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AstraZeneca
9 February 2023 07:00 GMT
Full year and Q4 2022 results
Strong performance and pipeline progress in 2022 underpins 2023 outlook On track to deliver industry-leading revenue growth through 2025 and beyond
Revenue and EPS summary
Product Sales
Collaboration Revenue Total Revenue Reported2 EPS3 Core4 EPS
FY 2022
Q4 2022
% Change
% Change
$m
Actual
CER1
$m
Actual
CER
42,998
18
24
10,798
(6)
2
1,353
54
56
409
(20)
(19)
44,351
19
25
11,207
(7)
1
$2.12
n/m
n/m
$0.58
n/m
n/m
$6.66
26
33
$1.38
(17)
(5)
Financial performance (FY 2022 figures unless otherwise stated, growth numbers and commentary at CER)
Total Revenue increased 25% to $44,351m, with growth coming from all therapy areas, and from the addition of Alexion, which was incorporated into the Group's results from 21 July 2021
Total Revenue in the fourth quarter was impacted by the decline in Vaxzevria. Excluding Vaxzevria, Total Revenue in the quarter increased 17%
Oncology Total Revenue including milestone receipts increased 20%; Oncology Product Sales increased 19%. Total Revenue CVRM5 increased 19%6, R&I7 increased 3%, and Rare Disease increased 10%6
Core Gross Margin of 80%, up six percentage points, reflecting the lower revenue from Vaxzevria and the increased share of Oncology and Rare Disease medicines. Core Gross Margin of 77% in the fourth quarter was impacted by inventory write downs and manufacturing termination fees for Evusheld
Core Total Operating Expense increased 23%, reflecting the addition of Alexion, and continued investment in new launches and the pipeline to deliver sustainable long-term growth
Core Operating Margin of 30%, up four percentage points
Core EPS increased 33% to $6.66. Second interim dividend declared of $1.97 per share, making a total dividend declared for FY 2022 of $2.90 for the year. The Core Tax Rate for the year was 17%, reflecting IP incentive regimes, geographical mix of profits and adjustments to prior year tax liabilities
FY 2023 Guidance summary (Growth numbers at CER)
Total Revenue is expected to increase by a low-to-midsingle-digit percentage
Total Revenue excluding COVID-19 medicines8 is expected to increase by a low double-digit percentage
Core EPS is expected to increase by a high single-digit to low double-digit percentage
Pascal Soriot, Chief Executive Officer, AstraZeneca, said:
"2022 was a year of continued strong company performance and execution of our long-term growth strategy. We made excellent pipeline progress with a record 34 approvals in major markets and we are initiating new late-stage trials for high potential medicines such as camizestrant, datopotamab deruxtecan and volrustomig.
In 2023, we expect to see another year of double-digit revenue growth at CER, excluding our COVID-19 medicines. We will continue to invest behind our pipeline and recent launches while continuing to improve profitability. We plan to initiate more than thirty Phase III trials this year, of which ten have the potential to deliver peak year sales over one billion dollars.
Our R&D success and revenue increase in 2022 demonstrate that we are on track to deliver industry-leading revenue growth through 2025 and beyond, and have set AstraZeneca on a path to deliver at least fifteen new medicines before the end of the decade."
1
Key milestones achieved since the prior results
Key regulatory approvals: US approval for Airsupra (PT027) in asthma. EU approvals for Lynparza9 in mCRPC10 (PROpel), Enhertu in gastric cancer (DESTINY-Gastric01) and HER211-low breast cancer (DESTINY-Breast04),Imfinzi in biliary tract cancer (TOPAZ-1),Imfinzi+Imjudo in HCC12 and Forxiga in heart failure with preserved ejection fraction. Five approvals in Japan, including Imfinzi and Imjudo in liver cancer (TOPAZ-1) and NSCLC13 (POSEIDON) and Calquence for treatment-naΓ―ve CLL (ELEVATE-TN)
Other regulatory milestones: US Fast Track designations for capivasertib in HR-positiveHER2-negative breast cancer (CAPItello-291), tozorakimab in treatment/prevention of acute respiratory failure in patients with viral lung infection (TILIA), and Orpathys plus Tagrisso in NSCLC with MET14 overexpression (SAVANNAH/SAFFRON); US Orphan Drug Designation for Saphnelo in idiopathic inflammatory myopathies; US Emergency Use Authorisation for Evusheld revised - as of January 2023, Evusheld is not currently authorised for use in the US.
Guidance
The Company provides guidance for FY 2023 at CER, based on the average exchange rates through 2022.
Total Revenue is expected to increase by a low-to-midsingle-digit percentage
Excluding COVID-19 medicines, Total Revenue is expected to increase by a low double-digit percentage
Core EPS is expected to increase by a high single-digit to low double-digit percentage
While challenging to forecast, Total Revenue from COVID-19 medicines (Vaxzevria, Evusheld and AZD3152, the COVID-19 LAAB15 currently in development) is expected to decline significantly in FY 2023, with minimal revenue from Vaxzevria
Total Revenue from China is expected to return to growth and increase by a low single-digit percentage in FY 2023
Collaboration Revenue and Other Operating Income are both expected to increase, driven by continued growth of our partnered medicines, success-based milestones, and certain anticipated transactions
Core Operating Expenses are expected to increase by a low-to-midsingle-digit percentage, driven by investment in recent launches and the ungating of new trials
The Core Tax Rate is expected to be between 18-22%
The Company is unable to provide guidance on a Reported basis because it cannot reliably forecast material elements of the Reported result, including any fair value adjustments arising on acquisition-related liabilities, intangible asset impairment charges and legal settlement provisions. Please refer to the cautionary statements section regarding forward-looking statements at the end of this announcement.
Currency impact
If foreign exchange rates for February to December 2023 were to remain at the average rates seen in January 2023, it is anticipated that FY 2023 Total Revenue and FY 2023 Core EPS would both incur a low single-digit adverse impact versus the performance at CER.
The Company's foreign exchange rate sensitivity analysis is provided in Table 17.
2
Table 1: Key elements of Total Revenue performance in Q4 2022
Revenue type
Product Sales
Collaboration Revenue
Total Revenue
Therapy areas
Oncology
CVRM6
R&I
V&I18
Rare Disease6
Other Medicines
Total Revenue
Regions inc. Vaxzevria
Emerging Markets
China
Ex-ChinaEmerging Markets
US Europe Established RoW
Total Revenue inc. Vaxzevria
% Change
$m
Actual
CER
10,798
(6)
2
ο Decline of 6% (2% increase at CER) due to lower
sales of Vaxzevria16
ο Strong growth in Oncology, CVRM and Rare
Disease
409
(20)
(19)
ο $188m for Enhertu (Q4 2021: $60m)
ο $37m for Tezspire (Q4 2021: $nil)
ο Milestone of $105m for Lynparza
11,207
(7)
1
ο Excluding Vaxzevria, Q4 2022 Total Revenue
increased by 8% (17% at CER) - see below
$m
Actual
CER
4,046
4
12
ο Strong performance across key medicines and
regions
2,284
12
22
ο Farxiga up 39% (52% CER), Lokelma up 50%
(63% at CER), roxadustat up 61% (83% CER),
Brilinta decreased 1% (increased 4% at CER)
1,485
(7)
(1)
ο Growth in Fasenra, Breztri and Saphnelo offset
by decline in Pulmicort of 33% (28% at CER)
primarily due to the impact of VBP17
implementation in China
1,163
(50)
(43)
ο $734m from Evusheld (Q4 2021: $135m)
ο $95m from Vaxzevria (Q4 2021: $1,762m)
1,816
4
10
ο Ultomiris up 52% (62% at CER) as gMG launch
and conversion progressed; offset by decline in
Soliris
ο Strensiq up 24% (27% at CER) reflecting
strength of patient demand and geographic
expansion
412
(2)
12
11,207
(7)
1
$m
Actual
CER
2,733
(25)
(18)
ο Decline due to lower sales of Vaxzevria (growth
rates excluding Vaxzevria shown below)
1,194
(9)
3
ο Second consecutive quarter of growth at CER
1,538
(35)
(29)
ο Decline due to lower sales of Vaxzevria
4,788
22
22
2,308
(20)
(8)
ο Decline due to lower sales of Vaxzevria
1,378
(11)
8
11,207
(7)
1
Regions exc. Vaxzevria
Emerging Markets
China
Ex-ChinaEmerging Markets
US Europe Established RoW
Total Revenue exc. Vaxzevria
$m
Actual
CER
2,678
7
18
1,194
(8)
4
1,484
24
33
4,788
24
24
2,268
(12)
1
1,378
4
27
11,112
8
17
Second consecutive quarter of growth at CER
Strong growth in Oncology and CVRM
$246m from Evusheld in Q4 (Q4 2021: $69m)
Growth in Oncology medicines
3
Table 2: Key elements of financial performance in Q4 2022
Metric
Reported
Reported
Core
Core
change
change
Total
$11,207m
-7% Actual
$11,207m
-7% Actual
Revenue
1% CER
1% CER
Gross
73%
13pp Actual
77%
3pp Actual
margin20
15pp CER
4pp CER
R&D
$2,625m
2% Actual
$2,526m
5% Actual
expense
9% CER
12% CER
SG&A
$4,621m
-10% Actual
$3,583m
6% Actual
expense
-3% CER
15% CER
Other
29% Actual
-11% Actual
operating
$189m
$130m
33% CER
-7% CER
income21
Operating
10%
12pp Actual
23%
-4pp Actual
margin
14pp CER
-3pp CER
Net finance
$315m
-6% Actual
$245m
5% Actual
expense
stable at CER
9% CER
Tax rate
-16%
n/m
10%
-7pp Actual
-6pp CER
EPS
$0.58
n/m
$1.38
-17% Actual
-5% CER
Comments19
Excluding Vaxzevria, Q4 2022 Total Revenue increased by 8% (17% at CER)
See Table 1 and the Total Revenue section of this document for further details
Increasing mix of sales from Oncology and Rare Disease medicines
Decreasing mix of Vaxzevria sales
Negative impact in the quarter from currency fluctuations
Inventory write downs and manufacturing termination fees relating to Evusheld reduced Gross Profit by $335m in Q4 2022
Mix impact from profit-sharing arrangements (e.g. Lynparza)
Reported Gross Margin impacted by unwind of Alexion inventory fair value adjustment
+ Increased investment in the pipeline
Core R&D-to-Total Revenue ratio of 23% (Q4 2021: 20%)
Market development activities for recent launches
Core SG&A-to-Total Revenue ratio of 32% (Q4 2021: 28%). The year-on-year comparison is impacted by differences in cost phasing during H2 2021 and H2 2022
Reported and Core OOI includes income from sale of the Waltham site
See Gross Margin and Expenses commentary above
Reported impacted by a reduction in the discount unwind on acquisition-related liabilities
The Reported and Core Tax Rates in the quarter reflected IP incentive regimes, geographical mix of profits and adjustments to prior year tax liabilities including several one-time items
Variations in the tax rate can be expected to continue quarter to quarter
Further details of differences between Reported and Core are shown in Table 12
4
Table 3: Pipeline highlights since prior results announcement
Event
Medicine
Indication / Trial
Event
Imfinzi +/- Imjudo
NSCLC (1st-line) (POSEIDON)
Regulatory approval (US, JP)
Imfinzi + Imjudo
Hepatocellular carcinoma (1st-line)
Regulatory approval (JP)
(HIMALAYA)
Imfinzi
Regulatory
Lynparza
approvals and
Enhertu
other regulatory
actions
Enhertu
Enhertu
Biliary tract cancer (TOPAZ-1) mCRPC (1st-line) (PROpel)
HER2-positive breast cancer (2nd-line)(DESTINY-Breast03)
HER2-low breast cancer (3rd-line)(DESTINY-Breast04)HER2-positive/HER2-low gastric (2nd-line)(DESTINY-Gastric01,DESTINY-Gastric02)
Regulatory approval (EU, JP) Regulatory approval (EU)
Regulatory approval (JP)
Regulatory approval (EU)
Regulatory approval (EU)
Calquence
CLL22 (ELEVATE-TN)
Regulatory approval (JP)
Calquence
Maleate tablet formulation
Regulatory approval (EU)
Forxiga
HFpEF23 (DELIVER)
Regulatory approval (EU, JP)
Airsupra
Severe asthma (MANDALA/DENALI)
Regulatory approval (US)
Tezspire
Pre-filled pen
Regulatory approval (US, EU)
Enhertu
HER2-mutated NSCLC (2nd-line+)
Regulatory submission (EU, JP)
Regulatory
(DESTINY-Lung01)
submissions
Calquence
CLL (ASCEND)
Regulatory submission (CN)
or acceptances
Beyfortus
RSV24 (MELODY/MEDLEY)
Regulatory submission (US)
Soliris
NMOSD25
Regulatory submission (CN)
Imfinzi
NSCLC (1st-line) (PEARL)
Primary endpoint not met
capivasertib
HR26+/HER2-negative breast cancer
Fast Track Designation (US)
(1st-line)(CAPItello-291)
Orpathys +
NSCLC with MET overexpression
Fast Track Designation (US)
Tagrisso
(SAVANNAH/SAFFRON)
Major Phase III
data readouts
Treatment/prevention of acute
and other
tozorakimab
respiratory failure in patients with viral
Fast Track Designation (US)
developments
lung infection (TILIA)
Saphnelo
Idiopathic inflammatory myopathies
Orphan Drug Designation (US)
Revision of Emergency Use
Evusheld
Pre-exposure prophylaxis of COVID-19
Authorisation (US) - Evusheld is not
currently authorised in the US until
further notice from the FDA27
5
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AstraZeneca plc published this content on 09 February 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 09 February 2023 07:12:41 UTC.
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