
>2x
58%
>3x
>5x
 
Region
 
 
Worldwide
 
Q3 Worldwide Total Revenue growth of 60% (63% at CER)
 
US
 
Increased new patient market share led to a strong performance, despite continued COVID-19 impacts on CLL[43] diagnosis rates
Maleate tablet formulation launch in August resulted in uptake by patients taking proton pump inhibitors and demand due to channel inventory build
 
Europe
 
Increased market share in new patient starts after launches in the region
 
 
Orpathys
Orpathys Total Revenue of $35m in the year to date (YTD 2021: $10m), growth was driven by the 2021 launch in China, where it is approved for patients with lung cancer and MET[44] gene alterations.
 
Other Oncology medicines
 
YTD 2022
% Change
 
Total Revenue
 
$m
Actual
CER
 
Zoladex
 
738
1%
7%
Increased use in ex-China Emerging Markets, offsetting a price cut in Japan
 
Faslodex
 
259
(21%)
(14%)
Generic competition
 
Iressa
 
90
(39%)
(37%)
Continued share loss to next generation TKIs[45]
 
Arimidex
 
85
(20%)
(16%)
 
 
Casodex
 
63
(48%)
(45%)
Ongoing impact from VBP implementation
 
Other Oncology
 
34
(9%)
(1%)
 
 
 
 
 
 
 
 
 
 
BioPharmaceuticals
Including Vaccines & Immune Therapies medicines, BioPharmaceuticals Total Revenue increased by 16% (21% at CER) in YTD 2022 to $15,078m, representing 45% of overall Total Revenue (YTD 2021: 51%). Growth was driven by strong Farxiga performance and growth in Evusheld.
 
Cardiovascular, Renal & Metabolism
CVRM Total Revenue increased by 13% (19% at CER) to $6,927m in YTD 2022, driven by a strong Farxiga performance, and represented 21% of overall Total Revenue (YTD 2021: 24%).
 
Farxiga
 
Total Revenue
 
Worldwide
 
Emerging Markets
US
Europe
Established RoW
YTD 2022  $m
 
3,208
 
1,224
748
955
281
Actual change
 
49%
 
40%
48%
64%
48%
CER change
 
58%
 
46%
48%
82%
64%
 
Region
 
 
Worldwide
 
Farxiga volume is growing faster than the overall SGLT2[46] market in all major regions
Additional benefit from growth in the overall SGLT2 inhibitor class
Further HF[47] and CKD launches and updated treatment guidelines including from ESC[48] and AHA[49]/ACC[50]/HFSA[51]. HF and CKD indications now launched in >100 markets
 
Emerging Markets
 
Growth despite generic competition in some markets. Solid growth in ex-China Emerging Markets, particularly Latin America
In China, Forxiga's NRDL status was renewed in the fourth quarter of 2021. Benefit from uACR[52] and MRF[53] screening programs
 
US
 
Regulatory approval for HEFrEF[54] in May 2020, treatment of CKD in May 2021
Both approvals included patients with and without T2D[55]
Farxiga continued to gain in-class brand share, driven by HF and CKD launches
 
Europe
 
The beneficial addition of cardiovascular outcomes trial data to the label, the HFrEF regulatory approval in November 2020, and CKD regulatory approval in August 2021
Forxiga continued gaining in-class market share in the period
 
Established RoW
 
In Japan, AstraZeneca sells to collaborator Ono Pharmaceutical Co., Ltd, which records in-market sales. Continued volume growth driven by HF and CKD launches
 
 
Brilinta
 
Total Revenue
 
Worldwide
 
Emerging Markets
US
Europe
Established RoW
YTD 2022  $m
 
1,013
 
222
538
215
38
Actual change
 
(10%)
 
(13%)
(4%)
(18%)
(20%)
CER change
 
(7%)
 
(11%)
(4%)
(9%)
(16%)
 
Region
 
 
Emerging Markets
 
Adverse impact from Brilinta's inclusion in China's VBP programme
Strong growth in ex-China Emerging Markets
 
US, Europe
 
Slower market recovery of oral antiplatelet therapies following the pandemic
 
 
Lokelma
Lokelma Total Revenue increased 71% (80% at CER) to $208m in YTD 2022, driven by Lokelma extending its branded market share lead in the US and also achieving total potassium binder market share leadership in the period. Continued progress in Europe from recent launches across the region where Lokelma extended its market share in the period. In China, Lokelma admitted to the NRDL with effect from 1 January 2022.
 
Andexxa
On a pro forma basis, Andexxa Total Revenue increased 17% (24% at CER) to $121m.
 
Roxadustat
Total Revenue increased 2% (4% at CER) to $151m. Total Revenue also increased quarter-on-quarter, with roxadustat benefitting from increased volumes in China following NRDL price cuts.
 
Other CVRM medicines
 
YTD 2022
% Change
 
Total Revenue
 
$m
Actual
CER
 
Crestor
 
825
(2%)
4%
Sales growth at CER driven by Emerging Markets, offset by declines in the US and Europe
 
Seloken
 
706
(6%)
(2%)
Emerging Markets sales impacted by China VBP implementation of Betaloc[56] oral in H2 2021. Betaloc ZOK VBP to be implemented in Q4 2022
 
Onglyza
 
205
(28%)
(25%)
Ongoing impact from VBP implementation
 
Bydureon
 
207
(29%)
(28%)
Continued competitive pressures
 
Other CVRM
 
282
(9%)
(7%)
 
 
 
 
 
 
 
 
 
 
Respiratory & Immunology
Total Revenue from R&I medicines was stable in YTD 2022 (increased 4% at CER) at $4,478m and represented 14% of overall Total Revenue (YTD 2021: 18%). In the third quarter, R&I Total Revenue grew 5% at CER primarily driven by the performance of recent launch brands, including FasenraTezspireBreztri and Saphnelo, and revenue milestones; this growth more than offset the sustained erosion of Pulmicort revenue following its inclusion in VBP in China in Q4 2021, and a marginal decline in Symbicort revenue.
 
Symbicort
Total Revenue
 
Worldwide
 
Emerging Markets
US
Europe
Established RoW
YTD 2022  $m
 
1,919
 
476
718
445
280
Actual change
 
(6%)
 
4%
(11%)
(11%)
(3%)
CER change
 
(2%)
 
8%
(11%)
(1%)
3%
 
Region
 
 
Worldwide
 
Symbicort remains the global market leader within stable ICS[57]/LABA[58] class
 
Emerging Markets
 
Growth in Emerging Markets driven primarily by market share growth in China, Latin America and Asia Area
 
US
 
Strong market share performance, consolidating leadership in a declining ICS/LABA market, offset by pricing pressure
 
Europe
 
Resilient market share in growing ICS/LABA market, offset by pricing pressure
 
Established RoW
 
Double digit growth in Canada and Australia/New Zealand, driven by market share gain
Sales in Japan declined due to generic erosion and the annual mandatory price reduction in April 2022
 
 
Fasenra
Total Revenue
 
Worldwide
 
Emerging Markets
US
Europe
Established RoW
YTD 2022  $m
 
1,015
 
30
649
229
107
Actual change
 
13%
 
99%
17%
9%
(10%)
CER change
 
17%
 
95%
17%
21%
-
                                                          
Region
 
 
Worldwide
 
Fasenra continues to be market leader in severe eosinophilic asthma in major markets, and leading in the IL-5 class
 
Emerging Markets
 
Strong volume growth driven by launch acceleration in Brazil and other markets
 
US
 
Maintained a strong new-to-brand share in the severe uncontrolled asthma market
 
Europe
 
Market leader in new-to-brand share of the severe uncontrolled asthma market
 
Established RoW
 
Maintained market leadership in Japan, partially offset by price erosion and impact in the dynamic market related to surge in COVID-19 cases
 
 
Breztri
 
Total Revenue
 
Worldwide
 
Emerging Markets
US
Europe
Established RoW
YTD 2022  $m
 
282
 
71
164
22
25
Actual change
 
>2x
 
76%
>2x
>5x
43%
CER change
 
>2x
 
78%
>2x
>6x
66%
 
Region
 
 
Worldwide
 
Breztri continued to gain market share within growing fixed-dose triple class across major markets
 
Emerging Markets
 
In China, the FDC triple class continued to penetrate the inhaled maintenance market whose growth has been impacted by COVID-19
Breztri continued its market share leadership within the fixed-dose triple class
 
US
 
Consistent new-to-brand and total market share growth within the fixed-dose triple class
 
Europe
 
Sustained growth across markets as new launches continue to progress
 
Established RoW
 
Strong new-to-brand market share performance in Japan within COPD[59], with the market impacted by access restrictions related to surge in COVID-19 cases
 
 
Saphnelo
Total Revenue of $69m in the year to date (YTD 2021: $1m) was driven by sales acceleration in the US, where Saphnelo achieved NBRx leadership in the i.v.[60] segment for SLE[61] and received a permanent J-code facilitating reimbursement. Growth was further supported by a strong launch in Germany and steady growth in Japan.
 
Tezspire
Tezspire is approved in the US, EU and Japan for the treatment of severe asthma without biomarker or phenotypic limitation. Total Revenue of $42m in the year to date (YTD 2021: $nil) was comprised entirely of Collaboration Revenue, and reflected the strong early launch performance in the US. Amgen records sales in the US and AstraZeneca records its share of gross profits in the US as Collaboration Revenue.
 
Other R&I medicines
 
YTD 2022
% Change
 
Total Revenue
 
$m
Actual
CER
 
Pulmicort
 
479
(33%)
(31%)
Revenue from Emerging Markets decreased 41% to $339m, impacted by VBP implementation in China and lower rates of elective surgery and limited access to nebulisation centres due to COVID-19 lockdowns
 
Daliresp
 
161
(5%)
(4%)
 
Bevespi
 
43
11%
13%
 
Other R&I
 
469
3%
4%
Collaboration Revenue of $118m (YTD 2021: $12m), including $111m of milestones relating to tralokinumab (YTD 2021: nil)
Product Sales of $350m decreased 21% (20% at CER)
 
 
 
 
 
 
 
 
 
 
Vaccines & Immune Therapies
Total Revenue from V&I medicines increased to $3,673m (YTD 2021: $2,465m) and represented 11% of overall Total Revenue (YTD 2021: 10%).
 
Vaxzevria
Total Revenue
 
Worldwide
 
Emerging Markets
US
Europe
Established RoW
YTD 2022  $m
 
1,780
 
751
79
325
625
Actual change
 
(20%)
 
(34%)
n/m
(56%)
82%
CER change
 
(16%)
 
(35%)
n/m
(51%)
96%
 
Region
 
 
Worldwide
 
Revenue in the third quarter decreased by 83% (82% at CER) due to the conclusion of  many of the initial Vaxzevria contracts
 
Emerging Markets
 
$46m of Collaboration Revenue came from a Chinese sub-licensee producing vaccines for export
Revenue in the third quarter decreased by 95% (96% at CER)
 
US
 
Purchases by the US government for donation overseas
No revenue recorded in the second and third quarters
 
Europe
 
Revenue in the third quarter decreased by 62% (56% at CER) vs Q3 2021
 
Established RoW
 
Sales in Japan, Canada and Australia
Revenue in the third quarter decreased by 63% (59% at CER)
 
 
Evusheld
 
Total Revenue
 
Worldwide
 
Emerging Markets
US
Europe
Established RoW
YTD 2022  $m
 
1,450
 
167
850
198
235
Actual change
 
n/m
 
n/m
n/m
n/m
n/m
CER change
 
n/m
 
n/m
n/m
n/m
n/m
 
Region
 
 
US
 
Evusheld received Emergency Use Authorisation for the prevention of COVID-19 in December 2021
AstraZeneca continued to fulfil the US Government's order for 1.7m units
 
Emerging Markets
 
Multiple government contracts in Central and Eastern Europe, Latin America and South East Asia
 
Europe
 
Approved in the EU for prevention of COVID-19 in March 2022 and treatment in September 2022
 
Established RoW
 
Approved in Japan for prevention and treatment of COVID-19 in August 2022
 
 
Other V&I medicines
 
 
YTD 2022
% Change
 
 
Total Revenue
 
$m
Actual
CER
 
Synagis
 
384
>2x
>2x
Strong RSV season
Ex-US rights reverted to AstraZeneca after 30 June 2021, from AbbVie Inc.
In Q3 2022, Synagis sales decreased by 15% (1% CER)
 
FluMist
 
59
(22%)
(13%)
 
 
Rare Disease
On a pro forma basis, Total Revenue from Rare Disease medicines increased by 4% (10% at CER) in YTD 2022 to $5,236m, representing 16% of overall Total Revenue.
 
Performance was driven by the durability of the C5 franchise, Soliris and Ultomiris, following Ultomiris gMG launch and expansion into new markets, and continued Soliris NMOSD growth.
 
Strensiq and Koselugo performances were driven by continued patient demand and market expansion efforts, respectively.
 
These tables show pro forma growth rates for each of the medicines acquired with Alexion, calculated by comparing YTD 2022 revenues with the medicine's revenues from 1 January 2021 to 30 September 2021.
 
Soliris
 
Total Revenue
 
Worldwide
 
Emerging Markets
US
Europe
Established RoW
YTD 2022 $m
 
2,918
 
218
1,688
627
385
Actual change9
 
(7%)
 
(29%)
(3%)
(20%)
20%
CER change9
 
(2%)
 
(9%)
(3%)
(10%)
34%
 
Region
 
 
US
 
Performance impacted by successful conversion to Ultomiris in PNH, aHUS and gMG, partially offset by Soliris growth in NMOSD
 
Ex-US
 
Growth driven by continued expansion of neurology indications, gMG and NMOSD, in new markets
 
 
Ultomiris
 
Total Revenue
 
Worldwide
 
Emerging Markets
US
Europe
Established RoW
YTD 2022 $m
 
1,371
 
34
771
347
219
Actual change9
 
27%
 
>2x
23%
55%
-
CER change9
 
35%
 
>3x
23%
74%
18%
 
Region
 
 
Worldwide
 
Performance driven by gMG launch in the US and expansion into new markets
Quarter-on-quarter variability in revenue growth can be expected due to Ultomiris every eight week dosing schedule and lower average annual treatment cost per patient compared to Soliris
 
US
 
Performance driven by successful conversion from Soliris across PNH, aHUS and gMG with increased utilisation from complement-naïve patients in gMG
 
Ex-US
 
Rapid conversion in new launch markets
 
 
Other Rare Disease medicines
 
 
YTD 2022
% Change
 
 
Total Revenue
 
$m
Actual
CER
Commentary
Strensiq9
 
687
13%
15%
Performance driven by strong patient demand
 
Koselugo
 
149
>2x
>2x
Growth driven by expansion in new markets and tender market order timing
 
Kanuma9
 
111
6%
11%
Continued demand growth in ex-US markets
 
 
Other medicines (outside the main disease areas)
 
 
YTD 2022
% Change
 
Total Revenue
 
$m
Actual
CER
Commentary
Nexium
 
1,063
(3%)
7%
Collaboration Revenue of $78m (YTD 2021: $92m)
Nexium (oral) was included in China's VBP programme implemented in February 2021 and Nexium i.v. was implemented in the fifth round of VBP in October 2021
 
Others
 
273
(12%)
(10%)
 
 
 
 
 
 
 
 
 
 
Financial performance

 
Table 9: Reported Profit and Loss
 
 
 
YTD 2022
YTD 2021
% Change 
Q3 2022
Q3 2021
% Change
 
 
 
$m 
$m 
Actual 
CER 
$m 
$m 
Actual 
CER 
Total Revenue
 
33,144 
25,406 
30 
37 
10,982 
9,866 
11 
19 
- Product Sales
 
32,200 
25,043 
29 
35 
10,590 
9,741 
9 
16 
- Collaboration Revenue
 
944 
363 
>2x 
>2x 
392 
125 
>3x 
>3x 
Cost of Sales
 
(9,491)
(7,812)
21 
28 
(2,982)
(3,757)
(21)
(18)
Gross Profit
 
23,653 
17,594 
34 
40 
8,000 
6,109 
31 
41 
Gross Margin
 
70.5% 
68.8% 
+2pp 
+2pp 
71.8% 
61.4% 
+10pp 
+11pp 
Distribution Expense
 
(380)
(322)
18 
25 
(126)
(120)
5 
13 
% Total Revenue
 
1.1% 
1.3% 
- 
- 
1.1% 
1.2% 
 - 
 - 
R&D Expense
 
(7,137)
(7,152)
- 
4 
(2,458)
(3,610)
(32)
(28)
% Total Revenue
 
21.5% 
28.2% 
+7pp 
+7pp 
22.4% 
36.6% 
+14pp 
 +14pp 
SG&A Expense
 
(13,798)
(10,117)
36 
41 
(4,277)
(4,090)
5 
9 
% Total Revenue
 
41.6% 
39.8% 
-2pp 
-1pp 
38.9% 
41.5% 
 +3pp 
+3pp 
OOI[62] & Expense
 
325 
1,345 
(76)
(75)
106 
37 
>2x 
>2x 
% Total Revenue
 
1.0% 
5.3% 
-4pp 
-4pp 
1.0% 
0.4% 
+1pp 
+1pp 
Operating Profit/(Loss)
 
2,663 
1,348 
98 
>2x 
1,245 
(1,674)
n/m 
n/m 
Operating Margin
 
8.0% 
5.3% 
+3pp 
+3pp 
11.3% 
-17.0% 
+28pp 
+30pp 
Net Finance Expense
 
(936)
(922)
1 
6 
(324)
(320)
1 
2 
Joint Ventures and Associates
 
(4)
(55)
(93)
(91)
1 
(7)
n/m 
n/m 
Profit/(Loss) before tax
 
1,723 
371 
>4x 
>4x 
922 
(2,001)
n/m 
n/m 
Taxation
 
668 
90 
>7x 
>7x 
720 
350 
>2x 
>2x 
Tax rate
 
-39% 
-24%
 
 
-78% 
-18% 
 
 
Profit/(Loss) after tax
 
2,391 
461 
>5x 
>5x 
1,642 
(1,651)
n/m 
n/m 
Earnings per share
 
$1.54 
$0.33 
>4x 
>4x 
$1.06 
$(1.10)
n/m 
n/m 
 
 
 
 
 
 
 
 
 
 
 
 
Table 10: Reconciliation of Reported Profit before tax to EBITDA
 
 
 
YTD 2022
YTD 2021
% Change
Q3 2022
Q3 2021
% Change
 
 
$m 
$m 
Actual 
CER 
$m 
$m 
Actual 
CER 
Reported Profit/(Loss) before tax 
 
1,723 
371 
>4x
>4x 
922 
(2,001)
n/m 
n/m 
Net Finance Expense 
 
936 
922 
1 
6 
324 
320 
1 
2 
Joint Ventures and Associates 
 
4 
55 
(93)
(91)
(1)
7 
n/m 
n/m 
Depreciation, Amortisation and Impairment 
 
4,000 
4,338 
(8)
(4)
1,334 
2,788 
(52)
(49)
EBITDA 
 
6,663 
5,686 
17 
26 
2,579 
1,114 
>2x 
>2x 
 
EBITDA of $6,663m in the year to date (YTD 2021: $5,686m) has been negatively impacted by the $3,175m (YTD 2021: $1,044m) unwind of inventory fair value uplift recognised on the acquisition of Alexion. EBITDA of $2,579m in the quarter (Q3 2021: $1,114m) has been negatively impacted by the $857m (Q3 2021: $1,044m) unwind of inventory fair value uplift recognised on the acquisition of Alexion. The unwind of inventory fair value is expected to depress EBITDA over the year in line with associated revenues, and by a smaller amount in 2023.
 
Table 11: Reconciliation of Reported to Core financial measures: YTD 2022
 
YTD 2022
 
Reported
Restructuring
Intangible Asset Amortisation & Impairments
Acquisitionof Alexion
Other
Core
Core
% Change
 
 
 
$m
$m 
$m
$m 
$m 
$m 
Actual 
CER 
Gross Profit
 
23,653 
156 
24 
3,186 
(1)
27,018 
43 
48 
Gross Margin
 
70.5% 
 
 
 
 
81.0% 
+7pp 
+6pp 
Distribution Expense
 
(380)
2 
- 
- 
- 
(378)
17 
24 
R&D Expense
 
(7,137)
57 
83 
23 
- 
(6,974)
25 
29 
SG&A Expense
 
(13,798)
263 
3,060 
35 
1,197[63] 
(9,243)
20 
24 
Total Operating Expense
 
(21,315)
322 
3,143 
58 
1,197 
(16,595)
22 
26 
Other Operating Income & Expense
 
325 
(8)
- 
- 
- 
317 
(76)
(76)
Operating Profit
 
2,663 
470 
3,167 
3,244 
1,196 
10,740 
63 
69 
Operating Margin
 
8.0% 
 
 
 
 
32.4% 
+6pp 
+6pp 
Net Finance Expense
 
(936)
- 
-
 
207 
(729)
16 
21 
Taxation
 
668 
(93)
(581)
(748)
(1,078)[64]
(1,832)
84 
90 
EPS
 
$1.54 
$0.25 
$1.67 
$1.61 
$0.21 
$5.28 
47 
52 
 
Table 12: Reconciliation of Reported to Core financial measures: Q3 2022
 
Q3 2022
 
Reported
Restructuring
Intangible Asset Amortisation & Impairments
Acquisitionof Alexion
Other
Core
Core
% Change
 
 
 
$m
$m 
$m
$m 
$m 
$m 
Actual 
CER 
Gross Profit
 
8,000 
75 
8 
866 
(1)
8,948 
21 
30 
Gross Margin
 
71.8% 
 
 
 
 
80.8% 
+6pp 
+7pp 
Distribution Expense
 
(126)
1 
- 
- 
- 
(125)
5 
12 
R&D Expense
 
(2,458)
19 
77 
5 
- 
(2,357)
10 
16 
SG&A Expense
 
(4,277)
65 
979 
5 
68 
(3,160)
10 
16 
Total Operating Expense
 
(6,861)
85 
1,056 
10 
68 
(5,642)
10 
16 
Other Operating Income & Expense
 
106 
1 
- 
- 
- 
107 
>2x 
>3x 
Operating Profit
 
1,245 
161 
1,064 
876 
67 
3,413 
50 
63 
Operating Margin
 
11.3% 
 
 
 
 
31.1% 
+8pp 
+9pp 
Net Finance Expense
 
(324)
- 
- 
- 
70 
(254)
16 
14 
Taxation
 
720 
(32)
(194)
(202)
(871)
(579)
31 
43 
EPS
 
$1.06 
$0.08 
$0.56 
$0.44 
($0.47)
$1.67 
55 
70 
 
 
Profit and Loss drivers

 
Gross Profit
‒    The Gross Margin (Reported and Core) in the year to date was impacted by:
 
‒      Positive mix effects: the increased contribution from Rare Disease and Oncology medicines had a positive impact on the Gross Margin
 
‒      Negative mix effects: sales of Vaxzevria and medicines with profit-sharing arrangements (primarily Lynparza) had a dilutive impact on the Gross Margin
 
‒      Pricing pressure relating to procurement programmes in China
 
‒    Reported Gross Profit was also impacted by the unwind of the fair value adjustment to Alexion inventories at the date of acquisition. The fair value uplift is expected to unwind through Reported Cost of Sales in line with associated revenues, and in YTD 2022, the impact of the fair value uplift unwind on Cost of Sales was $3,175m (YTD 2021: $1,044m)
 
‒    Currency fluctuations had a small positive impact on Gross Margin in the year to date. Currency fluctuations may have a positive or negative impact on Gross Margin in future quarters
 
‒    Variations in Gross Margin performance between periods can be expected to continue
 
R&D Expense
‒    Reported and Core R&D Expense was impacted by:
 
‒      The acquisition of Alexion in July 2021
 
‒      Recent positive data read outs for several high priority medicines that ungated late-stage Oncology trials
 
‒      The advancement of a number of mid-stage clinical development programmes in BioPharmaceuticals
 
‒      Investment in platforms, new technology and capabilities to enhance R&D productivity
 
‒    The decrease in Reported R&D Expense is primarily due to the prior year including an impairment charge of $1,172m, recognised in Q3 2021 on an intangible asset related to the acquisition of Ardea Biosciences, Inc.
 
SG&A Expense
‒    The increase in Reported and Core SG&A Expense was driven by:
 
‒      The acquisition of Alexion
 
‒      Market development activities for recent launches
 
‒    Reported SG&A Expense was also impacted by amortisation of intangible assets related to the Alexion acquisition and other acquisitions and collaborations, and a $775m legal settlement with Chugai
 
Other Operating Income
‒    Reported Other Operating Income of $325m consisted primarily of royalties and disposal proceeds on small divestments, including the divestment of rights to Plendil in the second quarter
 
‒    In YTD 2021, Reported Other Operating Income of $1,345m included $776m of divestment gains from AstraZeneca's share of Viela Bio, Inc. and $309m from the commercial rights to Crestor in over 30 countries in Europe (excluding UK and Spain)
 
Net Finance Expense
‒    The increase in Reported and Core Net Finance Expense in the year to date was driven by financing costs on debt for the Alexion transaction , with a reduction in the discount unwind on acquisition-related liabilities, including the Diabetes Alliance which impacted Reported Net Finance Expense
 
‒    In Q3 2022, the Net Finance Expense was also impacted by rising interest rates
 
Taxation
‒    The effective Reported Tax Rate for the nine months to 30 September 2022 was (39%) and the Core tax rate was 18%, and (24%) and 17% respectively in the nine months to 30 September 2021
 
‒    The Reported Tax Rate for the nine months included a one-time favourable net adjustment of $883m to deferred taxes arising from an internal reorganisation to integrate the Alexion organisation which took place in the quarter. The legal entity reorganisation did not result in any corporate income tax payable however did result in an estimated one-off deferred tax adjustment of $883m at Q3 to reflect the substantively enacted tax effects which would arise in impacted jurisdictions going forwards. A further $47m credit movement is included in OCI. This adjustment is based upon full-year forecast estimates and therefore may change for the full year results. This adjustment was excluded from the Core tax charge
 
‒    2021 Reported and Core Tax Rates were impacted by one-off items in 2021, including the non-taxable gain on the divestment of Viela and updates to estimates of prior period tax liabilities following settlements with tax authorities
 
‒    The net cash paid for the year to date was $1,335m (YTD 2021: $1,198m) representing 77% of Reported Profit before tax (YTD 2021: 323%). The cash tax amount increased due to the increase in profits and the impact of Non-core charges on the level of Reported Profit before tax and effects of US rules around deferral of tax relief on R&D costs. The cash tax rate decreased compared to 2021 due to the impact in YTD 2021 of low Reported Profit before tax
 
‒    The Reported Tax rate of (39%) was lower than the Core Tax Rate of 18% primarily due to the impact of the aforementioned internal restructuring. YTD 2022 Reported and Core Tax rates also benefited from the geographical mix of profits and favourable adjustments to prior year tax liabilities in a number of major jurisdictions
 
‒    On 20 July 2022, the UK Government issued draft legislation in relation to the new global minimum tax framework, expected to be brought into effect in the UK from 2024. The UK corporation tax rate continues to be expected to increase to 25%, effective April 2023. The Company is currently assessing potential impact of these draft rules upon its financial statements
 
Table 13: Cash Flow summary
 
 
 
YTD 2022 
YTD 2021 
Change 
 
 
$m 
$m 
$m 
Reported Operating Profit
 
2,663 
1,348 
1,315 
Depreciation, Amortisation and Impairment
 
4,000 
4,338 
(338)
Decrease in Working Capital and Short-term Provisions
 
3,458 
2,063 
1,395 
Gains on Disposal of Intangible Assets
 
(88)
(371)
283 
Gains on Disposal of Investments in Associates and Joint Ventures
 
- 
(776)
776 
Fair value movements on contingent consideration arising from business combinations
 
293 
33 
260 
Non-Cash and Other Movements
 
(973)
(370)
(603)
Interest Paid
 
(608)
(522)
(86)
Taxation Paid
 
(1,335)
(1,198)
(137)
Net Cash Inflow from Operating Activities
 
7,410 
4,545 
2,865 
Net Cash Inflow/(Outflow) before Financing Activities
 
4,699 
(5,600)
10,299 
Net Cash (Outflow)/Inflow from Financing Activities
 
(6,465)
4,700 
(11,165)
 
The increase in Net Cash Inflow from Operating Activities of $2,865m primarily reflected an underlying
improvement in business performance, including the contribution from Alexion.
 
The Reported Operating Profit of $2,663m in the period includes a negative impact of $3,175m relating to the unwind of the inventory fair value uplift recognised on the acquisition of Alexion. This is offset by a corresponding item (positive impact of $3,175m) in Decrease in Working Capital and Short-term Provisions. Overall, the unwind of the fair value uplift has no impact on Net Cash Inflow from Operating Activities.
 
The change in Working Capital and Short-term Provisions of $1,395m, whilst being positively impacted by the aforementioned inventory fair value uplift unwind, has been adversely impacted by the reduction of Vaxzevria working capital balances predominantly within Trade and other payables.
 
Capital Expenditure
Capital Expenditure amounted to $719m in the year to date (YTD 2021: $768m) including expenditure relating to Alexion. The Company anticipates stable Capital Expenditure in FY 2022 relative to FY 2021.
 
Table 14: Net Debt summary
 
 
At 30 
 Sep 2022 
At 31 
Dec 2021 
At 30 
 Sep 2021 
 
 
$m 
$m 
$m 
Cash and cash equivalents
 
4,458 
6,329 
7,067 
Other investments
 
440 
69 
82 
Cash and investments
 
4,898 
6,398 
7,149 
Overdrafts and short-term borrowings
 
(743)
(387)
(605)
Lease liabilities
 
(878)
(987)
(962)
Current instalments of loans
 
(4,665)
(1,273)
(2,139)
Non-current instalments of loans
 
(23,013)
(28,134)
(28,206)
Interest-bearing loans and borrowings (Gross Debt)
 
(29,299)
(30,781)
(31,912)
Net derivatives
 
(141)
61 
90 
Net Debt
 
(24,542)
(24,322)
(24,673)
 
Net Debt increased by $220m in the year to date to $24,542m. Details of the committed undrawn bank facilities are disclosed within the going concern section of Note 1. Details of the Company's solicited credit ratings are disclosed in Note 3.
 
Capital allocation
The Board's aim is to continue to strike a balance between the interests of the business, financial creditors and the Company's shareholders. The Company's capital allocation priorities include investing in the business and pipeline, maintaining a strong, investment-grade credit rating, potential value-enhancing business development opportunities, and supporting the progressive dividend policy.
 
In approving the declaration of dividends, the Board considers both the liquidity of the company and the level of reserves legally available for distribution. Dividends are paid to shareholders from AstraZeneca PLC, a Group holding company with no direct operations. The ability of AstraZeneca PLC to make shareholder distributions is dependent on the creation of profits for distribution and the receipt of funds from subsidiary companies. The consolidated Group reserves set out in the Condensed consolidated statement of financial position do not reflect the profit available for distribution to the shareholders of AstraZeneca PLC.
 
Summarised financial information for guarantee of securities of subsidiaries
AstraZeneca Finance LLC ("AstraZeneca Finance") is the issuer of 0.700% Notes due 2024, 1.200% Notes due 2026, 1.750% Notes due 2028 and 2.250% Notes due 2031 (the "AstraZeneca Finance Notes"). Each series of AstraZeneca Finance Notes has been fully and unconditionally guaranteed by AstraZeneca PLC. AstraZeneca Finance is 100% owned by AstraZeneca PLC and each of the guarantees by AstraZeneca PLC is full and unconditional and joint and several.
 
The AstraZeneca Finance Notes are senior unsecured obligations of AstraZeneca Finance and rank equally with all of AstraZeneca Finance's existing and future senior unsecured and unsubordinated indebtedness. The guarantee by AstraZeneca PLC of the AstraZeneca Finance Notes is the senior unsecured obligation of AstraZeneca PLC and ranks equally with all of AstraZeneca PLC's existing and future senior unsecured and unsubordinated indebtedness. Each guarantee by AstraZeneca PLC is effectively subordinated to any secured indebtedness of AstraZeneca PLC to the extent of the value of the assets securing such indebtedness. The AstraZeneca Finance Notes are structurally subordinated to indebtedness and other liabilities of the subsidiaries of AstraZeneca PLC, none of which guarantee the AstraZeneca Finance Notes.
 
AstraZeneca PLC manages substantially all of its operations through divisions, branches and/or investments in subsidiaries and affiliates. Accordingly, the ability of AstraZeneca PLC to service its debt and guarantee obligations is also dependent upon the earnings of its subsidiaries, affiliates, branches and divisions, whether by dividends, distributions, loans or otherwise.
 
Please refer to the consolidated financial statements of AstraZeneca PLC in our Annual Report on Form 20-F and reports on Form 6-K with our quarterly financial results as filed or furnished with the SEC[65] for further financial information regarding AstraZeneca PLC and its consolidated subsidiaries. For further details, terms and conditions of the AstraZeneca Finance Notes please refer to AstraZeneca PLC's Form 6-K furnished to the SEC on 28 May 2021.
 
Pursuant to Rule 13-01 and Rule 3-10 of Regulation S-X under the Securities Act of 1933, as amended (the "Securities Act"), we present below the summary financial information for AstraZeneca PLC, as Guarantor, excluding its consolidated subsidiaries, and AstraZeneca Finance, as the issuer, excluding its consolidated subsidiaries. The following summary financial information of AstraZeneca PLC and AstraZeneca Finance is presented on a combined basis and transactions between the combining entities have been eliminated. Financial information for non-guarantor entities has been excluded. Intercompany balances and transactions between the obligor group and the non-obligor subsidiaries are presented on separate lines.
 
Table 15: Obligor group summarised Statement of comprehensive income
 
 
 
YTD 2022
YTD 2021 
 
 
$m 
$m 
Total Revenue
 
Gross Profit
 
Operating loss
 
(3)
(131)
Loss for the period
 
(404)
(553)
Transactions with subsidiaries that are not issuers or guarantors
 
502 
5,731 
 
Table 16: Obligor group summarised Statement of financial position
 
 
 
At 30 Sep 2022 
At 30 Sep 2021
 
 
$m 
$m 
Current assets
 
12 
Non-current assets
 
Current liabilities
 
(3,067)
(2,347)
Non-current liabilities
 
(22,556)
(25,721)
Amounts due from subsidiaries that are not issuers or guarantors
 
7,349 
12,137 
Amounts due to subsidiaries that are not issuers or guarantors
 
(301)
(299)
 
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 17: Currency sensitivities
The Company provides the following currency-sensitivity information:
 
 
 
 
 
Average spot
rates vs USD
 
 
Spot rate vs USD
 
 
Annual impact of 5% strengthening inFY average rate vs USD ($m) [66]
 
Currency
Primary Relevance
 
FY     2021[67]
YTD   2022[68]
Change
 (%)
 
31 Oct 2022
Change[69]
 (%)
 
Total Revenue
Core Operating Profit
CNY
Total Revenue
 
6.43
6.62
(3)
 
7.31
(12)
 
 277
 158
EUR
Total Revenue
 
0.85
0.94
(10)
 
1.01
(16)
 
 317
 160
JPY
Total Revenue
 
109.83
128.34
(14)
 
148.02
(26)
 
 229
 158
Other[70]
 
 
 
 
 
 
 
 
 
 420
 196
GBP
Operating Expense
 
0.73
0.80
(9)
 
0.86
(16)
 
 61
 (93)
SEK
Operating Expense
 
8.58
9.92
(13)
 
10.98
(22)
 
 6
 (82)
 
Sustainability

Since the last quarterly report, AstraZeneca:
Access to healthcare
 
‒    CEO Pascal Soriot spoke at the UN General Assembly (UNGA) alongside heads of state and global leaders, including UN Secretary General António Guterres and World Health Organization (WHO) Director-General Dr Tedros, on "Ending the COVID-19 Pandemic through Equitable Access to Vaccines, Tests and Treatments"
 
‒    Progressed, with the Partnership for Health System Sustainability and Resilience (PHSSR), research in 13 Phase 2 countries, with key findings to be presented at the Global PHSSR Summit on 22-23 November. PHSSR launch events were held in Saudi Arabia and Brazil. Vietnam signed a three-year MoU with the Ministry of Health, including implementation projects furthering PHSSR recommendations
 
‒    Expanded the Healthy Heart Africa (HHA) programme into Nigeria in collaboration with the Nigeria Ministry of Health and the National Primary Healthcare Development Agency, and its implementing partner PSI. HHA also expanded into Zanzibar in collaboration with the Zanzibar Ministry of Health and its implementing partner HIPZ. Over 29 million blood pressure screenings have been conducted since launch in 2015
 
‒    Supported the largest delegation at the One Young World Summit in Manchester, with over 80 Young Health Programme (YHP) scholars and young AstraZeneca employees attending, together with senior executives who also hosted a site visit and workshops at the AstraZeneca Macclesfield site. The Company also announced a US $50,000 Lead2030 grant with One Young World, to support youth-led non-profits tackling air pollution for healthy people and a healthy planet
 
Environmental protection
 
‒    AstraZeneca attended COP27, where through the Sustainable Markets Initiative Health Systems Task Force made significant commitments to tackle the climate crisis, setting a benchmark for others to drive action at scale. This is the first time the global health sector has taken collective action to decarbonise, across our supply chains, patient care pathways, and clinical trials.
 
‒    Participated in the launch of the Sustainable Markets Initiative China Council, endorsed by President Xi Jinping and HM King Charles III, in his former role as HRH Prince of Wales.
 
‒    Attended the inaugural meeting of the SMI China Council at the CEO and Senior Executive Team level, which provides an important forum for cross-sector collaboration on sustainability. The Company was the only healthcare company invited to attend, offering the opportunity for a leadership role in accelerating action on climate change and supporting sustainability goals for a healthy society and planet
 
‒    Engaged at the World Economic Forum Sustainable Development Impact Meetings in New York during Climate Week, driving thought leadership on a range of topics including the interconnection of health and climate, accelerating the delivery of net-zero health systems, the circular economy and health equity. The Company's integrated approach to sustainability also included engagements on inclusion and diversity and health systems resilience
 
‒    Marked the fifth anniversary of Climate Group's global electric transport initiative, EV100, by participating in a Climate Week panel event on "Steering the global market towards EV100," sharing the experience of working towards its goal of a fully electric vehicle fleet by end of 2025 as a key part of the Ambition Zero Carbon programme
 
‒    Participated in a World Water Week event in Stockholm, Sweden, to share its water stewardship strategy and how it is improving circularity at its sites to reduce reliance on natural resources and improve water quality, increasing water efficiency at a local level and building climate resilience
 
‒    Spoke at a Reuters panel discussion "Drive environmental sustainability across biopharma to create meaningful system-wide change" on the connection between climate and health, and the industry's role in accelerating the delivery of net-zero health systems
 
‒    Published a concept letter in collaboration with regulators, academics, and industry as part of PREMIER, a European Innovative Health Initiative project led by the Company to find solutions to managing pharmaceutical pollution. The paper discusses how greener design could help minimise the impact on the environment of active pharmaceutical ingredients excreted from patients
 
‒    Received the prestigious Indiana Department of Environmental Management Governor's Award for Environmental Excellence in the category of 'Five-Year Continuous Improvement' for its manufacturing site in Mount Vernon, Indiana
 
Ethics and transparency
 
‒    Marked International Day of the Girl with its #GirlsBelongHere2022 initiative in collaboration with Plan International, welcoming more than 350 young women across 35 countries to step into leadership positions, join boardroom conversations and participate in roundtables and masterclasses. All of the Senior Executive Team participated, including country and regional leadership teams. Regions and functions also drove their own initiatives
 
‒    Furthered its commitment to gender and health equity through YHP awarding 80% of "Step Up" grants totalling $160,000 to women-led non-profit organisations working to improve the health of young people in their communities
 
‒    Launched a #ScienceCan sustainability campaign to shine a spotlight on the Company's work to drive sustainability across its interconnected strategic priorities through pioneering science. The campaign outlines the efforts to build a sustainable future for people, society, and the planet. All employees are being asked to crowdsource ideas in teams and identify ways to support the delivery of the Company's sustainability goals and identify objectives for 2023, to effect change from the grassroots level
 
‒    Celebrated its annual Power of Diversity day with the launch of a refreshed Global Inclusion and diversity strategy setting out priorities across three focus areas - Inclusion, Diversity and External Impact
 
‒    Marked Global Ethics Day with the launch of its annual Code of Ethics training for all employees, and with the launch of its Supplier Diversity Programme in Sweden, progressing the target to launch supplier diversity programmes in 10 countries by 2025 to accelerate inclusion and growth of local small and diverse businesses
 
Research and development

This section covers R&D events and milestones that have occurred since the prior results announcement on 29 July 2022, up to and including events announced on 9 November 2022.
 
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 IASLC 2022 World Conference on Lung Cancer (WCLC) in August, and the European Society for Medical Oncology (ESMO) in September. At ESMO, 75 abstracts featured 15 approved and potential new medicines from AstraZeneca across 13 different tumour types.  
 
Significant new trials in Oncology initiated during the period included TROPION-Lung07 a Phase III trial of datopotamab deruxtecan in 1st-line PDL1[71]-low NSCLC patients with PD-L1 TPS[72]<50% and LATIFY, a Phase III trial of ceralasertib in combination with Imfinzi in NSCLC patients whose disease has progressed on or after prior anti-PD-L1 therapy and platinum-based chemotherapy.
 
Tagrisso
 
 
At WCLC in August, preliminary results from the SAVANNAH Phase II trial showed that Tagrisso plus Orpathys demonstrated an ORR[73] of 49% (95% CI[74] 39-59%) in patients with EGFRm NSCLC with high levels of MET overexpression and/or amplification, defined as IHC90+[75] and/or FISH10+[76], whose disease progressed on treatment with Tagrisso. This combination is being further evaluated in the SAFFRON Phase III trial.
 
During the period, Tagrisso was approved in Japan for the adjuvant treatment of patients with EGFRm NSCLC after surgery based on the results from the global ADAURA Phase III trial.
 
Updated results from follow-up of the ADAURA Phase III trial presented at ESMO in September demonstrated a sustained, clinically meaningful improvement in disease free survival compared to placebo in the adjuvant treatment of patients with early-stage (IB, II and IIIA) EGFRm NSCLC after complete tumour resection, with nearly three in four patients treated with adjuvant Tagrisso alive and disease-free at four years.
 
Imfinzi and Imjudo
 
 
During the period, Imfinzi was approved in the US for the treatment of patients with locally advanced or metastatic biliary tract cancer, in combination with chemotherapy, based on the results from the TOPAZ-1 Phase III trial. In October, Imfinzi in combination with a single priming dose of Imjudo (tremelimumab) was approved in the US for the 1st-line treatment of patients with unresectable HCC based on the results from the HIMALAYA Phase III trial.
 
At ESMO, updated TOPAZ-1 results for Imfinzi plus chemotherapy (gemcitabine plus cisplatin) in biliary tract cancer showed enhanced clinical efficacy after an additional 6.5 months of follow-up, demonstrating a 24% reduction in the risk of death versus chemotherapy alone (based on a hazard ratio of 0.76; 95% CI, 0.64-0.91). Updated median OS[77] was 12.9 months versus 11.3 with chemotherapy. More than two times as many patients were estimated to be alive at two years versus chemotherapy alone (23.6% versus 11.5%).
 
Lynparza
 
 
In August, Lynparza was approved in the European Union for the adjuvant treatment of patients with gBRCAm high-risk early breast cancer and in Japan for BRCAm patients in the same setting based on the results from the OlympiA Phase III trial.
 
During the period, the Company and MSD received US regulatory submission acceptance with Priority Review for Lynparza in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mCRPC based on the PROpel Phase III trial.
 
At ESMO, AstraZeneca presented positive long-term follow-up results from the PAOLA-1 Phase III trial in the pre-specified descriptive analysis of the HRD-positive subgroup, and from the SOLO-1 Phase III trial in patients with BRCA mutations of Lynparza with or without bevacizumab. Both trials showed clinically meaningful improvements in OS. Further results showed PFS[78] in combination with bevacizumab for HRD-positive patients, versus active comparator, bevacizumab, and as monotherapy for patients with BRCA mutations, versus placebo, respectively. Five-year follow-up of the PAOLA-1 Phase III trial demonstrated that 65% of HRD-positive patients treated with Lynparza plus bevacizumab were alive at five years versus 48.4% treated with bevacizumab and placebo. Data from the SOLO-1 Phase III trial demonstrated 67% of advanced ovarian cancer patients with BRCA mutations treated with Lynparza were alive at seven years versus 47% on placebo.
 
In September, Lynparza was approved in China for the maintenance treatment of HRD-positive patients with advanced ovarian cancer who are in complete or partial response to 1st-line platinum-based chemotherapy in combination with bevacizumab, based on the PAOLA-1 Phase III trial.
 
During the period, AstraZeneca and MSD announced the voluntary withdrawal of the Lynparza indication for patients with gBRCAm advanced ovarian cancer who have been treated with three or more lines of chemotherapy. The decision to withdraw was made in consultation with the US FDA and based on a recent subgroup analysis that indicated a potential detrimental effect on OS for Lynparza compared to the chemotherapy control arm in the subgroup of patients who had received three or more lines of chemotherapy.
 
Calquence
 
In August, AstraZeneca's new maleate tablet formulation of Calquence was approved in the US for all current indications, including adult patients with CLL, SLL[79] and for patients with relapsed or refractory MCL[80], under accelerated approval based on results from the ELEVATE-PLUS trials. The tablet can be taken with gastric acid-reducing agents, including proton pump inhibitors, antacids and H2-receptor antagonists.
 
Enhertu
 
In August, AstraZeneca and Daiichi Sankyo's Enhertu was approved in the US for the treatment of patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy. The approval by the US FDA was based on positive results from the DESTINY-Breast04 Phase III trial.
 
During the period, Enhertu was also approved in the US for the treatment of adult patients with unresectable or metastatic NSCLC whose tumours have activating HER2 mutations and who have received a prior systemic therapy. The accelerated approval by the US FDA was based on the results of the DESTINY-Lung02 Phase II trial.
 
In August, positive high-level results from the DESTINY-Breast02 Phase III trial of Enhertu versus physician's choice of treatment showed the trial met the primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in PFS in patients with HER2-positive unresectable and/or metastatic breast cancer previously treated with trastuzumab emtansine. The trial also met the key secondary endpoint of improved OS.
 
Datopotamab deruxtecan (Dato-DXd)
 
At WCLC in August, initial results from the TROPION-Lung02 Phase Ib trial demonstrated promising clinical activity and a tolerable safety profile for Dato-DXd in combination with pembrolizumab with or without platinum chemotherapy in patients with previously untreated or pre-treated, advanced or metastatic NSCLC.
 
The data showed an ORR in the overall population of 37% (median follow-up of 6.5 months) in patients treated with Dato-DXd and pembrolizumab (doublet therapy) and an ORR of 41% (median follow-up of 4.4 months) in patients receiving Dato-DXd, pembrolizumab and platinum chemotherapy (triplet therapy). A DCR[81] of 84% was seen with both the doublet and triplet combination therapy in the overall population that comprised both 1st-line and 2nd-line settings.
 
In previously untreated patients, ORRs of 62% (eight of the 13 patients receiving doublet therapy) and 50% (10 of 20 patients receiving triplet therapy) were observed. Eight partial responses were seen in patients receiving doublet therapy and 10 partial responses (three pending confirmation) were seen in patients receiving triplet therapy. A DCR of 100% was observed with doublet therapy and a DCR of 90% was observed with triplet therapy.
 
Camizestrant
 
In October, positive high-level results from the SERENA-2 Phase II trial showed that AstraZeneca's next-generation oral selective estrogen receptor degrader camizestrant met the primary endpoint of demonstrating a statistically significant and clinically meaningful PFS benefit at both 75mg and 150mg dose levels versus Faslodex (fulvestrant) 500mg in post-menopausal patients with estrogen receptor-positive locally advanced or metastatic breast cancer, previously treated with endocrine therapy.
 
Capivasertib
 
In October, positive high-level results from the CAPItello-291 Phase III trial showed that AstraZeneca's AKT[82] inhibitor capivasertib in combination with Faslodex (fulvestrant) demonstrated a statistically significant and clinically meaningful improvement in PFS versus placebo plus Faslodex in patients with HR-positive, HER2-low or HER2-negative locally advanced or metastatic breast cancer, following recurrence or progression on or after endocrine therapy (with or without a CDK4/6[83] inhibitor).
 
Monalizumab
 
During the quarter, AstraZeneca informed Innate Pharma SA that the INTERLINK-1 Phase III trial will be discontinued, as a result of the trial not meeting a pre-defined threshold for efficacy at a planned futility interim analysis, with the decision being recommended by an Independent Data Monitoring Committee. INTERLINK-1 evaluated monalizumab in combination with cetuximab versus cetuximab in patients with recurrent or metastatic squamous cell carcinoma of the head and neck who have been previously treated with platinum-based chemotherapy and PD-L1 inhibitors.
 
BioPharmaceuticals - CVRM
Farxiga
 
Full data from the DELIVER Phase III trial was presented at the European Society of Cardiology Congress in August 2022. In the trial, which evaluated Farxiga in patients with heart failure with preserved ejection fraction, Farxiga reduced the composite outcome of cardiovascular death or worsening of heart failure by 18% with all individual components contributing to the superiority of the primary endpoint. The findings were consistent across key subgroups examined and extend the benefits of Farxiga to the full spectrum of patients with heart failure irrespective of left ventricular ejection fraction status. The trial also showed a symptom benefit in patient-reported outcomes measured by the Kansas City Cardiomyopathy Questionnaire total symptom score. In a separate pre-specified pooled analysis from the Phase III DAPA-HF and DELIVER trials, Farxiga demonstrated reduction in cardiovascular death by 14% and reduction in death from any cause by 10% in patients with heart failure irrespective of ejection fraction.
 
In September 2022, Forxiga was approved for the treatment of chronic kidney disease in China based on the data from the DAPA-CKD trial.
 
Eplontersen
  
In the period, AstraZeneca and Ionis Pharmaceuticals, Inc. presented data from the NEURO-TTransform Phase III trial in patients with hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN) at the International Symposium on Amyloidosis. In the trial, eplontersen demonstrated a significant and clinically meaningful change from baseline for co-primary and secondary endpoints at 35 weeks compared to external placebo group. On the co-primary endpoint of serum transthyretin concentration from baseline, eplontersen showed an 81.2% reduction.
 
BioPharmaceuticals - R&I
AstraZeneca presented new data across the R&I portfolio at the European Respiratory Society (ERS) International Congress 2022, with a total of 78 accepted abstracts, including 14 late breakers and 21 oral presentations.
 
Tezspire
 
In September, Tezspire was approved in the EU as an add-on maintenance treatment in patients 12 years and older with severe asthma who are inadequately controlled with high dose inhaled corticosteroids plus another medicinal product. Also in September, Tezspire was approved in Japan for the treatment of bronchial asthma in patients with severe or refractory disease in whom asthma symptoms cannot be controlled with mid- or high-dose inhaled corticosteroids and other long-term maintenance therapies.
 
Results from the DESTINATION Phase III extension trial were presented at ERS 2022. Tezspire demonstrated an overall long-term safety and efficacy profile consistent with the PATHWAY Phase II and NAVIGATOR Phase III trials, sustained over 104 weeks in a broad population of severe asthma patients regardless of biomarker status.
 
Additional analyses of the CASCADE Phase II and NAVIGATOR Phase III trials were also presented at the ERS International Congress 2022. The CASCADE Phase II mechanistic trial showed Tezspire as the first biologic to reduce mucus plugging compared to placebo. Reduction in mucus score with Tezspire was correlated with improvements in lung function. Mucus plugging as a clinical feature may predict the risk of future exacerbations and lung function decline in severe asthma.
 
Fasenra
 
During the period, AstraZeneca discontinued the Phase III MAHALE trial for the treatment of non-cystic fibrosis bronchiectasis, due to strategic portfolio prioritisation; this discontinuation was not related to any safety or efficacy findings.
 
In October 2022, AstraZeneca disclosed results from the MESSINA Phase III trial, evaluating Fasenra for the treatment of eosinophilic esophagitis. In the trial, Fasenra did not meet one of the two dual-primary endpoints, demonstrating a statistically significant improvement in histological disease remission but not in dysphagia symptoms compared to placebo. No new safety concerns were identified. The company will continue to analyse the complete data set and results will be shared at an upcoming medical meeting.
 
Tozorakimab
 
Data from the ACCORD-2 Phase II trial examined tozorakimab, in patients hospitalised with COVID-19. Results showed that patients receiving tozorakimab on top of standard of care had a 32 percent relative risk reduction in respiratory failure and death, this increased to 57% in IL-33 high patients (IL-33 high was defined as a baseline IL-33 level of >30.15 U/ml). This data suggests tozorakimab may be a novel therapy for patients with acute respiratory failure.
 
BioPharmaceuticals - V&I
Beyfortus (nirsevimab)
 
In November 2022, Beyfortus was approved in the EU for the prevention of RSV lower respiratory tract disease in newborns and infants during their first RSV season. The European Commission is the first regulatory body to grant approval to Beyfortus