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 April 2023
 
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. 1st Quarter Results
 
AstraZeneca
27 April 2023
 
Q1 2023 results
 
Strong start to the year with stable Total Revenue and 15% growth excluding COVID-19 medicines[1]
 
Revenue and EPS summary
 
 
 
 
 
Q1 2023
 
 
 
 
% Change
 
 
$m
Actual
CER [2]
- Product Sales
 
10,566 
(4)
- Alliance Revenue[3]
 
286 
88 
90 
- Collaboration Revenue3
 
27 
(89)
(89)
Total Revenue
 
10,879 
(4)
Total Revenue ex COVID-19
 
10,725 
  10 
 15 
Reported[4] EPS[5]
 
$1.16 
>4x 
>4x 
Core[6] EPS
 
$1.92 
 
Financial performance (Q1 2023 figures unless otherwise stated, growth numbers at CER)
 
Total Revenue stable at $10,879m, despite a decline of $1,460m from COVID-19 medicines
 
- Excluding COVID-19 medicines, Total Revenue increased 15% and Product Sales increased 16%
 
- Total Revenue from Oncology medicines increased 19%, CVRM[7] 22%, R&I[8] 8%, and Rare Disease 14%
 
- Core Gross margin of 83%, up four percentage points, reflecting the decline in sales of lower margin COVID-19 medicines, the cost of production in prior periods, and a mix shift to more speciality medicines
 
- Core Operating margin of 36%, up one percentage point, reflecting a $220m increase in Core Other operating income, which included a gain from the divestment of Pulmicort Flexhaler rights in the US
 
- Core EPS increased 6% to $1.92
 
- Reiterating guidance for FY 2023 Total Revenue and Core EPS
 
Pascal Soriot, Chief Executive Officer, AstraZeneca, said:
 
"AstraZeneca had a strong start to 2023, with Total Revenue excluding COVID-19 medicines increasing 15%. Our performance in Emerging Markets was particularly strong and I am impressed by the growth and pace of innovation I see in China, which underscores the competitive advantage of our leading presence in this country.  
 
Our pipeline momentum continued with positive Phase III results for a Lynparza-plus-Imfinzi combination in ovarian cancer, Imfinzi in lung cancer, and promising new data for Enhertu across a range of cancer types. Additionally, in the year to date we have started six new Phase III trials and are on track to initiate 30 over the course of 2023. 
 
Finally, I would like to thank Leif Johansson for his outstanding leadership during his time as Chair of the Board, and his contribution to our return to growth strategy. Leif has been a tremendous partner to me, and I look forward to building the same strong partnership with our new Chair, Michel Demaré."
 
Key milestones achieved since the prior results
 
- Key read outs: positive results for Lynparza and Imfinzi in ovarian cancer (DUO-O), Imfinzi in NSCLC[9] (AEGEAN) and Enhertu in multiple tumour types (DESTINY-PanTumor02). Tagrisso showed a statistically significant improvement in overall survival in NSCLC (ADAURA)
 
- Key regulatory approvals: EU approvals for Imfinzi and Imjudo in HCC[10] (HIMALAYA) and NSCLC (POSEIDON), Calquence maleate tablet formulation, and positive CHMP recommendation for Ultomiris in NMOSD[11]. China approvals for Enhertu in HER2-positive[12] breast cancer (DESTINY-Breast03) and Calquence in mantle cell lymphoma
 
As announced on 11 April 2023, AstraZeneca's results for Q2 2023 will include a gain of $718m in Core Other operating income resulting from an update to the contractual relationships for nirsevimab[13]
 
Guidance
 

The Company reiterates guidance for FY 2023 at CER, based on the average exchange rates through 2022.
 
Total Revenue is expected to increase by a low-to-mid single-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[14] and COVID-19 mAbs[15]) 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
 
- Alliance Revenue and Collaboration Revenue are both expected to increase[16], driven by continued growth of our partnered medicines and success-based milestones
 
- Other operating income is expected to increase
 
- Core Operating expenses are expected to increase by a low-to-mid single-digit percentage, driven by investment in recent launches and the ungating of new trials following pipeline success
 
- 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 results, including any fair value adjustments arising on acquisition-related liabilities, intangible asset impairment charges and legal settlement provisions. Please refer to the cautionary statements section regarding forward-looking statements at the end of this announcement.
 
Currency impact
 
If foreign exchange rates for April to December 2023 were to remain at the average rates seen in the month of March 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 18.
 
Table 1: Key elements of Total Revenue performance in Q1 2023
 
 
 
% Change 
 
 
Revenue type 
 
$m 
Actual 
CER 
 
 
Product Sales 
 
10,566 
(4)
 
 Decline of 4% (1% increase at CER) impacted by lower sales of COVID-19 medicines
 Strong growth in Oncology, CVRM, R&I and Rare Disease
Alliance Revenue
 
286 
88 
90 
 
 $220m for Enhertu (Q1 2022: $76m)
 $43m for Tezspire (Q1 2022: $3m)
 See Table 6 for further details
Collaboration Revenue 
 
27 
(89)
(89)
 
 No sales or regulatory milestones from Lynparza in the quarter (Q1 2022: $175m)
 See Table 7 for further details
Total Revenue 
 
10,879 
(4)
-- 
 
 Excluding COVID-19 medicines, Q1 2023 Total Revenue increased by 10% (15% at CER)
Therapy areas 
 
$m 
Actual %
CER %
 
 
Oncology 
 
4,148 
14 
19 
 
 Strong performance across key medicines and regions
 No sales or regulatory milestones from Lynparza in the quarter (Q1 2022: $175m)
CVRM
 
2,557 
15 
22 
 
 Farxiga up 32% (39% CER), Lokelma up 56% (64% at CER), roxadustat up 52% (66% CER), Brilinta up 3% (5% at CER)
R&I 
 
1,633 
 
 Fasenra up 10% (13% CER), Breztri up 67% (73% CER). Saphnelo and Tezspire continue to grow rapidly during their launch phase
 Collaboration Revenue of $nil (Q1 2022: $70m, relating to tralokinumab milestone)
V&I[17]
 
355 
(80)
(79)
 
 $127m from COVID-19 mAbs (Q1 2022: $469m)
 $28m from Vaxzevria (Q1 2022: $1,145m)
Rare Disease
 
1,866 
10 
14 
 
 Ultomiris up 55% (61% at CER), offset by decline in Soliris of 16% (13% at CER)
 Strensiq up 26% (28% at CER) reflecting strong patient demand and geographic expansion
Other Medicines 
 
320 
(26)
(21)
 
 
Total Revenue 
 
10,879 
(4)
 
 
Regions inc. COVID-19
 
$m 
Actual %
CER %
 
 
US 
 
4,299 
 
 
Emerging Markets 
 
3,162 
(6)
 
 Growth rate impacted by lower sales of COVID-19 medicines (numbers ex. COVID-19 below)
- China 
 
1,602 
(1)
 
 
- Ex-China Emerging Markets 
 
1,560 
(10)
(6)
 
 
Europe 
 
2,162 
(5)
 
 
Established RoW 
 
1,256 
(22)
(12)
 
 
Total Revenue inc. COVID-19  
 
10,879 
(4)
 
 
Regions ex. COVID-19 
 
$m 
Actual %
CER %
 
 
US 
 
4,299 
15 
15 
 
 
Emerging Markets 
 
3,136 
14 
22 
 
 
- China 
 
1,602 
11 
 
 Third consecutive quarter of growth at CER
 Recovery in inhaled products following lifting of COVID-19 restrictions
- Ex-China Emerging Markets 
 
1,534 
31 
38 
 
 Timing of Rare Disease tender orders
Europe 
 
2,148 
 
 
Established RoW 
 
1,142 
(5)
 
 
Total Revenue ex. COVID-19
 
10,725 
10 
15 
 
 
 
 
 
 
 
 
 
 
 
 
 
Table 2: Key elements of financial performance in Q1 2023
 
 
Metric
 
Reported
Reported change
Core
Corechange
 
Comments[18]
Total Revenue
$10,879m
-4% Actual   stable at CER
$10,879m
-4% Actual   stable at CER
 
 Excluding COVID-19 medicines, Q1 2023 Total Revenue increased by 10% (15% at CER)
 See Table 1 and the Total Revenue section of this document for further details
Gross Margin[19]
82%
14pp Actual   14pp CER
83%
4pp Actual   4pp CER
 
+  Increasing mix of sales from Oncology and Rare Disease medicines
+  Decreasing mix of Vaxzevria sales
‒   Increasing mix of products with profit-sharing arrangements
 Variations in Gross Margin can be expected between periods due to product seasonality, foreign exchange fluctuations, cost inflation and other effects
R&D expense
$2,611m
22% Actual   28% CER
$2,300m
5% Actual   10% CER
 
+  Increased investment in the pipeline
+  Reported R&D expense was also impacted by intangible asset impairments in Q1 2023, and by reversals of impairments in Q1 2022
 Core R&D-to-Total Revenue ratio of 21%(Q1 2022: 19%)
 Year-on-year comparisons can be impacted by differences in cost phasing
SG&A expense
$4,059m
-16% Actual   -13% CER
$3,054m
4% Actual   8% CER
 
+  Market development activities for recent launches
+  Core SG&A-to-Total Revenue ratio of 28%(Q1 2022: 26%).
‒   Reported SG&A in Q1 2022 included a $775m charge for a legal settlement with Chugai Pharmaceutical Co. Ltd
 Year-on-year comparisons can be impacted by differences in cost phasing
Other operating income[20]
$379m
>3x Actual   >3x CER
$318m
>3x Actual   >3x CER
 
 Reported and Core OOI includes a gain of $241m from the disposal of US rights to Pulmicort Flexhaler
Operating Margin
23%
16pp Actual   16pp CER
36%
2pp Actual   1pp CER
 
 See Gross Margin, Expenses and OOIcommentary above
Net finance expense
$287m
-10% Actual   -8% CER
$240m
-4% Actual   -3% CER
 
 Higher interest received on cash balances, partially offset by higher rates on floating debt and bond issuances
 Reported also impacted by a reduction in the discount unwind on acquisition-related liabilities
Tax rate
20%
-10pp Actual   -10pp CER
20%
-1pp Actual   -1pp CER
 
 Variations in the tax rate can be expected between periods
EPS
$1.16
>4x Actual   >4x CER
$1.92
1% Actual   6% CER
 
 Further details of differences between Reported and Core are shown in Table 13
 
Table 3: Pipeline highlights since prior results announcement
 
 
Event
Medicine
Indication / Trial
Event
Regulatory approvals and other regulatory actions
Imfinzi +/- Imjudo
NSCLC (1st-line) (POSEIDON)
Regulatory approval (EU)
Imfinzi + Imjudo
Hepatocellular carcinoma (1st-line) (HIMALAYA)
Regulatory approval (EU)
Enhertu
HER2-positive breast cancer (2nd-line) (DESTINY-Breast03)
Regulatory approval (CN)
Calquence
Maleate tablet formulation
Regulatory approval (EU)
Calquence
Mantle cell lymphoma
Regulatory approval (CN)
Ultomiris
NMOSD
Positive CHMP opinion (EU)
Regulatory submissionsor acceptances
 
Imfinzi
Biliary tract cancer (TOPAZ-1)
Regulatory submission (CN)
Enhertu
HER2+ breast cancer (3rd-line) (DESTINY-Breast02)
Regulatory submission (EU)
Beyfortus
RSV[21] (MELODY/MEDLEY)
Regulatory submission (JP)
eplontersen
ATTRv-PN[22] (NEURO-TTRansform)
Regulatory submission (US)
 
danicopan
PNH with EVH
Regulatory submission (EU)
Major Phase III data readouts and other developments
Lynparza + Imfinzi
Ovarian cancer (1st-line) (DUO-O)
Primary endpoint met
Imfinzi
NSCLC (neoadjuvant) (AEGEAN)
Dual primary endpoints met
 
Other pipeline updates
 
The Phase II/III trial for cotadutide daily formulation in NASH has been discontinued due to portfolio prioritisation. Development continues for AZD9550, a weekly injectable GLP-1/glucagon.
 
In April, the ALXN1840 programme in Wilson Disease was terminated. The decision was based on feedback from regulatory authorities on review of data from the Wilson Disease programme, including the Phase III FoCus and two Phase II mechanistic trials.
 
Table 4: New Phase III trials started since 1 January 2023
 
 
Medicine
Trial name
Indication
datopotamab deruxtecan
AVANZAR
NSCLC (1st-line)
TROPION-Lung07
Non-squamous NSCLC (1st-line)
camizestrant
CAMBRIA-1
HR-positive[23]/HER2-negative adjuvant breast cancer
Tezspire
CROSSING
Eosinophilic oesophagitis
AZD3152
SUPERNOVA
COVID-19 prophylaxis
Ultomiris
ARTEMIS
Cardiac surgery associated acute kidney injury
 
Corporate and business development 
In the quarter, AstraZeneca completed the previously-announced acquisitions of CinCor Pharma Inc. (CinCor) and Neogene Therapeutics Inc., and the disposal of US commercial rights to Pulmicort Flexhaler to Cheplapharm.
 
AstraZeneca expanded its collaboration with SOPHiA GENETICS to apply their multimodal technology and expertise to AstraZeneca's oncology portfolio. The multimodal approach will combine radiomics analysis of medical imaging data, molecular data, digital pathology, clinical and biologic data for a more comprehensive assessment of multimodal signatures.
              
In March 2023, AstraZeneca signed an investment agreement with Qingdao High-tech Industrial Development Zone to build a production and supply site in China for Breztri pressurised metered-dose inhalers. The Qingdao plant will address the country's growing COPD burden. China is home to about 100 million patients with COPD, which is the third leading cause of death in the country.
 
In April 2023, the contractual relationship between AstraZeneca and Swedish Orphan Biovitrum AB (Sobi) relating to future sales of nirsevimab in the US was replaced by a royalty relationship between Sanofi and Sobi. As a result, a liability representing AstraZeneca's future obligations to Sobi will be eliminated from AstraZeneca's Statement of Financial Position, and AstraZeneca will record a gain of $718m in Core Other operating income in Q2 2023.
 
Sustainability summary
AstraZeneca published its ninth Sustainability Report and Data Summary, along with the 2022 TCFD[24] Report and related case studies. AstraZeneca also hosted an annual Sustainability call for shareholders, reiterating its continued commitment to deliver across our pillars; Access to Healthcare, Environmental Protection and Ethics and Transparency. A recording of the call and accompanying materials are available on the AstraZeneca IR website.
 
Management changes
As previously communicated, Leif Johansson, will retire as Chair at the conclusion of the Company's Annual General Meeting today, 27 April 2023. Michel Demaré's appointment as Chair will take effect immediately on Leif's retirement, and Michel will step down as a member of the Audit Committee.
 
Conference call
A conference call and webcast for investors and analysts will begin today, 27 April 2023, at 11:45 UK time. Details can be accessed via astrazeneca.com.
 
Reporting calendar
The Company intends to publish its half-year and second-quarter results on Friday, 28 July 2023.
 
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. The performance shown in this announcement covers the three month period to 31 March 2023 ('the quarter' or 'Q1 2023') compared to the three month period to 31 March 2022 ('Q1 2022'), unless stated otherwise.
 
Core financial measures, EBITDA, Net debt, Gross Margin, Operating Margin and CER are non-GAAP financial measures because they cannot be derived directly from the Group's Interim Financial Statements. Management believes that these non-GAAP financial measures, when provided in combination with Reported results, provide investors and analysts with helpful supplementary information to understand better the financial performance and position of the Group on a comparable basis from period to period. These non-GAAP financial measures are not a substitute for, or superior to, financial measures prepared in accordance with GAAP.
 
Core financial measures are adjusted to exclude certain significant items, such as:
 
- Amortisation and impairment of intangible assets, including impairment reversals but excluding any charges relating to IT assets
 
- Charges and provisions related to restructuring programmes, which includes charges that relate to the impact of restructuring programmes on capitalised IT assets
 
- Alexion acquisition-related items, primarily fair value adjustments on acquired inventories and fair value impact of replacement employee share awards
 
- Other specified items, principally the imputed finance charges and fair value movements relating to contingent consideration on business combinations or asset acquisitions, legal settlements and remeasurement adjustments relating to Other payables
 
- 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 62 of the Annual Report and Form 20-F Information 2022.
 
Reference should be made to the Reconciliation of Reported to Core financial measures table included in the financial performance section in this announcement.
 
Gross Margin is the percentage by which Product Sales exceeds the Cost of Sales, calculated by dividing the difference between the two by the sales figure. The calculation of Reported and Core Gross Margin excludes the impact of Alliance Revenue and Collaboration Revenue and any associated costs, thereby reflecting the underlying performance of Product Sales.
 
EBITDA is defined as Reported Profit before tax after adding back Net finance expense, results from Joint ventures and associates and charges for Depreciation, amortisation and impairment. Reference should be made to the Reconciliation of Reported Profit before tax to EBITDA included in the financial performance section in this announcement.
 
Net debt is defined as Interest-bearing loans and borrowings and Lease liabilities, net of Cash and cash equivalents, Other investments, and Net derivative financial instruments. Reference should be made to Note 3 'Net debt' included in the Notes to the Interim Financial Statements in this announcement.
 
The Company strongly encourages investors and analysts not to rely on any single financial measure, but to review AstraZeneca's financial statements, including the Notes thereto, and other available Company reports, carefully and in their entirety.
 
Due to rounding, the sum of a number of dollar values and percentages in this announcement may not agree to totals.
 
Total Revenue
 

Table 5: Therapy area and medicine performance
 
 
 
Q1 2023 
 
 
 
 
% Change 
 
Product Sales 
 
$m 
% Total 
Actual 
CER 
Oncology 
 
3,920 
36 
16 
21 
Tagrisso 
 
1,424 
13 
15 
Imfinzi [25]
 
900 
50 
56 
Lynparza 
 
651 
10 
Calquence
 
532 
28 
31 
Enhertu
 
37 
>3x 
>3x 
Orpathys 
 
(33)
(27)
Zoladex 
 
227 
(6)
Faslodex 
 
75 
(19)
(11)
- Others 
 
66 
(32)
(27)
BioPharmaceuticals: CVRM
 
2,530 
23 
15 
21 
Farxiga 
 
1,299 
12 
30 
37 
Brilinta 
 
334 
Lokelma 
 
98 
56 
64 
- roxadustat 
 
61 
49 
63 
Andexxa
 
44 
34 
42 
Crestor 
 
305 
14 
23 
Seloken/Toprol-XL 
 
179 
(27)
(20)
- Onglyza
 
63 
(8)
(3)
- Bydureon
 
45 
(33)
(32)
- Others 
 
102 
BioPharmaceuticals: R&I 
 
1,583 
15 
10 
Symbicort 
 
688 
Fasenra
 
338 
10 
13 
Breztri  
 
144 
67 
73 
Saphnelo 
 
47 
>4x 
>4x 
Tezspire 
 
11 
n/m 
n/m 
Pulmicort 
 
221 
Bevespi
 
15 
(1)
Daliresp/Daxas 
 
13 
(75)
(75)
- Others 
 
106 
(27)
(22)
BioPharmaceuticals: V&I 
 
355 
(80)
(78)
-  COVID-19 mAbs
 
127 
(73)
(70)
   - Vaxzevria 
 
28 
(97)
(97)
Synagis
 
198 
(1)
FluMist
 
n/m 
n/m 
Rare Disease
 
1,866 
17 
10 
14 
- Soliris
 
834 
(16)
(13)
- Ultomiris 
 
651 
55 
61 
- Strensiq 
 
262 
26 
28 
Koselugo 
 
79 
>2x 
>2x 
Kanuma 
 
40 
Other Medicines 
 
312 
(26)
(21)
Nexium 
 
244 
(27)
(20)
- Others 
 
68 
(26)
(23)
Product Sales 
 
10,566 
97 
(4)
Alliance Revenue
 
286 
88 
90 
Collaboration Revenue 
 
27 
(89)
(89)
Total Revenue
 
10,879 
100 
(4)
-
 
 
 
 
 
 
 
 
 
 
Table 6: Alliance Revenue
 
 
 
Q1 2023
 
 
 
 
% Change
 
 
$m 
% Total 
Actual 
CER 
Enhertu
 
220 
77 
>2x 
>2x 
Tezspire
 
43 
15 
n/m 
n/m 
Vaxzevria: royalties 
 
n/m 
n/m 
Other royalty income 
 
20 
23 
24 
Other Alliance Revenue 
 
>3x 
>3x 
Total 
 
286 
100 
88 
90 
 
Table 7: Collaboration Revenue
 
 
 
Q1 2023
 
 
 
 
% Change
 
 
$m 
% Total 
Actual 
CER 
Farxiga: sales milestones 
 
24 
89 
n/m 
n/m 
Other Collaboration Revenue 
 
11 
(76)
(76)
Total 
 
27 
100 
(89)
(89)
 
Table 8: Total Revenue by therapy area
 
 
 
Q1 2023 
 
 
 
% Change 
 
 
 
 
$m 
% Total 
 Actual 
CER 
Oncology 
 
4,148 
38 
14 
19 
BioPharmaceuticals
 
4,545 
42 
(19)
(15)
- CVRM
 
2,557 
24 
15 
22 
- R&I 
 
1,633 
15 
- V&I 
 
355 
(80)
(79)
Rare Disease
 
1,866 
17 
10 
14 
Other Medicines 
 
320 
(26)
(21)
Total
 
10,879 
100 
(4)
 
 
 
 
 
 
 
 
 
Table 9: Total Revenue by region
 
 
 
Q1 2023 
 
 
 
 
% Change 
 
 
 
$m 
% Total 
 Actual 
CER 
US
 
4,299 
40 
Emerging Markets 
 
3,162 
29 
(6)
- China 
 
1,602 
15 
(1)
- Ex-China 
 
1,560 
14 
(10)
(6)
Europe 
 
2,162 
20 
(5)
-
Established RoW 
 
1,256 
12 
(22)
(12)
Total 
 
10,879 
100 
(4)
 
 
 
 
 
 
 
 
 
 
 
Table 10: Total Revenue by region - excluding COVID-19 medicines
 
 
 
 
Q1 2023 
 
 
 
 
 
% Change 
 
 
 
$m 
% Total 
 Actual 
CER 
US
 
4,299 
40 
15 
15 
Emerging Markets 
 
3,136 
29 
14 
22 
- China 
 
1,602 
15 
11 
- Ex-China 
 
1,534 
14 
31 
38 
Europe 
 
2,148 
20 
Established RoW 
 
1,142 
11 
(5)
Total 
 
10,725 
100 
10 
15 
 
 
 
 
 
 
 
 
 
 
 
 
 
Oncology
 
Oncology Total Revenue increased by 14% (19% at CER) in Q1 2023 to $4,148m and represented 38% of overall Total Revenue (Q1 2022: 32%). There was no Lynparza Collaboration Revenue in the quarter (Q1 2022: $175m) and Enhertu Alliance Revenue was $220m (Q1 2022: $76m). Product Sales increased by 16% (21% at CER) in Q1 2023 to $3,920m, reflecting new launches and increased patient access across key brands; partially offset by declines in legacy medicines.
 
Tagrisso
 
 
Total Revenue
 
Worldwide
 
US
Emerging Markets
Europe
Established RoW
Q1 2023  $m
 
1,424
 
521
444
257
202
Actual change
 
9%
 
19%
9%
2%
(2%)
CER change
 
15%
 
19%
17%
8%
11%
 
 
Region
 
 Drivers and commentary
Worldwide
 
 Increased use of Tagrisso in adjuvant and 1st-line setting and expansion of reimbursed access
US
 
 Increasing demand in 1st-line and adjuvant setting, partially offset by unfavourable inventory movements
Emerging Markets
 
 Rising demand from increased patient access in China continues to offset NRDL[26] renewal price reductions
 Recovery from Q4 2022 ordering dynamics in China
Europe
 
 Established standard of care in 1st-line and adjuvant setting across EU5[27], partially offset by pricing clawbacks in certain markets
Established RoW
 
 Increased use in 1st-line setting and launch acceleration in adjuvant, including Japan
 
Imfinzi
 
 
Total Revenue
 
Worldwide
 
US
Emerging Markets
Europe
Established RoW
Q1 2023  $m
 
900
 
522
81
163
134
Actual change
 
50%
 
66%
39%
31%
33%
CER change
 
56%
 
66%
47%
38%
52%
 
 
 
 
 
 
 
 
Region
 
 Drivers and commentary
Worldwide
 
 The Imfinzi revenue line includes sales of Imjudo, which launched in Q4 2022 following approvals in the US for patients with unresectable liver cancer (HIMALAYA) and Stage IV NSCLC (POSEIDON)
 Increased use of Imfinzi in BTC[28] (TOPAZ-1), liver cancer (HIMALAYA) and lung cancers (POSEIDON, CASPIAN)
US
 
 Continued growth in new patient starts across Stage III NSCLC and ES-SCLC[29]
 Strong launch in BTC following September 2022 FDA approval, and growing penetration of Imfinzi + Imjudo in liver and lung cancers
Emerging Markets
 
 Growth in ex-China driven increased market penetration in ES-SCLC and NSCLC (PACIFIC), and recovery of diagnosis and treatment rates following the COVID-19 pandemic
Europe
 
 Increased market penetration in ES-SCLC, launch trajectory in BTC, growth in the number of reimbursed markets
Established RoW
 
 New reimbursements, strong demand growth in BTC
 
Lynparza
 
 
Total Revenue
 
Worldwide
 
US
Emerging Markets
Europe
Established RoW
Q1 2023  $m
 
651
 
268
137
178
68
Actual change
 
(18%)
 
(1%)
13%
(47%)
2%
CER change
 
(14%)
 
(1%)
19%
(44%)
16%
 
 
Product Sales
 
Worldwide
 
US
Emerging Markets
Europe
Established RoW
Q1 2023  $m
 
651
 
268
137
178
68
Actual change
 
5%
 
(1%)
13%
11%
2%
CER change
 
10%
 
(1%)
19%
18%
16%
 
 
Region
 
 Drivers and commentary
Worldwide
 
 Lynparza remains the leading medicine in the PARP[30] inhibitor class globally across four tumour types, as measured by total prescription volume
 No regulatory milestones received in Q1 2023
US
 
 Positive demand growth driven by OlympiA (FDA approval March 2022) offset by flattening HRD testing rates in ovarian cancer and destocking following an inventory build in Q4 2022 in anticipation of PROpel launch
Emerging Markets
 
 Re-enlistment into China's NRDL for ovarian cancer indications (PSR[31] and BRCAm[32] 1st-line maintenance) and new enlistment in prostate cancer (PROfound)
Europe
 
 Growth driven by increased uptake in 1st-line HRD-positive ovarian cancer, gBRCAm[33] HER2-negative early breast cancer and BRCAm mCRPC, partially offset by new indication pricing impact and clawbacks in some markets
Established RoW
 
 Growth continues across tumour types
 
Enhertu
 
 
Total Revenue
 
Worldwide
 
US
Emerging Markets
Europe
Established RoW
Q1 2023  $m
 
257
 
161
38
55
3
Actual change
 
>2x
 
>2x
>4x
>2x
>5x
CER change
 
>3x
 
>2x
>4x
>2x
>6x
 
 
Region
 
 Drivers and commentary
Worldwide
 
 Combined sales of Enhertu, recorded by Daiichi Sankyo Company Limited (Daiichi Sankyo) and AstraZeneca, amounted to $508m in the quarter (Q1 2022: $166m)
 AstraZeneca's Total Revenue of $257m includes $220m of Alliance Revenue from its share of gross profit and royalties in territories where Daiichi Sankyo records product sales
US
 
 US in-market sales, recorded by Daiichi Sankyo, amounted to $336m in the quarter (Q1 2022: $119m)
 Rapid adoption as new standard of care across all launched indications including HER2-low mBC[34] with strong demand continuing from breast cancer launches
Emerging Markets
 
 Strong uptake driven by new approvals and launches
Europe
 
 Continued growth in 2nd-line and 3rd-line+ HER2-positive metastatic breast cancer
 Increased uptake following launches of 2nd-line+ HER2-positive gastric cancer and 2nd-line+ HER2-low metastatic breast cancer after EU approvals in December 2022 and January 2023 respectively (DESTINY-Gastric01, DESTINY-Gastric02, DESTINY-Breast04)
Established RoW
 
 In Japan, AstraZeneca receives a mid-single-digit percentage royalty on sales made by Daiichi Sankyo
 
Calquence
 
 
Total Revenue
 
Worldwide
 
US
Emerging Markets
Europe
Established RoW
Q1 2023 $m
 
532
 
384
18
108
22
Actual change
 
28%
 
13%
>2x
95%
76%
CER change
 
31%
 
13%
>2x
>2x
91%
 
 
Region
 
 Drivers and commentary
Worldwide
 
 Increased penetration globally; leading BTKi[35] in key markets
US
 
 
 1st-line patient share broadly stable, some competitive impact in relapsed refractory setting
 Q1 2023 performance impacted by destocking following inventory build-up that followed approval of the maleate tablet formulation
 
 
Orpathys
 
Total Revenue of $9m (Q1 2022: $11m) was driven by the 2021 launch in China, where Orpathys is approved for patients with lung cancer and MET[36] gene alterations. Orpathys is now included in the updated NRDL in China for the treatment of patients with NSCLC with MET exon 14 skipping alterations.
 
Other Oncology medicines
 
 
 
Q1 2023
Change
 
Total Revenue
 
$m
Actual
CER
 
Zoladex
 
235
(5%)
4%
 Increased use in ex-China Emerging Markets
Faslodex
 
75
(19%)
(11%)
 Generic competition
Other Oncology
 
66
(32%)
(27%)
 Includes IressaArimidexCasodex and other older medicines
 
 
 
 
 
 
 
 
BioPharmaceuticals
 
BioPharmaceuticals Total Revenue decreased by 19% (15% at CER) in Q1 2023 to $4,545m, representing 42% of overall Total Revenue (Q1 2022: 49%). The decrease was driven by declining revenues from COVID-19 medicines. Growth from Farxiga and newer R&I medicines offset decreases in some older medicines.
 
BioPharmaceuticals - CVRM
 
CVRM Total Revenue increased by 15% (22% at CER) to $2,557m in Q1 2023, driven by a strong Farxiga performance, and represented 24% of overall Total Revenue (Q1 2022: 19%).
 
Farxiga
 
 
Total Revenue
 
Worldwide
 
US
Emerging Markets
Europe
Established RoW
Q1 2023  $m
 
1,324
 
296
498
393
138
Actual change
 
32%
 
53%
27%
24%
39%
CER change
 
39%
 
53%
35%
31%
53%
 
 
Region
 
 Drivers and commentary
Worldwide
 
 
 Farxiga volume is growing faster than the overall SGLT2[37] market in all major regions
 Additional benefit from continued growth in the overall SGLT2 inhibitor class
 Further HF[38] and CKD[39] launches and supportive updates to treatment guidelines including from ESC[40] and AHA[41]/ACC[42]/HFSA[43]. HF and CKD indications now launched in >100 markets
US
 
 Growth driven by HFrEF[44] and CKD for patients with and without T2D[45]
 Favourable gross-to-net impact in the quarter
 Farxiga continued to gain in-class brand share, driven by HF and CKD launches
Emerging Markets
 
 Growth despite generic competition in some markets. Solid growth in ex-China Emerging Markets, particularly Latin America
Europe
 
 Benefited from the addition of cardiovascular outcomes trial data to the label, the HFrEF regulatory approval in November 2020, and CKD regulatory approval in August 2021. HFpEF[46] approval in February 2023
 Continued strong volume growth in the quarter partially offset by clawbacks
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. A milestone payment from Ono was recorded in the quarter
 
Brilinta
 
 
Total Revenue
 
Worldwide
 
US
Emerging Markets
Europe
Established RoW
Q1 2023 $m
 
334
 
179
82
67
6
Actual change
 
3%
 
8%
19%
(12%)
(59%)
CER change
 
5%
 
8%
25%
(7%)
(53%)
 
 
Region
 
 Drivers and commentary
US
 
 Favourable comparison due to COVID-19 impact in Q1 2022
Emerging Markets
 
 Growth in all major Emerging Markets regions following COVID-19 recovery
Europe
 
 European sales negatively impacted by clawbacks
 
Lokelma
 
Total Revenue increased 56% (64% at CER) to $98m in Q1 2023. Continued progress in Europe, with strong volume growth. In China, Lokelma was enlisted to the NRDL in January 2022 and is now the leading potassium binder in the country.
 
roxadustat
 
Total Revenue increased 52% (66% at CER) to $62m, with roxadustat benefitting from increased volumes in China following NRDL renewal in 2022.
 
Andexxa
 
Total Revenue increased 2% (8% at CER) to $44m.
 
Other CVRM medicines
 
 
 
Q1 2023
Change
 
Total Revenue
 
$m
Actual
CER
 
Crestor
 
306
14%
23%
 Strong sales growth in Emerging Markets, partly offset by declines in the US and Established RoW
Seloken
 
179
(27%)
(20%)
 Emerging Markets sales impacted by China VBP implementation of Betaloc[47] oral in H2 2021. Betaloc ZOK VBP was implemented in Q4 2022
Onglyza
 
63
(8%)
(3%)
 Continued decline for DPP-IV class
Bydureon
 
45
(33%)
(32%)
 Continued competitive pressures
Other CVRM
 
102
4%
9%
 
 
 
 
 
 
 
 
 
BioPharmaceuticals - R&I
 
Total Revenue of $1,633m from R&I medicines in Q1 2023 increased 3% (8% at CER) and represented 15% of overall Total Revenue (Q1 2022: 14%). This reflected growth in launch brands: FasenraTezspireBreztri and Saphnelo.
 
Symbicort
 
 
Total Revenue
 
Worldwide
 
US
Emerging Markets
Europe
Established RoW
Q1 2023  $m
 
688
 
233
229
147
79
Actual change
 
2%
 
(10%)
37%
(6%)
(14%)
CER change
 
7%
 
(10%)
48%
(1%)
(7%)
 
 
Region
 
 Drivers and commentary
Worldwide
 
 Symbicort remains the global market leader within a stable ICS[48]/LABA[49] class
US
 
 Market share resilience, consolidating leadership in a declining ICS/LABA market
 Generic entry expected in the US in 2023
Emerging Markets
 
 Post-COVID-19 recovery in China and channel inventory rebuild
Europe
 
 Resilient market share in growing ICS/LABA market, offset by pricing pressure
Established RoW
 
 Inventory destocking in some markets and generic erosion in Japan
 
Fasenra
 
 
Total Revenue
 
Worldwide
 
US
Emerging Markets
Europe
Established RoW
Q1 2023 $m
 
338
 
201
14
88
35
Actual change
 
10%
 
6%
>2x
17%
(4%)
CER change
 
13%
 
6%
>2x
23%
7%
 
 
Region
 
 Drivers and commentary
Worldwide
 
 Continues to be market leader in severe eosinophilic asthma in major markets, and leads in the IL-5[50] class
US
 
 Strong underlying demand growth, partially offset in the quarter by inventory dynamics
Emerging Markets
 
 Strong volume growth driven by launch acceleration across key markets
Europe
 
 Expanded leadership in severe eosinophilic asthma
Established RoW
 
 Maintained leadership of the dynamic market[51] in Japan
 
Breztri
 
 
Total Revenue
 
Worldwide
 
US
Emerging Markets
Europe
Established RoW
Q1 2023 $m
 
144
 
81
38
15
10
Actual change
 
67%
 
53%
71%
>3x
52%
CER change
 
73%
 
53%
85%
>3x
73%
 
 
Region
 
 Drivers and commentary
Worldwide
 
 Continues to gain market share within the growing FDC[52] triple class across major markets
US
 
 Consistent share growth within the FDC triple class in new-to-brand[53] and total market
Emerging Markets
 
 Maintained market share leadership in China within the FDC triple class
Europe
 
 Sustained growth across markets as new launches continue to progress
Established RoW
 
 Increasing new-to-brand market share within COPD plus ACO[54] in Japan
 
Saphnelo
 
 
Total Revenue
 
Worldwide
 
US
Emerging Markets
Europe
Established RoW
Q1 2023 $m
 
47
 
44
-
1
2
Actual change
 
>4x
 
>4x
n/m
>3x
>4x
CER change
 
>4x
 
>4x
n/m
>4x
>5x
 
 
Region
 
 Drivers and commentary
Worldwide
 
 Demand acceleration in the US, where Saphnelo has new-to-brand leadership in the i.v.[55]  segment for SLE[56], and the ongoing launches in Europe and Japan
 
Tezspire
 
 
Total Revenue
 
Worldwide
 
US
Emerging Markets
Europe
Established RoW
Q1 2023  $m
 
54
 
43
-
7
4
Actual change
 
>10x
 
>10x
n/m
n/m
n/m
CER change
 
>10x
 
>10x
n/m
n/m
n/m
 
 
Region
 
 Drivers and commentary
Worldwide
 
 Tezspire is approved in the US, EU and Japan (as well as other countries) for the treatment of severe asthma without biomarker or phenotypic limitation.
 Amgen records sales in the US, and AstraZeneca records its share of US gross profits as Alliance Revenue
 AstraZeneca books Product Sales in markets outside the US
 Combined sales of Tezspire by AstraZeneca and Amgen were $105m in the quarter
US
 
 Increasing new-to-brand market share with majority of patients new to biologics
Europe
 
 Achieved and maintained new-to-brand leadership in key markets
 Pre-filled pen approved in January 2023
Established RoW
 
 Japan achieved new-to-brand leadership by month two
 
Other R&I medicines
 
 
 
Q1 2023
% Change
 
Total Revenue
 
$m
Actual
CER
 
Pulmicort
 
221
2%
9%
 Revenues increased in Emerging Markets with continued recovery of nebulisation demand post COVID-19 and market share in China stabilising
 Revenue from the US declined 54%
Bevespi
 
15
(1%)
2%
 
Daliresp
 
13
(75%)
(75%)
 Impacted by uptake of multiple generics following loss of exclusivity in the US
Other R&I
 
113
(48%)
(45%)
 Collaboration Revenue of $nil (Q1 2022: $70m)
 Product Sales of $106m decreased 27% (22% at CER) due to generic competition
 
 
 
 
 
 
 
 
 
BioPharmaceuticals - V&I
 
Total Revenue from V&I medicines declined by 80% (79% at CER) to $355m (Q1 2022: $1,814m) and represented 3% of overall Total Revenue (Q1 2022: 16%).
 
COVID-19 mAbs
 
 
Total Revenue
 
Worldwide
 
US
Emerging Markets
Europe
Established RoW
Q1 2023 $m
 
127
 
-
8
4
115
Actual change
 
(73%)
 
n/m
(91%)
(94%)
>10x
CER change
 
(70%)
 
n/m
(91%)
(94%)
>10x
 
 
Region
 
 Drivers and commentary
US
 
 No revenue in the quarter following the completion of US government contract deliveries in Q4 2022, and the revision of Evusheld's emergency use authorisation in January 2023
Established RoW
 
 Deliveries in Japan
 
Vaxzevria
 
 
Total Revenue
 
Worldwide
 
US
Emerging Markets
Europe
Established RoW
Q1 2023  $m
 
28
 
-
18
10
-
Actual change
 
(98%)
 
n/m
(97%)
(93%)
n/m
CER change
 
(97%)
 
n/m
(97%)
(92%)
n/m
 
 
Region
 
 Drivers and commentary
Worldwide
 
 Revenue in the quarter decreased by 98% (97% at CER) due to the conclusion of Vaxzevria contracts
 
Other V&I medicines
 
 
 
Q1 2023
% Change
 
Total Revenue
 
$m
Actual
CER
 
Synagis
 
198
(1%)
5%
 
FluMist
 
2
n/m
n/m
 Normal seasonality
 
 
 
 
 
 
 
 
 
Rare Disease
 
Total Revenue from Rare Disease medicines increased by 10% (14% at CER) in Q1 2023 to $1,866m, representing 17% of overall Total Revenue (Q1 2022: 15%).
 
Performance was driven by the durability of the C5[57] franchise, Soliris and Ultomiris growth in neurology indications and expansion into new markets.
 
Soliris
 
 
Total Revenue
 
Worldwide
 
US
Emerging Markets
Europe
Established RoW
Q1 2023 $m
 
834
 
448
115
183
88
Actual change
 
(16%)
 
(24%)
63%
(17%)
(18%)
CER change
 
(13%)
 
(24%)
77%
(12%)
(10%)
 
 
Region
 
 Drivers and commentary
US
 
 Performance impacted by successful conversion of Soliris patients to Ultomiris in PNH, aHUS[58] and gMG[59], partially offset by Soliris growth in NMOSD
Emerging Markets
 
 Growth from expansion into new markets and favourable timing of tender orders in some markets
Europe,Established RoW
 
 Decline driven by successful conversion of Soliris patients to Ultomiris, slightly offset by growth in NMOSD
 
Ultomiris
 
 
Total Revenue
 
Worldwide
 
US
Emerging Markets
Europe
Established RoW
Q1 2023 $m
 
651
 
381
13
159
98
Actual change
 
55%
 
73%
(46%)
52%
39%
CER change
 
61%
 
73%
(45%)
61%
61%
 
 
Region
 
 Drivers and commentary
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
Emerging Markets
 
 Impacted by inventory movements at third-party distributors due to AstraZeneca bringing distribution in-house
Europe
 
 Growth driven by strong demand generation following new launch markets
Established RoW
 
 Rapid conversion from Soliris in Japan
 
Strensiq
 
 
Total Revenue
 
Worldwide
 
US
Emerging Markets
Europe
Established RoW
Q1 2023 $m
 
262
 
205 
15 
21 
21 
Actual change
 
26% 
 
28% 
70% 
10% 
7% 
CER change
 
28% 
 
28% 
58% 
17% 
22% 
 
 
Region
 
 Drivers and commentary
Worldwide
 
 Performance driven by strong patient demand and geographic expansion
 
Other Rare Disease medicines
 
 
 
Q1 2023
% Change
 
Total Revenue
 
$m
Actual
CER
Commentary
Koselugo
 
79
>2x
>2x
 Growth driven by expansion in new markets
Kanuma
 
40
4%
6%
 Continued demand growth in ex-US markets
 
 
 
 
 
 
 
 
 
Other medicines (outside the main therapy areas)
 
 
 
Q1 2023
% Change
 
Total Revenue
 
$m
Actual
CER
Commentary
Nexium
 
248
(26%)
(20%)
 Generic launches in Japan in the latter part of 2022
Others
 
72
(26%)
(22%)
 Continued impact of generic competition
 
 
 
 
 
 
 
 
 
Financial performance
 
Table 11: Reported Profit and Loss
 
 
 
 
Q1 2023
Q1 2022
% Change 
 
 
 
$m 
$m 
Actual 
CER 
Total Revenue
 
10,879 
11,390 
(4)
- Product Sales
 
10,566 
10,980 
(4)
- Alliance Revenue
 
286 
152 
88 
90 
- Collaboration Revenue
 
27 
258 
(89)
(89)
Cost of sales
 
(1,905)
(3,511)
(46)
(43)
Gross profit
 
8,974 
7,879 
14 
19 
Gross Margin
 
82.0% 
68.0% 
+14pp 
+14pp 
Distribution expense
 
(134)
(125)
12 
% Total Revenue
 
1.2% 
1.1% 
R&D expense
 
(2,611)
(2,133)
22 
28 
% Total Revenue
 
24.0% 
18.7% 
-5pp 
-5pp 
SG&A expense
 
(4,059)
(4,840)
(16)
(13)
% Total Revenue
 
37.3% 
42.5% 
+5pp 
+5pp 
OOI[60] & expense
 
379 
97 
>3x 
>3x 
% Total Revenue
 
3.5% 
0.9% 
+3pp 
+2pp 
Operating profit
 
2,549 
878 
>2x 
>2x 
Operating Margin
 
23.4% 
7.7% 
+16pp 
+16pp 
Net finance expense
 
(287)
(319)
(10)
(8)
Joint ventures and associates
 
(6)
(96)
(96)
Profit before tax
 
2,262 
553 
>4x 
>4x 
Taxation
 
(458)
(165)
>2x 
>2x 
Tax rate
 
20% 
30% 
 
 
Profit after tax
 
1,804 
388 
>4x 
>4x 
Earnings per share
 
$1.16 
$0.25
>4x 
>4x 
 
 
 
 
 
 
 
 
Table 12: Reconciliation of Reported Profit before tax to EBITDA
 
 
 
 
Q1 2023
Q1 2022
% Change
 
 
 
$m
$m 
Actual 
CER 
Reported Profit before tax 
 
2,262 
553 
>4x 
>4x 
Net finance expense 
 
287 
319 
(10)
(8)
Joint ventures and associates 
 
(96)
(96)
Depreciation, amortisation and impairment 
 
1,502 
1,309 
15 
18 
EBITDA 
 
4,051 
2,187 
85 
92 
 
 
 
 
 
 
 
 
EBITDA for the comparative Q1 2022 was negatively impacted by $1,180m unwind of inventory fair value uplift recognised on the acquisition of Alexion. This unwind had $36m negative impact on Q1 2023 and will continue to be minimal in future quarters.
 
Table 13: Reconciliation of Reported to Core financial measures: Q1 2023
 
 
Q1 2023
 
Reported
Restructuring
Intangible Asset Amortisation & Impairments
Acquisitionof Alexion
Other
Core
Core
% Change
 
 
 
$m 
$m 
$m 
$m 
$m 
$m 
Actual 
CER 
Gross profit
 
8,974 
95 
37 
9,116 
Gross Margin
 
82.0% 
 
 
 
 
83.3% 
+4pp 
+4pp 
Distribution expense
 
(134)
(134)
13 
R&D expense
 
(2,611)
30 
280 
(1)
(2,300)
10 
SG&A expense
 
(4,059)
41 
954 
(3,054)
Total operating expense
 
(6,804)
71 
1,234 
(5,488)
Other operating income & expense
 
379 
(61)
318 
>3x
>3x
Operating profit
 
2,549 
105 
1,242 
41 
3,946 
Operating Margin
 
23.4% 
 
 
 
 
36.3% 
+2pp 
+1pp 
Net finance expense
 
(287)
47 
(240)
(4)
(3)
Taxation
 
(458)
(24)
(231)
(9)
(9)
(731)
(5)
(1)
EPS
 
$1.16 
$0.05 
$0.66 
$0.02 
$0.03 
$1.92 
 
 
 
 
 
 
 
 
 
 
 
 
Profit and Loss drivers
 
Gross profit
 
- The change in Gross Margin (Reported and Core) in the quarter was impacted by:
 
- Positive mix effects. The increased contribution from Rare Disease and Oncology medicines had a positive impact on the Gross Margin. Vaxzevria sales, which are also dilutive to gross margin, declined substantially
 
- Negative mix effects. The rising contribution of Product Sales with profit sharing arrangements (Lynparza, Enhertu and Tezspire) has a negative impact on gross margin because AstraZeneca records product revenues in certain markets but pays away half of the gross profit to its collaboration partners. Emerging Markets, where gross margins tend to be below the Company average, grew as a proportion of Total Revenue excluding COVID-19 medicines
 
- Positive impact from cost of production in prior periods
 
- Reported Gross profit was also impacted by a reduction in the unwind of the fair value adjustment to Alexion inventories at the date of acquisition. In Q1 2023, the negative impact of the fair value uplift unwind on Cost of Sales was $36m (Q1 2022: $1,180m)
 
- Variations in Gross Margin performance between periods can continue to be expected, due to product seasonality, foreign exchange fluctuations, cost inflation and other effects. The full impact of cost inflation is not seen in the Income Statement until older inventory built at lower cost has been sold; for some product lines the lag between inflation and impact can be several quarters
 
R&D expense
 
- The change in R&D expense (Reported and Core) was impacted by:
 
- Recent positive data read outs for several high priority medicines that have ungated late-stage trials
 
- Investment in platforms, new technology and capabilities to enhance R&D productivity
 
Reported R&D expense was also impacted by intangible asset impairments in the quarter, and reversals of intangible asset impairments in Q1 2022
 
SG&A expense
 
- The change in SG&A Expense (Reported and Core) was driven primarily by market development activities for launches
 
- Reported SG&A Expense was also impacted by amortisation of intangible assets related to the Alexion acquisition and other acquisitions and collaborations. In Q1 2022, the Reported SG&A expense included a $775m legal settlement with Chugai Pharmaceutical Co. Ltd
 
Other operating income
 
Reported Other operating income of $379m included a gain on the disposal of the US rights to Pulmicort Flexhaler, disposal proceeds on the sale of tangible assets, and royalties on certain medicines
 
Net finance expense
 
- The reduction in Net finance expense (Reported and Core) was primarily driven by an increase in finance income on cash investments, which benefited from higher interest rates. That was partially offset by increased interest expense on floating rate debt, and the interest on the $3.8bn of bonds issued in the quarter
 
- Reported Net finance expense also benefited from a reduction in the discount unwind on acquisition related liabilities
 
Taxation
 
- The effective Reported Tax rate for the three months to 31 March 2023 was 20% (Q1 2022: 30%) and the Core Tax rate was 20% (Q1 2022: 21%). The Reported Tax rate in the prior period was impacted by Non-Core charges on the level of Reported Profit before tax
 
- The net cash paid for the quarter was $225m (Q1 2022: $228m) representing 10% of Reported Profit before tax (Q1 2022: 41%). The cash tax rate of 10% benefits from the phasing of tax payments
 
- On 23 March 2023, the UK Government presented the draft legislation in relation to the new global minimum tax framework to the House of Commons and this is now proceeding through the UK Parliamentary process. This is expected to be brought into effect in the UK from 2024. The Company is currently assessing the potential impact of these draft rules upon its financial statements
 
Table 14: Cash Flow summary
 
 
 
 
Q1 2023 
Q1 2022 
Change 
 
 
$m 
$m 
$m 
Reported Operating profit
 
2,549 
878 
1,671 
Depreciation, amortisation and impairment
 
1,502 
1,309 
193 
Decrease in working capital and short-term provisions
 
242 
1,804 
(1,562)
Gains on disposal of intangible assets
 
(249)
(10)
(239)
Non-cash and other movements
 
(429)
(327)
(102)
Interest paid
 
(257)
(194)
(63)
Taxation paid
 
(225)
(228)
Net cash inflow from operating activities
 
3,133 
3,232 
(99)
Net cash inflow before financing activities
 
1,887 
3,064 
(1,177)
Net cash outflow from financing activities
 
(2,031)
(3,740)
1,709 
 
 
In Q1 2022, the Reported Operating profit of $878m included a negative impact of $1,180m relating to the unwind of the inventory fair value uplift recognised on the acquisition of Alexion. This was offset by a corresponding item (positive impact of $1,180m) in Decrease in working capital and short-term provisions. Overall, the unwind of the fair value uplift had no impact on Net cash inflow from operating activities. This unwind had $36m negative impact on Q1 2023 and will continue to be minimal in future quarters.
 
The change in Net cash inflow before financing activities is primarily driven by the movement in Purchase of intangible assets of $1,079m, including the acquisition of CinCor, in the quarter to 31 March 2023.
 
The change in Net cash outflow from financing activities is primarily driven by the issue of bonds of $3,826m, offset by the repayment of loans and borrowings of $2,004m and dividends paid of $3,047m in the quarter to 31 March 2023.
 
Included within Net cash inflow before financing activities is a movement in the profit-participation liability of $175m, resulting from the cash receipt from Sobi in Q1 2023 after achievement of a regulatory milestone. The associated cash flow is presented within investing activities.
 
Capital expenditure
 
Capital expenditure amounted to $247m in the quarter (Q1 2022: $219m).
 
Table 15: Net debt summary
 
 
 
At 31 
 Mar 2023 
At 31 
Dec 2022 
At 31 
Mar 2022 
 
 
$m 
$m 
$m 
Cash and cash equivalents
 
6,232 
6,166 
5,762 
Other investments
 
230 
239 
61 
Cash and investments
 
6,462 
6,405 
5,823 
Overdrafts and short-term borrowings
 
(667)
(350)
(805)
Lease liabilities
 
(962)
(953)
(949)
Current instalments of loans
 
(2,958)
(4,964)
(1,264)
Non-current instalments of loans
 
(26,916)
(22,965)
(28,081)
Interest-bearing loans and borrowings (Gross debt)
 
(31,503)
(29,232)
(31,099)
Net derivatives
 
(21)
(96)
59 
Net debt
 
(25,062)
(22,923)
(25,217)
 
Net debt increased by $2,139m in the quarter to date to $25,062m. 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, 4.875% Notes due 2028, 4.900% Notes due 2030, 2.250% Notes due 2031 and 4.875% Notes due 2033 (the "AstraZeneca Finance Notes"). Each series of AstraZeneca Finance Notes has been fully and unconditionally guaranteed by AstraZeneca PLC. AstraZeneca Finance is 100% owned by AstraZeneca PLC and each of the guarantees by AstraZeneca PLC is full and unconditional and joint and several.
 
The AstraZeneca Finance Notes are senior unsecured obligations of AstraZeneca Finance and rank equally with all of AstraZeneca Finance's existing and future senior unsecured and unsubordinated indebtedness. The guarantee by AstraZeneca PLC of the AstraZeneca Finance Notes is the senior unsecured obligation of AstraZeneca PLC and ranks equally with all of AstraZeneca PLC's existing and future senior unsecured and unsubordinated indebtedness. Each guarantee by AstraZeneca PLC is effectively subordinated to any secured indebtedness of AstraZeneca PLC to the extent of the value of the assets securing such indebtedness. The AstraZeneca Finance Notes are structurally subordinated to indebtedness and other liabilities of the subsidiaries of AstraZeneca PLC, none of which guarantee the AstraZeneca Finance Notes.
 
AstraZeneca PLC manages substantially all of its operations through divisions, branches and/or investments in subsidiaries and affiliates. Accordingly, the ability of AstraZeneca PLC to service its debt and guarantee obligations is also dependent upon the earnings of its subsidiaries, affiliates, branches and divisions, whether by dividends, distributions, loans or otherwise.
 
Please refer to the consolidated financial statements of AstraZeneca PLC in our Annual Report on Form 20-F and reports on Form 6-K with our quarterly financial results as filed or furnished with the SEC[61] for further financial information regarding AstraZeneca PLC and its consolidated subsidiaries. For further details, terms and conditions of the AstraZeneca Finance Notes please refer to AstraZeneca PLC's reports on Form 6-K furnished to the SEC on 3 March 2023 and 28 May 2021.
 
Pursuant to Rule 13-01 and Rule 3-10 of Regulation S-X under the Securities Act of 1933, as amended (the "Securities Act"), we present below the summary financial information for AstraZeneca PLC, as Guarantor, excluding its consolidated subsidiaries, and AstraZeneca Finance, as the issuer, excluding its consolidated subsidiaries. The following summary financial information of AstraZeneca PLC and AstraZeneca Finance is presented on a combined basis and transactions between the combining entities have been eliminated. Financial information for non-guarantor entities has been excluded. Intercompany balances and transactions between the obligor group and the non-obligor subsidiaries are presented on separate lines.
 
Table 16: Obligor group summarised Statement of comprehensive income
 
 
 
 
Q1 2023
Q1 2022
 
 
$m 
$m 
Total Revenue
 
Gross profit
 
Operating loss
 
(1)
Loss for the period
 
(237)
(155)
Transactions with subsidiaries that are not issuers or guarantors
 
7,502 
164 
 
Table 17: Obligor group summarised Statement of financial position
 
 
 
 
At 31 Mar 2023 
At 31 Mar 2022 
 
 
$m 
$m 
Current assets
 
10 
19 
Non-current assets
 
Current liabilities
 
(2,952)
(1,682)
Non-current liabilities
 
(26,747)
(25,605)
Amounts due from subsidiaries that are not issuers or guarantors
 
14,067 
8,652 
Amounts due to subsidiaries that are not issuers or guarantors
 
(296)
(297)
 
Foreign exchange
 
The Company's transactional currency exposures on working-capital balances, which typically extend for up to three months, are hedged where practicable using forward foreign exchange contracts against the individual companies' reporting currency. Foreign exchange gains and losses on forward contracts for transactional hedging are taken to profit or loss. In addition, the Company's external dividend payments, paid principally in pounds sterling and Swedish krona, are fully hedged from announcement to payment date.
 
Table 18: Currency sensitivities
 
The Company provides the following currency-sensitivity information:
 
 
 
 
 
Average
rates vs USD
 
Annual impact ($m) of 5% strengthening (FY2023 average rate vs FY 2022 average) [62]
Currency
Primary Relevance
 
FY 2022[63]
YTD   2023[64]
Change
 (%)
Mar 2023[65]
Change[66]
 (%)
 
Total Revenue
Core Operating Profit
EUR
Total Revenue
 
0.95 
0.93
2
0.93
2
 
323 
159 
CNY
Total Revenue
 
6.74 
6.85
(1)
6.90
(2)
 
309 
174 
JPY
Total Revenue
 
131.59 
132.35
(1)
133.77
(2)
 
181 
122 
Other[67]
 
 
 
 
 
 
 
 
385 
202 
GBP
Operating expense
 
0.81 
0.82
(2)
0.82
(2)
 
46 
(92)
SEK
Operating expense
 
10.12 
10.43
(3)
10.47
(3)
 
7 
(55)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Sustainability

 
Since the last quarterly report, AstraZeneca:
 
Access to healthcare
 
- Partnership for Health System Sustainability and Resilience (PHSSR) published country reports in Belgium, Ireland, and the Netherlands, and key findings were presented at events held in those countries. PHSSR also launched a health system sustainability index in Germany in collaboration with key stakeholders. AstraZeneca is a founding member and one of six global partners of the PHSSR, which is now active in more than 30 countries worldwide
 
- Strengthened healthcare innovation in China, partnering with government and the healthcare ecosystem, building on the Company's position as an industry leader and on its 30-year history. During events attended by CEO Pascal Soriot, the Company made the following announcements:
 
- New investment to build a manufacturing plant in Qingdao city to produce Breztri pressurised metered-dose inhalers (pMDI) for COPD patients in China. The local investment provides increased access to a life-changing medicine for Chinese patients to meet a very significant unmet need, and helps to tackle the burden of COPD on the health system in China
 
- Partnership with Shandong province to establish an innovative rare diseases diagnosis and treatment hub
 
- Partnership with the Chinese Red Cross Foundation to revitalise rural parts of China through an RMB 30 million investment to enhance health services and support disaster relief
 
- Healthy Heart Africa programme launched in eight of 10 new countries planned by 2024, working with implementing partners ACHAP and PATH, in addition to the existing nine countries of operation. Over 34 million blood pressure screenings have been conducted since screenings began in 2015, with over one million screenings in February alone, and more than 10,600 healthcare workers trained to date, as at end of February 2023
 
- Renewed Young Health Programme commitments in five countries (Canada, France, Italy, Israel and Sweden). Directly reached more than 700,000 young people with health information and trained more than 35,000 young people, healthcare professionals and others, in 39 countries
 
- A.Catalyst Network, AstraZeneca's interconnected and dynamic global network of more than 20 health innovation hubs, has now launched in Africa. The Africa health innovation hub will focus on disease education, early diagnosis, technology and data generation, to reduce mortality rates and improve patient quality of life. The Company also signed a partnership with MedSol Ai Solutions to develop Melusi Breast AI, a state-of-the-art Wi-Fi ultrasound probe for rapid breast cancer detection
 
Environmental protection
 
o CEO Pascal Soriot convened the SMI Health Systems Task Force which announced joint minimum climate and sustainability targets for pharmaceutical suppliers in March 2023, to address greenhouse gas emissions across the value chain and reduce the complexity for suppliers of multiple requirements
 
o The Company's commitment to reducing its Scope 3 indirect greenhouse gas emissions is shown by its target of 95% of suppliers by spend covering purchased goods and services and capital goods, and 50% of suppliers by spend covering upstream transportation and distribution and business travel, to have science-based targets by the end of 2025. AstraZeneca was also recognised in March by CDP as a 2022 Supplier Engagement Rating Leader
 
o Committed to the Business Leaders' Open Call to Accelerate Action on Water, which coincided with the UN 2023 Water Conference. The Company's efforts are underpinned by a partnership with the WWF and membership of the Alliance for Water Stewardship. AstraZeneca works with suppliers and across sectors to improve water resilience, focusing on 100 priority water basins. Starting in 2024, the Company will invest $5 million per year to fund nature restoration and water stewardship projects in the communities where it operates. Details are included in the Biodiversity Statement, published alongside the 2022 Sustainability Report and Data Summary
 
o Marked UN International Day of Forests by reflecting on AZ Forest progress. AZ Forest is the Company's global initiative to plant and maintain over 50 million trees worldwide by end of 2025, in partnership with expert delivery partners focused on forest landscape restoration, and by investing in community-led projects adapted to the local context. More than 10.5 million trees have been planted to date in Australia, Ghana, Indonesia, the UK and the US
 
Ethics and transparency
 
- Marked International Women's Day (IWD) in March, including an article published on "championing women in the workplace and beyond", highlighting what AstraZeneca is doing to champion women and promote a culture of inclusion and diversity, including advancing women's careers in science, technology, engineering, and mathematics (STEM) inside and outside the Company. AstraZeneca also recognised UN International Day of Women and Girls in Science in February, a day dedicated to promoting equal access for women and girls to participate in STEM careers. Currently 39.8% of STEM-related positions at AstraZeneca are held by women
 
- Marked UN International Day for the Elimination of Racial Discrimination in March, with an update on the progress AstraZeneca has made against its racial equity commitments since becoming a founding member of the World Economic Forum Partnering for Racial Justice in Business initiative
 
- Recognised Neurodiversity Celebration Week across the organisation with events across the organisation including an experience lab designed to give colleagues an opportunity to experience what it is like to live with autism, sensory processing disorder and other neurodiversities
 
- Reported the results of the first employee Ethics Survey 2022, carried out to gain a deeper understanding of employee perspectives on ethics at AstraZeneca and identify opportunities for improvement. Almost 7,000 employees participated, 97% of whom know how to raise a concern, with 88% saying it is easy to do the right thing in their day-to-day work
 
Research and development
 
This section covers R&D events and milestones that have occurred since the prior results announcement on 9 February 2023, up to and including events on 26 April 2023.
 
A comprehensive view of AstraZeneca's pipeline of medicines in human trials can be found in the latest clinical trials appendix, available on www.astrazeneca.com/investor-relations. The clinical trials appendix includes tables with details of the ongoing clinical trials for AstraZeneca medicines and new molecular entities in the pipeline.
 
Oncology
 
AstraZeneca presented new data across its diverse portfolio of cancer medicines at two major medical congresses during the quarter: the 2023 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) in February and American Association for Cancer Research (AACR) in April. At ASCO GU, AstraZeneca presented 11 abstracts spanning three approved medicines and four pipeline medicines. At AACR, AstraZeneca presented 70 abstracts showcasing new data across 21 pipeline molecules and eight marketed products across the oncology portfolio.
 
AstraZeneca completed an exclusive global license agreement with KYM Biosciences Inc. for CMG901, a potential first-in-class antibody drug conjugate targeting Claudin 18.2, a promising therapeutic target in gastric cancers, with a molecule monomethyl auristatin E (MMAE) warhead. CMG901 is currently being evaluated in a Phase I trial for the treatment of Claudin 18.2-positive solid tumours, including gastric cancer with preliminary results showing an encouraging profile for CMG901.
 
- Significant new trials that achieved first patient dosed during the period included:
 
- CAMBRIA-1, a Phase III trial of camizestrant vs standard endocrine therapy in ER+/HER2- early breast cancer after at least 2 years of standard adjuvant endocrine therapy
 
Tagrisso
 
 
Event
 
 
Commentary
Phase III trial read out
ADAURA
 
Met key secondary endpoint demonstrating statistically significant and clinically meaningful improvement in OS[68] compared to placebo in the adjuvant treatment of patients with early-stage EGFRm[69] NSCLC after complete tumour resection with curative intent. (March 2023)
 
 
Imfinzi and Imjudo
 
 
Event
 
 
Commentary
Approval
EU
 
Imfinzi in combination with Imjudo for the 1st-line treatment of adult patients with advanced or unresectable HCC. (HIMALAYA, February 2023)
 
 
 
 
Imfinzi in combination with Imjudo for the treatment of adult patients with metastatic NSCLC. (POSEIDON, February 2023)
 
Presentation: AACR
AEGEAN
 
Results from interim EFS analysis of the AEGEAN Phase III trial, presented at AACR, demonstrated statistically significant and clinically meaningful 32% reduction in risk of disease recurrence, progression events or death for Imfinzi in combination with neoadjuvant chemotherapy before surgery and as adjuvant monotherapy after surgery versus neoadjuvant chemotherapy alone followed by surgery for patients with resectable early-stage NSCLC. (April 2023)
 
 
Lynparza
 
 
Event
 
 
Commentary
Presentation: ASCO GU
PROpel final OS
 
Results from the final prespecified OS analysis of the PROpel Phase III trial, presented at ASCO GU, demonstrated Lynparza in combination with abiraterone resulted in median OS improvement of 7.4-months vs standard of care in mCRPC (not statistically significant). (February 2023)
FDA ODAC
US
 
 
The FDA will convene a meeting of the ODAC on 28 April 2023 to discuss the sNDA[70] for Lynparza in combination with abiraterone for the treatment of mCRPC. (PROpel, March 2023)
 
Phase III trial read-out
DUO-O (Lynparza and Imfinzi)
 
Met primary endpoint demonstrating a statistically significant and clinically meaningful improvement in PFS versus chemotherapy plus bevacizumab in newly diagnosed patients with advanced high-grade epithelial ovarian cancer without tumour BRCA mutations. (April 2023)
 
Calquence
 
 
Event
 
 
Commentary
Approval
EU
 
Maleate tablet formulation. (ELEVATE-PLUS, February 2023)
 
Conditional approval
China
 
Patients with mantle cell lymphoma who have received at least one prior therapy. (ACE-LY-004 and Phase I/II trial in Chinese patients, March 2023)
 
 
Enhertu
 
 
Event
 
 
Commentary
Approval
China
 
Patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens, based on DESTINY-Breast03 trial. (February 2023)
 
Phase II read out
DESTINY-PanTumor02
 
 
Met the prespecified target for objective response rate and demonstrated durable response across multiple HER2-expressing advanced solid tumours in heavily pre-treated patients. (DESTINY-PanTumor02, March 2023)
 
 
BioPharmaceuticals - CVRM
 
eplontersen
 
 
Event
 
 
Commentary
Presentation: AAN
NEURO-TTRansform
 
Detailed results from the NEURO-TTRansform Phase III trial in patients with hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN) presented at the American Academy of Neurology (AAN) 2023 Annual Meeting showed that eplontersen met all co-primary and secondary endpoints at 66 weeks versus an external placebo group. (April 2023).
 
cotadutide
 
 
Event
 
 
Commentary
Termination
PROXYMO ADVANCE
 
Strategic decision to discontinue the development of once-daily cotadutide and focus on AZD9550, a once-weekly injectable GLP-1 glucagon co-agonist, and the broader NASH pipeline. (March 2023)
 
 
BioPharmaceuticals - R&I
 
Significant new trials that achieved first patient dosed during the period included:
 
‒   CROSSING, a Phase III trial of Tezspire in eosinophilic oesophagitis
 
Fasenra
 
 
Event
 
 
Commentary
Phase III trial read-out
MIRACLE
 
Met the primary endpoint, demonstrating a statistically significant reduction in annual asthma exacerbation rate (AAER) over 48 weeks compared to placebo in patients in China with a history of uncontrolled asthma.
 
Phase III trial read-out
TATE
 
Met the primary endpoints, demonstrating that the safety and tolerability profile in severe eosinophilic asthma patients aged 6 to 11 years was consistent with previous trials in patients ages 12 years and older.
 
 
BioPharmaceuticals - V&I
 
AstraZeneca highlighted new data across its Vaccines and Immune Therapies portfolio at the 33rd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) in April 2023. The company presented 15 abstracts, including four oral presentations.
 
AZD3152
 
 
Event
 
 
Commentary
Presentation: ECCMID 2023
US
 
AstraZeneca presented the first in vitro neutralisation data on AZD3152, including activity against past and currently circulating COVID-19 variants. The data showed that AZD3152 neutralises all known variants of concern to date.  (April 2023)
 
 
Flumist
 
 
Event
 
 
Commentary
Regulatory approval
Japan
 
As previously announced in 2015, Daiichi Sankyo has responsibility for the development and commercialisation of FluMist Quadrivalent in Japan, and holds the marketing authorisation following approval in Japan in March 2023. AstraZeneca will supply FluMist Quadrivalent to Daiichi Sankyo, and will receive development milestones and sales-related payments post launch.  (March 2023)
 
 
Beyfortus
 
 
Event
 
 
Commentary
Publication: Nature
MELODY
 
Serum samples were collected from 2,143 infants to characterise the duration of RSV nAb[71] levels following nirsevimab administration. Nirsevimab recipients had RSV nAb levels >140-fold higher than baseline at day 31, and remained >50-fold
higher at day 151 and >7-fold higher at day 361. (April 2023)
 
Presentation: ECCMID 2023
MUSIC
 
At ECCMID 2023, AstraZeneca presented results from the MUSIC trial for nirsevimab in immunocompromised children ≤ 24 months of age. A single dose of nirsevimab was well tolerated and no safety concerns arose over 151 days. (April 2023)
 
Contract update
 
 
In April 2023, AstraZeneca, Sanofi and Sobi simplified their contractual arrangements relating to the development and commercialisation of nirsevimab in the US. The updated arrangements replaced the cash flows from AstraZeneca to Sobi with a royalty relationship between Sanofi and Sobi. Sanofi continues to lead commercialisation globally, and AstraZeneca will co-promote Beyfortus in the UK, Germany, Italy, Spain, Japan and China. (April 2023)
 
 
Rare Disease
 
Alexion, AstraZeneca Rare Disease, showcased the potential for its pioneering therapies to redefine the treatment landscape for certain rare neurological diseases at the American Academy of Neurology (AAN) Annual Meeting. Alexion presented 18 abstracts, including seven oral presentations, across generalised myasthenia gravis (gMG), neuromyelitis optica spectrum disorder (NMOSD) and dermatomyositis.
 
- Significant new trials that achieved first patient dosed during the period included:
 
- ARTEMIS, a Phase III trial assessing the efficacy of a single dose of Ultomiris compared with placebo in reducing the risk of the clinical consequences of acute kidney injury in adult participants with CKD who undergo non-emergent cardiac surgery with cardiopulmonary bypass.
 
Ultomiris
 
 
Event
 
 
Commentary
Positive opinion
EU
 
Recommended for approval in the EU by CHMP for the treatment of adults with NMOSD
 
 
ALXN1840
 
Event
 
 
Commentary
Termination
Wilson Disease programme
 
In April, the ALXN1840 programme in Wilson Disease was terminated. The decision was based on feedback from regulators, on review of data from the Wilson Disease programme, including the Phase III FoCus and two Phase II mechanistic trials
 
Interim Financial Statements
 
Table 19: Condensed consolidated statement of comprehensive income: Q1 2023
 
 
For the quarter ended 31 March
 
2023 
2022 
 
 
$m 
$m 
Total Revenue[72]
 
10,879 
11,390 
Product Sales
 
10,566 
10,980 
Alliance Revenue
 
286 
152 
Collaboration Revenue
 
27 
258 
Cost of sales
 
(1,905)
(3,511)
Gross profit
 
8,974 
7,879 
Distribution expense
 
(134)
(125)
Research and development expense
 
(2,611)
(2,133)
Selling, general and administrative expense
 
(4,059)
(4,840)
Other operating income and expense
 
379 
97 
Operating profit
 
2,549 
878 
Finance income
 
78 
17 
Finance expense
 
(365)
(336)
Share of after tax losses in associates and joint ventures
 
(6)
Profit before tax
 
2,262 
553 
Taxation
 
(458)
(165)
Profit for the period
 
1,804 
388 
Other comprehensive income
 
 
 
Items that will not be reclassified to profit or loss
 
 
 
Remeasurement of the defined benefit pension liability
 
(10)
335 
Net gains on equity investments measured at fair value through other comprehensive income
 
46 
18 
Fair value movements related to own credit risk on bonds designated as fair value through profit or loss
 
Tax on items that will not be reclassified to profit or loss
 
24 
(94)
 
 
62 
259 
Items that may be reclassified subsequently to profit or loss
 
 
 
Foreign exchange arising on consolidation
 
314 
(219)
Foreign exchange arising on designated liabilities in net investment hedges
 
(7)
(32)
Fair value movements on cash flow hedges
 
56 
Fair value movements on cash flow hedges transferred to profit and loss
 
(75)
11 
Fair value movements on derivatives designated in net investment hedges
 
16 
(8)
Tax on items that may be reclassified subsequently to profit or loss
 
12 
 
 
316 
(242)
Other comprehensive income, net of tax
 
378 
17 
Total comprehensive income for the period
 
2,182 
405 
Profit attributable to:
 
 
 
Owners of the Parent
 
1,803 
386 
Non-controlling interests
 
 
 
1,804 
388 
Total comprehensive income attributable to:
 
 
 
Owners of the Parent
 
2,181 
405 
Non-controlling interests
 
 
 
2,182 
405 
Basic earnings per $0.25 Ordinary Share
 
$1.16 
$0.25 
Diluted earnings per $0.25 Ordinary Share
 
$1.16 
$0.25 
Weighted average number of Ordinary Shares in issue (millions)
 
1,549 
1,548 
Diluted weighted average number of Ordinary Shares in issue (millions)
 
1,560 
1,561 
 
 
Table 20: Condensed consolidated statement of financial position
 
 
 
At 31 Mar
2023
At 31 Dec
2022
At 31 Mar
2022
 
 
$m 
$m
$m 
Assets
 
 
 
 
Non-current assets
 
 
 
 
Property, plant and equipment
 
8,644 
8,507 
9,061
Right-of-use assets
 
955 
942 
954
Goodwill
 
20,001 
19,820 
19,963
Intangible assets
 
39,291 
39,307 
41,265
Investments in associates and joint ventures
 
77 
76 
63
Other investments
 
1,157 
1,066 
1,174
Derivative financial instruments
 
116 
74 
87
Other receivables
 
682 
835 
864
Deferred tax assets
 
3,498 
3,263 
4,195
 
 
74,421 
73,890 
77,626
Current assets
 
 
 
 
Inventories
 
4,967 
4,699 
7,624
Trade and other receivables
 
10,289 
10,521 
8,683
Other investments
 
230 
239 
61
Derivative financial instruments
 
40 
87 
54
Intangible assets
 
96
Income tax receivable
 
508 
731 
367
Cash and cash equivalents
 
6,232 
6,166 
5,762
Assets held for sale
 
150 
-
 
 
22,266 
22,593 
22,647
Total assets
 
96,687 
96,483 
100,273
Liabilities
 
 
 
 
Current liabilities
 
 
 
 
Interest-bearing loans and borrowings
 
(3,625)
(5,314)
(2,069)
Lease liabilities
 
(232)
(228)
(225)
Trade and other payables
 
(19,210)
(19,040)
(17,864)
Derivative financial instruments
 
(44)
(93)
(35)
Provisions
 
(546)
(722)
(1,423)
Income tax payable
 
(1,203)
(896)
(1,124)
 
 
(24,860)
(26,293)
(22,740)
Non-current liabilities
 
 
 
 
Interest-bearing loans and borrowings
 
(26,916)
(22,965)
(28,081)
Lease liabilities
 
(730)
(725)
(724)
Derivative financial instruments
 
(133)
(164)
(47)
Deferred tax liabilities
 
(2,795)
(2,944)
(5,626)
Retirement benefit obligations
 
(1,128)
(1,168)
(1,991)
Provisions
 
(914)
(896)
(949)
Other payables
 
(3,400)
(4,270)
(3,756)
 
 
(36,016)
(33,132)
(41,174)
Total liabilities
 
(60,876)
(59,425)
(63,914)
Net assets
 
35,811 
37,058 
36,359 
Equity
 
 
 
 
Capital and reserves attributable to equity holders of the Parent
 
 
 
 
Share capital
 
387 
387 
387 
Share premium account
 
35,159 
35,155 
35,131 
Other reserves
 
2,068 
2,069 
2,050 
Retained earnings
 
(1,825)
(574)
(1,228)
 
 
35,789 
37,037 
36,340 
Non-controlling interests
 
22 
21 
19 
Total equity
 
35,811 
37,058 
36,359 
 
Table 21: Condensed consolidated statement of changes in equity
 
 
 
 
Share capital
Share premium account
Other reserves
Retained earnings
Total attributable to owners of the parent
Non-controlling interests
Total equity
 
 
$m 
$m 
$m 
$m 
$m 
$m 
$m 
At 1 Jan 2022
 
387 
35,126 
2,045 
1,710 
39,268 
19 
39,287 
Profit for the period
 
386 
386 
388 
Other comprehensive income
 
19 
19 
(2)
17 
Transfer to other reserves
 
(5)
Transactions with owners