REG - AstraZeneca PLC - 1st Quarter Results
25/04/2024 07:00
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RNS Number : 9406L AstraZeneca PLC 25 April 2024
AstraZeneca
25 April 2024
Q1 2024 results
Very strong revenue and EPS growth in the first quarter coupled with exciting
pipeline delivery
Revenue and EPS summary
Q1 2024 % Change
$m Actual CER 1 (#_ftn1)
- Product Sales 12,177 15 18
- Alliance Revenue 457 59 59
- Collaboration Revenue 45 66 66
Total Revenue 12,679 17 19
Reported EPS $1.41 21 30
Core 2 (#_ftn2) EPS $2.06 7 13
Financial performance for Q1 2024 (Growth numbers at CER)
‒ Total Revenue up 19% to $12,679m, driven by an 18% increase in
Product Sales and continued growth in Alliance Revenue from partnered
medicines
‒ Double-digit growth in Total Revenue from Oncology at 26%, CVRM at
23%, R&I at 17%, and Rare Disease at 16%.
‒ Core Product Sales Gross Margin 3 (#_ftn3) of 82%
‒ Core Operating Margin of 34%
‒ Core Tax Rate of 21%
‒ Core EPS increased 13% to $2.06. The increase in Core EPS was lower
than Total Revenue growth principally due to a $241m gain in the prior year
period on the disposal of Pulmicort Flexhaler US rights
‒ As announced at the Annual General Meeting on 11 April 2024, the
total dividend for FY 2024 will increase by $0.20 per share to $3.10 per share
‒ Total Revenue and Core EPS guidance at CER for FY 2024 reiterated
Pascal Soriot, Chief Executive Officer, AstraZeneca, said:
"AstraZeneca had a very strong start in 2024 with substantial Total Revenue
growth of 19% in the first quarter.
Our strong pipeline momentum continued and already this year we announced
positive trial results for Imfinzi and Tagrisso that were unprecedented in
lung cancer, the data from both of these studies will be presented during the
ASCO plenary in June. We are also looking forward to seeing the results of
several other important trials throughout the year.
At our Annual General Meeting we were pleased to announce a 7% increase in the
annual dividend, and at our Investor Day on 21 May 2024 we will outline the
evolution of our company, underscoring our confidence in sustaining
industry-leading growth."
Key milestones achieved since the prior results announcement
‒ Positive read-outs for Tagrisso in unresectable, Stage III EGFRm
NSCLC (LAURA), Imfinzi in LS-SCLC (ADRIATIC)
‒ US approvals for Tagrisso with the addition of chemotherapy for
EGFRm NSCLC (FLAURA2), Enhertu in HER2-positive solid tumours
(DESTINY-PanTumor02, DESTINY-Lung01, DESTINY-CRC02) and Ultomiris for NMOSD.
US and EU approval for Voydeya as an add-on therapy to Ultomiris or Soliris
for PNH with EVH (ALPHA). Japan approval for Truqap plus Faslodex in
unresectable or recurrent PIK3CA-, AKT1-, or PTEN-altered HR-positive,
HER2-negative breast cancer (CAPItello-291).
‒ Datopotamab deruxtecan BLAs accepted in the US for non-squamous
NSCLC (TROPION-Lung01) and HR-positive, HER2-negative breast cancer
(TROPION-Breast01).
Guidance
The Company reiterates its Total Revenue and Core EPS guidance for FY 2024 at
CER, based on the average foreign exchange rates through 2023.
Total Revenue is expected to increase by a low double-digit to low teens
percentage
Core EPS is expected to increase by a low double-digit to low teens percentage
‒ Collaboration Revenue is expected to increase substantially, driven
by success-based milestones and certain anticipated transactions
‒ Other operating income is expected to decrease substantially (FY
2023 included a $241m gain on the disposal of Pulmicort Flexhaler US rights,
and a $712m one-time gain relating to updates to contractual arrangements for
Beyfortus)
‒ 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 2024 to December 2024 were to remain at
the average rates seen in March 2024, compared to the performance at CER it is
anticipated that FY 2024 Total Revenue would incur a low single-digit adverse
impact and Core EPS would incur a mid single-digit adverse impact (previously
low single-digit). The Company's foreign exchange rate sensitivity analysis is
provided in Table 16.
Investor Day
AstraZeneca will host an Investor Day on 21 May 2024. For more information,
see www.astrazeneca.com/investor-relations.html
(https://www.astrazeneca.com/investor-relations.html) .
Table 1: Key elements of Total Revenue performance in Q1 2024
% Change
Revenue type $m Actual % CER %
Product Sales 12,177 15 18
Alliance Revenue 457 59 59 * $339m Enhertu (Q1 2023: $220m)
* $77m Tezspire (Q1 2023: $43m)
Collaboration Revenue 45 66 66 * $45m Farxiga (Q1 2023: $24m)
Total Revenue 12,679 17 19
Therapy areas $m Actual % CER %
Oncology 5,108 23 26 * Strong performance across all key medicines and regions
CVRM( ) 3,060 20 23 * Farxiga up 43% (45% at CER) with continued demand growth and the launch
of an authorised generic in the US, Lokelma up 16% (19% at CER), roxadustat up
24% (28% at CER), Brilinta decreased 3% (1% at CER)
R&I 1,886 15 17 * Continued strong growth from Fasenra up 6% (6% CER), Breztri up 52% (54%
CER). Saphnelo up 94% (95% CER) and Tezspire up >2x (>2x CER). Symbicort
was up 12% (14% CER)
V&I 232 (35) (34) * Beyfortus revenue was $46m (Q1 2023: $nil), which more than offset a
$27m decline in Synagis
* The drop in V&I revenue was driven by lower sales of COVID-19 mAbs
and Vaxzevria. Vaxzevria revenues are now included in the 'Other' V&I line
Rare Disease( ) 2,096 12 16 * Ultomiris up 32% (34% at CER), partially offset by decline in Soliris of
11% (8% at CER)
* Strensiq up 20% (21% at CER) and Koselugo up 68% (82% at CER) reflecting
strong patient demand, and also tender market order timing
Other Medicines 297 (7) -
Total Revenue 12,679 17 19
Regions $m Actual % CER %
US 5,124 19 19
Emerging Markets 3,732 18 26
- China 1,748 9 13
- Ex-China Emerging Markets 1,984 27 40
Europe 2,634 22 19
Established RoW 1,189 (5) 2 * Decline in COVID-19 mAbs revenue
Total Revenue 12,679 17 19
Combined sales of Enhertu, recorded by Daiichi Sankyo Company Limited (Daiichi
Sankyo) and AstraZeneca, amounted to $879m in Q1 2024 (Q1 2023: $531m).
Combined sales of Tezspire, recorded by Amgen and AstraZeneca, amounted to
$216m in Q1 2024 (Q1 2023: $105m).
Table 2: Key elements of financial performance in Q1 2024
Metric Reported Reported change Core Core Comments 4 (#_ftn4)
change
Total Revenue $12,679m 17% Actual 19% CER $12,679m 17% Actual 19% CER * See Table 1 and the Total Revenue section of this document for further
details
Product Sales Gross Margin 82% Stable 82% -1pp Actual -1pp CER * Variations in Product Sales Gross Margin can be expected between periods
due to product seasonality, foreign exchange fluctuations and other effects
R&D expense $2,783m 7% Actual 7% CER $2,698m 17% Actual 18% CER + Increased investment in the pipeline
* Core R&D-to-Total Revenue ratio of 21%
(Q1 2023: 21%)
SG&A expense $4,495m 11% Actual 12% CER $3,413m 12% Actual 13% CER + Market development for recent launches and pre-launch activities
* Core SG&A-to-Total Revenue ratio of 27%
(Q1 2023: 28%)
Other operating income and expense 5 (#_ftn5) $67m -83% Actual -83% CER $65m -80% Actual -80% CER ‒ The prior year quarter included a $241m gain on the disposal of Pulmicort
Flexhaler US rights
Operating Margin 25% +1pp Actual +2pp CER 34% -2pp Actual -1pp CER * See commentary above on Other operating income and expense
Net finance expense $302m 5% Actual 1% CER $245m 2% Actual -3% CER + Higher rates on floating debt and bond issuances
‒ Higher interest received on cash and short-term investments
Tax rate 22% +2pp Actual +2pp CER 21% +2pp Actual +2pp CER * Variations in the tax rate can be expected between periods
EPS $1.41 21% Actual 30% CER $2.06 7% Actual 13% CER * Further details of differences between Reported and Core are shown in
Table 11
Table 3: Pipeline highlights since prior results announcement
Event Medicine Indication / Trial Event
Regulatory approvals and other regulatory actions Enhertu HER2-expressing tumours (DESTINY-PanTumor02) Regulatory approval (US)
Tagrisso EGFRm NSCLC (1st-line) (FLAURA2) Regulatory approval (US)
Truqap HR+/HER2-neg breast cancer (2nd-line) (CAPItello-291) Regulatory approval (JP)
Beyfortus RSV (MELODY-MEDLEY) Regulatory approval (JP)
Ultomiris NMOSD (CHAMPION-NMOSD) Regulatory approval (US)
Voydeya PNH with EVH (ALPHA) Regulatory approval (US, EU)
Regulatory submissions Dato-DXd Non-squamous NSCLC (2nd- and 3rd-line) (TROPION-Lung01) Regulatory submission (US)
or acceptances*
Dato-DXd HR+/HER2- breast cancer (inoperable and/or met.) (TROPION-Breast01) Regulatory submission (US, EU, JP, CN)
acoramidis ATTR-CM (ALXN2060-TAC-302) Regulatory submission (JP)
Major Phase III data readouts and other developments Tagrisso EGFRm NSCLC (unresectable Stg. III) (LAURA) Primary endpoint met
Imfinzi SCLC (limited-stage) (ADRIATIC) Primary endpoint met
*US, EU and China regulatory submission denotes filing acceptance
Upcoming pipeline catalysts
For recent trial starts and anticipated timings of key trial readouts, please
refer to the Clinical Trials Appendix, available on
www.astrazeneca.com/investor-relations.html
(https://www.astrazeneca.com/investor-relations.html) .
Corporate and business development
In February 2024, AstraZeneca completed the acquisition of Gracell
Biotechnologies, Inc. (Gracell), a global clinical-stage biopharmaceutical
company developing innovative cell therapies for the treatment of cancer and
autoimmune diseases. The acquisition enriches AstraZeneca's growing pipeline
of cell therapies with AZD0120 (formerly GC012F), a novel, clinical-stage
T-cell (CAR-T) therapy. AZD0120 is a potential new treatment for multiple
myeloma, as well as other haematologic malignancies and autoimmune diseases,
including SLE. The upfront cash portion of the consideration was approximately
$1.0 billion. Combined, the upfront and potential contingent value payments
represent, if achieved, a transaction value of approximately $1.2 billion.
AstraZeneca acquired the cash and cash equivalents on Gracell's balance sheet,
which totalled $209 million at the close of the transaction.
In February 2024, AstraZeneca completed the acquisition of Icosavax, Inc., a
US-based clinical-stage biopharmaceutical company focused on developing
differentiated, high-potential vaccines using an innovative, protein
virus-like particle platform. The upfront cash portion of the consideration
was approximately $0.8 billion. Combined, the upfront and maximum potential
contingent value payments represent, if achieved, a transaction value of
approximately $1.1 billion. AstraZeneca acquired the cash, cash equivalents
and marketable securities on Icosavax's balance sheet, which totalled $192
million at the close of the transaction.
In March 2024, AstraZeneca announced that it has entered into a definitive
agreement to acquire Amolyt Pharma, a clinical-stage biotechnology company
focused on developing novel treatments for rare endocrine diseases. The
proposed acquisition will bolster the Rare Disease late-stage pipeline and
expand on its bone metabolism franchise with the notable addition of
eneboparatide (AZP-3601), a Phase III investigational therapeutic peptide with
a novel mechanism of action designed to meet key therapeutic goals for
hypoparathyroidism. The upfront cash portion of the consideration is $0.8
billion at deal closing. Combined, the upfront and maximum potential
contingent value payments represent, if achieved, a transaction value of $1.05
billion. AstraZeneca will acquire all of Amolyt Pharma's outstanding shares on
a cash and debt free basis. Subject to the satisfaction of customary closing
conditions in the acquisition agreement, including regulatory clearances, the
transaction is expected to close by the end of the third quarter of 2024.
In March 2024, AstraZeneca entered into a definitive agreement to acquire
Fusion Pharmaceuticals Inc., a clinical-stage biopharmaceutical company
developing next-generation radioconjugates. This complements AstraZeneca's
leading oncology portfolio with the addition of the Fusion pipeline of RCs,
including their most advanced programme, FPI-2265, a potential new treatment
for patients with mCRPC. The acquisition marks a major step forward in
AstraZeneca delivering on its ambition to transform cancer treatment and
outcomes for patients by replacing traditional regimens like chemotherapy and
radiotherapy with more targeted treatments. The upfront cash portion of the
consideration is approximately $2 billion. Combined, the upfront and maximum
potential contingent value payments represent, if achieved, a transaction
value of approximately $2.4 billion. AstraZeneca will acquire the cash, cash
equivalents and short term investments on Fusion's balance sheet, which
totalled $234 million as of 31 December 2023. The transaction is expected to
close in the second quarter of 2024, subject to customary closing conditions,
including the approval of Fusion shareholders and regulatory clearances.
Sustainability highlights
Our newly announced collaboration with China Resources Gas and Everbright
Environment will supply biomethane and biomethane-based steam to our Wuxi
site. Using domestic waste, including food and plant waste, this new
partnership will enable us to reduce our greenhouse gas emissions footprint by
80% in China.
AstraZeneca announced at WEF that it will be one of the inaugural Early
Adopter organisations that intend to start making disclosures aligned with the
Taskforce on Nature-related Financial Disclosures Recommendations in corporate
reporting.
AstraZeneca also hosted an annual Sustainability call for shareholders,
reiterating its continued commitment to deliver across our pillars; Access to
Healthcare, Environmental Protection and Ethics and Transparency. A recording
of the call and accompanying materials are available on the AstraZeneca IR
website.
Conference call
A conference call and webcast for investors and analysts will begin today, 25
April 2024, at 11:45 UK time. Details can be accessed via astrazeneca.com
(https://www.astrazeneca.com/) .
Reporting calendar
The Company intends to publish its H1 and Q2 2024 results on 25 July 2024.
Operating and financial review
All narrative on growth and results in this section is based on actual
exchange rates, and financial figures are in US$ millions ($m), unless stated
otherwise. Unless stated otherwise, the performance shown in this announcement
covers the three month period to 31 March 2024 ('the quarter' or 'Q1 2024')
compared to the three month period to 31 March 2023 ('Q1 2023'). References to
'first quarter', 'second quarter', 'third quarter' and fourth quarter' refer
to the respective quarters in FY 2024.
Core financial measures, EBITDA, Net debt, Product Sales Gross Margin,
Operating Margin and CER are non-GAAP financial measures because they cannot
be derived directly from the Group's Condensed consolidated 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:
‒ Charges and provisions related to restructuring programmes, which
includes charges that relate to the impact of restructuring programmes on
capitalised IT assets
‒ Amortisation and impairment of intangible assets, including
impairment reversals but excluding any charges relating to IT assets
‒ Other specified items, principally the imputed finance charges and
fair value movements relating to contingent consideration on business
combinations, imputed finance charges and remeasurement adjustments on certain
Other payables arising from intangible asset acquisitions, legal settlements
and remeasurement adjustments relating to Other payables assumed from the
Alexion acquisition
‒ The tax effects of the adjustments above are excluded from the Core
Tax charge
Details on the nature of Core financial measures are provided on page 61 of
the Annual Report and Form 20-F Information 2023.
(https://www.astrazeneca.com/content/dam/az/Investor_Relations/annual-report-2023/pdf/AstraZeneca_AR_2023.pdf)
Reference should be made to the Reconciliation of Reported to Core financial
measures table included in the financial performance section in this
announcement.
Product Sales Gross Margin is calculated by dividing the difference between
Product Sales and Cost of Sales by the Product Sales. The calculation of
Reported and Core Product Sales Gross Margin excludes the impact of Alliance
Revenue and Collaboration Revenue and any associated costs, thereby reflecting
the underlying performance of Product Sales.
EBITDA is defined as Reported Profit before tax after adding back Net finance
expense, results from Joint ventures and associates and charges for
Depreciation, amortisation and impairment. Reference should be made to the
Reconciliation of Reported Profit before tax to EBITDA included in the
financial performance section in this announcement.
Operating margin is defined as Operating profit as a percentage of Total
Revenue.
Net debt is defined as Interest-bearing loans and borrowings and Lease
liabilities, net of Cash and cash equivalents, Other investments, and Net
derivative financial instruments. Reference should be made to Note 3 'Net
debt' included in the Notes to the Interim financial statements in this
announcement.
The Company strongly encourages investors and analysts not to rely on any
single financial measure, but to review AstraZeneca's financial statements,
including the Notes thereto, and other available Company reports, carefully
and in their entirety.
Due to rounding, the sum of a number of dollar values and percentages in this
announcement may not agree to totals.
Total Revenue
Table 4: Total Revenue by therapy area and medicine 6 (#_ftn6)
Q1 2024
% Change
Total Revenue $m % Total Actual CER
Oncology 5,108 40 23 26
- Tagrisso 1,595 13 12 15
- Imfinzi 1,113 9 29 33
- Calquence 718 6 35 35
- Lynparza 705 6 8 11
- Enhertu 461 4 79 79
- Zoladex 285 2 21 28
- Imjudo 62 - 66 70
- Truqap 50 - n/m n/m
- Orpathys 12 - 43 49
- Other Oncology 107 1 (24) (19)
BioPharmaceuticals: CVRM 3,060 24 20 23
- Farxiga 1,892 15 43 45
- Brilinta 323 3 (3) (1)
- Crestor 297 2 (3) 2
- Seloken/Toprol-XL 165 1 (8) (2)
- Lokelma 114 1 16 19
- roxadustat 77 1 24 28
- Andexxa 47 - 6 6
- Wainua 5 - n/m n/m
- Other CVRM 141 1 (33) (31)
BioPharmaceuticals: R&I 1,886 15 15 17
- Symbicort 769 6 12 14
- Fasenra 358 3 6 6
- Pulmicort 224 2 1 5
- Breztri 219 2 52 54
- Tezspire 120 1 >2x >2x
- Saphnelo 91 1 94 95
- Airsupra 7 - n/m n/m
- Other R&I 98 1 (30) (29)
BioPharmaceuticals: V&I 232 2 (35) (34)
- Synagis 171 1 (13) (13)
- Beyfortus 46 - n/m n/m
- FluMist 7 - >2x >2x
- COVID-19 mAbs 2 - (99) (99)
- Other V&I 6 - (79) (80)
Rare Disease 2,096 17 12 16
- Ultomiris 859 7 32 34
- Soliris 739 6 (11) (8)
- Strensiq 313 2 20 21
- Koselugo 132 1 68 82
- Kanuma 53 - 32 35
Other Medicines 297 2 (7) -
- Nexium 243 2 (2) 7
- Others 54 - (25) (23)
Total Medicines 12,679 100 17 19
Table 5: Alliance Revenue
Q1 2024
% Change
$m % Total Actual CER
Enhertu 339 74 54 54
Tezspire 77 17 80 80
Beyfortus 20 4 n/m n/m
Other Alliance Revenue 21 5 (10) (9)
Total 457 100 59 59
Table 6: Collaboration Revenue
Q1 2024
% Change
$m % Total Actual CER
Farxiga: sales milestones 45 100 86 86
Other Collaboration Revenue - - n/m n/m
Total 45 100 66 66
Table 7: Total Revenue by therapy area
Q1 2024
% Change
$m % Total Actual CER
Oncology 5,108 40 23 26
Biopharmaceuticals 5,178 41 14 16
CVRM 3,060 24 20 23
R&I 1,886 15 15 17
V&I 232 2 (35) (34)
Rare Disease 2,096 17 12 16
Other Medicines 297 2 (7) -
Total 12,679 100 17 19
Table 8: Total Revenue by region
Q1 2024
% Change
$m % Total Actual CER
US 5,124 40 19 19
Emerging Markets 3,732 29 18 26
China 1,748 14 9 13
Emerging Markets ex. China 1,984 16 27 40
Europe 2,634 21 22 19
Established ROW 1,189 9 (5) 2
Total 12,679 100 17 19
Oncology
Oncology Total Revenue of $5,108m in Q1 2024 increased by 23% (26% at CER),
representing 40% of overall Total Revenue (Q1 2023: 38%). Product Sales
increased by 21% (24% at CER) in Q1 2024 to $4,760m, reflecting new launches
and expanded reimbursement across key brands.
Tagrisso
Total Revenue Worldwide US Emerging Markets Europe Established RoW
Q1 2024 $m 1,595 623 488 302 182
Actual change 12% 20% 10% 18% (10%)
CER change 15% 20% 17% 15% (2%)
Region Drivers and commentary
Worldwide * Strong global demand for Tagrisso in adjuvant (ADAURA) and 1st -line
setting (FLAURA)
US * Continued strong adjuvant and 1st-line demand growth
Emerging Markets * Encouraging demand growth across markets with some positive impact of
hospital ordering dynamics in China
* Strong performance across Latin America and Asia Pacific markets
Europe * Continued growth in 1st-line setting and increasing adjuvant demand
Established RoW * Increased demand in adjuvant and 1st-line offset by a 10.5% mandatory
price reduction in Japan effective June 2023
Imfinzi
Total Revenue Worldwide US Emerging Markets Europe Established RoW
Q1 2024 $m 1,113 582 129 232 170
Actual change 29% 19% 59% 43% 31%
CER change 33% 19% 83% 40% 45%
Region Drivers and commentary
Worldwide * Continued growth driven by BTC (TOPAZ-1), HCC (HIMALAYA), and increased
patient share in Stage IV NSCLC (POSEIDON) and extensive-stage SCLC (CASPIAN)
US * Continued demand growth driven by BTC, HCC, and extensive-stage SCLC
* Growth in BTC slowing with Imfinzi now the clear standard-of-care
Emerging Markets * Continued China growth driven by demand in HCC
Europe * Growth driven by share gains in extensive-stage SCLC and new indications
Established RoW * Increased demand from new launches, offset by a 25% mandatory price
reduction in Japan effective 1 February 2024
Lynparza
Total Revenue Worldwide US Emerging Markets Europe Established RoW
Q1 2024 $m 705 288 167 191 59
Actual change 8% 7% 23% 7% (13%)
CER change 11% 7% 33% 5% (6%)
Region Drivers and commentary
Worldwide * Lynparza remains the leading medicine in the PARP inhibitor class
globally across four tumour types (ovarian, breast, prostate, pancreatic), as
measured by total prescription volume
* No Collaboration Revenue for Lynparza was recognised in either Q1 2024
or Q1 2023, hence the Product Sales numbers are identical to the Total Revenue
numbers shown above
US * Continued leadership within PARPi class despite increasing competition,
negative class pressure and maturity of the market
Emerging Markets * Demand growth in China coming from newly diagnosed BRCA-mutated ovarian
cancer (SOLO-1) and inclusion of HRD-positive ovarian cancer (PAOLA-1) on NRDL
with no price reduction
Europe * Demand growth driven by mCRPC (PROpel) and early breast cancer (OlympiA)
Established RoW * Demand growth coming from HRD-positive ovarian cancer, partially offset
by price reduction in Japan effective from November 2023
Enhertu
Total Revenue Worldwide US Emerging Markets Europe Established RoW
Q1 2024 $m 461 202 112 134 13
Actual change 79% 26% >2x >2x >3x
CER change 79% 26% >2x >2x >3x
Region Drivers and commentary
Worldwide * Combined sales of Enhertu, recorded by Daiichi Sankyo and AstraZeneca,
amounted to $879m in Q1 2024 (Q1 2023: $531m)
US * US in-market sales, recorded by Daiichi Sankyo, amounted to $423m in Q1
2024 (Q1 2023: $336m)
* Strong demand across launched indications
Emerging Markets * Strong uptake in China following HER2-positive (DESTINY-Breast03) and
HER2-low (DESTINY-Breast04) launches
* Some launch-related inventory build was observed in China in Q1 2024
Europe * Continued growth driven by increasing adoption in HER2-positive and
HER2-low metastatic breast cancer
Established RoW * AstraZeneca's Alliance Revenue includes a mid single-digit percentage
royalty on Daiichi Sankyo's sales in Japan
Calquence
Total Revenue Worldwide US Emerging Markets Europe Established RoW
Q1 2024 $m 718 494 39 153 32
Actual change 35% 29% >2x 42% 44%
CER change 35% 29% >2x 39% 47%
Region Drivers and commentary
Worldwide * Sustained leadership in front-line CLL with increased global penetration
US * Continued market growth and maintaining leading share of new CLL patient
starts in the front line
Europe * Continued growth supported by launches in further European markets
Other Oncology medicines
Q1 2024 Change
Total Revenue $m Actual CER Drivers and commentary
Zoladex 285 21% 28% * Strong underlying growth in China and Emerging Markets and moderate
growth in Europe offset by drop in Japan
Imjudo 62 66% 70% * Continued growth across markets slightly offset by US inventory
destocking in Q1 2024
Truqap 50 n/m n/m * Rapid adoption following US approval in November 2023 for HR-positive
HER2-negative metastatic breast cancer with one or more biomarker alterations
(CAPItello-291)
* Some benefit from later-line use
Orpathys 12 43% 49% * Demand in in China for the treatment of patients with NSCLC with MET
exon 14 skipping alterations
Other Oncology 107 (24%) (19%) * Decline in use of Iressa in China
BioPharmaceuticals
BioPharmaceuticals Total Revenue increased by 14% (16% at CER) in Q1 2024 to
$5,178m, representing 41% of overall Total Revenue (Q1 2023: 42%).
BioPharmaceuticals - CVRM
CVRM Total Revenue increased by 20% (23% at CER) to $3,060m in Q1 2024 and
represented 24% of overall Total Revenue (Q1 2023: 24%).
Farxiga
Total Revenue Worldwide US Emerging Markets Europe Established RoW
Q1 2024 $m 1,892 475 711 553 152
Actual change 43% 61% 43% 41% 10%
CER change 45% 61% 50% 37% 18%
Region Drivers and commentary
Worldwide * Farxiga volume is growing faster than the overall SGLT2 market in most
major regions, fuelled by launches in heart failure and CKD, and also the
launch of an authorised generic in the US. SGLT2 class growth underpinned by
updated cardiorenal guidelines
US * Growth driven by heart failure and CKD
* Sales in the quarter benefitted from the introduction of an authorised
generic
Emerging Markets * Solid growth despite entry of generic competition in some markets
* Strong momentum in Latin America
* Sales in the quarter benefited from the timing of government tenders
Europe * Continued strong class growth and market share gains fuelled by HFpEF
approval in 2023 and guidelines updates
Established RoW * In Japan, a milestone payment of $45m was received in the quarter from
AstraZeneca's partner Ono Pharmaceutical Co., Ltd, which records in-market
sales
Brilinta
Total Revenue Worldwide US Emerging Markets Europe Established RoW
Q1 2024 $m 323 163 88 67 5
Actual change (3%) (9%) 8% (1%) (12%)
CER change (1%) (9%) 21% (3%) (14%)
Region Drivers and commentary
US * Stable volume but unfavourable gross-to-net adjustments in the quarter
Emerging Markets * Growth despite generics pressure in some markets
Europe * Declining volume
Established RoW * Sales decline driven by generic entry in Canada
Other CVRM medicines
Q1 2024 Change
Total Revenue $m Actual CER Drivers and commentary
Crestor 297 (3%) 2% * Continued sales growth in Emerging Markets
Seloken 165 (8%) (2%) * Ongoing impact of China VBP implementation
Lokelma 114 16% 19% * Continued launches in new markets
roxadustat 77 24% 28% * Increased demand in both the dialysis and non-dialysis-dependent
populations. NRDL listing renewed
* Growth driven by Europe
Andexxa 47 6% 6%
Wainua 5 n/m n/m * Approved for ATTRv-PN in the US in December 2023
Other CVRM 141 (33%) (31%)
BioPharmaceuticals - R&I
Total Revenue of $1,886m from R&I medicines increased 15% (17% at CER) and
represented 15% of overall Total Revenue (Q1 2023: 15%). This reflected growth
in Fasenra, Tezspire, Breztri, Saphnelo and Airsupra following its recent
launch.
Fasenra
Total Revenue Worldwide US Emerging Markets Europe Established RoW
Q1 2024 $m 358 210 22 93 33
Actual change 6% 5% 56% 6% (6%)
CER change 6% 4% 61% 4% -
Region Drivers and commentary
Worldwide * Continued asthma market share leadership in IL-5 class across major
markets
US * Maintained share of a growing market
Emerging Markets * Continued strong demand growth driven by launch acceleration across key
markets
Europe * Expanded leadership in severe eosinophilic asthma
Established RoW * In Japan, maintained class leadership in a broadly stable market
Breztri
Total Revenue Worldwide US Emerging Markets Europe Established RoW
Q1 2024 $m 219 105 70 30 14
Actual change 52% 30% 83% 97% 43%
CER change 54% 30% 91% 93% 53%
Region Drivers and commentary
Worldwide * Fastest growing medicine within the expanding FDC triple class, across
major markets
US * Consistent share growth within the FDC triple class in new-to-brand and
the total market
Emerging Markets * Maintained market share leadership in China with strong triple FDC class
penetration
* Further expansion with launches in additional geographies
Europe * Sustained growth across markets as new launches continue to progress
Established RoW * Increased market share within the COPD indication in Japan and strong
launch in Canada
Tezspire
Total Revenue Worldwide US Emerging Markets Europe Established RoW
Q1 2024 $m 120 77 2 27 14
Actual change >2x 80% n/m >4x >3x
CER change >2x 80% n/m >3x >3x
Region Drivers and commentary
Worldwide * Combined sales of Tezspire, recorded by Amgen and AstraZeneca, amounted
to $216m in Q1 2024 (Q1 2023: $105m)
US * Continued growth in total prescriptions, and maintained new-to-brand
market share with majority of patients new to biologics
Europe * Achieved new-to-brand leadership across multiple markets, new launches
continue to progress
Established RoW * Japan maintained new-to-brand leadership
Symbicort
Total Revenue Worldwide US Emerging Markets Europe Established RoW
Q1 2024 $m 769 299 253 142 75
Actual change 12% 28% 11% (3%) (5%)
CER change 14% 28% 18% (6%) (3%)
Region Drivers and commentary
Worldwide * Symbicort remained the global market leader within a stable ICS/LABA
class
US * Encouraging demand following list price reduction
Emerging Markets * Strong underlying demand for Symbicort in both China and Ex-China
Emerging Markets, strengthened position as market leader in the region
Europe * Continued price and volume erosion from generics and a slowing overall
market
Established RoW * Continued generic erosion in Japan
Other R&I medicines
Q1 2024 Change
Total Revenue $m Actual CER Drivers and commentary
Pulmicort 224 1% 5% * >80% of revenues from Emerging Markets
Saphnelo 91 94% 95% * Demand acceleration in the US, and additional growth driven by ongoing
launches in Europe and Established RoW
Airsupra 7 n/m n/m * Strong launch momentum with increase class penetration and volume
uptake. Revenue in the quarter reflects introductory discounts as early access
continues to build
Other R&I 98 (30%) (29%) * Generic competition
BioPharmaceuticals - V&I
Total Revenue from V&I medicines reduced by 35% (34% at CER) to $232m (Q1
2023: $355m) and represented 2% of overall Total Revenue (Q1 2023: 3%),
principally due to a decline in sales of COVID-19 mAbs.
V&I medicines
Q1 2024 Change
Total Revenue $m Actual CER Drivers and commentary
Beyfortus 46 n/m n/m * Product Sales recognises AstraZeneca's sales of manufactured Beyfortus
product to Sanofi
* Alliance Revenue recognises AstraZeneca's 50% share of gross profits on
sales of Beyfortus in major markets outside the US, and 25% of brand revenues
in rest of world markets
* AstraZeneca has no participation in US profits or losses
Synagis 171 (13%) (13%) * Decline in Synagis more than offset by growth in Beyfortus
COVID-19 mAbs 2 (99%) (99%) * Decline in Evusheld sales (Q1 2023: $127m)
FluMist 7 >2x >2x * Normal seasonality
Other V&I 6 (79%) (80%) * Decline in Vaxzevria sales (Q1 2023: $28m)
Rare Disease
Total Revenue from Rare Disease medicines increased by 12% (16% at CER) in Q1
2024 to $2,096m, representing 17% of overall Total Revenue (Q1 2023: 17%).
Ultomiris
Total Revenue Worldwide US Emerging Markets Europe Established RoW
Q1 2024 $m 859 482 32 202 143
Actual change 32% 27% >2x 27% 46%
CER change 34% 27% >2x 24% 61%
Region Drivers and commentary
Worldwide * Growth across neurology, geographic expansion, patient demand and
Soliris conversion
* Quarter-on-quarter variability in revenue growth can be expected due to
Ultomiris every eight-week dosing schedule and lower average annual treatment
cost compared to Soliris
US * Growth in naïve patients in gMG and conversion from Soliris across
shared indications
Emerging Markets * Continued growth following launches in new markets
Europe * Strong demand generation following launches in new markets, particularly
in neurology indications, as well as accelerated conversion from Soliris in
key markets, partially offset by price reductions to secure reimbursement
for new indications
Established RoW * Continued conversion from Soliris and strong demand following new
launches
Soliris
Total Revenue Worldwide US Emerging Markets Europe Established RoW
Q1 2024 $m 739 411 125 142 61
Actual change (11%) (8%) 9% (23%) (30%)
CER change (8%) (8%) 37% (24%) (28%)
Region Drivers and commentary
US * Decline driven by successful conversion of Soliris patients to Ultomiris
in PNH, aHUS and gMG, partially offset by Soliris growth in NMOSD
Emerging Markets * Growth driven by patient demand following launches in new markets
Europe * Decline driven by successful conversion from Soliris to Ultomiris as
well as biosimilar erosion in PNH and aHUS
Established RoW * Decline driven by successful conversion from Soliris to Ultomiris
Strensiq
Total Revenue Worldwide US Emerging Markets Europe Established RoW
Q1 2024 $m 313 246 21 24 22
Actual change 20% 20% 44% 15% 4%
CER change 21% 20% 67% 12% 14%
Region Drivers and commentary
Worldwide * Growth driven by strong patient demand
Other Rare Disease medicines
Q1 2024 Change
Total Revenue $m Actual CER Drivers and commentary
Koselugo 132 68% 82% * Driven by patient demand and expansion in new markets. The quarter
benefitted from tender market order timing in Emerging Markets
Kanuma 53 32% 35% * Continued global demand
Other medicines (outside the main therapy areas)
Q1 2024 Change
Total Revenue $m Actual CER Drivers and commentary
Nexium 243 (2%) 7% * Growth in Emerging Markets offset declines elsewhere
Others 54 (25%) (23%) * Continued impact of generic competition
Financial performance
Table 9: Reported Profit and Loss
Q1 2024 Q1 2023 % Change
$m $m Actual CER
Total Revenue 12,679 10,879 17 19
- Product Sales 12,177 10,566 15 18
- Alliance Revenue 457 286 59 59
- Collaboration Revenue 45 27 66 66
Cost of sales (2,218) (1,905) 16 18
Gross profit 10,461 8,974 17 20
Distribution expense (135) (134) 1 3
R&D expense (2,783) (2,611) 7 7
SG&A expense (4,495) (4,059) 11 12
Other operating income & expense 67 379 (83) (83)
Operating profit 3,115 2,549 22 31
Net finance expense (302) (287) 5 1
Joint ventures and associates (13) - n/m n/m
Profit before tax 2,800 2,262 24 34
Taxation (620) (458) 35 46
Tax rate 22% 20%
Profit after tax 2,180 1,804 21 30
Earnings per share $1.41 $1.16 21 30
Table 10: Reconciliation of Reported Profit before tax to EBITDA
Q1 2024 Q1 2023 % Change
$m $m Actual CER
Reported Profit before tax 2,800 2,262 24 34
Net finance expense 302 287 5 1
Joint ventures and associates 13 - n/m n/m
Depreciation, amortisation and impairment 1,255 1,502 (16) (17)
EBITDA 4,370 4,051 8 13
Table 11: Reconciliation of Reported to Core financial measures: Q1 2024 7
(#_ftn7)
Q1 2024 Reported Restructuring Intangible Asset Amortisation & Impairments Other Core Core
% Change
$m $m $m $m $m Actual CER
Gross profit 10,461 20 10 - 10,491 15 18
Product Sales Gross Margin 82% 82% -1pp -1pp
Distribution expense (135) - - - (135) 1 3
R&D expense (2,783) 80 4 1 (2,698) 17 18
% of Total Revenue 22% 21% - -
SG&A expense (4,495) 97 941 44 (3,413) 12 13
% of Total Revenue 35% 27% +1pp +1pp
Total operating expense (7,413) 177 945 45 (6,246) 14 15
Other operating income & expense 67 (2) - - 65 (80) (80)
Operating profit 3,115 195 955 45 4,310 9 15
Operating Margin 25% 34% -2pp -1pp
Net finance expense (302) - - 57 (245) 2 (3)
Taxation (620) (45) (183) (19) (867) 19 25
EPS $1.41 $0.10 $0.50 $0.05 $2.06 7 13
Profit and Loss drivers
Gross profit
‒ The calculation of Reported and Core Product Sales Gross Margin
excludes the impact of Alliance Revenue and Collaboration Revenue
‒ The change in Product Sales Gross Margin (Reported and Core) in Q1
2024 was impacted by:
‒ Positive effects from product mix. The increased contribution from
Rare Disease and Oncology medicines had a positive impact on the Product Sales
Gross Margin
‒ Dilutive effects from product mix. The rising contribution of
Product Sales with profit sharing arrangements (Lynparza, Enhertu, Tezspire,
Koselugo) has a negative impact on Product Sales Gross Margin because
AstraZeneca records Product Sales in certain markets and pays away a share of
the gross profits to its collaboration partners. The growth in Beyfortus also
has a dilutive impact on Product Sales Gross Margin, as AstraZeneca is
responsible for manufacturing, and Sanofi is responsible for distribution.
AstraZeneca records its sales to Sanofi as Product Sales, which generate a
lower Product Sales Gross Margin than the Company average
‒ Dilutive effects from geographic mix. In Emerging Markets, the
Product Sales Gross Margin tends to be below the Company average
‒ Variations in Product Sales Gross Margin performance between periods
can continue to be expected due to product seasonality, foreign exchange
fluctuations, and other effects
R&D expense
‒ The change in R&D expense (Reported and Core) in the period was
impacted by:
‒ Recent positive data read-outs for several high priority medicines
that have ungated late-stage trials
‒ Investment in platforms, new technology and capabilities to enhance
R&D productivity
‒ The change in Reported R&D expense was also impacted by
intangible asset impairments in the prior period
SG&A expense
‒ The change in SG&A expense (Reported and Core) in the period was
driven primarily by market development activities for launches
Other operating income and expense
‒ In the prior year period, Other operating income and expense
included a $241m gain on the disposal of the US rights to Pulmicort Flexhaler
Net finance expense
‒ Core Net finance expense increased 2% (3% decrease at CER) with
higher rates on floating debt and bond issuances broadly offset by higher
interest received on cash and short-term investments
Taxation
‒ The effective Reported Tax rate for the three months to 31 March
2024 was 22% (Q1 2023: 20%) and the effective Core Tax rate was 21% (Q1 2023:
20%)
‒ The cash tax paid for the three months to 31 March 2024 was $430m
(Q1 2023: $225m), representing 15% of Reported Profit before tax (Q1 2023:
10%)
Table 12: Cash Flow summary
Q1 2024 Q1 2023 Change
$m $m $m
Reported Operating profit 3,115 2,549 566
Depreciation, amortisation and impairment 1,255 1,502 (247)
Movement in working capital and short-term provisions (455) 242 (697)
Gains on disposal of intangible assets - (249) 249
Fair value movements on contingent consideration arising from 16 - 16
business combinations
Non-cash and other movements (674) (429) (245)
Interest paid (341) (257) (84)
Taxation paid (430) (225) (205)
Net cash inflow from operating activities 2,486 3,133 (647)
Net cash inflow before financing activities 73 1,887 (1,814)
Net cash inflow/(outflow) from financing activities 2,028 (2,031) 4,059
The change in Net cash inflow before financing activities in the quarter to 31
March 2024 is primarily driven by the movement in Acquisitions of
subsidiaries, net of cash acquired, of $537m, and relates to the acquisition
of Gracell Biotechnologies, Inc. for $726m compared to the acquisition of
Neogene Therapeutics, Inc. for $189m in Q1 2023.
The change in Net cash inflow/(outflow) from financing activities of $4,059m
is primarily driven by the increase in Issue of loans and borrowings of
$1,150m, and by the decrease in Repayment of loans and borrowings of $1,997m.
Capital expenditure
Capital expenditure amounted to $417m in the three months to 31 March 2024 (Q1
2023: $247m). Capital expenditure is expected to increase substantially in
2024, driven by investment in several major manufacturing projects and
continued investment in technology upgrades.
Table 13: Net debt summary
At 31 At 31 At 31
Mar 2024 Dec 2023 Mar 2023
$m $m $m
Cash and cash equivalents 7,841 5,840 6,232
Other investments 180 122 230
Cash and investments 8,021 5,962 6,462
Overdrafts and short-term borrowings (477) (515) (593)
Commercial paper (980) - (74)
Lease liabilities (1,242) (1,128) (962)
Current instalments of loans (4,593) (4,614) (2,958)
Non-current instalments of loans (27,259) (22,365) (26,916)
Interest-bearing loans and borrowings (Gross debt) (34,551) (28,622) (31,503)
Net derivatives 81 150 (21)
Net debt (26,449) (22,510) (25,062)
Net debt increased by $3,939m in the three months to 31 March 2024 to
$26,449m. Details of the committed undrawn bank facilities are disclosed
within the going concern section of Note 1. Details of the Company's solicited
credit ratings and further details on Net debt are disclosed in Note 3.
Capital allocation
The Board's aim is to continue to strike a balance between the interests of
the business, financial creditors and the Company's shareholders. The
Company's capital allocation priorities include: investing in the business and
pipeline; maintaining a strong, investment-grade credit rating; potential
value-enhancing business development opportunities; and supporting the
progressive dividend policy.
In approving the declaration of dividends, the Board considers both the
liquidity of the company and the level of reserves legally available for
distribution. Dividends are paid to shareholders from AstraZeneca PLC, a Group
holding company with no direct operations. The ability of AstraZeneca PLC to
make shareholder distributions is dependent on the creation of profits for
distribution and the receipt of funds from subsidiary companies. The
consolidated Group reserves set out in the Condensed consolidated statement of
financial position do not reflect the profit available for distribution to the
shareholders of AstraZeneca PLC.
Summarised financial information for guarantee of securities of subsidiaries
AstraZeneca Finance LLC ("AstraZeneca Finance") is the issuer of 0.7% Notes
due 2024, 1.2% Notes due 2026, 4.8% Notes due 2027, 4.875% Notes due 2028,
1.75% Notes due 2028, 4.85% Notes due 2029, 4.9% Notes due 2030, 4.9% Notes
due 2031, 2.25% Notes due 2031, 4.875% Notes due 2033 and 5% Notes due 2034
(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 issued 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 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 22
February 2024, 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 14: Obligor group summarised Statement of comprehensive income
Q1 2024 Q1 2023
$m $m
Total Revenue - -
Gross profit - -
Operating loss - -
Loss for the period (234) (237)
Transactions with subsidiaries that are not issuers or guarantors 588 7,502
Table 15: Obligor group summarised Statement of financial position
At 31 Mar 2024 At 31 Mar 2023
$m $m
Current assets 12 10
Non-current assets - -
Current liabilities (5,778) (2,952)
Non-current liabilities (27,161) (26,747)
Amounts due from subsidiaries that are not issuers or guarantors 21,242 14,067
Amounts due to subsidiaries that are not issuers or guarantors - (296)
Foreign exchange
The Company's transactional currency exposures on working capital balances,
which typically extend for up to three months, are hedged where practicable
using forward foreign exchange contracts against the individual companies'
reporting currency. Foreign exchange gains and losses on forward contracts
transacted for transactional hedging are taken to profit or to Other
comprehensive income if the contract is in a designated cashflow hedge. In
addition, the Company's external dividend payments, paid principally in pound
sterling and Swedish krona, are fully hedged from announcement to payment
date.
Table 16: Currency sensitivities
The Company provides the following information on currency-sensitivity:
Average Annual impact ($m) of 5% strengthening (FY 2024 average rate vs. FY 2023
average) (( 8 (#_ftn8) ))
rates vs. USD
Currency Primary Relevance FY YTD Change Mar 2024 11 (#_ftn11) Change Total Revenue Core Operating Profit
2023 9 (#_ftn9)
2024 10 (#_ftn10)
(%) (%)
EUR Total Revenue 0.92 0.92 0 0.92 0 397 179
CNY Total Revenue 7.09 7.20 (2) 7.22 (2) 322 182
JPY Total Revenue 140.60 148.49 (5) 149.87 (6) 177 119
Other(( 12 (#_ftn12) )) 453 227
GBP Operating expense 0.80 0.79 2 0.79 2 60 (126)
SEK Operating expense 10.61 10.39 2 10.41 2 9 (63)
Sustainability
AstraZeneca published its tenth annual Sustainability Report
(https://www.astrazeneca.com/sustainability/resources.html) , including a data
annex for performance measures and targets, along with the 2023 Taskforce on
Climate-related Financial Disclosures Statement.
Access to healthcare
‒ Chair Michel Demaré participated in a panel discussion with global
health leaders at the 54(th) Annual Meeting of the World Economic Forum
(WEF) in Davos on utilising learnings from the COVID-19 pandemic to prepare
for future health challenges and the importance of investing in strong,
resilient health systems.
‒ Engagements linked to the Partnership for Health System
Sustainability and Resilience (PHSSR), continued in Germany, Belgium,
Switzerland and Japan, highlighting the need for measurable policy targets for
non-communicable disease management. In India, a PHSSR report was published
assessing the sustainability and resilience of the Indian health system, while
in the Netherlands, an academic publication was launched with policy
recommendations to improve health system resilience.
‒ Healthy Heart Africa (HHA), AstraZeneca's flagship health equity
programme, reached its goal of identifying more than 10 million people with
elevated blood pressure by 2025 nearly two years ahead of target. At the end
of February 2024, more than 11,480 healthcare workers have been trained and
more than 52 million blood pressure screenings conducted cumulatively since
the programme launched in 2014, maintaining an average of more than one
million screenings per month since 2023. HHA also launched a pilot programme
in Ghana in March 2024 as a first step to broadening its scope to include
chronic kidney disease screening.
‒ Since 2021, the Young Health Programme (YHP) has directly reached
more than 10 million youth, influenced 16 policies and has employee volunteer
programmes in 36 countries, exceeding its core targets for 2021-2025 nearly
two years early. YHP received the Driving Health Equity Award in the 2024
Reuters Pharma Awards Europe for the programme's work empowering young people
to catalyse a healthier future.
Environmental protection
‒ The Company signed a clean heat agreement in March 2024 to
decarbonise our medicines manufacturing in China. Through the agreement,
biomethane and biomethane-based steam will be supplied to our Wuxi
manufacturing site and we will reduce our Scope 1 and 2 greenhouse gas (GHG)
emissions by up to 80% in China, supporting the broader decarbonisation of the
healthcare system.
‒ The Company announced at WEF that it will be one of the inaugural
Early Adopter organisations that intend to start making disclosures aligned
with the Taskforce on Nature-related Financial Disclosures (TNFD)
Recommendations in corporate reporting by the fiscal year 2024.
‒ AstraZeneca was one of the five healthcare companies, convened
through the Sustainable Markets Initiative Health Systems Task Force, that
launched an industry-first multi-party agreement to access renewable power in
China in January 2024. This is the first time companies from across the global
healthcare sector have come together to decarbonise their operations in China,
and the agreement will result in potential annual emissions savings of
approximately 120,000 tonnes of carbon dioxide equivalent (CO2e).
‒ AstraZeneca received the Sustainability Award in the 2024 Reuters
Pharma Awards Europe for accelerating the electronic product information
industry transition in Europe.
Ethics and transparency
‒ The Company achieved seventh place overall, and third in the Health
Care sector, in the FTSE Women Leaders Review 2023, as one of the top
performers in both the FTSE 100 and FTSE 350 for representation of women
across the organisation.
‒ The Company's latest Modern Slavery Act Statement was published
detailing activities undertaken to mitigate the risks of modern slavery both
within the Company's operations and supply chain, in line with the Code of
Ethics and our commitment to operating with integrity and in compliance with
relevant legislation.
‒ In Poland, AstraZeneca was named an 'Ethics Leader' by Bonnier Press
for the third year. This award recognises five companies for their commitment
to upholding high ethical standards, treating business partners with respect,
applying the principles of fair competition, and building trust and good
relationships between employees and stakeholder groups.
Research and development
This section covers R&D events and milestones that have occurred since the
prior results announcement on 8 February 2024, up to and including events on
24 April 2024.
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
(https://www.astrazeneca.com/investor-relations.html) . 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 four major medical congresses since the prior results
announcement: the Society of Gynecologic Oncology Annual Meeting on Women's
Cancer (SGO) in March 2024, the European Lung Cancer Congress (ELCC) in March
2024, American Association for Cancer Research Annual Meeting (AACR) in April
2024 and the 2024 Cholangiocarcinoma Foundation Conference (CFC) in April
2024.
Tagrisso
Event Commentary
Phase III trial read out LAURA Met primary endpoint, demonstrating that Tagrisso resulted in a statistically
significant and highly clinically meaningful improvement in PFS for patients
with unresectable, Stage III EGFRm NSCLC after chemoradiotherapy compared to
placebo after chemoradiotherapy. (February 2024)
Approval US Tagrisso with the addition of chemotherapy for the treatment of adult patients
with locally advanced or metastatic EGFRm NSCLC. (FLAURA2, February 2024)
Presentation: ELCC FLAURA2 OS interim analysis of the Phase III FLAURA2 trial, presented at ELCC, showed
at 41% data maturity, a favourable trend with the Tagrisso plus chemotherapy
arm (HR 0.75) vs Tagrisso monotherapy. The OS data were not statistically
significant at this interim analysis and will continue to be assessed as a key
secondary endpoint at final analysis. (March 2024)
Imfinzi and Imjudo
Event Commentary
Phase III trial read out ADRIATIC Met primary endpoint, demonstrating that Imfinzi resulted in a statistically
significant and clinically meaningful improvement in the dual primary
endpoints of OS and PFS in patients with LS-SCLC who had not progressed
following cCRT compared to placebo after cCRT. (April 2024).
Presentation: CFC TOPAZ-1 Updated exploratory results of the Phase III TOPAZ-1 trial, presented at CFC,
showed Imfinzi in combination with standard-of-care chemotherapy demonstrated
a clinically meaningful long-term OS benefit at three years for patients with
advanced BTC. (April 2024)
Lynparza
Event Commentary
Presentation: SGO DUO-E (Lynparza and Imfinzi) Post-hoc exploratory subgroup analysis of the Phase III DUO-E trial, presented
at SGO, assessed patients by mismatch repair status and demonstrated that
median duration of response in proficient mismatch repair patients in the
Lynparza and Imfinzi arm was more than double versus the control arm (18.7
versus 7.6 months) in patients with advanced or recurrent endometrial cancer.
(March 2024)
Enhertu
Event Commentary
Approval US For the treatment of adult patients with unresectable or metastatic
HER2-positive (IHC 3+) solid tumours who have received prior systemic
treatment and have no satisfactory alternative treatment options
(DESTINY-PanTumor02, DESTINY-Lung01, DESTINY-CRC02, April 2024)
Truqap
Event Commentary
Approval Japan In combination with Faslodex for the treatment of adult patients with
unresectable or recurrent PIK3CA, AKT1, or PTEN-altered HR-positive,
HER2-negative breast cancer following progression after treatment with
endocrine therapy. (CAPItello-291, March 2024)
BioPharmaceuticals - R&I
Fasenra
Event Commentary
Label expansion US Fasenra's approval in severe eosinophilic asthma has been expanded to include
patients 6 years and older, from the previous 12 years and older (TATE, April
2024)
Publication (Respiratory Medicine) MIRACLE Results from the MIRACLE Phase III trial showed treatment with Fasenra
resulted in a reduction of 74% in annual exacerbation rate in patients in Asia
with severe eosinophilic asthma (April 2024)
Rare Disease
AstraZeneca presented new clinical and real-world data from its leading rare
neurology portfolio at the American Academy of Neurology (AAN) Annual Meeting
in Denver, CO, 13 to 18 April 2024. The Company presented 14 abstracts,
including five oral presentations, across both gMG and NMOSD.
Ultomiris
Event Commentary
Approval US For the treatment of adult patients with anti-aquaporin-4 antibody-positive
(Ab+) NMOSD. (CHAMPION-NMOSD, March 2024)
Voydeya
Event Commentary
Approval US For the treatment of extravascular haemolysis in adults with paroxysmal
nocturnal haemoglobinuria, as add-on therapy to Ultomiris or Soliris. (ALPHA,
April 2024)
Approval EU For the treatment of adult patients with paroxysmal nocturnal haemoglobinuria
who have residual haemolytic anaemia, as an add-on therapy to Ultomiris or
Soliris. (ALPHA, February 2024).
Interim financial statements
Table 17: Condensed consolidated statement of comprehensive income: Q1 2024
For the quarter ended 31 March 2024 2023
$m $m
Total Revenue 12,679 10,879
Product Sales 12,177 10,566
Alliance Revenue 457 286
Collaboration Revenue 45 27
Cost of sales (2,218) (1,905)
Gross profit 10,461 8,974
Distribution expense (135) (134)
Research and development expense (2,783) (2,611)
Selling, general and administrative expense (4,495) (4,059)
Other operating income and expense 67 379
Operating profit 3,115 2,549
Finance income 111 78
Finance expense (413) (365)
Share of after tax losses in associates and joint ventures (13) -
Profit before tax 2,800 2,262
Taxation (620) (458)
Profit for the period 2,180 1,804
Other comprehensive income:
Items that will not be reclassified to profit or loss:
Remeasurement of the defined benefit pension liability 144 (10)
Net gains on equity investments measured at fair value through other 35 46
comprehensive income
Fair value movements related to own credit risk on bonds designated as fair - 2
value through profit or loss
Tax on items that will not be reclassified to profit or loss (39) 24
140 62
Items that may be reclassified subsequently to profit or loss:
Foreign exchange arising on consolidation (515) 314
Foreign exchange arising on designated liabilities in net investment hedges (98) (7)
Fair value movements on cash flow hedges (86) 56
Fair value movements on cash flow hedges transferred to profit and loss 70 (75)
Fair value movements on derivatives designated in net investment hedges 22 16
Costs of hedging 15 -
Tax on items that may be reclassified subsequently to profit or loss 35 12
(557) 316
Other comprehensive (expense)/income, net of tax (417) 378
Total comprehensive income for the period 1,763 2,182
Profit attributable to:
Owners of the Parent 2,179 1,803
Non-controlling interests 1 1
2,180 1,804
Total comprehensive income attributable to:
Owners of the Parent 1,762 2,181
Non-controlling interests 1 1
1,763 2,182
Basic earnings per $0.25 Ordinary Share $1.41 $1.16
Diluted earnings per $0.25 Ordinary Share $1.40 $1.16
Weighted average number of Ordinary Shares in issue (millions) 1,549 1,549
Diluted weighted average number of Ordinary Shares in issue (millions) 1,560 1,560
Table 18: Condensed consolidated statement of financial position
At 31 Mar At 31 Dec At 31 Mar
2024 2023 2023
$m $m $m
Assets
Non-current assets
Property, plant and equipment 9,411 9,402 8,644
Right-of-use assets 1,205 1,100 955
Goodwill 19,978 20,048 20,001
Intangible assets 38,834 38,089 39,291
Investments in associates and joint ventures 130 147 77
Other investments 1,565 1,530 1,157
Derivative financial instruments 213 228 116
Other receivables 745 803 682
Deferred tax assets 4,618 4,718 3,498
76,699 76,065 74,421
Current assets
Inventories 5,337 5,424 4,967
Trade and other receivables 11,072 12,126 10,289
Other investments 180 122 230
Derivative financial instruments 11 116 40
Income tax receivable 1,153 1,426 508
Cash and cash equivalents 7,841 5,840 6,232
25,594 25,054 22,266
Total assets 102,293 101,119 96,687
Liabilities
Current liabilities
Interest-bearing loans and borrowings (6,050) (5,129) (3,625)
Lease liabilities (281) (271) (232)
Trade and other payables (19,699) (22,374) (19,210)
Derivative financial instruments (92) (156) (44)
Provisions (1,148) (1,028) (546)
Income tax payable (1,631) (1,584) (1,203)
(28,901) (30,542) (24,860)
Non-current liabilities
Interest-bearing loans and borrowings (27,259) (22,365) (26,916)
Lease liabilities (961) (857) (730)
Derivative financial instruments (51) (38) (133)
Deferred tax liabilities (2,621) (2,844) (2,795)
Retirement benefit obligations (1,280) (1,520) (1,128)
Provisions (1,123) (1,127) (914)
Other payables (2,596) (2,660) (3,400)
(35,891) (31,411) (36,016)
Total liabilities (64,792) (61,953) (60,876)
Net assets 37,501 39,166 35,811
Equity
Capital and reserves attributable to equity holders of the Parent
Share capital 388 388 387
Share premium account 35,194 35,188 35,159
Other reserves 2,075 2,065 2,068
Retained earnings (212) 1,502 (1,825)
37,445 39,143 35,789
Non-controlling interests 56 23 22
Total equity 37,501 39,166 35,811
Table 19: 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 2023 387 35,155 2,069 (574) 37,037 21 37,058
Profit for the period - - - 1,803 1,803 1 1,804
Other comprehensive income - - - 378 378 - 378
Transfer to other reserves - - (1) 1 - - -
Transactions with owners
Dividends - - - (3,047) (3,047) - (3,047)
Issue of Ordinary Shares - 4 - - 4 - 4
Share-based payments charge for the period - - - 132 132 - 132
Settlement of share plan awards - - - (518) (518) - (518)
Net movement - 4 (1) (1,251) (1,248) 1 (1,247)
At 31 Mar 2023 387 35,159 2,068 (1,825) 35,789 22 35,811
At 1 Jan 2024 388 35,188 2,065 1,502 39,143 23 39,166
Profit for the period - - - 2,179 2,179 1 2,180
Other comprehensive expense - - - (417) (417) - (417)
Transfer to other reserves - - 10 (10) - - -
Transactions with owners
Dividends - - - (3,052) (3,052) - (3,052)
Issue of Ordinary Shares - 6 - - 6 - 6
Changes in non-controlling interests - - - - - 32 32
Share-based payments charge for the period - - - 159 159 - 159
Settlement of share plan awards - - - (573) (573) - (573)
Net movement - 6 10 (1,714) (1,698) 33 (1,665)
At 31 Mar 2024 388 35,194 2,075 (212) 37,445 56 37,501
Table 20: Condensed consolidated statement of cash flows
For the quarter ended 31 March 2024 2023
$m $m
Cash flows from operating activities
Profit before tax 2,800 2,262
Finance income and expense 302 287
Share of after tax losses of associates and joint ventures 13 -
Depreciation, amortisation and impairment 1,255 1,502
Movement in working capital and short-term provisions (455) 242
Gains on disposal of intangible assets - (249)
Fair value movements on contingent consideration arising from business 16 -
combinations
Non-cash and other movements (674) (429)
Cash generated from operations 3,257 3,615
Interest paid (341) (257)
Tax paid (430) (225)
Net cash inflow from operating activities 2,486 3,133
Cash flows from investing activities
Acquisition of subsidiaries, net of cash acquired (726) (189)
Payments upon vesting of employee share awards attributable to business - (23)
combinations
Payment of contingent consideration from business combinations (222) (214)
Purchase of property, plant and equipment (417) (247)
Disposal of property, plant and equipment 53 125
Purchase of intangible assets (1,188) (1,223)
Disposal of intangible assets 75 264
Movement in profit-participation liability - 175
Purchase of non-current asset investments (41) -
Disposal of non-current asset investments 9 10
Movement in short-term investments, fixed deposits and other investing (57) 9
instruments
Disposal of investments in associates and joint ventures 8 -
Interest received 93 67
Net cash outflow from investing activities (2,413) (1,246)
Net cash inflow before financing activities 73 1,887
Cash flows from financing activities
Proceeds from issue of share capital 6 4
Issue of loans and borrowings 4,976 3,826
Repayment of loans and borrowings (7) (2,004)
Dividends paid (3,033) (3,047)
Hedge contracts relating to dividend payments (8) 27
Repayment of obligations under leases (74) (67)
Movement in short-term borrowings 1,001 97
Payment of Acerta Pharma share purchase liability (833) (867)
Net cash inflow/(outflow) from financing activities 2,028 (2,031)
Net increase/(decrease) in Cash and cash equivalents in the period 2,101 (144)
Cash and cash equivalents at the beginning of the period 5,637 5,983
Exchange rate effects (46) (11)
Cash and cash equivalents at the end of the period 7,692 5,828
Cash and cash equivalents consist of:
Cash and cash equivalents 7,841 6,232
Overdrafts (149) (404)
7,692 5,828
Notes to the Interim financial statements
Note 1: Basis of preparation and accounting policies
These unaudited condensed consolidated Interim financial statements for the
three months ended 31 March 2024 have been prepared in accordance with
International Accounting Standard 34, 'Interim Financial Reporting' (IAS 34),
as issued by the International Accounting Standards Board (IASB), IAS 34 as
adopted by the European Union, UK-adopted IAS 34 and the Disclosure Guidance
and Transparency Rules sourcebook of the United Kingdom's Financial Conduct
Authority and with the requirements of the Companies Act 2006 as applicable to
companies reporting under those standards.
The unaudited Interim financial statements for the three months ended 31 March
2024 were approved by the Board of Directors for publication on 25 April 2024.
This results announcement does not constitute statutory accounts of the Group
within the meaning of sections 434(3) and 435(3) of the Companies Act 2006.
The annual financial statements of the Group for the year ended 31 December
2023 were prepared in accordance with UK-adopted international accounting
standards and with the requirements of the Companies Act 2006. The annual
financial statements also comply fully with IFRS Accounting Standards as
issued by the IASB and International Accounting Standards as adopted by the
European Union. Except for the estimation of the interim income tax charge,
the Interim financial statements have been prepared applying the accounting
policies that were applied in the preparation of the Group's published
consolidated financial statements for the year ended 31 December 2023.
The comparative figures for the financial year ended 31 December 2023 are not
the Group's statutory accounts for that financial year. Those accounts have
been reported on by the Group's auditors and will be delivered to the
Registrar of Companies; their report was (i) unqualified, (ii) did not include
a reference to any matters to which the auditors drew attention by way of
emphasis without qualifying their report, and (iii) did not contain a
statement under section 498(2) or (3) of the Companies Act 2006.
Going concern
The Group has considerable financial resources available. As at 31 March 2024,
the Group has $14.7bn in financial resources (cash and cash equivalent
balances of $7.8bn and undrawn committed bank facilities of $6.9bn, with
$6.3bn of borrowings due within one year). These facilities contain no
financial covenants and were undrawn at 31 March 2024. $2bn of the facilities
are available until February 2025 and the other $4.9bn are available until
April 2029.
The Group's revenues are largely derived from sales of medicines covered by
patents, which provide a relatively high level of resilience and
predictability to cash inflows, although government price interventions in
response to budgetary constraints are expected to continue to adversely affect
revenues in some of our significant markets. The Group, however, anticipates
new revenue streams from both recently launched medicines and those in
development, and the Group has a wide diversity of customers and suppliers
across different geographic areas.
Consequently, the Directors believe that, overall, the Group is well placed to
manage its business risks successfully. Accordingly, they continue to adopt
the going concern basis in preparing the Interim financial statements.
Legal proceedings
The information contained in Note 6 updates the disclosures concerning legal
proceedings and contingent liabilities in the Group's Annual Report and Form
20-F Information 2023.
(https://www.astrazeneca.com/content/dam/az/Investor_Relations/annual-report-2023/pdf/AstraZeneca_AR_2023.pdf)
Note 2: Intangible assets
In accordance with IAS 36 'Impairment of Assets', reviews for triggers of
impairment or impairment reversals at an individual asset or cash generating
unit level were conducted, and impairment tests carried out where triggers
were identified. This review resulted in $nil impairment charge during the
three months ended 31 March 2024 (31 March 2023: $271m net charge). In Q1
2023, net impairment charges included the $244m impairment of the ALXN1840
intangible asset, following the decision to discontinue this development
programme in Wilson's disease.
The acquisition of Icosavax, Inc. completed on 19 February 2024. The
transaction is recorded as an asset acquisition based on the concentration
test permitted under IFRS 3 'Business Combinations', with consideration of
$841m principally relating to $639m of intangible assets, $141m of cash and
cash equivalents and $51m of marketable securities. Contingent consideration
of up to $300m could be paid on achievement of regulatory and sales
milestones; these potential liabilities would be recorded when relevant
milestones are triggered or performance conditions satisfied.
Note 3: Net debt
The table below provides an analysis of Net debt and a reconciliation of Net
Cash flow to the movement in Net debt. The Group monitors Net debt as part of
its capital management policy as described in Note 28 of the Annual Report and
Form 20-F Information 2023
(https://www.astrazeneca.com/content/dam/az/Investor_Relations/annual-report-2023/pdf/AstraZeneca_AR_2023.pdf)
. Net debt is a non-GAAP financial measure.
Table 21: Net debt
At 1 Jan 2024 Cash flow Acquisitions Non-cash Exchange movements At 31 Mar 2024
& other
$m $m $m $m $m $m
Non-current instalments of loans (22,365) (4,976) (3) (2) 87 (27,259)
Non-current instalments of leases (857) - (2) (114) 12 (961)
Total long-term debt (23,222) (4,976) (5) (116) 99 (28,220)
Current instalments of loans (4,614) 7 (9) (1) 24 (4,593)
Current instalments of leases (271) 86 (2) (100) 6 (281)
Commercial paper - (980) - - - (980)
Bank collateral received (215) 60 - - - (155)
Other short-term borrowings excluding overdrafts (97) (81) - - 5 (173)
Overdrafts (203) 54 - - - (149)
Total current debt (5,400) (854) (11) (101) 35 (6,331)
Gross borrowings (28,622) (5,830) (16) (217) 134 (34,551)
Net derivative financial instruments 150 8 - (77) - 81
Net borrowings (28,472) (5,822) (16) (294) 134 (34,470)
Cash and cash equivalents 5,840 1,837 209 1 (46) 7,841
Other investments - current 122 57 3 - (2) 180
Cash and investments 5,962 1,894 212 1 (48) 8,021
Net debt (22,510) (3,928) 196 (293) 86 (26,449)
Net debt increased by $3,939m in the three months to 31 March 2024 to
$26,449m. Details of the committed undrawn bank facilities are disclosed
within the going concern section of Note 1. Non-cash movements in the period
include fair value adjustments under IFRS 9 'Financial Instruments'.
In February 2024, AstraZeneca issued the following:
- $1,250m of fixed-rate notes with a coupon of 4.8% maturing in
February 2027
- $1,250m of fixed-rate notes with a coupon of 4.85% maturing in
February 2029
- $1,000m of fixed-rate notes with a coupon of 4.9% maturing in
February 2031
- $1,500m of fixed-rate notes with a coupon of 5% maturing in February
2034
-
The Group has agreements with some bank counterparties whereby the parties
agree to post cash collateral on financial derivatives, for the benefit of the
other, equivalent to the market valuation of the derivative positions above a
predetermined threshold. The carrying value of such cash collateral held by
the Group at 31 March 2024 was $155m (31 December 2023: $215m) and the
carrying value of such cash collateral posted by the Group at 31 March 2024
was $136m (31 December 2023: $102m).
The equivalent GAAP measure to Net debt is 'liabilities arising from financing
activities', which excludes the amounts for cash and overdrafts, other
investments and non-financing derivatives shown above and includes the Acerta
Pharma share purchase liability of $nil (31 December 2023: $833m).
During the quarter ended 31 March 2024, there have been no changes to the
Company's solicited long term credit ratings. Moody's credit ratings were long
term: A2; short term: P-1. Standard and Poor's credit ratings were long term:
A; short term: A-1.
Note 4: Financial Instruments
As detailed in the Group's most recent annual financial statements, the
principal financial instruments consist of derivative financial instruments,
other investments, trade and other receivables, cash and cash equivalents,
trade and other payables, lease liabilities and interest-bearing loans and
borrowings.
The Group has certain equity investments that are categorised as Level 3 in
the fair value hierarchy that are held at $309m at (31 December 2023: $313m)
and for which a fair value loss of $1m has been recognised in the three months
ended 31 March 2024 (31 March 2023: fair value gain of $1m). In the absence of
specific market data, these unlisted investments are held at fair value based
on the cost of investment and adjusted as necessary for impairments and
revaluations on new funding rounds, which are seen to approximate the fair
value. All other fair value gains and/or losses that are presented in Net
gains on equity investments measured at fair value through other comprehensive
income in the Condensed consolidated statement of comprehensive income for the
three months ended 31 March 2024 are Level 1 fair value measurements, valued
based on quoted prices in active markets.
Financial instruments measured at fair value include $1,605m of other
investments, $5,504m held in money-market funds and $81m of derivatives as at
31 March 2024. With the exception of derivatives being Level 2 fair valued,
and certain equity investments of $320m categorised as Level 3, the
aforementioned balances are Level 1 fair valued. Financial instruments
measured at amortised cost include $136m of cash collateral pledged to
counterparties. The total fair value of interest-bearing loans and borrowings
at 31 March 2024, which have a carrying value of $34,551m in the Condensed
consolidated statement of financial position, was $33,364m.
Table 22: Financial instruments - contingent consideration
2024 2023
Diabetes alliance Other Total Total
$m $m $m $m
At 1 January 1,945 192 2,137 2,222
Additions through business combinations - 54 54 60
Settlements (221) (1) (222) (214)
Revaluations - 16 16 -
Discount unwind 26 2 28 33
At 31 March 1,750 263 2,013 2,101
Contingent consideration arising from business combinations is fair valued
using decision-tree analysis, with key inputs including the probability of
success, consideration of potential delays and the expected levels of future
revenues.
The contingent consideration balance relating to BMS's share of the global
diabetes alliance of $1,750m (31 December 2023: $1,945m) would
increase/decrease by $175m with an increase/decrease in sales of 10%, as
compared with the current estimates.
Note 5: Business combinations
The acquisition of Gracell Biotechnologies, Inc. completed on 22 February 2024
and was recorded as a business combination using the acquisition method of
accounting in accordance with IFRS 3 'Business Combinations'. Consequently the
assets acquired, and liabilities assumed are recorded at fair value. Given the
proximity of the completion of the transaction to the reporting date, the
identification and determination of the fair values related to the acquired
balance sheet is on-going. This exercise is expected to complete in Q2 2024
with the majority of the fair value expected to be allocated to the intangible
assets, as currently reported. The upfront cash portion of the consideration
represents a transaction value of approximately $1.0bn. Combined, the upfront
and potential contingent value payments if achieved, represent, a transaction
value of approximately $1.2bn. The cash and cash equivalents acquired on
Gracell's balance sheet, totalled to $209m at the close of the transaction.
Note 6: Legal proceedings and contingent liabilities
AstraZeneca is involved in various legal proceedings considered typical to its
business, including litigation and investigations, including Government
investigations, relating to product liability, commercial disputes,
infringement of intellectual property (IP) rights, the validity of certain
patents, anti-trust law and sales and marketing practices. The matters
discussed below constitute the more significant developments since publication
of the disclosures concerning legal proceedings in the Company's Annual Report
and Form 20-F Information 2023 (the Disclosures). Information about the nature
and facts of the cases is disclosed in accordance with IAS 37.
As discussed in the Disclosures, the majority of claims involve highly complex
issues. Often these issues are subject to substantial uncertainties and,
therefore, the probability of a loss, if any, being sustained and/or an
estimate of the amount of any loss is difficult to ascertain.
In cases that have been settled or adjudicated, or where quantifiable fines
and penalties have been assessed and which are not subject to appeal, or where
a loss is probable and we are able to make a reasonable estimate of the loss,
AstraZeneca records the loss absorbed or makes a provision for its best
estimate of the expected loss. The position could change over time and the
estimates that the Company made, and upon which the Company have relied in
calculating these provisions are inherently imprecise. There can, therefore,
be no assurance that any losses that result from the outcome of any legal
proceedings will not exceed the amount of the provisions that have been booked
in the accounts. The major factors causing this uncertainty are described more
fully in the Disclosures and herein.
AstraZeneca has full confidence in, and will vigorously defend and enforce,
its IP.
Matters disclosed in respect of the first quarter of 2024 and to 25 April 2024
Patent litigation
Legal proceedings brought against AstraZeneca considered to be contingent liabilities
Forxiga
UK patent proceedings
In the UK, one of AstraZeneca's patents relating to Forxiga is being
challenged by Generics (UK) Limited, Teva Pharmaceutical Industries Limited,
and Glenmark Pharmaceuticals Europe Limited. Trial is scheduled for March
2025.
Tagrisso
US patent proceedings
In September 2021, Puma Biotechnology, Inc. (Puma) and Wyeth LLC (Wyeth) filed
a patent infringement lawsuit in the US District Court for the District of
Delaware (District Court) against AstraZeneca relating to Tagrisso. In March
2024, the District Court dismissed Puma. A trial, with Wyeth as the plaintiff,
has been scheduled for May 2024.
Legal proceedings brought by AstraZeneca considered to be contingent assets
Calquence
US patent proceedings
In February 2022, in response to Paragraph IV notices from multiple ANDA
filers, AstraZeneca filed patent infringement lawsuits in the US District
Court for the District of Delaware (District Court). In its complaint,
AstraZeneca alleged that a generic version of Calquence capsules, if approved
and marketed, would infringe patents that are owned or licensed by
AstraZeneca. Trial is scheduled for March 2025.
In March and April 2024, AstraZeneca entered into settlement agreements with
generic manufacturers, Sandoz Inc., and Natco Pharma Limited with Natco Pharma
Inc., resulting in dismissal of the corresponding Calquence capsule ANDA
litigation proceedings. Additional Calquence capsule ANDA litigation
proceedings with the remaining three generic manufacturers are ongoing in the
District Court.
In April 2024, AstraZeneca received a Paragraph IV notice from an ANDA filer
relating to patents listed in the FDA Orange Book with reference to Calquence
tablets. AstraZeneca is considering its response.
Lokelma
US patent proceedings
In August 2022, in response to Paragraph IV notices, AstraZeneca initiated
ANDA litigation against multiple generic filers in the US District Court for
the District of Delaware (District Court). Trial is scheduled for March 2025.
AstraZeneca entered into a settlement agreement with a generic manufacturer,
Alkem Laboratories, which resulted in dismissal of the corresponding
litigation. Additional proceedings with the remaining generic manufacturers
are ongoing in the District Court.
Soliris
US patent proceedings
In January 2024, Alexion initiated patent infringement litigation against
Samsung Bioepis Co. Ltd. (Samsung) in the US District Court for the District
of Delaware alleging that Samsung's biosimilar eculizumab product, for which
Samsung is currently seeking FDA approval, will infringe six Soliris-related
patents. No trial date has been scheduled. Five of the six asserted patents
are also the subject of inter partes review proceedings before the US Patent
and Trademark Office. In February 2024, Alexion filed a motion for a
preliminary injunction seeking to enjoin Samsung from launching its biosimilar
eculizumab product upon FDA approval. A hearing on Alexion's preliminary
injunction motion is scheduled for May 2024.
European patent proceedings
In March 2024, Alexion filed motions for preliminary injunctions against Amgen
and Samsung at the Hamburg Local Division of the Unified Patent Court on the
basis that Amgen's and Samsung's biosimilar eculizumab products infringe
Alexion's eculizumab molecule patent that is expected to grant in Q2 2024. No
hearing date for the preliminary injunction motions has been set.
Tagrisso
Russia patent proceedings
In Russia, in August 2023, AstraZeneca filed lawsuits in the Arbitration Court
of the Moscow Region (Court) against the Ministry of Health of the Russian
Federation and Axelpharm LLC (Axelpharm) related to Axelpharm's improper use
of AstraZeneca's information to obtain authorisation to market a generic
version of Tagrisso. In December 2023, the Court dismissed the lawsuit against
the Ministry of Health of the Russian Federation. In January 2024, AstraZeneca
filed an appeal, and the appellate court affirmed the dismissal in March 2024.
The lawsuit against Axelpharm remains pending.
In Russia, in November 2023, Axelpharm filed a compulsory licensing action
against AstraZeneca in the Court related to a patent that covers Tagrisso. The
compulsory licensing action remains pending.
Product liability litigation
Legal proceedings brought against AstraZeneca for which a provision has been taken
Nexium and Losec/Prilosec
US proceedings
AstraZeneca has been defending lawsuits brought in federal and state courts
involving claims that plaintiffs have been diagnosed with various injuries
following treatment with proton pump inhibitors (PPIs), including Nexium and
Prilosec. Most of the lawsuits alleged kidney injury. In August 2017, the
pending federal court cases were consolidated into a multidistrict litigation
(MDL) proceeding in the US District Court for the District of New Jersey for
pre-trial purposes. Cases alleging kidney injury were also filed in Delaware
and New Jersey state courts.
In addition, AstraZeneca has been defending lawsuits involving allegations of
gastric cancer following treatment with PPIs, including one such claim in the
US District Court for the Middle District of Louisiana (Louisiana District
Court).
In October 2023, AstraZeneca resolved all pending claims in the MDL, as well
as all pending claims in Delaware and New Jersey state courts, for $425M, for
which a provision has been taken. The only remaining case is the one pending
in the Louisiana District Court, which is scheduled for trial in January 2025.
Canada proceedings
In Canada, in July and August 2017, AstraZeneca was served with three putative
class action lawsuits. Two of the lawsuits have been dismissed, one in 2019
and one in 2021. The third lawsuit seeks authorisation to represent individual
residents in Canada who allegedly suffered kidney injuries from the use of
proton pump inhibitors, including Nexium and Losec.
Legal proceedings brought against AstraZeneca considered to be contingent liabilities
Onglyza and Kombiglyze
US proceedings
In the US, AstraZeneca has been defending various lawsuits in both California
state court and in a consolidated federal proceeding alleging heart failure,
cardiac injuries, and/or death from treatment with Onglyza or Kombiglyze. In
the California state court proceeding, the trial court granted summary
judgment for AstraZeneca, which the California appellate court affirmed. The
California Supreme Court has declined further review, and the California
matter has concluded. The consolidated federal cases were dismissed in August
2022 by the US District Court for the Eastern District of Kentucky. That
dismissal was affirmed by the US Court of Appeals for the Sixth Circuit in
February 2024.
Vaxzevria
UK proceedings
AstraZeneca is defending lawsuits in the UK involving multiple claimants
alleging injuries following vaccination with AstraZeneca's COVID-19 vaccine.
Most of the lawsuits involve claims of thrombosis with thrombocytopenia
syndrome. No trial dates have been scheduled.
Commercial litigation
Legal proceedings brought against AstraZeneca considered to be contingent liabilities
340B Antitrust Litigation
US proceedings
In September 2021, AstraZeneca was served with a class-action antitrust
complaint filed in the US District Court for the Western District of New York
(District Court) by Mosaic Health alleging a conspiracy to restrict access to
340B discounts in the diabetes market through contract pharmacies. In
September 2022, the District Court granted AstraZeneca's motion to dismiss the
Complaint. In February 2024, the District Court denied Plaintiffs' request to
file an amended complaint and entered an order closing the matter. In March
2024, Plaintiffs filed an appeal.
Definiens
Germany proceedings
In Germany, in July 2020, AstraZeneca received a notice of arbitration filed
with the German Institution of Arbitration from the sellers of Definiens AG
(the Sellers) regarding the 2014 Share Purchase Agreement (SPA) between
AstraZeneca and the Sellers. The Sellers claim that they are owed
approximately $140m in earn-outs under the SPA. In December 2023, after an
arbitration hearing, the arbitration panel made a final award of $46.43m in
favour of the Sellers. In March 2024, AstraZeneca filed an application with
the Bavarian Supreme Court to set aside the arbitration award.
Legal proceedings brought by AstraZeneca considered to be contingent assets
PARP Inhibitor Royalty Dispute
UK proceedings
In October 2012, Tesaro, Inc. (now wholly owned by GlaxoSmithKline plc, (GSK))
entered into two worldwide, royalty-bearing patent license agreements with
AstraZeneca related to GSK's product niraparib. In May 2021, AstraZeneca filed
a lawsuit against GSK in the Commercial Court of England and Wales alleging
that GSK had failed to pay all of the royalties due on niraparib sales under
the license agreements. In April 2023, after trial, the trial court issued a
decision in AstraZeneca's favour. In February 2024, Court of Appeal reversed.
In March 2024, AstraZeneca filed a request for permission to appeal with the
Supreme Court of the United Kingdom.
Government investigations/proceedings
Legal proceedings brought against AstraZeneca considered to be contingent liabilities
340B Qui Tam
US proceedings
In July 2023, AstraZeneca was served with an unsealed civil lawsuit brought by
a qui tam relator on behalf of the United States, several states, and the
District of Columbia in the US District Court for the Central District of
California (District Court). The complaint alleges that AstraZeneca violated
the US False Claims Act and state law analogues. In March 2024, the District
Court granted AstraZeneca's motion to dismiss the First Amended Complaint
without leave to amend. In April 2024, the relator filed an appeal.
Legal proceedings brought by AstraZeneca considered to be contingent assets
Inflation Reduction Act Litigation
US proceedings
In August 2023, AstraZeneca filed a lawsuit in the US District Court for the
District of Delaware (District Court) against the US Department of Health and
Human Services (HHS) challenging aspects of the drug price negotiation
provisions of the Inflation Reduction Act and the implementing guidance and
regulations. In March 2024, the District Court granted HHS' motions and
dismissed AstraZeneca's lawsuit.
Arkansas 340B Litigation
US proceedings
In March 2024, AstraZeneca filed a lawsuit against the State of Arkansas
alleging that the Arkansas's 340B statute is pre-empted by federal law and
unconstitutional.
Other
Additional government inquiries
As is true for most, if not all, major prescription pharmaceutical companies,
AstraZeneca is currently involved in multiple inquiries into drug marketing
and pricing practices. In addition to the investigations described above,
various law enforcement offices have, from time to time, requested information
from the Group. There have been no material developments in those matters.
Note 7
Table 23: Q1 2024 - Product Sales year-on-year analysis
13 (#_ftn13)
World US Emerging Markets Europe Established RoW
$m Act % chg CER % chg $m % chg $m Act % chg CER % chg $m Act % chg CER % chg $m Act % chg CER % chg
Oncology 4,760 21 24 2,084 22 1,202 24 33 953 26 23 521 6 16
Tagrisso 1,595 12 15 623 20 488 10 17 302 18 15 182 (10) (2)
Imfinzi 1,113 29 33 582 19 129 59 83 232 43 40 170 31 45
Calquence 718 35 35 494 29 39 n/m n/m 153 42 39 32 44 47
Lynparza 705 8 11 288 7 167 23 33 191 7 5 59 (13) (6)
Enhertu 122 n/m n/m - - 83 n/m n/m 26 n/m n/m 13 n/m n/m
Zoladex 276 22 28 3 9 214 28 35 35 9 6 24 (1) 7
Imjudo 62 67 70 39 22 4 n/m n/m 8 n/m n/m 11 n/m n/m
Truqap 50 n/m n/m 50 n/m - - - - - - - - -
Orpathys 12 48 53 - - 12 48 53 - - - - - -
Others 107 (24) (19) 5 (10) 66 (24) (20) 6 (52) (53) 30 (16) (7)
BioPharmaceuticals: CVRM 3,012 19 22 748 20 1,365 17 24 716 29 26 183 (2) 7
Farxiga 1,845 42 45 473 60 711 43 50 553 41 37 108 (4) 5
Brilinta 323 (3) (1) 163 (9) 88 9 21 67 (1) (3) 5 (17) (14)
Crestor 297 (3) 2 10 (32) 241 - 4 12 (26) (27) 34 2 11
Seloken/Toprol-XL 165 (8) (2) - (96) 161 (7) (2) 3 (23) (23) 1 (39) (36)
Lokelma 114 16 19 52 (7) 21 83 90 18 60 56 23 16 29
roxadustat 75 24 28 - - 75 24 28 - - - - - -
Andexxa 47 5 6 20 (3) 1 n/m n/m 18 24 21 8 (14) (4)
Wainua 5 n/m n/m 5 n/m - - - - - - - - -
Others 141 (33) (31) 25 (55) 67 (32) (27) 45 (11) (12) 4 3 5
BioPharmaceuticals: R&I 1,804 14 16 737 19 588 10 16 330 13 11 149 6 11
Symbicort 769 12 14 299 28 253 11 18 142 (3) (6) 75 (5) (3)
Fasenra 358 6 6 210 4 22 53 61 93 6 4 33 (6) -
Pulmicort 224 2 5 5 (52) 191 5 9 20 - (3) 8 (7) (4)
Breztri 219 52 54 105 30 70 83 91 30 97 93 14 43 53
Tezspire 43 n/m n/m - - 2 n/m n/m 27 n/m n/m 14 n/m n/m
Saphnelo 91 94 95 83 89 1 n/m n/m 4 n/m n/m 3 80 99
Airsupra 7 n/m n/m 7 n/m - - - - - - - - -
Others 93 (30) (29) 28 (41) 49 (30) (27) 14 3 1 2 (17) (15)
BioPharmaceuticals: V&I 212 (40) (40) 27 n/m 90 (13) (12) 74 (27) (26) 21 (87) (86)
Synagis 171 (13) (13) (1) 76 90 16 18 61 (25) (27) 21 (46) (43)
Beyfortus 26 n/m n/m 26 n/m - - - - - - - - -
FluMist 7 n/m n/m 2 n/m - 59 59 5 n/m n/m - n/m n/m
COVID-19 mAbs 2 (99) (99) - - - n/m n/m 2 (53) (56) - n/m n/m
Others 6 (79) (80) - - - n/m n/m 6 (42) (43) - - -
Rare Disease 2,096 12 16 1,207 10 251 45 73 401 4 1 237 12 21
Ultomiris 859 32 34 482 27 32 n/m n/m 202 27 24 143 46 61
Soliris 739 (11) (8) 411 (8) 125 9 37 142 (22) (24) 61 (30) (28)
Strensiq 313 20 21 246 20 21 44 67 24 15 12 22 4 14
Koselugo 132 68 82 46 13 59 n/m n/m 18 72 69 9 n/m n/m
Kanuma 53 30 35 22 13 14 n/m n/m 15 19 18 2 (3) 2
Other medicines 293 (6) 1 24 (33) 206 - 11 29 31 30 34 (31) (25)
Nexium 240 (2) 7 22 (27) 172 10 23 13 13 11 33 (30) (24)
Others 53 (23) (21) 2 (63) 34 (31) (29) 16 52 52 1 (53) (49)
Total Product Sales 12,177 15 18 4,827 19 3,702 18 26 2,503 18 16 1,145 (7) 1
Table 24: Alliance Revenue
Q1 2024 Q1 2023
$m $m
Enhertu 339 220
Tezspire 77 43
Beyfortus 20 -
Other Alliance Revenue 21 23
Total 457 286
Table 25: Collaboration Revenue
Q1 2024 Q1 2023
$m $m
Farxiga: sales milestones 45 24
Other Collaboration Revenue - 3
Total 45 27
Table 26: Other operating income and expense
Q1 2024 Q1 2023
$m $m
brazikumab licence termination funding - 38
Divestment of US rights to Pulmicort Flexhaler - 241
Other 67 100
Total 67 379
Other shareholder information
Financial calendar
Announcement of H1 and Q2 2024
results: 25 July
2024
Announcement of 9M and Q3 2024
results: 12
November 2024
Dividends are normally paid as follows:
First interim: announced with the half year results and paid in
September
Second interim: announced with full year results and paid in March
Contacts
For details on how to contact the Investor Relations Team, please click here
(https://www.astrazeneca.com/investor-relations.html#Contacts) . For Media
contacts, click here (https://www.astrazeneca.com/media-centre/contacts.html)
.
Addresses for correspondence
Registered office Registrar and transfer office Swedish Central Securities Depository US depositary
Deutsche Bank Trust Company Americas
1 Francis Crick Avenue Equiniti Limited Euroclear Sweden AB PO Box 191 American Stock Transfer
Cambridge Biomedical Campus Aspect House SE-101 23 Stockholm 6201 15th Avenue
Cambridge Spencer Road Brooklyn
CB2 0AA Lancing NY 11219
West Sussex
BN99 6DA
United Kingdom United Kingdom Sweden United States
+44 (0) 20 3749 5000 0800 389 1580 +46 (0) 8 402 9000 +1 (888) 697 8018
+44 (0) 121 415 7033 +1 (718) 921 8137
db@astfinancial.com (mailto:db@astfinancial.com)
Trademarks
Trademarks of the AstraZeneca group of companies appear throughout this
document in italics. Medical publications also appear throughout the document
in italics. AstraZeneca, the AstraZeneca logotype and the AstraZeneca symbol
are all trademarks of the AstraZeneca group of companies. Trademarks of
companies other than AstraZeneca that appear in this document include: FasT
CAR owned by Gracell Biotechnology, Co., Ltd.; Plendil owned by AstraZeneca or
Glenwood GmbH (depending on geography); Beyfortus, a trademark of Sanofi
Pasteur Inc.; Enhertu, a trademark of Daiichi Sankyo; Seloken, owned by
AstraZeneca or Taiyo Pharma Co., Ltd (depending on geography); Synagis, owned
by AstraZeneca or Sobi aka Swedish Orphan Biovitrum AB (publ). (depending on
geography); and Tezspire, a trademark of Amgen, Inc.
Information on or accessible through AstraZeneca's websites, including
astrazeneca.com (https://www.astrazeneca.com/) , does not form part of and is
not incorporated into this announcement.
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical
company that focuses on the discovery, development, and commercialisation of
prescription medicines in Oncology, Rare Disease, and BioPharmaceuticals,
including Cardiovascular, Renal & Metabolism, and Respiratory &
Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries
and its innovative medicines are used by millions of patients worldwide.
Please visit astrazeneca.com (http://www.astrazeneca.com/) and follow the
Company on Social Media @AstraZeneca
(https://www.linkedin.com/company/astrazeneca) .
Cautionary statements regarding forward-looking statements
In order, among other things, to utilise the 'safe harbour' provisions of the
US Private Securities Litigation Reform Act of 1995, AstraZeneca (hereafter
'the Group') provides the following cautionary statement:
This document contains certain forward-looking statements with respect to the
operations, performance and financial condition of the Group, including, among
other things, statements about expected revenues, margins, earnings per share
or other financial or other measures. Although the Group believes its
expectations are based on reasonable assumptions, any forward-looking
statements, by their very nature, involve risks and uncertainties and may be
influenced by factors that could cause actual outcomes and results to be
materially different from those predicted. The forward-looking statements
reflect knowledge and information available at the date of preparation of this
document and the Group undertakes no obligation to update these
forward-looking statements. The Group identifies the forward-looking
statements by using the words 'anticipates', 'believes', 'expects', 'intends'
and similar expressions in such statements. Important factors that could cause
actual results to differ materially from those contained in forward-looking
statements, certain of which are beyond the Group's control, include, among
other things:
‒ the risk of failure or delay in delivery of pipeline or launch of
new medicines
‒ the risk of failure to meet regulatory or ethical requirements for
medicine development or approval
‒ the risk of failures or delays in the quality or execution of the
Group's commercial strategies
‒ the risk of pricing, affordability, access and competitive pressures
‒ the risk of failure to maintain supply of compliant, quality
medicines
‒ the risk of illegal trade in the Group's medicines
‒ the impact of reliance on third-party goods and services
‒ the risk of failure in information technology or cybersecurity
‒ the risk of failure of critical processes
‒ the risk of failure to collect and manage data in line with legal
and regulatory requirements and strategic objectives
‒ the risk of failure to attract, develop, engage and retain a
diverse, talented and capable workforce
‒ the risk of failure to meet regulatory or ethical expectations on
environmental impact, including climate change
‒ the risk of the safety and efficacy of marketed medicines being
questioned
‒ the risk of adverse outcome of litigation and/or governmental
investigations
‒ intellectual property-related risks to the Group's products
‒ the risk of failure to achieve strategic plans or meet targets or
expectations
‒ the risk of failure in financial control or the occurrence of fraud
‒ the risk of unexpected deterioration in the Group's financial
position
‒ the impact that global and/or geopolitical events may have or
continue to have on these risks, on the Group's ability to continue to
mitigate these risks, and on the Group's operations, financial results or
financial condition
There can be no guarantees that the conditions to the closing of the proposed
transaction with Fusion will be satisfied on the expected timetable or at all
or that "FPI-2265" (Ac225-PSMA I&T) or any combination product will
receive the necessary regulatory approvals or prove to be commercially
successful if approved. There can be no guarantees that the conditions to the
closing of the proposed transaction with Amolyt Pharma will be satisfied on
the expected timetable or at all or that eneboparatide ("AZP-3601") will
receive the necessary regulatory approvals or prove to be commercially
successful if approved.
Glossary
1L, 2L, etc First line, second line, etc
ADC Antibody drug
conjugate
aHUS Atypical haemolytic
uraemic syndrome
AKT Protein kinase B
AL amyloidosis Light chain amyloidosis
ANDA Abbreviated New Drug
Application (US)
ASO Antisense
oligonucleotide
ATTR-CM Transthyretin-mediated amyloid
cardiomyopathy
ATTRv / -PN / -CM Hereditary transthyretin-mediated amyloid /
polyneuropathy / cardiomyopathy
BCMA B-cell maturation
antigen
BRCA / m Breast cancer gene / mutation
BTC Biliary tract
cancer
BTK Bruton tyrosine
kinase
C5 Complement
component 5
CAR-T Chimeric antigen
receptor T-cell
cCRT Concurrent
chemoradiotherapy
CD19 A gene expressed in
B-cells
CER Constant exchange
rates
CHMP Committee for Medicinal
Products for Human Use (EU)
CI
Confidence interval
CKD Chronic kidney
disease
CLL Chronic
lymphocytic leukaemia
COPD Chronic obstructive
pulmonary disease
COP28 28th annual United Nations
(UN) climate meeting
CRC Colorectal cancer
CRL Compete Response
Letter
CRPC Castration-resistant
prostate cancer
CSPC Castration-sensitive
prostate cancer
CTLA-4 Cytotoxic
T-lymphocyte-associated antigen 4
CVRM Cardiovascular, Renal
and Metabolism
DDR DNA damage
response
DNA Deoxyribonucleic
acid
EBITDA Earnings before interest,
tax, depreciation and amortisation
EGFR / m Epidermal growth factor
receptor / mutation
EGPA Eosinophilic
granulomatosis with polyangiitis
EPS Earnings per
share
ERBB2 v-erb-b2 avian
erythroblastic leukaemia viral oncogene homologue 2
EVH Extravascular
haemolysis
FDA Food and Drug
Agency (US)
FDC Fixed dose
combination
g
Germline, e.g. gBRCAm
GAAP Generally Accepted
Accounting Principles
GEJ Gastro
oesophageal junction
GI
Gastrointestinal
GLP1 / -RA Glucagon-like peptide-1 /
receptor agonist
gMG Generalised
myasthenia gravis
HCC Hepatocellular
carcinoma
HER2 / +/- / low / m Human epidermal growth factor receptor 2 / positive /
negative / low level expression / mutant
HF/ pEF / rEF Heart failure / with preserved ejection
fraction / with reduced ejection fraction
hMPV Human metapneumovirus
HR / + / - Hormone receptor /
positive / negative
HRD Homologous
recombination deficiency
HRRm Homologous
recombination repair gene mutation
i.m. Intramuscular
injection
i.v.
Intravenous injection
IAS / B International
Accounting Standards / Board
ICS Inhaled
corticosteroid
IFRS International
Financial Reporting Standards
IgAN Immunoglobulin A
neuropathy
IHC
Immunohistochemistry
IL-5, IL-33, etc Interleukin-5, Interleukin-33, etc
IP
Intellectual Property
IVIg Intravenous
immune globulin
LABA Long-acting
beta-agonist
LAMA Long-acting
muscarinic-agonist
LS-SCLC Limited stage small cell lung
cancer
LRTD Lower respiratory
tract disease
m
Metastatic, e.g. mBTC , mCRPC, mCSPC
mAb Monoclonal
antibody
MDL Multidistrict
litigation
MET Mesenchymal
epithelial transition
NF1-PN Neurofibromatosis type 1
with plexiform neurofibromas
n/m Not meaningful
NMOSD Neuromyelitis optica
spectrum disorder
NRDL National
reimbursement drug list
NSCLC Non-small cell lung cancer
OECD Organisation for
Economic Co-operation and Development
OOI Other
operating income
ORR Overall response
rate
OS Overall
survival
PARP / i / -1sel Poly ADP ribose polymerase / inhibitor
/-1 selective
pCR Pathologic
complete response
PCSK9 Proprotein convertase
subtilisin/kexin type 9
PD Progressive
disease
PD-1 Programmed cell
death protein 1
PD-L1 Programmed cell death
ligand 1
PDUFA Prescription Drug User Fee
Act
PHSSR Partnership for Health
System Sustainability and Resilience
PFS Progression free
survival
PIK3CA
Phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha
PMDI Pressure metered
dose inhaler
PNH / -EVH Paroxysmal nocturnal haemoglobinuria
/ with extravascular haemolysis
PPI Proton pump
inhibitors
PSR Platinum
sensitive relapse
PTEN Phosphatase and
tensin homologue
Q3W, Q4W, etc Every three weeks, every four weeks, etc
R&D Research and
development
R&I
Respiratory & Immunology
RSV Respiratory
syncytial virus
sBLA Supplemental
biologics license application (US)
SCLC Small cell lung
cancer
s.c.
Subcutaneous injection
SEA Severe
eosinophilic asthma
SEC Securities
Exchange Commission (US)
SG&A Sales, general
and administration
SGLT2 Sodium-glucose
cotransporter 2
SLL Small
lymphocytic lymphoma
SMI Sustainable
Markets Initiative
SPA Share Purchase
Agreement
T2D Type-2 diabetes
TACE Transarterial
chemoembolization
THP A treatment
regimen: docetaxel, trastuzumab and pertuzumab
TNBC Triple negative
breast cancer
TNF Tumour necrosis
factor
TOP1 Topoisomerase I
TROP2 Trophoblast cell surface
antigen 2
USPTO US Patent and Trademark
Office
V&I Vaccines
& Immune Therapies
VBP Volume-based
procurement
VLP Virus like
particle
- End of document -
1 (#_ftnref1) Constant exchange rates. The differences between Actual Change
and CER Change are due to foreign exchange movements between periods in 2024
vs. 2023. CER financial measures are not accounted for according to generally
accepted accounting principles (GAAP) because they remove the effects of
currency movements from Reported results.
2 (#_ftnref2) Core financial measures are adjusted to exclude certain items.
The differences between Reported and Core measures are primarily due to costs
relating to the amortisation of intangibles, impairments, legal settlements
and restructuring charges. A full reconciliation between Reported EPS and Core
EPS is provided in Table 11 in the Financial performance section of this
document.
3 (#_ftnref3) The calculation of Reported and Core Product Sales Gross
Margin excludes the impact of Alliance Revenue and Collaboration Revenue.
4 (#_ftnref4) In Table 2, the plus and minus symbols denote the directional
impact of the item being discussed, e.g. a '+' symbol next to a comment
related to the R&D expense indicates that the item resulted in an increase
in the R&D spend relative to the prior year.
5 (#_ftnref5) Income from disposals of assets and businesses, where the
Group does not retain a significant ongoing economic interest, continue to be
recorded in Other operating income and expense in the Company's financial
statements.
6 (#_ftnref6) The presentation of Table 4 has been updated to show Total
Revenue by medicine, by including Alliance Revenue and Collaboration Revenue
within each revenue figure. Previously, this table showed Product Sales for
each medicine and therapy area, and the Company's total Alliance Revenue and
Collaboration Revenue were shown as separate lines at the bottom of the table.
7 (#_ftnref7) The presentation of this table has been updated by removing
the "Acquisition of Alexion" column due to immateriality of items in this
category
8 (#_ftnref8) Based on best prevailing assumptions around currency profiles.
9 (#_ftnref9) Based on average daily spot rates 1 Jan 2023 to 31 Dec 2023.
10 (#_ftnref10) Based on average daily spot rates 1 Jan 2024 to 31 Mar 2024.
11 (#_ftnref11) Based on average daily spot rates 1 Mar 2024 to 31 Mar 2024.
12 (#_ftnref12) Other currencies include AUD, BRL, CAD, KRW and RUB.
13 (#_ftnref13) The table provides an analysis of year-on-year Product
Sales, with Actual and CER growth rates reflecting year-on-year growth. Due to
rounding, the sum of a number of dollar values and percentages may not agree
to totals.
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