Last checked at 9 Nov 2023 07:00
AstraZeneca
9 November 2023
9M and Q3 2023 results
Strong momentum in the year to date leads to increased guidance for Total Revenue ex COVID-19 medicines and Core EPS
Revenue and EPS summary
9M 2023 | Q3 2023 | ||||||
% Change | % Change | ||||||
|
| $m | Actual | CER[1] | $m | Actual | CER |
- Product Sales | 32,466 | 1 | 4 | 11,018 | 4 | 5 | |
- Alliance Revenue[2] | 1,004 | 99 | 99 | 377 | 76 | 75 | |
- Collaboration Revenue | 317 | (28) | (28) | 97 | (46) | (47) | |
Total Revenue | 33,787 | 2 | 5 | 11,492 | 5 | 6 | |
Total Revenue ex COVID-19 |
| 33,453 | 12 | 15 | 11,492 | 12 | 13 |
Reported[3] EPS[4] | $3.22 | >2x | >2x | $0.89 | (16) | (6) | |
Core[5] EPS | $5.80 | 10 | 17 | $1.73 | 4 | 9 | |
Financial performance (9M 2023 figures unless otherwise stated, growth numbers at CER)
? Total Revenue $33,787m, up 5% despite a decline of $2,896m from COVID-19 medicines[6]
? Excluding COVID-19 medicines, both Total Revenue and Product Sales increased 15%
? Total Revenue from Oncology medicines increased 20%, CVRM[7] 19%, R&I[8] 9%, and Rare Disease 12%
? Core Product Sales Gross Margin[9] of 82%, up two percentage points, reflecting the decline in sales of lower margin COVID?19 medicines
? Core Operating Margin of 35% increased by three percentage points including the previously-announced gain from an update to the contractual relationships for Beyfortus, totalling $712m and recorded in Core Other operating income
? Core EPS increased 17% to $5.80
? FY 2023 Total Revenue excluding COVID-19 medicines now expected to increase by a low-teens percentage at CER
? FY 2023 Core EPS now expected to increase by a low double-digit to low-teens percentage at CER
Pascal Soriot, Chief Executive Officer, AstraZeneca, said:
"Our company continued its strong growth trajectory in the third quarter with Total Revenue from our non?COVID-19 medicines up 13% compared to last year.
We initiated several Phase III trials of high-potential molecules this quarter, including for volrustomig, our PD?1/CTLA-4[10] bispecific antibody. Our portfolio of bispecifics has the potential to replace the first-generation checkpoint inhibitors across a range of cancers. We also initiated a fixed dose combination study of zibotentan with Farxiga which has the potential to significantly improve outcomes for patients with kidney disease not well controlled on current standard of care.
I am excited about the acceleration of our cardiometabolic and obesity pipeline with today's licensing agreement for ECC5004, a potential best-in-class, oral GLP-1RA[11]. This molecule could offer an important advance, as both a monotherapy and in combinations, for the estimated one billion people living with cardiometabolic diseases such as type-2 diabetes and obesity.
Given the momentum in the year to date we have increased our full-year guidance for Total Revenue excluding COVID medicines as well as for Core EPS."
Key milestones achieved since the prior results announcement
? Key positive read-outs: datopotamab deruxtecan in metastatic HR[12]-positive breast cancer (TROPION?Breast01); Imfinzi in liver cancer (EMERALD-1); Fasenra in EGPA[13] (MANDARA)
? Key regulatory approvals: EU approval for Enhertu in HER2[14]-mutant lung cancer (DESTINY?Lung02); China approvals for Forxiga in heart failure regardless of ejection fraction (DELIVER); Calquence in r/rCLL[15] (ASCEND); Soliris in NMOSD[16]. Japan approvals for Lynparza in prostate cancer (PROpel); Enhertu in HER2-mutant lung cancer (DESTINY-Lung02)
? Other milestones: Tagrisso granted US Breakthrough Therapy Designation and US Priority Review in combination with chemotherapy for treatment of patients with locally advanced or metastatic EGFRm[17] NSCLC[18] (FLAURA2); Enhertu granted US Breakthrough Therapy Designations in HER2-positive colorectalcancer (DESTINY-CRC01, DESTINY-CRC02) and multiple types of HER2?expressing tumours (DESTINY?PanTumor02)
Guidance
The Company updates its Total Revenue and Core EPS guidance for FY 2023 at CER, based on the average foreign exchange rates through 2022.
Total Revenue is expected to increase by a mid single-digit percentage(previously low-to-mid single-digit).
Excluding COVID-19 medicines, Total Revenue is expected to increase by a low-teens percentage(previously low double-digit).
Core EPS is expected to increase by a low double-digit to low-teens percentage(previously high single-digit to low double-digit).
Other elements of the Income Statement are expected to be broadly in line with the indications issued in the Company's H1 2023 results announcement.
The Company is unable to provide guidance on a Reported basis because it cannot reliably forecast material elements of the Reported results, including any fair value adjustments arising on acquisition-related liabilities, intangible asset impairment charges and legal settlement provisions. Please refer to the cautionary statements section regarding forward-looking statements at the end of this announcement.
Currency impact
If foreign exchange rates for October to December 2023 were to remain at the average rates seen in September 2023, it is anticipated that FY 2023 Total Revenue would incur a low single-digit adverse impact versus the performance at CER, and Core EPS would incur a mid single-digit adverse impact (previously a low-to-mid single-digit adverse impact).
The Company's foreign exchange rate sensitivity analysis is provided in Table 19.
Table 1: Key elements of Total Revenue performance in Q3 2023
| % Change |
|
|
Revenue type | $m | Actual | CER |
|
| |
Product Sales | 11,018 | 4 | 5 | * Double-digit growth at CER in Oncology, CVRM and Rare Disease | ||
Alliance Revenue | 377 | 76 | 75 | * $266m for Enhertu (Q3 2022: $160m) * $74m for Tezspire (Q3 2022: $26m) | ||
Collaboration Revenue | 97 | (46) | (47) | * $71m for Beyfortus regulatory milestone | ||
Total Revenue | 11,492 | 5 | 6 | * Excluding COVID-19 medicines, Q3 2023 Total Revenue increased by 12% (13% at CER) | ||
Therapy areas | $m | Actual % | CER % |
|
| |
Oncology | 4,664 | 15 | 17 | * Strong performance across key medicines and regions * No milestones from Lynparza in the quarter (Q3 2022: $75m) | ||
CVRM | 2,687 | 14 | 16 |
| * Farxiga up 41%, Lokelma up 30% (31% at CER), roxadustat up 31% (39% CER), Brilinta declined 2% (1% at CER) | |
R&I | 1,549 | 3 | 5 | * Fasenra up 10%, Breztri up 66% (69% CER). Saphnelo and Tezspire also continue to grow rapidly during their launch phase, partially offset by a 12% decline (10% at CER) in Symbicort following entry of a generic competitor in the US during the quarter | ||
V&I[19] | 312 | (64) | (65) | * $nil revenue from COVID-19 mAbs and Vaxzevria in the quarter (Q3 2022: $536m and $180m respectively) * Beyfortus $138m, including $50m of Product Sales from product supplied to Sanofi, $71m of Collaboration Revenue for a regulatory milestone and $17m of Alliance Revenue for AstraZeneca's share of gross profit outside US | ||
Rare Disease | 1,974 | 13 | 14 | * Ultomiris up 50% (49% at CER), partially offset by decline in Soliris of 13% (12% at CER) * Strensiq up 20% (21% at CER) and Koselugo up 81% reflecting strong patient demand | ||
Other Medicines | 306 | (36) | (32) | * Nexium generic competition in Japan | ||
Total Revenue | 11,492 | 5 | 6 | |||
Regions inc. COVID-19 | $m | Actual % | CER % |
|
| |
US | 4,859 | 5 | 4 | |||
Emerging Markets | 2,964 | 4 | 12 | |||
- China |
| 1,452 | (6) | 1 |
| |
- Ex-China Emerging Markets |
| 1,513 | 15 | 25 |
| |
Europe | 2,392 | 16 | 9 | |||
Established RoW | 1,276 | (10) | (6) | |||
Total Revenue inc. COVID-19 | 11,492 | 5 | 6 | · Growth rates impacted by lower sales of COVID?19 medicines (see table below) | ||
Regions ex. COVID-19 |
| $m | Actual % | CER % |
|
|
US | 4,859 | 12 | 12 | |||
Emerging Markets | 2,964 | 8 | 16 | |||
- China | 1,452 | (6) | 1 | |||
- Ex-China Emerging Markets |
| 1,513 | 25 | 36 | ||
Europe | 2,392 | 23 | 16 | |||
Established RoW | 1,276 | 5 | 10 | |||
Total Revenue ex. COVID-19 | 11,492 | 12 | 13 |
Table 2: Key elements of financial performance in Q3 2023
Metric | Reported | Reported change | Core | Corechange | Comments[20] | |
Total Revenue | $11,492m | 5% Actual 6% CER | $11,492m | 5% Actual 6% CER | * Excluding COVID-19 medicines, Q3 2023 Total Revenue increased by 12% (13% at CER) * See Table 1 and the Total Revenue section of this document for further details | |
Product Sales Gross Margin | 81% | +9pp Actual +10pp CER | 81% | +1pp Actual +1pp CER | + Favourable mix of sales from Oncology and Rare Disease medicines + No sales of COVID-19 medicines ? Increasing mix of products with profit-sharing arrangements, where AstraZeneca books Product Sales and records an expense in COGS[21] for the profit share due to its partner * Variations in Product Sales Gross Margin can be expected between periods due to product seasonality, foreign exchange fluctuations and other effects | |
R&D expense | $2,584m | 5% Actual 4% CER | $2,485m | 5% Actual 5% CER | + Increased investment in the pipeline * Core R&D-to-Total Revenue ratio of 22% (Q3 2022: 21%) * Year-on-year comparisons can be impacted by differences in cost phasing driven by study starts and execution | |
SG&A expense | $4,800m | 12% Actual 12% CER | $3,355m | 6% Actual 7% CER | + Market development for recent launches and pre-launch activities + Reported SG&A impacted by increased charges for legal provisions, including a $425m charge to provisions relating to a legal settlement in Q3 2023 (see Note 6) * Core SG&A-to-Total Revenue ratio of 29%(Q3 2022: 29%) * Year-on-year comparisons can be impacted by differences in cost phasing | |
Other operating income (and expense)[22] | $70m | -34% Actual -33% CER | $70m | -35% Actual -34% CER | ? Discontinuation of brazikumab development | |
Operating Margin | 17% | +6pp Actual +7pp CER | 31% | Stable at Actual +1pp CER | * See Product Sales Gross Margin, expenses and Other operating income and expense commentary above | |
Net finance expense | $291m | -9% Actual -6% CER | $223m | -12% Actual -7% CER | + Higher interest received on cash and short-term investments, broadly offset by higher rates on floating debt and bond issuances | |
Tax rate | 17% | n/m Actual n/m CER | 19% | +1pp Actual +1pp CER | * Variations in the tax rate can be expected between periods | |
EPS | $0.89 | -16% Actual -6% CER | $1.73 | 4% Actual 9% CER | * Further details of differences between Reported and Core are shown in Table 14 |
Table 3: Pipeline highlights since prior results announcement
Event | Medicine | Indication / Trial | Event |
Regulatory approvals and other regulatory actions | Lynparza | mCRPC[23] (1st-line) (PROpel) | Regulatory approval (JP) |
Enhertu | HER2m[24] NSCLC (2nd-line+) (DESTINY-Lung02) | Positive CHMP Opinion (EU), Regulatory approval (EU, JP) | |
Calquence | CLL[25] (ASCEND) | Regulatory approval (CN) | |
Forxiga | HFpEF[26] (DELIVER) | Regulatory approval (CN) | |
Soliris | NMOSD | Regulatory approval (CN) | |
Regulatory submissionsor acceptances* | Tagrisso | EGFRm NSCLC (1st-line) (FLAURA2) | Regulatory submission (US, EU, CN), Priority Review (US) |
Imfinzi | NSCLC (neoadjuvant) (AEGEAN) | Regulatory submission (US) | |
capivasertib | HR+/HER2-negative breast cancer (2nd-line) (CAPItello-291) | Regulatory submission (CN) | |
roxadustat | Chemotherapy-induced anaemia | Regulatory submission (CN) | |
FluMist | Self-administered influenza vaccine | Regulatory submission (US) | |
Major Phase III data readouts and other developments | Imfinzi | Liver cancer (locoregional) (EMERALD-1) | Primary endpoint met |
datopotamab deruxtecan | HR+/HER2-breast cancer (inoperable and/or metastatic) (TROPION-Breast01) | Primary endpoint met | |
Fasenra | EGPA (MANDARA) | Primary endpoint met |
*US, EU and China regulatory submission denotes filing acceptance
Upcoming pipeline catalysts
For a table of anticipated timings of key trial readouts, please refer to page 2 of the Clinical Trials Appendix, available on www.astrazeneca.com/investor-relations.html.
Other pipeline updates
Ultomiris discontinued plans to deliver subcutaneous administration for adults with aHUS[27] or PNH[28]. This decision follows persistent efforts to reliably secure the availability of the on-body delivery system.
Table 4: Phase III trials started since 1 January 2023
Medicine | Trial name | Indication |
datopotamab deruxtecan | AVANZAR | NSCLC (1st-line) |
TROPION-Lung07 | Non-squamous NSCLC (1st-line) | |
camizestrant | CAMBRIA-1 | HR-positive/HER2-negative adjuvant breast cancer |
CAMBRIA-2 | HR-positive/HER2-negative adjuvant breast cancer | |
capivasertib | CAPItello-292 | HR-positive/HER2-negative advanced breast cancer |
volrustomig | eVOLVE-Cervical | High-risk locally advanced cervical cancer |
eVOLVE-Lung02 | mNSCLC (1st-line) with PD-L1[29] | |
zibo/dapa | ZENITH High Proteinuria | CKD[30] and high proteinuria |
Saphnelo | DAISY | Systemic sclerosis |
Tezspire | CROSSING | Eosinophilic oesophagitis |
Breztri | LITHOS | Mild to moderate asthma |
Breztri | ATHLOS | COPD[31] |
pMDI[32] portfolio | HFO1234ze | Mucociliary clearance in healthy volunteers |
pMDI portfolio | HFO1234ze | Well-controlled or partially-controlled asthma |
tozorakimab | MIRANDA | Symptomatic COPD |
AZD3152 | SUPERNOVA | COVID-19 prophylaxis |
Ultomiris | ARTEMIS | Cardiac surgery-associated acute kidney injury |
Corporate and business development
In September, AstraZeneca and Verge Genomics (Verge) announced a multi-target collaboration to identify novel drug targets for rare neurodegenerative and neuromuscular diseases. Verge is a clinical-stage drug discovery company using artificial intelligence and patient tissue data. Under the terms of the four-year agreement, Verge will receive up to $42 million, consisting of upfront fee, equity, and near-term payments, with potential downstream royalties. AstraZeneca will take an equity position in Verge.
In September, AstraZeneca completed the definitive purchase and licence agreement for a portfolio of preclinical rare disease gene therapy programmes and enabling technologies from Pfizer Inc. The agreement has a total consideration of up to $1bn, plus tiered royalties on sales.
Cellectis
In November, AstraZeneca announced a collaboration and investment agreement with Cellectis, a clinical-stage biotechnology company, to accelerate the development of next generation therapeutics in areas of high unmet need, including oncology, immunology and rare diseases. Under the terms of the collaboration agreement, AstraZeneca will leverage the Cellectis proprietary gene editing technologies and manufacturing capabilities, to design novel cell and gene therapy products, strengthening AstraZeneca's growing offering in this space. As part of the agreement, 25 genetic targets have been exclusively reserved for AstraZeneca, from which up to 10 candidate products could be explored for development.
In Q4 2023, Cellectis will receive an initial payment of $105m from AstraZeneca, which comprises a $25m upfront cash payment under the terms of a research collaboration agreement and an $80m equity investment. A further $140m equity investment is expected to close in early 2024 subject to the signing of a final binding agreement. Post-closing of this second investment, AstraZeneca will hold a total equity stake of approximately 44% in Cellectis. Under the terms of the research collaboration, Cellectis is also eligible to receive an investigational new drug option fee and development, regulatory and sales-related milestone payments, ranging from $70m up to $220m, per each of the 10 candidate products, plus tiered royalties.
Eccogene licence
In November, AstraZeneca and Eccogene entered into an exclusive licence agreement for ECC5004, an investigational oral once-daily glucagon-like peptide 1 receptor agonist (GLP-1RA) for the treatment of obesity, type-2 diabetes and other cardiometabolic conditions. Preliminary results from the Phase I trial have shown a differentiating clinical profile for ECC5004, with good tolerability and encouraging glucose and body weight reduction across the dose levels tested compared to placebo.
Under the terms of the agreement, Eccogene will receive an initial upfront payment of $185m and up to an additional $1.825bn in future clinical, regulatory, and commercial milestones and tiered royalties. AstraZeneca is granted exclusive global rights for the development and commercialisation of ECC5004 for any indication in all territories except China, where Eccogene has the right to co-develop and co-commercialise alongside AstraZeneca.
Sustainability summary
This quarter AstraZeneca entered into long-term renewable energy partnerships in the UK and Sweden. The UK agreement will support the transition away from fossil fuels at Company sites in Macclesfield, Cambridge, Luton and Speke. The Sweden agreement corresponds to approximately 80 percent of total electricity needs at both the Company's Gothenburg site and at Södertälje, one of the world's largest drug manufacturing centres. See the Sustainability section for further details.
Conference call
A conference call and webcast for investors and analysts will begin today, 9 November 2023, at 14:00 UK time. Details can be accessed via astrazeneca.com.
Reporting calendar
The Company intends to publish its full year and fourth quarter results on Thursday 8 February 2024.
Operating and financial review
All narrative on growth and results in this section is based on actual foreign exchange rates, and financial figures are in US$ millions ($m), unless stated otherwise. The performance shown in this announcement covers the nine-month period to 30 September 2023 ('the period' or '9M 2023') compared to the nine-month period to 30 September 2022 ('9M 2022'), or the three-month period to 30 September 2023 ('the quarter' or 'Q3 2023') compared to the three-month period to 30 September 2022 ('Q3 2022'), unless stated otherwise.
Core financial measures, EBITDA, Net debt, Product Sales Gross Margin (formerly termed as Gross Margin), Operating Margin and CER are non-GAAP financial measures because they cannot be derived directly from the Group's Interim financial statements. Management believes that these non-GAAP financial measures, when provided in combination with Reported results, provide investors and analysts with helpful supplementary information to understand better the financial performance and position of the Group on a comparable basis from period to period. These non-GAAP financial measures are not a substitute for, or superior to, financial measures prepared in accordance with GAAP.
Core financial measures are adjusted to exclude certain significant items, such as:
? Amortisation and impairment of intangible assets, including impairment reversals but excluding any charges relating to IT assets
? Charges and provisions related to restructuring programmes, which includes charges that relate to the impact of restructuring programmes on capitalised IT assets
? Alexion acquisition-related items, primarily fair value adjustments on acquired inventories and fair value impact of replacement employee share awards
? Other specified items, principally the imputed finance charges and fair value movements relating to contingent consideration on business combinations or asset acquisitions, imputed finance charges and remeasurement adjustments on certain Other payables arising from intangible asset acquisitions, legal settlements and remeasurement adjustments relating to Other payables assumed from the Alexion acquisition
? The tax effects of the adjustments above are excluded from the Core Tax charge
Details on the nature of Core financial measures are provided on page 63 of the Annual Report and Form 20-F Information 2022.
Reference should be made to the Reconciliation of Reported to Core financial measures table included in the financial performance section in this announcement.
Product Sales Gross Margin (formerly termed Gross Margin) is the percentage by which Product Sales exceeds the Cost of Sales, calculated by dividing the difference between the two by the sales figure. The calculation of Reported and Core Product Sales Gross Margin excludes the impact of Alliance Revenue and Collaboration Revenue and any associated costs, thereby reflecting the underlying performance of Product Sales.
EBITDA is defined as Reported Profit before tax after adding back Net finance expense, results from Joint ventures and associates and charges for Depreciation, amortisation and impairment. Reference should be made to the Reconciliation of Reported Profit before tax to EBITDA included in the financial performance section in this announcement.
Operating Margin is defined as Operating profit as a percentage of Total Revenue.
Net debt is defined as Interest-bearing loans and borrowings and Lease liabilities, net of Cash and cash equivalents, Other investments, and Net derivative financial instruments. Reference should be made to Note 3 'Net debt' included in the Notes to the Interim financial statements in this announcement.
The Company strongly encourages investors and analysts not to rely on any single financial measure, but to review AstraZeneca's financial statements, including the Notes thereto, and other available Company reports, carefully and in their entirety.
Due to rounding, the sum of a number of dollar values and percentages in this announcement may not agree to totals.
Total Revenue
Table 5: Therapy area and medicine performance - Product Sales and Total Revenue
|
| 9M 2023 | Q3 2023 | ||||||
|
|
|
| % Change |
|
| % Change | ||
Product Sales |
| $m | % Total | Actual | CER | $m | % Total | Actual | CER |
Oncology |
| 12,692 | 38 | 17 | 20 | 4,389 | 38 | 16 | 17 |
- Tagrisso | 4,380 | 13 | 7 | 10 | 1,465 | 13 | 5 | 6 | |
- Imfinzi [33] | 3,102 | 9 | 53 | 56 | 1,126 | 10 | 53 | 54 | |
- Lynparza | 2,070 | 6 | 6 | 9 | 702 | 6 | 7 | 8 | |
- Calquence | 1,839 | 5 | 25 | 26 | 654 | 6 | 16 | 15 | |
- Enhertu | 178 | 1 | >3x | >3x | 73 | 1 | >3x | >3x | |
- Orpathys | 33 | - | (3) | 4 | 12 | - | 6 | 13 | |
- Zoladex | 699 | 2 | (3) | 5 | 239 | 2 | - | 5 | |
- Faslodex | 217 | 1 | (16) | (10) | 64 | 1 | (21) | (16) | |
- Others | 174 | 1 | (36) | (32) | 54 | - | (33) | (30) | |
BioPharmaceuticals: CVRM |
| 7,887 | 23 | 14 | 18 | 2,683 | 23 | 14 | 16 |
- Farxiga | 4,358 | 13 | 36 | 40 | 1,554 | 14 | 41 | 41 | |
- Brilinta | 996 | 3 | (2) | - | 331 | 3 | (2) | (1) | |
- Lokelma | 300 | 1 | 44 | 49 | 102 | 1 | 30 | 31 | |
- roxadustat | 208 | 1 | 41 | 51 | 74 | 1 | 31 | 39 | |
- Andexxa | 129 | - | 16 | 19 | 40 | - | (3) | (5) | |
- Crestor | 860 | 3 | 4 | 11 | 275 | 2 | (1) | 6 | |
- Seloken/Toprol-XL | 496 | 1 | (30) | (23) | 153 | 1 | (36) | (29) | |
- Onglyza | 180 | 1 | (12) | (8) | 53 | - | (20) | (17) | |
- Bydureon | 123 | - | (40) | (40) | 35 | - | (48) | (49) | |
- Others | 237 | 1 | (16) | (13) | 66 | 1 | (23) | (21) | |
BioPharmaceuticals: R&I |
| 4,517 | 13 | 5 | 8 | 1,451 | 13 | 2 | 3 |
- Symbicort | 1,842 | 5 | (4) | (1) | 555 | 5 | (12) | (10) | |
- Fasenra | 1,134 | 3 | 12 | 13 | 389 | 3 | 10 | 10 | |
- Breztri | 478 | 1 | 69 | 73 | 171 | 1 | 66 | 69 | |
- Saphnelo | 191 | 1 | >2x | >2x | 76 | 1 | >2x | >2x | |
- Tezspire | 51 | - | >10x | >10x | 21 | - | >10x | >10x | |
- Pulmicort | 493 | 1 | 3 | 10 | 148 | 1 | 2 | 7 | |
- Bevespi | 42 | - | (2) | (2) | 13 | - | (5) | (4) | |
- Daliresp/Daxas | 41 | - | (74) | (74) | 11 | - | (79) | (79) | |
- Others | 245 | 1 | (30) | (27) | 67 | 1 | (31) | (28) | |
BioPharmaceuticals: V&I |
| 667 | 2 | (82) | (81) | 224 | 2 | (74) | (74) |
- COVID-19 mAbs[34] |
| 126 | - | (91) | (90) | - | - | n/m | n/m |
- Vaxzevria |
| 28 | - | (98) | (98) | - | - | n/m | n/m |
- Beyfortus | 52 | - | n/m | n/m | 50 | - | n/m | n/m | |
- Synagis | 383 | 1 | - | 6 | 99 | 1 | (5) | (1) | |
- FluMist | 78 | - | 32 | 28 | 75 | 1 | 28 | 23 | |
Rare Disease |
| 5,793 | 17 | 11 | 12 | 1,974 | 17 | 13 | 14 |
- Soliris | 2,429 | 7 | (17) | (15) | 781 | 7 | (13) | (12) | |
- Ultomiris | 2,141 | 6 | 56 | 58 | 777 | 7 | 50 | 49 | |
- Strensiq | 847 | 3 | 23 | 24 | 285 | 2 | 20 | 21 | |
- Koselugo | 246 | 1 | 65 | 65 | 87 | 1 | 81 | 81 | |
- Kanuma | 130 | - | 17 | 18 | 44 | - | 21 | 19 | |
Other Medicines |
| 910 | 3 | (27) | (22) | 297 | 3 | (27) | (22) |
- Nexium |
| 735 | 2 | (25) | (20) | 244 | 2 | (22) | (17) |
- Others | 175 | 1 | (33) | (31) | 53 | - | (43) | (41) | |
Product Sales |
| 32,466 | 96 | 1 | 4 | 11,018 | 96 | 4 | 5 |
Alliance Revenue |
| 1,004 | 3 | 99 | 99 | 377 | 3 | 76 | 75 |
Collaboration Revenue |
| 317 | 1 | (28) | (28) | 97 | 1 | (46) | (47) |
Total Revenue |
| 33,787 | 100 | 2 | 5 | 11,492 | 100 | 5 | 6 |
Table 6: Alliance Revenue
9M 2023 | Q3 2023 | ||||||||
% Change |
|
| % Change | ||||||
| $m | % Total | Actual | CER | $m | % Total | Actual | CER | |
Enhertu | 741 | 74 | >2x | >2x | 266 | 70 | 66 | 65 | |
Tezspire | 179 | 18 | >4x | >4x | 74 | 20 | >2x | >2x | |
Vaxzevria: royalties | - | - | n/m | n/m | - | - | n/m | n/m | |
Other royalty income | 59 | 6 | 16 | 15 | 18 | 5 | 10 | 9 | |
Other Alliance Revenue | 25 | 2 | >2x | >2x | 19 | 5 | >3x | >3x | |
Total | 1,004 | 100 | 99 | 99 | 377 | 100 | 76 | 75 | |
Table 7: Collaboration Revenue
9M 2023 | Q3 2023 | ||||||||
| % Change |
|
| % Change | |||||
| $m | % Total | Actual | CER | $m | % Total | Actual | CER | |
COVID-19 mAbs: licence fees | 180 | 57 | n/m | n/m | - | - | n/m | n/m | |
Farxiga: sales milestones | 28 | 9 | n/m | n/m | 3 | 3 | n/m | n/m | |
tralokinumab: sales milestones | 20 | 6 | (82) | (82) | 20 | 21 | (50) | (50) | |
Lynparza: regulatory milestones | - | - | n/m | n/m | - | - | n/m | n/m | |
Beyfortus: regulatory milestones | 71 | 22 | n/m | n/m | 71 | 73 | n/m | n/m | |
Other Collaboration Revenue | 18 | 6 | (76) | (76) | 3 | 3 | (95) | (95) | |
Total |
| 317 | 100 | (28) | (28) | 97 | 100 | (46) | (47) |
Table 8: Total Revenue by therapy area
9M 2023 | Q3 2023 | ||||||||
| % Change |
|
| % Change | |||||
| $m | % Total | Actual | CER | $m | % Total | Actual | CER | |
Oncology | 13,458 | 40 | 17 | 20 | 4,664 | 41 | 15 | 17 | |
BioPharmaceuticals | 13,599 | 40 | (10) | (7) | 4,548 | 40 | (4) | (2) | |
- CVRM | 7,926 | 23 | 14 | 19 | 2,687 | 23 | 14 | 16 | |
- R&I | 4,729 | 14 | 6 | 9 | 1,549 | 13 | 3 | 5 | |
- V&I | 944 | 3 | (74) | (73) | 312 | 3 | (64) | (65) | |
Rare Disease | 5,793 | 17 | 11 | 12 | 1,974 | 17 | 13 | 14 | |
Other Medicines | 937 | 3 | (30) | (26) | 306 | 3 | (36) | (32) | |
Total |
| 33,787 | 100 | 2 | 5 | 11,492 | 100 | 5 | 6 |
Table 9: Total Revenue by region
9M 2023 | Q3 2023 | ||||||||
% Change | % Change | ||||||||
$m | % Total | Actual | CER | $m | % Total | Actual | CER | ||
US | 13,940 | 41 | 6 | 6 | 4,859 | 42 | 5 | 4 | |
Emerging Markets | 9,242 | 27 | 3 | 10 | 2,964 | 26 | 4 | 12 | |
- China |
| 4,495 | 13 | (2) | 5 | 1,452 | 13 | (6) | 1 |
- Ex-China |
| 4,747 | 14 | 8 | 15 | 1,513 | 13 | 15 | 25 |
Europe | 6,765 | 20 | 5 | 5 | 2,392 | 21 | 16 | 9 | |
Established RoW | 3,840 | 11 | (16) | (9) | 1,276 | 11 | (10) | (6) | |
Total |
| 33,787 | 100 | 2 | 5 | 11,492 | 100 | 5 | 6 |
Table 10: Total Revenue by region - excluding COVID-19 medicines
9M 2023 | Q3 2023 | ||||||||
% Change | % Change | ||||||||
$m | % Total | Actual | CER | $m | % Total | Actual | CER | ||
US | 13,940 | 42 | 14 | 14 | 4,859 | 42 | 12 | 12 | |
Emerging Markets | 9,038 | 27 | 12 | 20 | 2,964 | 26 | 8 | 16 | |
- China |
| 4,495 | 13 | (1) | 6 | 1,452 | 13 | (6) | 1 |
- Ex-China |
| 4,544 | 14 | 28 | 37 | 1,513 | 13 | 25 | 36 |
Europe | 6,748 | 20 | 14 | 14 | 2,392 | 21 | 23 | 16 | |
Established RoW | 3,726 | 11 | - | 8 | 1,276 | 11 | 5 | 10 | |
Total |
| 33,453 | 100 | 12 | 15 | 11,492 | 100 | 12 | 13 |
Oncology
Oncology Total Revenue of $13,458m in 9M 2023 increased by 17% (20% at CER), representing 40% of overall Total Revenue (9M 2022: 35%). There was no Lynparza Collaboration Revenue in 9M 2023 (9M 2022: $250m), and Enhertu Alliance Revenue was $741m (9M 2022: $335m). Product Sales increased by 17% (20% at CER) in 9M 2023 to $12,692m, reflecting new launches and expanded reimbursement across key brands; partially offset by declines in legacy medicines.
Tagrisso
Total Revenue | Worldwide | US | Emerging Markets | Europe | Established RoW | ||
9M 2023 $m | 4,380 | 1,679 | 1,261 | 821 | 619 | ||
Actual change | 7% | 14% | 4% | 6% | (4%) | ||
CER change | 10% | 14% | 11% | 6% | 5% |
Region | Drivers and commentary | |
Worldwide | * Increased global demand for Tagrisso in adjuvant and 1st-line settings combined with expanded reimbursement in the adjuvant setting | |
US | * Continued growth in demand in 1st-line and adjuvant settings | |
Emerging Markets | * Growing demand in adjuvant and 1st-line settings offset by impact of NRDL[35] renewal price in China effective March 2023, some additional impact in China in the third quarter resulting from reduced promotional activities following the government campaign announced at the end of July 2023 | |
Europe | * Increased demand growth in 1st-line and growing adjuvant demand | |
Established RoW | * Increased demand in 1st-line and adjuvant settings offset by mandatory price reduction in Japan effective June 2023 |
Imfinzi and Imjudo
Total Revenue | Worldwide | US | Emerging Markets | Europe | Established RoW | ||
9M 2023 $m | 3,102 | 1,708 | 270 | 547 | 577 | ||
Actual change | 53% | 55% | 20% | 36% | 90% | ||
CER change | 56% | 55% | 31% | 35% | >2x |
Region | Drivers and commentary | |
Worldwide | * Includes $161m of Total Revenue from Imjudo, which launched in Q4 2022 following approvals in the US for patients with unresectable liver cancer (HIMALAYA) and Stage IV NSCLC (POSEIDON) * Growth across all regions, driven by recent launches (BTC[36], HCC[37], Stage IV NSCLC) and established indications (Stage III NSCLC, SCLC[38]) | |
US | * Continued demand growth for BTC and HCC indications, increased uptake in SCLC | |
Emerging Markets | * Growth across markets driven by BTC launches and recovery of diagnosis and treatment rates following the COVID-19 pandemic, slightly offset by decreased promotional activities in China due to the government campaign announced at the end of July 2023 | |
Europe | * Competitive share gain in SCLC, and expanded reimbursement for new launch indications (BTC, HCC and Stage IV NSCLC) | |
Established RoW | * Growth driven by launch of HCC and BTC and increased share across indications in Japan |
Lynparza
Total Revenue | Worldwide | US | Emerging Markets | Europe | Established RoW | ||
9M 2023 $m | 2,070 | 902 | 409 | 543 | 216 | ||
Actual change | (6%) | 1% | 14% | (27%) | 7% | ||
CER change | (3%) | 1% | 24% | (27%) | 16% |
Product Sales | Worldwide | US | Emerging Markets | Europe | Established RoW | ||
9M 2023 $m | 2,070 | 902 | 409 | 543 | 216 | ||
Actual change | 6% | 1% | 14% | 10% | 7% | ||
CER change | 9% | 1% | 24% | 10% | 16% |
Region | Drivers and commentary | |
Worldwide | * Lynparza remains the leading medicine in the PARP[39] inhibitor class globally across four tumour types (ovarian, breast, prostate, pancreatic), as measured by total prescription volume * No regulatory milestones received in the period | |
US | * Continued share growth within the PARP inhibitor class, offset by declining class use and the label restriction in 2nd-line ovarian cancer effective September 2023 | |
Emerging Markets | * Increased demand, offset by price reduction in China associated with NRDL renewal that took effect March 2023 for ovarian cancer indications (PSR[40] and BRCAm[41] 1st-line maintenance) and new NRDL enlistment in prostate cancer (PROfound) as well as some impact in the third quarter resulting from reduced promotional activities following the government campaign announced end of July 2023 | |
Europe | * Demand growth from increased uptake in 1st-line HRD-positive ovarian cancer, gBRCAm[42] HER2?negative early breast cancer and mCRPC, offset by reduced use in 2nd-line ovarian cancer and pricing * Total Revenue in the prior year period included $250m of milestones | |
Established RoW | * Growth driven by increased uptake in testing and use in 1st-line HRD-positive ovarian cancer |
Enhertu
Total Revenue | Worldwide | US | Emerging Markets | Europe | Established RoW | ||
9M 2023 $m | 919 | 518 | 179 | 204 | 17 | ||
Actual change | >2x | >2x | >3x | >2x | >3x | ||
CER change | >2x | >2x | >3x | >2x | >3x |
Region | Drivers and commentary | |
Worldwide | * Combined sales of Enhertu, recorded by Daiichi Sankyo Company Limited (Daiichi Sankyo) and AstraZeneca, amounted to $1,844m in 9M 2023 (9M 2022: $750m) * AstraZeneca's Total Revenue of $919m in the period includes $741m of Alliance Revenue from its share of gross profit and royalties in territories where Daiichi Sankyo records product sales | |
US | * US in-market sales, recorded by Daiichi Sankyo, amounted to $1,087m in 9M 2023 (9M 2022: $532m) * Increased demand across launched indications. Q3 2023 impacted by HER2-low bolus depletion | |
Emerging Markets | * Continued uptake driven by recent approvals and launches including strong demand growth in China following HER2-positive and HER2-low breast cancer launches | |
Europe | * Continued growth driven by increasing adoption in HER2-positive and HER2-low metastatic breast cancer | |
Established RoW | * In Japan, AstraZeneca receives a mid-single-digit percentage royalty on sales made by Daiichi Sankyo |
Calquence
Total Revenue | Worldwide | US | Emerging Markets | Europe | Established RoW | ||
9M 2023 $m | 1,839 | 1,337 | 69 | 353 | 80 | ||
Actual change | 25% | 12% | >2x | 76% | 64% | ||
CER change | 26% | 12% | >2x | 77% | 74% |
Region | Drivers and commentary | |
Worldwide | * Increased penetration globally; leading BTKi[43] in key markets | |
US | * Leadership maintained in growing BTKi class, sustained leading share in the front-line setting, offset by some competitive impact in relapsed refractory setting and increased utilisation of free goods program in Q3 | |
EU | * Solid growth continued amidst growing competitive pressure * Increased new patients starts following expanded access in key markets |
Orpathys
Orpathys Total Revenue of $34m declined 1% (6% increase at CER), (9M 2022: $35m), following its inclusion in the updated NRDL in China from March 2023, for the treatment of patients with NSCLC with MET exon 14 skipping alterations.
Other Oncology medicines
9M 2023 | Change |
Total Revenue | $m | Actual | CER | ||
Zoladex | 723 | (2%) | 5% | * Underlying growth due to continued demand growth in Emerging Markets, partially offset by price reduction in China following NRDL renewal | |
Faslodex | 217 | (16%) | (10%) | * Generic competition | |
Other Oncology | 174 | (36%) | (32%) | * Generic competition |
BioPharmaceuticals
BioPharmaceuticals Total Revenue decreased by 10% (7% at CER) in 9M 2023 to $13,599m, representing 40% of overall Total Revenue (9M 2022: 45%). The decline was driven by COVID-19 medicines, partially offset by strong growth from Farxiga and newer R&I medicines.
BioPharmaceuticals - CVRM
CVRM Total Revenue increased by 14% (19% at CER) to $7,926m in 9M 2023, driven by the strong Farxiga performance, and represented 23% of overall Total Revenue (9M 2022: 21%).
Farxiga
Total Revenue | Worldwide | US | Emerging Markets | Europe | Established RoW | ||
9M 2023 $m | 4,389 | 1,000 | 1,655 | 1,356 | 378 | ||
Actual change | 37% | 34% | 35% | 42% | 35% | ||
CER change | 41% | 34% | 43% | 41% | 45% |
Region | Drivers and commentary | |
Worldwide | * Farxiga volume is growing faster than the overall SGLT2[44] market in most major regions, fuelled by launches in heart failure and CKD * Additional benefit from continued growth in the overall SGLT2 inhibitor class | |
US | * Growth driven by heart failure and CKD for patients with and without T2D[45] resulting in an increasing market share | |
Emerging Markets | * Solid growth despite generic competition in some markets | |
Europe | * Benefited from the addition of cardiovascular outcomes trial data to the label and growth in HFrEF[46], CKD and the HFpEF approval in February 2023. ESC[47] guidelines updated in August 2023 to also include treatment of patients with HFpEF * Continued strong volume growth in the quarter and expanded class leadership in several key markets | |
Established RoW | * In Japan, AstraZeneca sells to collaborator Ono Pharmaceutical Co., Ltd, which records in-market sales. Continued volume growth driven by HF and CKD launches. Generics launched in Canada in the third quarter |
Brilinta
Total Revenue | Worldwide | US | Emerging Markets | Europe | Established RoW | ||
9M 2023 $m | 996 | 551 | 224 | 203 | 18 | ||
Actual change | (2%) | 2% | 1% | (5%) | (54%) | ||
CER change | - | 2% | 10% | (5%) | (51%) |
Region | Drivers and commentary | |
US | * Sales in the third quarter benefitted from channel inventory movements | |
Emerging Markets | * Sales declined by 16% (4% at CER) in the third quarter driven by tender phasing | |
Europe | * Sales partly impacted by clawbacks | |
Established RoW | * Sales decline driven by generic entry in Canada |
Lokelma
Lokelma Total Revenue increased 44% (49% at CER) to $300m with strong demand growth in all regions.
Roxadustat
Total Revenue increased 40% (50% at CER) to $212m, benefitting from increased demand in both the dialysis- and non-dialysis-dependent populations
Andexxa
Andexxa Total Revenue increased 7% (9% at CER) to $129m.
Other CVRM medicines
9M 2023 | Change |
Total Revenue | $m | Actual | CER | ||
Crestor | 862 | 4% | 11% | * Continued sales growth in Emerging Markets, partly offset by declines in the US and Established RoW | |
Seloken | 496 | (30%) | (23%) | * Ongoing impact of China VBP implementation | |
Onglyza | 180 | (12%) | (8%) | * Continued decline for DPP-IV class | |
Bydureon | 123 | (40%) | (40%) | * Continued competitive pressures | |
Other CVRM | 237 | (16%) | (13%) |
BioPharmaceuticals - R&I
Total Revenue of $4,729m from R&I medicines in 9M 2023 increased 6% (9% at CER) and represented 14% of overall Total Revenue (9M 2022: 14%). This reflected growth in Fasenra, Tezspire, Breztri and Saphnelo, offsetting a decline in Symbicort and other mature brands.
Fasenra
Total Revenue | Worldwide | US | Emerging Markets | Europe | Established RoW | ||
9M 2023 $m | 1,134 | 718 | 48 | 262 | 106 | ||
Actual change | 12% | 11% | 62% | 14% | (1%) | ||
CER change | 13% | 11% | 69% | 14% | 6% |
Region | Drivers and commentary | |
Worldwide | * Retained market share leadership in severe eosinophilic asthma across major markets | |
US | * Expanded leadership in eosinophilic asthma and maintained total share in a growing market, leading to double-digit volume growth, partially offset by managed market price difference | |
Emerging Markets | * Continued strong volume growth driven by launch acceleration across key markets | |
Europe | * Expanded leadership in severe eosinophilic asthma, with strong volume growth partially offset by price in some markets | |
Established RoW | * Maintained class leadership in Japan while market growth remained stable |
Breztri
Total Revenue | Worldwide | US | Emerging Markets | Europe | Established RoW | ||
9M 2023 $m | 478 | 263 | 123 | 55 | 37 | ||
Actual change | 69% | 60% | 73% | >2x | 48% | ||
CER change | 73% | 60% | 86% | >2x | 58% |
Region | Drivers and commentary | |
Worldwide | * Continued to gain market share within the growing FDC[48] triple class across major markets | |
US | * Consistent share growth within the FDC triple class in new-to-brand[49] and the total market | |
Emerging Markets | * Maintained market share leadership in China with strong triple FDC class penetration | |
Europe | * Sustained growth across markets as new launches continue to progress | |
Established RoW | * Increased market share gains within COPD in Japan and strong launch performance in Canada |
Tezspire
Total Revenue | Worldwide | US | Emerging Markets | Europe | Established RoW | ||
9M 2023 $m | 230 |
| 179 | - | 28 | 23 | |
Actual change | >5x |
| >4x | - | n/m | n/m | |
CER change | >5x |
| >4x | - | n/m | n/m |
Region | Drivers and commentary | |
Worldwide | * Tezspire is approved in the US, EU and Japan (as well as other countries) for the treatment of severe asthma without biomarker or phenotypic limitation * Amgen records sales in the US, and AstraZeneca records its share of US gross profits as Alliance Revenue. AstraZeneca books Product Sales in markets outside the US * Combined sales of Tezspire by AstraZeneca and Amgen were $438m in 9M 2023 | |
US | * Increased new-to-brand market share with majority of patients new to biologics * Pre-filled pen approved in February 2023 | |
Europe | * Achieved and maintained new-to-brand leadership in key markets * Pre-filled pen approved in January 2023 | |
Established RoW | * Japan maintained new-to-brand leadership |
Saphnelo
Total Revenue | Worldwide | US | Emerging Markets | Europe | Established RoW | ||
9M 2023 $m | 191 | 178 | 1 | 5 | 7 | ||
Actual change | >2x | >2x | n/m | >4x | >3x | ||
CER change | >2x | >2x | n/m | >4x | >3x |
Region | Drivers and commentary | |
Worldwide | * Demand acceleration in the US, and additional growth driven by ongoing launches in Europe and Japan |
Symbicort
Total Revenue | Worldwide | US | Emerging Markets | Europe | Established RoW | ||
9M 2023 $m | 1,842 | 589 | 600 | 408 | 245 | ||
Actual change | (4%) | (18%) | 26% | (8%) | (12%) | ||
CER change | (1%) | (18%) | 36% | (8%) | (7%) |
Region | Drivers and commentary | |
Worldwide | * Symbicort remained the global market leader within a stable ICS[50]/LABA[51] class | |
US | * Generic competition entered the US market in the third quarter, leading to price and volume share declines | |
Emerging Markets | * Strong underlying demand. Growth in China benefitted from the post-COVID-19 recovery at the start of the year | |
Europe | * Continued price and volume erosion from generics and a slowing overall market | |
Established RoW | * Generic erosion in Japan |
Other R&I medicines
9M 2023 | Change |
Total Revenue | $m | Actual | CER | ||
Pulmicort |
| 493 | 3% | 10% | * 80% of revenues from Emerging Markets * China market share has stabilised, with VBP having been in effect for over 12 months |
Bevespi |
| 42 | (2%) | (2%) | |
Daliresp |
| 41 | (74%) | (74%) | * Impacted by uptake of multiple generics following loss of exclusivity in the US |
Other R&I | 278 | (41%) | (38%) | * Collaboration Revenue of $20m (9M 2022: $110m) * Product Sales of $245m decreased 30% (27% at CER) due to generic competition |
BioPharmaceuticals - V&I
Total Revenue from V&I medicines declined by 74% (73% at CER) to $944m (9M 2022: $3,673m) and represented 3% of overall Total Revenue (9M 2022: 11%). In Q3 2023, no revenue was generated from COVID?19 medicines.
COVID-19 mAbs
Total Revenue | Worldwide | US | Emerging Markets | Europe | Established RoW | ||
9M 2023 $m | 306 | - | 185 | 7 | 114 | ||
Actual change | (79%) | n/m | 11% | (97%) | (51%) | ||
CER change | (78%) | n/m | 11% | (96%) | (45%) |
Region | Drivers and commentary | |
Worldwide | * All Product Sales in 9M 2023 were derived from sales of Evusheld in the first quarter | |
Emerging Markets | * $180m license fee from Serum Institute of India in Q2 2023 recorded as Collaboration Revenue |
Vaxzevria
Total Revenue | Worldwide | US | Emerging Markets | Europe | Established RoW | ||
9M 2023 $m | 28 | - | 18 | 10 | - | ||
Actual change | (98%) | n/m | (98%) | (97%) | n/m | ||
CER change | (98%) | n/m | (98%) | (97%) | n/m |
Region | Drivers and commentary | |
Worldwide | * Revenue in the period decreased by 98% due to the conclusion of Vaxzevria contracts |
Other V&I medicines
9M 2023 | Change |
Total Revenue | $m | Actual | CER | ||
Beyfortus |
| 139 | n/m | n/m | * In Q3 2023 AstraZeneca reported $50m of Product Sales, $17m of Alliance Revenue, and also $71m of Collaboration Revenue relating to a regulatory milestone * The Product Sales relates to sales to Sanofi of Beyfortus product manufactured by AstraZeneca. In Q3 Product Sales benefitted from stock building for the 2023-2024 RSV[52] season * The Alliance Revenue consists of AstraZeneca's 50% share of gross profits on sales of Beyfortus in major markets outside the US. AstraZeneca will also book 25% of revenues in rest of world markets. AstraZeneca has no participation in US profits or losses |
Synagis |
| 383 | - | 6% | * Performance broadly in-line with prior year |
FluMist | 88 | 49% | 45% | * $10m milestone received from Daiichi Sankyo in the second quarter following FluMist approval in Japan |
Rare Disease
Total Revenue from Rare Disease medicines increased by 11% (12% at CER) in 9M 2023 to $5,793m, representing 17% of overall Total Revenue (9M 2022: 16%).
Performance was driven by the continued growth and durability of the C5[53] franchise, and also the strength of Strensiq and Koselugo patient demand.
Ultomiris
Total Revenue | Worldwide | US | Emerging Markets | Europe | Established RoW | ||
9M 2023 $m | 2,141 | 1,260 | 47 | 495 | 339 | ||
Actual change | 56% | 63% | 38% | 43% | 54% | ||
CER change | 58% | 63% | 39% | 42% | 68% |
Region | Drivers and commentary | |
Worldwide | * Growth in neurology indications, expansion into new markets and continued conversion from Soliris * Quarter-on-quarter variability in revenue growth can be expected due to Ultomiris every eight-week dosing schedule and lower average annual treatment cost per patient compared to Soliris | |
US | * Growth in naïve patients in gMG[54] and NMOSD as well as successful conversion from Soliris across shared indications | |
Emerging Markets | * Continued progress following launches in new markets | |
Europe | * Strong demand generation following launches in new markets, particularly in neurology indications, as well as accelerated conversion from Soliris in key markets | |
Established RoW | * Continued conversion from Soliris and strong demand following new launches, particularly NMOSD in Japan |
Soliris
Total Revenue | Worldwide | US | Emerging Markets | Europe | Established RoW | ||
9M 2023 $m | 2,429 | 1,313 | 338 | 530 | 248 | ||
Actual change | (17%) | (22%) | 55% | (15%) | (36%) | ||
CER change | (15%) | (22%) | 74% | (15%) | (31%) |
Region | Drivers and commentary | |
US | * Decline driven by successful conversion of Soliris patients to Ultomiris in PNH, aHUS and gMG, partially offset by Soliris growth in NMOSD | |
Emerging Markets | * Continued progress, launching in new markets | |
Europe,Established RoW | * Decline driven by successful conversion from Soliris to Ultomiris, partially offset by growth in NMOSD |
Strensiq
Total Revenue | Worldwide | US | Emerging Markets | Europe | Established RoW | ||
9M 2023 $m | 847 | 690 | 29 | 64 | 64 | ||
Actual change | 23% | 26% | 14% | 9% | 12% | ||
CER change | 24% | 26% | 16% | 8% | 22% |
Region | Drivers and commentary | |
Worldwide | * Strong patient demand particularly in the US and Japan |
Other Rare Disease medicines
9M 2023 | Change |
Total Revenue | $m | Actual | CER | Commentary | |
Koselugo | 246 | 65% | 65% | * Driven by patient demand and expansion in new markets | |
Kanuma | 130 | 17% | 18% | * Continued demand growth in ex-US markets |
Other medicines (outside the main therapy areas)
9M 2023 | Change |
Total Revenue | $m | Actual | CER | Commentary | |
Nexium |
| 748 | (30%) | (25%) | * Generic launches in Japan in the latter part of 2022 |
Others | 189 | (31%) | (29%) | * Continued impact of generic competition |
Financial performance
Table 11: Reported Profit and Loss
9M 2023 | 9M 2022 | % Change | Q3 2023 | Q3 2022 | % Change |
|
| $m | $m | Actual | CER | $m | $m | Actual | CER |
Total Revenue |
| 33,787 | 33,144 | 2 | 5 | 11,492 | 10,982 | 5 | 6 |
- Product Sales | 32,466 | 32,200 | 1 | 4 | 11,018 | 10,590 | 4 | 5 | |
- Alliance Revenue | 1,004 | 504 | 99 | 99 | 377 | 214 | 76 | 75 | |
- Collaboration Revenue | 317 | 440 | (28) | (28) | 97 | 178 | (46) | (47) | |
Cost of sales | (5,960) | (9,491) | (37) | (38) | (2,095) | (2,982) | (30) | (31) | |
Gross profit |
| 27,827 | 23,653 | 18 | 22 | 9,397 | 8,000 | 17 | 20 |
Product Sales Gross Margin |
| 81.6% | 70.5% | +11pp | +12pp | 81.0% | 71.8% | +9pp | +10pp |
Distribution expense | (394) | (380) | 4 | 6 | (129) | (126) | 2 | 2 | |
% Total Revenue | 1.2% | 1.1% | - | - | 1.1% | 1.1% | - | - | |
R&D expense | (7,862) | (7,137) | 10 | 12 | (2,584) | (2,458) | 5 | 4 | |
% Total Revenue | 23.3% | 21.5% | -2pp | -2pp | 22.5% | 22.4% | - | - | |
SG&A expense | (13,845) | (13,798) | - | 2 | (4,800) | (4,277) | 12 | 12 | |
% Total Revenue | 41.0% | 41.6% | +1pp | +1pp | 41.8% | 38.9% | -3pp | -2pp | |
OOI[55] & expense | 1,233 | 325 | >3x | >3x | 70 | 106 | (34) | (33) | |
% Total Revenue | 3.6% | 1.0% | +3pp | +3pp | 0.6% | 1.0% | - | - | |
Operating profit |
| 6,959 | 2,663 | >2x | >2x | 1,954 | 1,245 | 57 | 69 |
Operating Margin |
| 20.6% | 8.0% | +13pp | +14pp | 17.0% | 11.3% | +6pp | +7pp |
Net finance expense | (945) | (936) | 1 | 1 | (291) | (324) | (9) | (6) | |
Joint ventures and associates | (12) | (4) | >2x | >2x | (11) | 1 | n/m | n/m | |
Profit before tax |
| 6,002 | 1,723 | >3x | >3x | 1,652 | 922 | 79 | 91 |
Taxation | (1,000) | 668 | n/m | n/m | (274) | 720 | n/m | n/m | |
Tax rate |
| 17% | -39% | 17% | -78% |
|
| ||
Profit after tax |
| 5,002 | 2,391 | >2x | >2x | 1,378 | 1,642 | (16) | (6) |
Earnings per share |
| $3.22 | $1.54 | >2x | >2x | $0.89 | $1.06 | (16) | (6) |
Table 12: Reconciliation of Reported Profit before tax to EBITDA
9M 2023 | 9M 2022 | % Change | Q3 2023 | Q3 2022 | % Change |
$m | $m | Actual | CER | $m | $m | Actual | CER | ||
Reported Profit before tax | 6,002 | 1,723 | >3x | >3x | 1,652 | 922 | 79 | 91 | |
Net finance expense | 945 | 936 | 1 | 1 | 291 | 324 | (9) | (6) | |
Joint ventures and associates | 12 | 4 | >2x | >2x | 11 | (1) | n/m | n/m | |
Depreciation, amortisation and impairment | 4,060 | 4,000 | 2 | 3 | 1,282 | 1,334 | (4) | (4) | |
EBITDA | 11,019 | 6,663 | 65 | 77 | 3,236 | 2,579 | 25 | 32 |
EBITDA for the comparative 9M 2022 was negatively impacted by $3,175m unwind of inventory fair value uplift recognised on the acquisition of Alexion. EBITDA for the comparative Q3 2022 was negatively impacted by $857m unwind of inventory fair value uplift recognised on the acquisition of Alexion. This unwind had a $78m negative impact on 9M 2023 and a $23m negative impact on Q3 2023. It will continue to be minimal and will unwind fully over the next quarter.
Table 13: Reconciliation of Reported to Core financial measures: 9M 2023
9M 2023 | Reported | Restructuring | Intangible Asset Amortisation & Impairments | Acquisitionof Alexion | Other[56] | Core | Core % Change |
$m | $m | $m | $m | $m | $m | Actual | CER | ||
Gross profit |
| 27,827 | 133 | 24 | 82 | (4) | 28,062 | 4 | 8 |
Product Sales Gross Margin |
| 81.6% |
|
|
|
| 82.4% | +1pp | +2pp |
Distribution expense | (394) | - | - | - | - | (394) | 4 | 6 | |
R&D expense | (7,862) | 117 | 386 | 5 | 1 | (7,353) | 5 | 7 | |
SG&A expense | (13,845) | 163 | 2,863 | 7 | 1,107 | (9,705) | 5 | 8 | |
Total operating expense | (22,101) | 280 | 3,249 | 12 | 1,108 | (17,452) | 5 | 7 | |
Other operating income & expense | 1,233 | (61) | - | - | - | 1,172 | >3x | >3x | |
Operating profit |
| 6,959 | 352 | 3,273 | 94 | 1,104 | 11,782 | 10 | 16 |
Operating Margin |
| 20.6% |
|
|
|
| 34.9% | +2pp | +3pp |
Net finance expense | (945) | - | - | - | 220 | (725) | (1) | (2) | |
Taxation | (1,000) | (81) | (617) | (22) | (329) | (2,049) | 12 | 19 | |
EPS |
| $3.22 | $0.17 | $1.72 | $0.05 | $0.64 | $5.80 | 10 | 17 |
Table 14: Reconciliation of Reported to Core financial measures: Q3 2023
Q3 2023 | Reported | Restructuring | Intangible Asset Amortisation & Impairments | Acquisition of Alexion | Other[57] | Core | Core % Change |
$m | $m | $m | $m | $m | $m | Actual | CER | ||
Gross profit |
| 9,397 | 15 | 8 | 25 | (1) | 9,444 | 6 | 7 |
Product Sales Gross Margin |
| 81.0% |
|
|
|
| 81.4% | +1pp | +1pp |
Distribution expense | (129) | - | - | - | - | (129) | 3 | 2 | |
R&D expense | (2,584) | 48 | 49 | 2 | - | (2,485) | 5 | 5 | |
SG&A expense | (4,800) | 61 | 957 | 3 | 424 | (3,355) | 6 | 7 | |
Total operating expense | (7,513) | 109 | 1,006 | 5 | 424 | (5,969) | 6 | 6 | |
Other operating income & expense | 70 | - | - | - | - | 70 | (35) | (34) | |
Operating profit |
| 1,954 | 124 | 1,014 | 30 | 423 | 3,545 | 4 | 9 |
Operating Margin |
| 17.0% |
|
|
|
| 30.8% | - | +1pp |
Net finance expense | (291) | - | - | - | 68 | (223) | (12) | (7) | |
Taxation | (274) | (29) | (189) | (7) | (125) | (624) | 8 | 13 | |
EPS |
| $0.89 | $0.06 | $0.53 | $0.01 | $0.24 | $1.73 | 4 | 9 |
Profit and Loss drivers
Gross profit
? The calculation of Reported and Core Product Sales Gross Margin excludes the impact of Alliance Revenue and Collaboration Revenue. The change in Product Sales Gross Margin (Reported and Core) in the nine months was impacted by:
? Positive effects from product mix. The increased contribution from Rare Disease and Oncology medicines had a positive impact on the Product Sales Gross Margin. Vaxzevria sales, which are dilutive to Product Sales Gross Margin, declined substantially
? Dilutive effects from product mix. The rising contribution of Product Sales with profit sharing arrangements (Lynparza, Enhertu and Tezspire) has a negative impact on Product Sales Gross Margin because AstraZeneca records product revenues in certain markets but pays away a share of the gross profit to its collaboration partners
? Dilutive effects from geographic mix. Emerging Markets, where Product Sales Gross Margin tends to be below the Company average, grew as a proportion of Total Revenue excluding COVID-19 medicines
? Variations in Product Sales Gross Margin performance between periods can continue to be expected due to product seasonality, foreign exchange fluctuations and other effects.
R&D expense
? The change in R&D expense (Reported and Core) in the period was impacted by:
? Recent positive data read-outs for several high priority medicines that have ungated late-stage trials
? Investment in platforms, new technology and capabilities to enhance R&D productivity
? Reported R&D expense was also impacted by intangible asset impairments
SG&A expense
? The change in SG&A expense (Reported and Core) in the period was driven primarily by market development activities for launches
? Reported SG&A expense was also impacted by amortisation of intangible assets related to the Alexion acquisition and other acquisitions and collaborations
? Reported SG&A expense was also impacted by a $510m charge to provisions relating to a legal settlement in Q2 2023 with Bristol-Myers Squibb and Ono Pharmaceutical, and a $425m charge to provisions in Q3 2023 for product liability litigations related to Nexium and Prilosec. The prior nine month period was impacted by a $775m legal settlement with Chugai Pharmaceutical Co. Ltd
Other operating income and expense
? Reported and Core Other operating income and expense in the period included a $712m gain resulting from an update to the contractual relationships for Beyfortus (nirsevimab), a $241m gain on the disposal of the US rights to Pulmicort Flexhaler, and other disposal proceeds on the sale of tangible assets, and royalties on certain medicines
? In the third quarter Reported and Core Other operating income decreased by $36m and $37m respectively, principally due to the discontinuation of brazikumab development. Prior to this, AstraZeneca received quarterly development contributions for brazikumab development from AbbVie, which were recognised as Other operating income
Net finance expense
? Reported Net finance expense was impacted by the discount unwind on acquisition-related liabilities. Core Net finance expense reduced by 1% (2% at CER) with higher interest received on cash and short-term investments, broadly offset by higher rates on floating debt and bond issuances
Taxation
? The effective Reported Tax rate for the nine months to 30 September 2023 was 17% (9M 2022: (39%)) and the effective Core Tax rate was 19% (9M 2022: 18%). The Q3 2022 effective Reported Tax rate was lower as it included a one-time favourable adjustment of $883m relating to deferred taxes arising from an internal reorganisation to integrate the Alexion business
? The cash tax paid for the nine months to 30 September 2023 was $1,710m (9M 2022: $1,335m), representing 28% of Reported Profit before tax (9M 2022: 77%)
? On 20 June 2023, Finance (No.2) Act 2023 was substantively enacted in the UK, introducing a global minimum effective tax rate of 15%. The legislation implements a domestic top-up tax and a multinational top-up tax, effective for accounting periods starting on or after 31 December 2023. The Company is currently assessing the impact of these rules upon its financial statements. The Company has applied the exception under the IAS 12 'Income Taxes' amendment for recognising and disclosing information about deferred tax assets and liabilities related to top-up income taxes
Table 15: Cash Flow summary
9M 2023 | 9M 2022 | Change | ||
$m | $m | $m | ||
Reported Operating profit | 6,959 | 2,663 | 4,296 | |
Depreciation, amortisation and impairment | 4,060 | 4,000 | 60 | |
Decrease in working capital and short-term provisions | 150 | 3,458 | (3,308) | |
Gains on disposal of intangible assets | (247) | (88) | (159) | |
Fair value movements on contingent consideration arising from business combinations | 202 | 293 | (91) | |
Non-cash and other movements | (623) | (973) | 350 | |
Interest paid | (826) | (608) | (218) | |
Taxation paid | (1,710) | (1,335) | (375) | |
Net cash inflow from operating activities | 7,965 | 7,410 | 555 | |
Net cash inflow before financing activities | 4,978 | 4,699 | 279 | |
Net cash outflow from financing activities | (6,276) | (6,465) | 189 |
In 9M 2022, the Reported Operating profit of $2,663m included a negative impact of $3,175m relating to the unwind of the inventory fair value uplift recognised on the acquisition of Alexion. This was offset by a corresponding item (positive impact of $3,175m) in Decrease in working capital and short-term provisions. Overall, the unwind of the fair value uplift had no impact on Net cash inflow from operating activities. This unwind had $78m negative impact on 9M 2023 Reported Operating profit and offsetting positive impact on Working capital movements, and will continue to be minimal in the next quarter. As a result of the update to the contractual relationships between AstraZeneca, Sobi and Sanofi relating to the future sales of Beyfortus (nirsevimab) in the US, a gain of $712m has been recorded in non-cash and other movements, with no overall net impact on the Net cash inflow from operating activities.
Included within Net cash inflow before financing activities is a movement in the profit-participation liability of $190m, including a cash receipt from Sobi in Q1 2023 after achievement of a regulatory milestone. The associated cash flow is presented within investing activities.
The decrease in Net cash outflow from financing activities of $189m is primarily driven by the Issue of loans and borrowings of $3,816m, offset by the increase in Repayment of loans and borrowings of $3,394m.
Capital expenditure
Capital expenditure amounted to $836m in the nine months to 30 September 2023 (9M 2022: $719m).
Table 16: Net debt summary
| At 30 Sep 2023 | At 31 Dec 2022 | At 30 Sep 2022 | |
| $m | $m | $m | |
Cash and cash equivalents | 4,871 | 6,166 | 4,458 | |
Other investments | 244 | 239 | 440 | |
Cash and investments |
| 5,115 | 6,405 | 4,898 |
Overdrafts and short-term borrowings | (515) | (350) | (743) | |
Lease liabilities | (979) | (953) | (878) | |
Current instalments of loans | (4,857) | (4,964) | (4,665) | |
Non-current instalments of loans | (22,225) | (22,965) | (23,013) | |
Interest-bearing loans and borrowings (Gross debt) |
| (28,576) | (29,232) | (29,299) |
Net derivatives | 90 | (96) | (141) | |
Net debt |
| (23,371) | (22,923) | (24,542) |
Net debt increased by $448m in the nine months to 30 September 2023 to $23,371m. Details of the committed undrawn bank facilities are disclosed within the going concern section of Note 1. Details of the Company's solicited credit ratings and further details on Net Debt are disclosed in Note 3.
Capital allocation
The Board's aim is to continue to strike a balance between the interests of the business, financial creditors and the Company's shareholders. The Company's capital allocation priorities include: investing in the business and pipeline; maintaining a strong, investment-grade credit rating; potential value-enhancing business development opportunities; and supporting the progressive dividend policy.
In approving the declaration of dividends, the Board considers both the liquidity of the company and the level of reserves legally available for distribution. Dividends are paid to shareholders from AstraZeneca PLC, a Group holding company with no direct operations. The ability of AstraZeneca PLC to make shareholder distributions is dependent on the creation of profits for distribution and the receipt of funds from subsidiary companies. The consolidated Group reserves set out in the Condensed consolidated statement of financial position do not reflect the profit available for distribution to the shareholders of AstraZeneca PLC.
Summarised financial information for guarantee of securities of subsidiaries
AstraZeneca Finance LLC ("AstraZeneca Finance") is the issuer of 0.700% Notes due 2024, 1.200% Notes due 2026, 4.875% Notes due 2028, 1.750% Notes due 2028, 4.900% Notes due 2030, 2.250% Notes due 2031 and 4.875% Notes due 2033 (the "AstraZeneca Finance Notes"). Each series of AstraZeneca Finance Notes has been fully and unconditionally guaranteed by AstraZeneca PLC. AstraZeneca Finance is 100% owned by AstraZeneca PLC and each of the guarantees by AstraZeneca PLC is full and unconditional and joint and several.
The AstraZeneca Finance Notes are senior unsecured obligations of AstraZeneca Finance and rank equally with all of AstraZeneca Finance's existing and future senior unsecured and unsubordinated indebtedness. The guarantee by AstraZeneca PLC of the AstraZeneca Finance Notes is the senior unsecured obligation of AstraZeneca PLC and ranks equally with all of AstraZeneca PLC's existing and future senior unsecured and unsubordinated indebtedness. Each guarantee by AstraZeneca PLC is effectively subordinated to any secured indebtedness of AstraZeneca PLC to the extent of the value of the assets securing such indebtedness. The AstraZeneca Finance Notes are structurally subordinated to indebtedness and other liabilities of the subsidiaries of AstraZeneca PLC, none of which guarantee the AstraZeneca Finance Notes.
AstraZeneca PLC manages substantially all of its operations through divisions, branches and/or investments in subsidiaries and affiliates. Accordingly, the ability of AstraZeneca PLC to service its debt and guarantee obligations is also dependent upon the earnings of its subsidiaries, affiliates, branches and divisions, whether by dividends, distributions, loans or otherwise.
Please refer to the consolidated financial statements of AstraZeneca PLC in our Annual Report on Form 20-F and reports on Form 6-K with our quarterly financial results as filed or furnished with the SEC[58] for further financial information regarding AstraZeneca PLC and its consolidated subsidiaries. For further details, terms and conditions of the AstraZeneca Finance Notes please refer to AstraZeneca PLC's reports on Form 6-K furnished to the SEC on 3 March 2023 and 28 May 2021.
Pursuant to Rule 13-01 and Rule 3-10 of Regulation S-X under the Securities Act of 1933, as amended (the "Securities Act"), we present below the summary financial information for AstraZeneca PLC, as Guarantor, excluding its consolidated subsidiaries, and AstraZeneca Finance, as the issuer, excluding its consolidated subsidiaries. The following summary financial information of AstraZeneca PLC and AstraZeneca Finance is presented on a combined basis and transactions between the combining entities have been eliminated. Financial information for non-guarantor entities has been excluded. Intercompany balances and transactions between the obligor group and the non-obligor subsidiaries are presented on separate lines.
Table 17: Obligor group summarised Statement of comprehensive income
| 9M 2023 | 9M 2022 | |
| $m | $m | |
Total Revenue | - | - | |
Gross profit | - | - | |
Operating loss | (2) | (3) | |
Loss for the period | (695) | (404) | |
Transactions with subsidiaries that are not issuers or guarantors | 9,758 | 502 |
Table 18: Obligor group summarised Statement of financial position
| At 30 Sep 2023 | At 30 Sep 2022 | |
| $m | $m | |
Current assets | 6 | 5 | |
Non-current assets | - | - | |
Current liabilities | (4,760) | (3,067) | |
Non-current liabilities | (22,077) | (22,556) | |
Amounts due from subsidiaries that are not issuers or guarantors | 12,921 | 7,349 | |
Amounts due to subsidiaries that are not issuers or guarantors | (295) | (301) |
Foreign exchange
The Company's transactional currency exposures on working-capital balances, which typically extend for up to three months, are hedged where practicable using forward foreign exchange contracts against the individual companies' reporting currency. Foreign exchange gains and losses on forward contracts for transactional hedging are taken to profit or loss. In addition, the Company's external dividend payments, paid principally in pounds sterling and Swedish krona, are fully hedged from announcement to payment date.
Table 19: Currency sensitivities
The Company provides the following currency-sensitivity information:
| Average rates vs. USD | Annual impact ($m) of 5% strengthening (FY2023 average rate vs. FY 2022 average) [59] |
Currency | Primary Relevance |
| FY 2022[60] | YTD 2023[61] | Change (%) | Sep 2023[62] | Change[63] (%) |
| Total Revenue | Core Operating Profit |
EUR | Total Revenue | 0.95 | 0.92 | 3 | 0.94 | 1 | 323 | 159 | ||
CNY | Total Revenue | 6.74 | 7.04 | (4) | 7.30 | (8) | 309 | 174 | ||
JPY | Total Revenue | 131.59 | 138.18 | (5) | 147.71 | (11) | 181 | 122 | ||
Other[64] | 385 | 202 | ||||||||
GBP | Operating expense | 0.81 | 0.80 | 1 | 0.81 | 0 | 46 | (92) | ||
SEK | Operating expense | 10.12 | 10.59 | (4) | 11.08 | (9) | 7 | (55) |
Sustainability
Since the last quarterly report, AstraZeneca:
Access to healthcare
? Hosted the first dedicated side-event on Chronic Kidney Disease (CKD) "How improving kidney health can transform health systems for all" during the 78th United Nations General Assembly (UNGA) meeting in New York, with public, private and patient voices represented. During UNGA, the Company also engaged with the cancer community on access, services within universal health coverage (UHC) and the need for investment in cancer and non-communicable diseases (NCDs)
? Continued to make a high-level contribution to the work of the Partnership for Health System Sustainability and Resilience (PHSSR), which provides a valuable platform for dialogue with policymakers, the Company and other stakeholders. In Canada, a workshop with participation from the Minister of Health of Quebec fed into the discussions on transformation of Quebec's health system. In Japan, AstraZeneca's Chair Michel Demaré participated in a PHSSR roundtable co-hosted by the British Embassy, which focused on health equity and digital healthcare. PHSSR also engaged at leading global and regional healthcare events, including the European Health Forum Gastein, the Global Congress on Population, Health and Development, ICHOM 2023 and the World Health Summit in Berlin
? Ruud Dobber, EVP BioPharmaceuticals Business Unit, delivered the opening keynote address at the POLITICO EU Healthcare Summit in Brussels where he called for bold action and collaboration across the healthcare ecosystem to support early diagnosis and treatment. He highlighted the need for regulatory frameworks that accelerate access to medical innovation, as well as the urgency to combat the effects of the climate crisis on health
? Marked World Heart Day and the ninth anniversary of Healthy Heart Africa (HHA)'s launch, by convening African health stakeholders to take stock of the programme's achievements and share insights on the critical role of public-private partnerships in supporting primary healthcare. Speakers included representatives of Ministries of Health from nine countries and HHA implementing partners, with more than 70 attendees. HHA has trained more than 11,000 healthcare workers and conducted over 43 million blood pressure screenings, identifying 8.6 million with elevated blood pressure since launch, moving closer to the programme ambition of 10 million by 2025, and achieving one million screenings per month since February 2023 (data as at end of September 2023)
? Young Health Programme is now active in 40 countries, with new programmes launched in Costa Rica and Taiwan. Through the Young Health Programme Impact Fellowship, the Company supported a delegation of 17 young health leaders from 13 countries to attend One Young World 2023 in Belfast. Three of these changemakers joined AstraZeneca leadership in on-stage appearances, discussing their impact on NCD prevention for young people in their communities. AstraZeneca and Plan International UK were awarded 'Highly Commended' at the Corporate Engagement Awards for Best Educational Programme
Environmental protection
? Entered into an agreement in Sweden with Statkraft, Europe's largest renewable energy producer, on wind power deliveries that will increase the supply of renewable electricity in Sweden. The agreement is based on the commissioning of new wind farms. Under the agreement, AstraZeneca commits to purchasing 200 gigawatt-hours per year for 10 years, equivalent to two terawatt-hours. This corresponds to approximately 80 percent of total electricity needs at both the Company's Gothenburg site and at Södertälje, the largest manufacturing centre and one of the world's largest drug manufacturing centres
? Agreed a 15-year partnership with Future Biogas to establish the first unsubsidised industrial-scale supply of biomethane in the UK. This biomethane will support the transition away from fossil fuels at Company sites in Macclesfield, Cambridge, Luton and Speke. A new biomethane plant will add renewable energy capacity to existing UK infrastructure and supply more than 100 gigawatt hours of biomethane, equivalent to the heat needs of more than 8,000 homes. Using crops grown locally as part of diverse crop rotations, the plant will also contribute to the development of a circular economy, supporting UK farms with sustainable land management practices
? In China, CEO Pascal Soriot and EVP and China President Leon Wang witnessed the launch of the Sustainable Markets Initiative (SMI) China Council Health Working Group. Inspired by the SMI Health Systems Task Force, members of this new partnership will collaborate to accelerate the delivery of a net zero health system, for domestic and global impact. AstraZeneca China will co-chair this Working Group, which comprises China-based organisations and Chinese affiliates of global pharmaceutical companies
? In the U.S., advocated for climate action and sustainable healthcare reform during Climate Week NYC by convening high-level representatives from the US government, WHO, civil society and philanthropy at a plenary event with Climate Group on "Addressing the climate-health-equity nexus: The path to a sustainable future". The Company also discussed accelerating health sector decarbonisation at the Forbes Sustainability Leaders Summit in a session on "How the healthcare industry is responding to climate change" alongside US National Academy of Medicine President Dr. Victor J. Dzau. Furthermore, the Company participated in an event on water stewardship
? Contributed to a joint report on Advancing water stewardship through supplier collaboration in partnership with the World Wide Fund for Nature
? Ranked in first position for climate action in a new STAT Report "Climate rankings: How top drug companies measure up in combating climate change", which noted that "Companies like AstraZeneca are the exception in an industry that, as a whole, could be doing much more to measure and report its climate impacts, according to organizations that pool data on this topic"
? Received the EcoVadis Gold Medal for 2023, improving on the 2022 Silver rating. AstraZeneca was scored in four areas: Environment, Ethics, Labor and Human Rights, and Sustainable Procurement, and received an Advanced rating in the Environment and Human Rights categories
? Recognised with two awards from My Green Lab and the International Institute for Sustainable Laboratories' in the 2023 Freezer Challenge: the Top Organization Award and the Small Size Lab Award for our site in Gothenburg, Sweden
Ethics and transparency
? Received three supplier diversity awards from the Diversity for Science Alliance including 2023 Company of the year
? Launched Global Ethics training ahead of Global Ethics Day in October, an annual reminder to employees of the Company's commitment to high ethical standards in all areas of AstraZeneca's business, marking the day with local and virtual events and an #EmpoweringEthics employee social campaign
? Held an internal Power of Diversity panel discussion with members of the Company's Global Inclusion & Diversity (I&D) Council on the topic of putting an I&D lens over our AZ Values. This focused on building a sense of belonging through allyship, mutual support and the sharing of diverse perspectives. Supporting materials were made available through employee communication channels
Research and development
This section covers R&D events and milestones that have occurred since the prior results announcement on 28 July 2023, up to and including events on 8 November 2023.
A comprehensive view of AstraZeneca's pipeline of medicines in human trials can be found in the latest Clinical Trials Appendix, available on www.astrazeneca.com/investor-relations. The Clinical Trials Appendix includes tables with details of the ongoing clinical trials for AstraZeneca medicines and new molecular entities in the pipeline.
Oncology
AstraZeneca presented new data across its diverse portfolio of cancer medicines at two major medical congresses during the quarter: the 2023 World Conference on Lung Cancer (WCLC) in September and the 2023 European Society of Medical Oncology (ESMO) in October. At WCLC, AstraZeneca presented more than 40 abstracts featuring eight approved and potential new medicines, including nine oral presentations and a late-breaking plenary Presidential Symposium presentation of results from the FLAURA2 Phase III trial of Tagrisso plus chemotherapy in 1st-line EGFRm NSCLC. At ESMO, AstraZeneca presented nearly 100 abstracts featuring 19 approved and potential new medicines including 26 oral presentations and two late-breaking Presidential Symposia of the TROPION-Lung01 and TROPION-Breast 01 Phase III trials of monotherapy Dato-DXd versus conventional chemotherapy in lung and breast cancers.
Tagrisso
Event | Commentary | ||
Breakthrough Designation | US | Tagrisso in combination with chemotherapy for the treatment of adult patients with locally advanced or metastatic EGFRm lung cancer. (FLAURA2, August 2023) | |
Presentation: WCLC | FLAURA2 | Interim analysis of the Phase III FLAURA2 trial, presented at WCLC, demonstrated Tagrisso plus chemotherapy extended median PFS[65] by nearly nine months and reduced the risk of disease progression by 38% in EGFRm advanced lung cancer vs. Tagrisso monotherapy. (September 2023) | |
Priority Review | US | Tagrisso in combination with chemotherapy for the treatment of adult patients with locally advanced or metastatic EGFRm lung cancer. (FLAURA2, October 2023) | |
Presentation: ESMO | FLAURA2 CNS analysis | Prespecified exploratory analysis of the Phase III FLAURA2 trial, presented at ESMO, showed Tagrisso plus chemotherapy demonstrated a 42% improvement in CNS[66] PFS vs. Tagrisso monotherapy in patients with EGFRm advanced lung cancer and brain metastases at baseline, representing 40% of patients in the trial, as assessed by blinded independent central review. (October 2023) |
Imfinzi and Imjudo
Event | Commentary | ||
Positive Opinion
| EU
|
| The Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for Type II Extension of Indication Variation for Imfinzi as monotherapy for the first line treatment of adults with advanced or unresectable HCC. (HIIMALAYA, July 2023) |
Presentation: ESMO | MATTERHORN |
| Interim analysis of the Phase III MATTERHORN III trial, presented at ESMO, showed that Imfinzi in combination with standard-of-care FLOT[67] neoadjuvant chemotherapy demonstrated a statistically significant and clinically meaningful 12% improvement in the key secondary endpoint of pCR[68] vs. neoadjuvant chemotherapy alone for patients with resectable, early-stage and locally gastric and GEJ[69] cancers. (October 2023) |
Phase III data readout | EMERALD-1 |
| Positive high-level results from the EMERALD-1 Phase III trial showed Imfinzi in combination with TACE[70] and bevacizumab demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of PFS versus TACE alone in patients with HCC eligible for embolisation. The trial continues to follow the secondary endpoint of OS[71]. (November 2023) |
Lynparza
Event | Commentary | ||
Approval | Japan | Lynparza in combination with abiraterone and prednisolone for the treatment of adult patients with BRCAm mCRPC. (August 2023) | |
Label restriction | US | Restriction of the Lynparza indication for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy to the BRCAm (germline or somatic) patient population only. (September 2023) | |
Presentation: ESMO | DUO-E (Lynparza and Imfinzi) | Primary analysis of the Phase III DUO-E Phase III trial, presented at ESMO, showed that treatment with Imfinzi plus chemotherapy followed by either Imfinzi monotherapy or Imfinzi plus Lynparza demonstrated a reduction in the risk of disease progression or death, by 45% and 29%, respectively, vs. chemotherapy alone in patients with advanced or recurrent endometrial cancer. (October 2023) |
Enhertu
Event | Commentary | ||
Approval | Japan |
| For the treatment of adult patients with unresectable advanced or recurrent NSCLC with HER2 (ERBB2) mutations that has progressed after chemotherapy. (DESTINY-Lung02, August 2023) |
Breakthrough Designation | US
|
| For the treatment of adult patients with unresectable or metastatic HER2-positive (IHC[72] 3+) solid tumours that have progressed following prior treatment and who have no alternative treatment options. (DESTINY-PanTumor02, August 2023) |
| For the treatment of patients with HER2-positive (IHC 3+) metastatic colorectal cancer who have received two or more prior regimens. (DESTINY-CRC01, DESTINY-CRC02, August 2023) | ||
Presentation: WCLC | DESTINY-Lung02 |
| Results from the primary analysis of the DESTINY-Lung02 Phase II trial, presented at WCLC, showed Enhertu provided a median PFS of 9.9 months at a dose of 5.4mg/kg, and 15.4 months at a dose of 6.4mg/kg, with a favourable safety profile that confirm 5.4mg/kg is the optimal dose in this tumour type. (September 2023) |
Approval | EU |
| As monotherapy for the treatment of adult patients with advanced NSCLC whose tumours have an activating HER2 (ERBB2[73]) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy. (DESTINY-Lung02, October 2023) |
Presentation: ESMO | DESTINY-PanTumor02 |
| Primary analysis of the Phase II DESTINY-PanTumor02 trial, presented at ESMO, showed that treatment with Enhertu resulted in confirmed ORR[74] of 37.1%, a median PFS of 6.9 months and median OS of 13.4 months in previously treated patients across multiple HER2-expressing advanced solid tumours. (October 2023) |
Calquence
Event | Commentary | ||
Approval | China
|
| For the treatment of adult patients with CLL or SLL[75] who have received at least one prior therapy. (ASCEND, September 2023) |
datopotamab deruxtecan (Dato-Dxd)
Event | Commentary | ||
Presentation: WCLC | TROPION-Lung04 |
| Results from a planned interim analysis of the Phase Ib TROPION-Lung04 trial, presented at WCLC, showed that Dato-DXd in combination with Imfinzi, with or without carboplatin demonstrated objective response rates of 77% and 50% and disease control rates of 92% and 93% respectively, with no new safety signals in patients with previously untreated advanced or metastatic NSCLC without actionable genomic alterations. (September 2023) |
Presentation: ESMO | BEGONIA |
| Updated results from the Phase Ib/II BEGONIA trial, presented at ESMO, showed Dato-DXd plus Imfinzi demonstrated a confirmed objective response rate of 79% and a median PFS of 13.8 months in patients with previously untreated advanced or metastatic triple-negative breast cancer. (October 2023) |
Presentation: ESMO | TROPION-Lung01 |
| Primary analysis for the Phase III TROPION-Lung01 trial, presented at ESMO, showed that Dato-DXd reduced the risk of disease progression or death by 25% in the overall population and by 37% in non-squamous tumours vs. docetaxel in patients with previously treated NSCLC. (October 2023) |
Presentation: ESMO | TROPION-Breast01 |
| Primary analysis for the Phase III TROPION-Breast01 trial, presented at ESMO, showed that Dato-DXd reduced the risk of disease progression or death by 37%, providing a two-month median PFS benefit, and was well tolerated in the post-endocrine therapy setting vs. investigator's choice of chemotherapy in patients with inoperable or metastatic HR-positive, HER2-low or HER2-negative breast cancer previously treated with endocrine-based therapy and at least one systemic therapy. (October 2023) |
Other oncology pipeline
Event | Commentary | ||
Trial update | MONETTE |
| Phase II trial of ceralasertib + Imfinzi in unresectable or advanced melanoma and resistance to PD-(L)1 inhibition stopped enrolment following a pre-specified futility (efficacy) assessment. There were no concerning safety signals identified at this interim analysis or during the two prior data review meetings. |
Presentation: ASCO Virtual Plenary | NCT04805307 |
| Interim analysis for the Phase I trial (NCT04805307) of CMG901 (Claudin 18.2 ADC[76]) demonstrated promising clinical efficacy in patients with heavily pre-treated CLDN18.2-positive gastric/GEJ cancer, with a manageable safety profile. (November 2023) |
BioPharmaceuticals - CVRM
AstraZeneca presented 19 abstracts, including 10 oral presentations and five late-breaking presentations, at the European Society of Cardiology (ESC) Congress in August, including data highlighting the opportunities for improved management in heart failure, and AstraZeneca's leadership across the interconnectedness of chronic diseases. At the American Society of Nephrology's (ASN) Kidney Week in November, AstraZeneca presented 53 abstracts showcasing the strength of its portfolio, including new ZORA and REVOLUTIONIZE real-world evidence data for Lokelma and compelling next-wave pipeline innovation with results from the ZENITH-CKD Phase IIb trial for zibotentan/dapagliflozin.
Farxiga
Event | Commentary | ||
Approval
| China
| Approved in China to reduce the risk of cardiovascular death, hospitalisation for HF[77] or urgent HF visits in adults with symptomatic chronic HF. (June 2023) | |
Data | T2NOW | Positive data from the Phase III T2NOW trial, demonstrating a significant reduction in A1C in patients aged 10-17 years compared to patients receiving placebo. (October 2023) | |
Data | DAPA-MI | Primary endpoint met, non-registrational trial. (August 2023) |
zibotentan/dapagliflozin
Event | Commentary | ||
Presentation: ASN
| ZENITH-CKD | Phase IIb data showed statistically significant and clinically meaningful reductions in urinary albumin-to-creatinine ratio (UACR), used to assess albuminuria, at 12 weeks compared with the standard of care of dapagliflozin alone. After 12 weeks of treatment, the UACR difference of zibotentan/dapagliflozin versus dapagliflozin alone was -33.7% (90% CI -42.5 to -23.5; p high-dose (1.5 mg zibotentan / 10 mg dapagliflozin) and -27.0% (90% CI -38.4 to -13.6; p=0.002) for low dose (0.25 mg/10mg). (November 2023) |
Eplontersen
Event | Commentary | ||
Orphan Drug Designation
| EU | Orphan drug designation received for the treatment of ATTR[78]. (October 2023) |
BioPharmaceuticals - R&I
AstraZeneca presented new data across its inhaled, biologic and early science respiratory portfolio at the European Respiratory Society (ERS) International Congress 2023. The company presented over 90 abstracts, including 18 oral presentations, which focused on unmet needs in severe asthma, chronic obstructive pulmonary disease and other acute respiratory diseases. Data from Fasenra and Tezspire advanced clinical remission as a treatment target to change the trajectory of severe asthma care.
Fasenra
Event | Commentary | ||
Phase III data readout | MANDARA | Positive high-level results from the MANDARA Phase III trial for Fasenra demonstrated non-inferior rates of remission compared to mepolizumab in patients with EGPA who were receiving oral corticosteroids with or without stable immunosuppressive therapy. MANDARA was the first head-to-head trial of biologics in EGPA, comparing a single monthly injection of Fasenra to three injections per month of mepolizumab, the only currently approved treatment. (September 2023) | |
Presentation: ERS | SHAMAL | SHAMAL assessed the ability of Fasenra to permit a progressive reduction from high-dose ICS/LABA down to anti-inflammatory reliever whilst maintaining control in SEA[79] pts who were well-controlled on Fasenra. Fasenra enabled the majority of SEA patients to maintain disease control and remain exacerbation-free despite a reduction in background therapy to anti-inflammatory reliever only. (September 2023) | |
Presentation: ERS | MIRACLE | The positive MIRACLE Phase III trial demonstrated a reduction in annual asthma exacerbation rate of 74% among patients in China with uncontrolled SEA vs. placebo. A filing for regulatory approval in China has been submitted, with a decision expected in H2 2024. (September 2023) |
Tezspire
Event | Commentary | ||
Presentation: ERS | DESTINATION | In a post-hoc exploratory analysis of the DESTINATION Phase III trial of patients with severe, uncontrolled asthma, a numerically greater proportion of patients who received tezepelumab than placebo achieved remission during the time periods assessed. (September 2023) | |
BioPharmaceuticals - V&I
AZD3152
Event | Commentary | ||
Presentation:ID Week | In-vitro neutralisation data
| In vitro neutralisation data presented at ID Week showed that AZD3152 potently neutralises across a broad range of historical and contemporary SARS-CoV-2 variants, including the newly emerging BA.2.86 variant. AZD3152 loses activity against XBB variants with the F456L mutation. (October 2023)
The SUPERNOVA Phase III efficacy trial, which is now fully enrolled, will assess the potential benefit of AZD3152 in protecting immunocompromised patients in an environment with many variants in circulation. | |
FluMist
Event | Commentary | ||
sBLA submission | Self administration | The FDA has accepted for review a sBLA for the approval of a self- or caregiver-administered option for FluMist. If approved, FluMist will be the first flu vaccine available to be self-administered by eligible patients or administered by caregivers. The sBLA is supported by a usability study which confirmed that individuals over 18 years of age could self-administer or administer FluMist to eligible patients 2-49 years of age when given instructions for use without any additional guidance. (October 2023) |
Rare Disease
Alexion, AstraZeneca Rare Disease presented new real-world and clinical data at the European Committee for Treatment and Research in Multiple Sclerosis and Americas Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS-ACTRIMS), offering further evidence to support the established safety and efficacy of Soliris and Ultomiris in treating NMOSD.
Alexion, AstraZeneca Rare Disease presented new clinical data at the American Society of Nephrology (ASN) for Ultomiris in IgAN[80] as well as real-world data in aHUS.
Alexion, AstraZeneca Rare Disease presented new real-world and clinical data at the American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting and Myasthenia Gravis Foundation of America Scientific Session (MGFA SS). Data shared across 13 abstracts, reinforcing the safety and efficacy of C5 inhibition in treating generalized myasthenia gravis (gMG).
Soliris
Event | Commentary | ||
Approval | Japan |
| Paediatric patients with gMG. (August 2023) |
Approval | China |
| Adults with anti- aquaporin-4 antibody-positive NMOSD. (October 2023) |
Ultomiris
Event | Commentary | ||
CRL | US |
| The US FDA issued a CRL[81] regarding the sBLA[82] for Ultomiris for the treatment of adults with NMOSD. The sBLA included data from the CHAMPION-NMOSD Phase III trial, which met the primary endpoint with a safety profile consistent with the known profile of the medicine. The CRL requested modifications to enhance the Ultomiris Risk Evaluation and Mitigation Strategy to further validate patients' meningococcal vaccination status or prophylactic administration of antibiotics prior to treatment. (September 2023) |
Presentation: ASN | SANCTUARY Phase II | Ultomiris demonstrated clinically meaningful efficacy and proof-of-concept as a potential treatment for IgAN, based on rapid and sustained proteinuria reduction. (November 2023) |
vemircopan
Event | Commentary | ||
Termination | ACH228-110 Phase II |
| Trial discontinued due to lack of efficacy. Following an interim analysis, vemircopan's ability to appropriately control intravascular haemolysis was not adequately shown, due to significantly increased rates of breakthrough haemolysis and high levels of LDH[83]. No new safety findings were observed, and the safety profile of vemircopan has been favourable to date. This decision does not impact ongoing Phase II trials. (September 2023) |
gefurulimab
Event | Commentary | ||
Orphan Drug Designation | US |
| gefurulimab was granted orphan drug designation by the FDA for the treatment of patients with gMG. (September 2023) |
ALXN2220
Event | Commentary | ||
Orphan Drug Designation | US |
| ALXN2220 was granted orphan drug designation by the FDA for the treatment of patients with ATTR-CM[84]. (September 2023) |
Interim financial statements
Table 20: Condensed consolidated statement of comprehensive income: 9M 2023
For the nine months ended 30 September |
| 2023 | 2022 |
|
| $m | $m |
Total Revenue[85] |
| 33,787 | 33,144 |
Product Sales |
| 32,466 | 32,200 |
Alliance Revenue |
| 1,004 | 504 |
Collaboration Revenue |
| 317 | 440 |
Cost of sales | (5,960) | (9,491) | |
Gross profit |
| 27,827 | 23,653 |
Distribution expense | (394) | (380) | |
Research and development expense | (7,862) | (7,137) | |
Selling, general and administrative expense | (13,845) | (13,798) | |
Other operating income and expense | 1,233 | 325 | |
Operating profit |
| 6,959 | 2,663 |
Finance income | 236 | 50 | |
Finance expense | (1,181) | (986) | |
Share of after tax losses in associates and joint ventures | (12) | (4) | |
Profit before tax |
| 6,002 | 1,723 |
Taxation | (1,000) | 668 | |
Profit for the period |
| 5,002 | 2,391 |
Other comprehensive income |
|
|
|
Items that will not be reclassified to profit or loss |
|
|
|
Remeasurement of the defined benefit pension liability | (1) | 1,283 | |
Net gains/(losses) on equity investments measured at fair value through other comprehensive income | 45 | (21) | |
Fair value movements related to own credit risk on bonds designated as fair value through profit or loss | 5 | 1 | |
Tax on items that will not be reclassified to profit or loss | - | (291) | |
|
| 49 | 972 |
Items that may be reclassified subsequently to profit or loss | |||
Foreign exchange arising on consolidation | (201) | (2,493) | |
Foreign exchange arising on designated liabilities in net investment hedges | (63) | (321) | |
Fair value movements on cash flow hedges | 62 | (214) | |
Fair value movements on cash flow hedges transferred to profit and loss | 28 | 250 | |
Fair value movements on derivatives designated in net investment hedges | 47 | 33 | |
Costs of hedging | (3) | (11) | |
Tax on items that may be reclassified subsequently to profit or loss | (7) | 95 | |
(137) | (2,661) | ||
Other comprehensive loss, net of tax |
| (88) | (1,689) |
Total comprehensive income for the period |
| 4,914 | 702 |
Profit attributable to: | |||
Owners of the Parent | 4,995 | 2,387 | |
Non-controlling interests | 7 | 4 | |
5,002 | 2,391 | ||
Total comprehensive income attributable to: | |||
Owners of the Parent | 4,907 | 701 | |
Non-controlling interests | 7 | 1 | |
4,914 | 702 | ||
Basic earnings per $0.25 Ordinary Share | $3.22 | $1.54 | |
Diluted earnings per $0.25 Ordinary Share | $3.20 | $1.53 | |
Weighted average number of Ordinary Shares in issue (millions) | 1,549 | 1,548 | |
Diluted weighted average number of Ordinary Shares in issue (millions) | 1,560 | 1,560 |
Table 21: Condensed consolidated statement of comprehensive income: Q3 2023
For the quarter ended 30 September |
| 2023 | 2022 |
|
| $m | $m |
Total Revenue85 |
| 11,492 | 10,982 |
Product Sales |
| 11,018 | 10,590 |
Alliance Revenue |
| 377 | 214 |
Collaboration Revenue |
| 97 | 178 |
Cost of sales | (2,095) | (2,982) | |
Gross profit |
| 9,397 | 8,000 |
Distribution expense | (129) | (126) | |
Research and development expense | (2,584) | (2,458) | |
Selling, general and administrative expense | (4,800) | (4,277) | |
Other operating income and expense | 70 | 106 | |
Operating profit |
| 1,954 | 1,245 |
Finance income | 101 | 15 | |
Finance expense | (392) | (339) | |
Share of after tax (losses)/profits in associates and joint ventures | (11) | 1 | |
Profit before tax |
| 1,652 | 922 |
Taxation | (274) | 720 | |
Profit for the period |
| 1,378 | 1,642 |
Other comprehensive income |
|
|
|
Items that will not be reclassified to profit or loss |
|
|
|
Remeasurement of the defined benefit pension liability | (8) | 252 | |
Net gains/(losses) on equity investments measured at fair value through other comprehensive income | 93 | (9) | |
Fair value movements related to own credit risk on bonds designated as fair value through profit or loss | 1 | (1) | |
Tax on items that will not be reclassified to profit or loss | 5 | (16) | |
|
| 91 | 226 |
Items that may be reclassified subsequently to profit or loss | |||
Foreign exchange arising on consolidation | (306) | (1,167) | |
Foreign exchange arising on designated liabilities in net investment hedges | 38 | (126) | |
Fair value movements on cash flow hedges | (27) | (76) | |
Fair value movements on cash flow hedges transferred to profit and loss | 99 | 119 | |
Fair value movements on derivatives designated in net investment hedges | 7 | (1) | |
Costs of hedging | (2) | 2 | |
Tax on items that may be reclassified subsequently to profit or loss | (19) | 49 | |
(210) | (1,200) | ||
Other comprehensive loss, net of tax |
| (119) | (974) |
Total comprehensive income for the period |
| 1,259 | 668 |
Profit attributable to: | |||
Owners of the Parent | 1,374 | 1,640 | |
Non-controlling interests | 4 | 2 | |
1,378 | 1,642 | ||
Total comprehensive income attributable to: | |||
Owners of the Parent | 1,255 | 667 | |
Non-controlling interests | 4 | 1 | |
1,259 | 668 | ||
Basic earnings per $0.25 Ordinary Share | $0.89 | $1.06 | |
Diluted earnings per $0.25 Ordinary Share | $0.88 | $1.05 | |
Weighted average number of Ordinary Shares in issue (millions) | 1,549 | 1,548 | |
Diluted weighted average number of Ordinary Shares in issue (millions) | 1,560 | 1,559 |
Table 22: Condensed consolidated statement of financial position
| At 30 Sep 2023 | At 31 Dec 2022 | At 30 Sep 2022 | |
| $m | $m | $m | |
Assets | ||||
Non-current assets | ||||
Property, plant and equipment | 8,723 | 8,507 | 8,352 | |
Right-of-use assets | 977 | 942 | 875 | |
Goodwill | 19,939 | 19,820 | 19,707 | |
Intangible assets | 37,687 | 39,307 | 39,585 | |
Investments in associates and joint ventures | 62 | 76 | 53 | |
Other investments | 1,228 | 1,066 | 1,049 | |
Derivative financial instruments | 151 | 74 | 112 | |
Other receivables | 761 | 835 | 792 | |
Deferred tax assets | 4,057 | 3,263 | 3,436 | |
| 73,585 | 73,890 | 73,961 | |
Current assets | ||||
Inventories | 5,292 | 4,699 | 5,078 | |
Trade and other receivables | 11,300 | 10,521 | 9,336 | |
Other investments | 244 | 239 | 440 | |
Derivative financial instruments | 97 | 87 | 105 | |
Intangible assets | - | - | 82 | |
Income tax receivable | 697 | 731 | 725 | |
Cash and cash equivalents | 4,871 | 6,166 | 4,458 | |
Assets held for sale | - | 150 | - | |
| 22,501 | 22,593 | 20,224 | |
Total assets |
| 96,086 | 96,483 | 94,185 |
Liabilities |
|
|
|
|
Current liabilities | ||||
Interest-bearing loans and borrowings | (5,372) | (5,314) | (5,408) | |
Lease liabilities | (235) | (228) | (210) | |
Trade and other payables | (20,542) | (19,040) | (17,694) | |
Derivative financial instruments | (83) | (93) | (68) | |
Provisions | (1,193) | (722) | (377) | |
Income tax payable | (1,163) | (896) | (1,093) | |
| (28,588) | (26,293) | (24,850) | |
Non-current liabilities | ||||
Interest-bearing loans and borrowings | (22,225) | (22,965) | (23,013) | |
Lease liabilities | (744) | (725) | (668) | |
Derivative financial instruments | (75) | (164) | (290) | |
Deferred tax liabilities | (2,752) | (2,944) | (3,479) | |
Retirement benefit obligations | (1,048) | (1,168) | (919) | |
Provisions | (1,189) | (896) | (930) | |
Other payables | (2,244) | (4,270) | (4,882) | |
(30,277) | (33,132) | (34,181) | ||
Total liabilities |
| (58,865) | (59,425) | (59,031) |
Net assets |
| 37,221 | 37,058 | 35,154 |
Equity | ||||
Capital and reserves attributable to equity holders of the Parent | ||||
Share capital | 387 | 387 | 387 | |
Share premium account | 35,166 | 35,155 | 35,137 | |
Other reserves | 2,078 | 2,069 | 2,081 | |
Retained earnings | (434) | (574) | (2,471) | |
| 37,197 | 37,037 | 35,134 | |
Non-controlling interests | 24 | 21 | 20 | |
Total equity |
| 37,221 | 37,058 | 35,154 |
Table 23: Condensed consolidated statement of changes in equity
Share capital | Share premium account | Other reserves | Retained earnings | Total attributable to owners of the parent | Non-controlling interests | Total equity | ||
| $m | $m | $m | $m | $m | $m | $m | |
At 1 Jan 2022 | 387 | 35,126 | 2,045 | 1,710 | 39,268 | 19 | 39,287 | |
Profit for the period | - | - | - | 2,387 | 2,387 | 4 | 2,391 | |
Other comprehensive loss | - | - | - | (1,686) | (1,686) | (3) | (1,689) | |
Transfer to other reserves | - | - | 36 | (36) | - | - | - | |
Transactions with owners: | ||||||||
Dividends | - | - | - | (4,486) | (4,486) | - | (4,486) | |
Issue of Ordinary Shares | - | 11 | - | - | 11 | - | 11 | |
Share-based payments charge for the period | - | - | - | 471 | 471 | - | 471 | |
Settlement of share plan awards | - | - | - | (831) | (831) | - | (831) | |
Net movement |
| - | 11 | 36 | (4,181) | (4,134) | 1 | (4,133) |
At 30 Sep 2022 |
| 387 | 35,137 | 2,081 | (2,471) | 35,134 | 20 | 35,154 |
|
|
|
|
|
|
|
|
|
At 1 Jan 2023 |
| 387 | 35,155 | 2,069 | (574) | 37,037 | 21 | 37,058 |
Profit for the period | - | - | - | 4,995 | 4,995 | 7 | 5,002 | |
Other comprehensive loss | - | - | - | (88) | (88) | - | (88) | |
Transfer to other reserves | - | - | 9 | (9) | - | - | - | |
Transactions with owners: | ||||||||
Dividends | - | - | - | (4,487) | (4,487) | - | (4,487) | |
Dividends paid to non-controlling interests | - | - | - | - | - | (4) | (4) | |
Issue of Ordinary Shares | - | 11 | - | - | 11 | - | 11 | |
Share-based payments charge for the period | - | - | - | 429 | 429 | - | 429 | |
Settlement of share plan awards | - | - | - | (700) | (700) | - | (700) | |
Net movement | - | 11 | 9 | 140 | 160 | 3 | 163 | |
At 30 Sep 2023 |
| 387 | 35,166 | 2,078 | (434) | 37,197 | 24 | 37,221 |
Table 24: Condensed consolidated statement of cash flows
For the nine months ended 30 September | 2023 | 2022 | |
$m | $m |
Cash flows from operating activities | |||
Profit before tax | 6,002 | 1,723 | |
Finance income and expense | 945 | 936 | |
Share of after tax losses of associates and joint ventures | 12 | 4 | |
Depreciation, amortisation and impairment | 4,060 | 4,000 | |
Decrease in working capital and short-term provisions | 150 | 3,458 | |
Gains on disposal of intangible assets | (247) | (88) | |
Fair value movements on contingent consideration arising from business combinations | 202 | 293 | |
Non-cash and other movements | (623) | (973) | |
Cash generated from operations |
| 10,501 | 9,353 |
Interest paid | (826) | (608) | |
Tax paid | (1,710) | (1,335) | |
Net cash inflow from operating activities |
| 7,965 | 7,410 |
Cash flows from investing activities |
| ||
Acquisition of subsidiaries, net of cash acquired | (189) | - | |
Payments upon vesting of employee share awards attributable to business combinations | (84) | (297) | |
Payment of contingent consideration from business combinations | (610) | (570) | |
Purchase of property, plant and equipment | (836) | (719) | |
Disposal of property, plant and equipment | 131 | 17 | |
Purchase of intangible assets | (1,996) | (1,298) | |
Disposal of intangible assets | 288 | 442 | |
Movement in profit-participation liability | 190 | - | |
Purchase of non-current asset investments | (109) | (28) | |
Disposal of non-current asset investments | 32 | 42 | |
Movement in short-term investments, fixed deposits and other investing instruments | (12) | (321) | |
Payments to associates and joint ventures | - | (5) | |
Interest received | 208 | 26 | |
Net cash outflow from investing activities | (2,987) | (2,711) | |
Net cash inflow before financing activities |
| 4,978 | 4,699 |
Cash flows from financing activities | |||
Proceeds from issue of share capital | 12 | 11 | |
Issue of loans and borrowings | 3,816 | - | |
Repayment of loans and borrowings | (4,655) | (1,261) | |
Dividends paid | (4,479) | (4,364) | |
Hedge contracts relating to dividend payments | (19) | (127) | |
Repayment of obligations under leases | (194) | (182) | |
Movement in short-term borrowings | 110 | 378 | |
Payment of Acerta Pharma share purchase liability | (867) | (920) | |
Net cash outflow from financing activities |
| (6,276) | (6,465) |
Net decrease in Cash and cash equivalents in the period | (1,298) | (1,766) | |
Cash and cash equivalents at the beginning of the period | 5,983 | 6,038 | |
Exchange rate effects | (66) | (86) | |
Cash and cash equivalents at the end of the period |
| 4,619 | 4,186 |
Cash and cash equivalents consist of: | |||
Cash and cash equivalents | 4,871 | 4,458 | |
Overdrafts | (252) | (272) | |
|
| 4,619 | 4,186 |
Notes to the Interim financial statements
Note 1: Basis of preparation and accounting policies
These unaudited condensed consolidated Interim financial statements for the nine months ended 30 September 2023 have been prepared in accordance with International Accounting Standard 34, 'Interim Financial Reporting' (IAS 34), as issued by the International Accounting Standards Board (IASB), IAS 34 as adopted by the European Union, UK-adopted IAS 34 and the Disclosure Guidance and Transparency Rules sourcebook of the United Kingdom's Financial Conduct Authority and with the requirements of the Companies Act 2006 as applicable to companies reporting under those standards.
The unaudited Interim financial statements for the nine months ended 30 September 2023 were approved by the Board of Directors for publication on 9 November 2023.
This results announcement does not constitute statutory accounts of the Group within the meaning of sections
434(3) and 435(3) of the Companies Act 2006. The annual financial statements of the Group for the year ended 31 December 2022 were prepared in accordance with UK-adopted International Accounting Standards and with the requirements of the Companies Act 2006. The annual financial statements also comply fully with IFRSs as issued by the IASB and International Accounting Standards as adopted by the European Union. Except for the estimation of the interim income tax charge, the Interim financial statements have been prepared applying the accounting policies that were applied in the preparation of the Group's published consolidated financial statements for the year ended 31 December 2022.
The comparative figures for the financial year ended 31 December 2022 are not the Group's statutory accounts for that financial year. Those accounts have been reported on by the Group's auditors and have been delivered to the registrar of companies; their report was (i) unqualified, (ii) did not include a reference to any matters to which the auditors drew attention by way of emphasis without qualifying their report, and (iii) did not contain a statement under section 498(2) or (3) of the Companies Act 2006.
Alliance and Collaboration Revenues
Effective 1 January 2023, the Group has updated the presentation of Total Revenue on the face of the Statement of Comprehensive Income to include Alliance Revenue as a separate element to Collaboration Revenue. Alliance Revenue, previously reported within Collaboration Revenue, comprises income related to sales made by collaboration partners, where AstraZeneca is entitled to a profit share, revenue share or royalties, which are recurring in nature while the collaboration arrangement remains in place. Alliance Revenue does not include Product Sales where AstraZeneca is leading commercialisation in a territory. Collaboration Revenue arising from collaborative arrangements where the Group retains a significant ongoing economic interest and receives upfront amounts and event-triggered milestones, which arise from the licensing of intellectual property, will continue to be reported as Collaboration Revenue. In collaboration arrangements either AstraZeneca or the collaborator acts as principal in sales to the end customer. Where AstraZeneca acts as principal, we record 100% of sales to the end customer within Product Sales. The revised presentation reflects the increasing importance of income arising from profit share arrangements where collaboration partners are responsible for booking revenues in some or all territories.
The comparative revenue reported in 9M 2023 relating to the nine months to 30 September 2022 has been retrospectively adjusted to reflect the new split of Total Revenue, resulting in Alliance Revenue of $504m being reported for the nine months to 30 September 2022, however the combined total of Alliance Revenue and Collaboration Revenue is equal to the previously reported Collaboration Revenue total for the nine months to 30 September 2022.
Going concern
The Group has considerable financial resources available. As at 30 September 2023, the Group has $11.8bn in financial resources (Cash and cash equivalent balances of $4.9bn and undrawn committed bank facilities of $6.9bn available, of which $2.0bn of the facilities are available until February 2025 and the other $4.9bn are available until April 2026, with $5.6bn of borrowings due within one year). These facilities contain no financial covenants and were undrawn at 30 September 2023.
The Group's revenues are largely derived from sales of medicines covered by patents which provide a relatively high level of resilience and predictability to cash inflows, although government price interventions in response to budgetary constraints are expected to continue to adversely affect revenues in some of our significant markets. The Group, however, anticipates new revenue streams from both recently launched medicines and those in development, and the Group has a wide diversity of customers and suppliers across different geographic areas.
Consequently, the Directors believe that, overall, the Group is well placed to manage its business risks successfully. Accordingly, they continue to adopt the going concern basis in preparing the Interim financial statements.
Legal proceedings
The information contained in Note 6 updates the disclosures concerning legal proceedings and contingent liabilities in the Group's Annual Report and Form 20-F Information 2022.
IAS 12 'Income Taxes'
On 25 May 2023, the IASB issued an amendment to IAS 12 'Income Taxes' to clarify how the effects of the global minimum tax framework should be accounted for and disclosed effective 1 January 2023. This was endorsed by the UK Endorsement Board on 19 July 2023 and has been adopted by the Company for 2023 reporting. The Company is currently assessing the potential impact of these rules upon its financial statements. The Company has applied the exception to recognising and disclosing information about deferred tax assets and liabilities related to Pillar 2 income taxes.
Note 2: Intangible assets
In accordance with IAS 36 'Impairment of Assets', reviews for triggers of impairment or impairment reversals at an individual asset or cash generating unit level were conducted, and impairment tests carried out where triggers were identified. As a result, total impairment charges of $376m have been recorded against intangible assets during the nine months ended 30 September 2023 (9M 2022: $44m net charge). Impairment charges in respect of medicines in development were $359m (9M 2022: $61m net charge) including the $244m impairment of the ALXN1840 intangible asset, following decision to discontinue this development programme in Wilson's disease. Impairment charges in respect of launched medicines were $17m (9M 2022: $nil).
As previously disclosed, on 16 January 2023 AstraZeneca completed the acquisition of Neogene Therapeutics Inc. (Neogene), a global clinical-stage biotechnology company pioneering the discovery, development and manufacturing of next-generation T-cell receptor therapies (TCR-Ts). The purchase price allocation exercise has completed, with the fair value of total consideration determined at $267m. Intangible assets of $100m and goodwill of $158m were recognised in the acquisition balance sheet, as well as a cash outflow of $189m net of cash acquired. Future contingent milestones-based and non-contingent consideration is payable to a maximum of $120m. Neogene's results have been consolidated into the Group's results from 16 January 2023.
The acquisition of CinCor completed on 24 February 2023, recorded as an asset acquisition, with consideration and net assets acquired of $1,268m, which included intangible assets acquired of $780m, $424m of cash and cash equivalents, and $75m of marketable securities. The Condensed consolidated statement of cash flows includes a $1,204m payment for the intangible assets which is presented net of the $424m cash and cash equivalents acquired within Purchase of intangible assets, whilst the $75m increase in marketable securities is presented within Movement in short-term investments, fixed deposits and other investing instruments. Contingent consideration of up to $496m could be paid on achievement of regulatory milestones, and will be recognised when the associated milestones are triggered.
Note 3: Net debt
The table below provides an analysis of Net Debt and a reconciliation of Net Cash Flow to the movement in Net Debt. The Group monitors Net Debt as part of its capital-management policy as described in Note 28 of the Annual Report and Form 20-F Information 2022. Net Debt is a non-GAAP financial measure.
Table 25: Net debt
| At 1 Jan 2023 | Cash flow | Acquisitions | Non-cash & other | Exchange movements | At 30 Sep 2023 | |
| $m | $m | $m | $m | $m | $m | |
Non-current instalments of loans | (22,965) | (3,826) | - | 4,592 | (26) | (22,225) | |
Non-current instalments of leases | (725) | (1) | (6) | (23) | 11 | (744) | |
Total long-term debt |
| (23,690) | (3,827) | (6) | 4,569 | (15) | (22,969) |
Current instalments of loans | (4,964) | 4,655 | - | (4,587) | 39 | (4,857) | |
Current instalments of leases | (228) | 215 | (2) | (230) | 10 | (235) | |
Bank collateral received | (89) | (95) | - | - | - | (184) | |
Other short-term borrowings excluding overdrafts |
(78) | (15) | - | - | 14 | (79) | |
Overdrafts | (183) | (69) | - | - | - | (252) | |
Total current debt |
| (5,542) | 4,691 | (2) | (4,817) | 63 | (5,607) |
Gross borrowings |
| (29,232) | 864 | (8) | (248) | 48 | (28,576) |
Net derivative financial instruments | (96) | 19 | - | 167 | - | 90 | |
Net borrowings |
| (29,328) | 883 | (8) | (81) | 48 | (28,486) |
Cash and cash equivalents | 6,166 | (1,229) | - | - | (66) | 4,871 | |
Other investments - current | 239 | 12 | - | - | (7) | 244 | |
Cash and investments |
| 6,405 | (1,217) | - | - | (73) | 5,115 |
Net debt |
| (22,923) | (334) | (8) | (81) | (25) | (23,371) |
Non-cash movements in the period include fair value adjustments under IFRS 9 Financial Instruments.
The Group has agreements with some bank counterparties whereby the parties agree to post cash collateral on financial derivatives, for the benefit of the other, equivalent to the market valuation of the derivative positions above a predetermined threshold. The carrying value of such cash collateral held by the Group at 30 September 2023 was $184m (31 December 2022: $89m) and the carrying value of such cash collateral posted by the Group at 30 September 2023 was $175m (31 December 2022: $162m).
The equivalent GAAP measure to Net debt is 'liabilities arising from financing activities', which excludes the amounts for cash and overdrafts, other investments and non-financing derivatives shown above and includes the Acerta Pharma share purchase liability of $819m (31 December 2022: $1,646m), which is shown in current other payables.
Net debt increased by $448m in the nine months to 30 September 2023 to $23,371m. Details of the committed undrawn bank facilities are disclosed within the going concern section of Note 1.
During the quarter to 30 September 2023, Moody's upgraded the Company's solicited long term credit rating from A3 to A2 and its short term rating from P-2 to P-1. Standard and Poor's credit ratings were unchanged (long term: A; short term: A-1).
Note 4: Financial Instruments
As detailed in the Group's most recent annual financial statements, the principal financial instruments consist of derivative financial instruments, other investments, trade and other receivables, cash and cash equivalents, trade and other payables, lease liabilities and interest-bearing loans and borrowings.
The Group has certain equity investments that are categorised as Level 3 in the fair value hierarchy that are held at $281m at 30 September 2023 (31 December 2022: $186m) and for which fair value gains of $17m have been recognised in the nine months ended 30 September 2023 (9M 2022: $50m). In the absence of specific market data, these unlisted investments are held at fair value based on the cost of investment and adjusting as necessary for impairments and revaluations on new funding rounds, which are seen to approximate the fair value. All other fair value gains and/or losses that are presented in Net gains/(losses) on equity investments measured at fair value through other comprehensive income in the Condensed consolidated statement of comprehensive income for the nine months ended 30 September 2023 are Level 1 fair value measurements, valued based on quoted prices in active markets.
Financial instruments measured at fair value include $1,296m of other investments, $3,551m held in money-market funds, $289m of loans designated at fair value through profit or loss and $90m of derivatives as at 30 September 2023. With the exception of derivatives being Level 2 fair valued, certain equity investments as described above and an equity warrant of $14m categorised as Level 3, the aforementioned balances are Level 1 fair valued. Financial instruments measured at amortised cost include $175m of cash collateral pledged to counterparties. The total fair value of interest-bearing loans and borrowings at 30 September 2023, which have a carrying value of $28,576m in the Condensed consolidated statement of financial position, was $26,576m.
As announced in April 2023, the contractual relationship between AstraZeneca and Swedish Orphan Biovitrum AB (Sobi) relating to future sales of Beyfortus (nirsevimab) in the US has been replaced by a royalty relationship between Sanofi and Sobi. As a result, a non-current other payable representing AstraZeneca's future obligations to Sobi was eliminated from AstraZeneca's Statement of Financial Position in the quarter to 30 June 2023, and AstraZeneca recorded a gain of $712m in Core Other operating income.
Table 26: Financial instruments - contingent consideration
| 2023 | 2022 |
|
| Diabetes alliance | Other | Total | Total |
|
| $m | $m | $m | $m |
At 1 January | 2,124 | 98 | 2,222 | 2,865 | |
Additions through business combinations | - | 60 | 60 | - | |
Settlements | (608) | (2) | (610) | (570) | |
Disposals | - | - | - | (121) | |
Revaluations | 229 | (27) | 202 | 293 | |
Discount unwind | 93 | 6 | 99 | 126 | |
At 30 September |
| 1,838 | 135 | 1,973 | 2,593 |
Contingent consideration arising from business combinations is fair valued using decision-tree analysis, with key inputs including the probability of success, consideration of potential delays and the expected levels of future revenues.
The contingent consideration balance relating to BMS's share of the global diabetes alliance of $1,838m (31 December 2022: $2,124m) would increase/decrease by $184m with an increase/decrease in sales of 10%, as compared with the current estimates.
Note 5: Pensions and other post-retirement benefit obligations
During the nine months ended 30 September 2023, AstraZeneca Pharmaceuticals PLP terminated its main defined benefit pension plan. A total of $839m of pension obligations were discharged, $142m of which was settled via a cash payment to the participants and the remaining $697m was transferred to an external insurer via a buy-out. At 30 September 2023, the plan contained immaterial residual assets and obligations which are expected to be discharged by the end of 2023, with minimal impact to the income statement.
Note 6: Legal proceedings and contingent liabilities
AstraZeneca is involved in various legal proceedings considered typical to its business, including litigation and investigations, including Government investigations, relating to product liability, commercial disputes, infringement of intellectual property (IP) rights, the validity of certain patents, anti-trust law and sales and marketing practices. The matters discussed below constitute the more significant developments since publication of the disclosures concerning legal proceedings in the Company's Annual Report and Form 20-F Information 2022 and the Interim Financial Statements for the six months ended 30 June 2023 (the Disclosures).
As discussed in the Disclosures, the majority of claims involve highly complex issues. Often these issues are subject to substantial uncertainties and, therefore, the probability of a loss, if any, being sustained and/or an estimate of the amount of any loss is difficult to ascertain.
Unless specifically identified below, AstraZeneca considers each of the claims to represent a contingent liability or a contingent asset where the matter is brought by AstraZeneca, and discloses information with respect to the nature and facts of the cases in accordance with IAS 37.
In cases that have been settled or adjudicated, or where quantifiable fines and penalties have been assessed and which are not subject to appeal, or where a loss is probable and we are able to make a reasonable estimate of the loss, AstraZeneca records the loss absorbed or makes a provision for its best estimate of the expected loss. The position could change over time and the estimates that the Company made, and upon which the Company have relied in calculating these provisions are inherently imprecise. There can, therefore, be no assurance that any losses that result from the outcome of any legal proceedings will not exceed the amount of the provisions that have been booked in the accounts. The major factors causing this uncertainty are described more fully in the Disclosures and herein.
AstraZeneca has full confidence in, and will vigorously defend and enforce, its IP.
Matters disclosed in respect of the third quarter of 2023 and to 9 November 2023
Patent litigation
Legal proceedings brought against AZ considered to be contingent liabilities
Enhertu
US patent proceedings
In October 2020, Seagen Inc. (Seagen) filed a complaint against Daiichi Sankyo Company, Limited (Daiichi Sankyo) in the US District Court for the Eastern District of Texas (District Court) alleging that Enhertu infringes a Seagen patent. AstraZeneca Pharmaceuticals LP co-commercialises Enhertu with Daiichi Sankyo, Inc. in the US. After trial in April 2022, the jury found that the patent was infringed and awarded Seagen $41.82m in past damages. In July 2022, the District Court entered final judgment and declined to enhance damages on the basis of willfulness. In October 2023, the District Court entered an amended final judgment that requires Daiichi Sankyo to pay Seagen a royalty of 8% on US sales of Enhertu from April 1, 2022 through November 4, 2024, in addition to the past damages previously awarded by the Court.
In December 2020 and January 2021, AstraZeneca and Daiichi Sankyo, Inc. filed post-grant review (PGR) petitions with the US Patent and Trademark Office (USPTO) alleging, inter alia, that the Seagen patent is invalid for lack of written description and enablement. The USPTO initially declined to institute the PGRs, but, in April 2022, the USPTO granted the rehearing requests, instituting both PGR petitions. Seagen subsequently disclaimed all patent claims at issue in one of the PGR proceedings. In July 2022, the USPTO reversed its institution decision and declined to institute the other PGR petition. AstraZeneca and Daiichi Sankyo requested reconsideration of the decision not to institute review of the patent. In February 2023, the USPTO reinstituted the PGR proceeding. An oral hearing took place in August 2023. The parties await a decision.
Legal proceedings brought by AZ considered to be contingent assets
Faslodex
Patent proceedings outside the US
In 2021 in Japan, AstraZeneca received notice from the Japan Patent Office (JPO) that Sandoz K.K. (Sandoz) and Sun Pharma Japan Ltd. (Sun) were seeking to invalidate the Faslodex formulation patent. AstraZeneca defended the challenged patent, and Sun withdrew from the JPO patent challenge. In July 2023, the JPO issued a final decision upholding various claims of the challenged patent and determining that other patent claims were invalid. In August 2023, Sandoz appealed the JPO decision to the Japan IP High Court.
Calquence
US patent proceedings
In February 2022, in response to Paragraph IV notices from multiple ANDA filers, AstraZeneca filed patent infringement lawsuits in the US District Court for the District of Delaware. In its complaint, AstraZeneca alleges that a generic version of Calquence, if approved and marketed, would infringe patents listed in the US FDA Orange Book with reference to Calquence that are owned or licensed by AstraZeneca. Trial has been scheduled for March 2025.
In February 2023, Sandoz Inc. filed a petition for inter partes review with the US Patent and Trademark Office (USPTO) of certain Calquence patent claims. AstraZeneca has asserted claims for patent infringement against Sandoz and other defendants in the US ANDA litigation. In August 2023, the Patent Trial and Appeal Board issued a decision denying institution of inter partes review.
Product liability litigation
Legal proceedings brought against AZ for which a provision has been taken
Nexium and Losec/Prilosec
US proceedings
In the US, AstraZeneca is defending various lawsuits brought in federal and state courts involving multiple plaintiffs claiming that they have been diagnosed with various injuries following treatment with proton pump inhibitors (PPIs), including Nexium and Prilosec. The vast majority of those lawsuits related to allegations of kidney injuries. In August 2017, the pending federal court cases were consolidated in a multidistrict litigation (MDL) proceeding in the US District Court for the District of New Jersey for pre-trial purposes. A bellwether trial had been scheduled for October 2023, with subsequent bellwether trials scheduled for November 2023 and January 2024. In addition to the MDL cases, there were cases filed in Delaware and New Jersey state courts.
In addition, AstraZeneca has been defending lawsuits involving allegations of gastric cancer following treatment with PPIs. One such claim was filed in the US District Court for the Middle District of Louisiana and is scheduled to go to trial in April 2024.
In October 2023, AstraZeneca resolved all pending claims in the MDL, as well as all of the pending claims in Delaware and New Jersey state courts, for $425m, for which a current provision has been taken. A single case remains pending in the US District Court for the Middle District of Louisiana.
Legal proceedings brought against AZ considered to be contingent liabilities
Farxiga and Xigduo XR
US proceedings
In several jurisdictions in the US, AstraZeneca has been named as a defendant in lawsuits involving plaintiffs claiming physical injury, including Fournier's Gangrene and necrotising fasciitis, from treatment with Farxiga and/or Xigduo XR. A majority of these claims are filed in Delaware state court and remain pending. In September of 2023, the parties resolved by settlement one case, filed in state court in Minnesota, previously scheduled for trial in October 2023.
Commercial litigation
Legal proceedings brought against AZ for which a provision has been taken
Alexion Shareholder Litigation (US)
In December 2016, putative securities class action lawsuits were filed in the US District Court for the District of Connecticut (the District Court) against Alexion and certain officers and directors, on behalf of purchasers of Alexion publicly traded securities during the period 30 January 2014 through 26 May 2017. The amended complaint alleges that defendants engaged in securities fraud, including by making misrepresentations and omissions in its public disclosures concerning Alexion's Soliris sales practices, management changes, and related investigations. In August 2021, the District Court issued a decision denying in part Defendants' motion to dismiss the matter. The Court granted plaintiffs' motion for class certification in April 2023. In August 2023, the parties reached a settlement in principle of this matter. In September 2023, the court granted preliminary approval of the class settlement. The court scheduled a hearing in December 2023 to rule on final approval. A provision has been recognised in the quarter.
Legal proceedings brought by AZ considered to be contingent assets
US 340B litigations and proceedings
US proceedings
AstraZeneca has been involved in several matters relating to its contract pharmacy recognition policy under the 340B Drug Pricing Program in the US.
In August 2023, AstraZeneca filed a lawsuit against the Attorney General of the State of Louisiana alleging that the Louisiana's 340B statute, which requires manufacturers to recognize an unlimited number of contract pharmacies, is preempted on several grounds and violates the Contracts Clause of the U.S. Constitution.
In September 2023, the Arkansas Insurance Department sent AstraZeneca an administrative complaint concerning compliance with Arkansas's 340B Statute, which requires manufacturers to recognize an unlimited number of contract pharmacies. AstraZeneca response is due in November 2023.
Inflation Reduction Act Litigation
US proceedings
In August 2023, AstraZeneca filed a lawsuit in the US District Court for the District of Delaware challenging aspects of the drug price negotiation provisions of the Inflation Reduction Act and the implementing guidance and regulations promulgated by the Department of Health and Human Services.
Government investigations/proceedings
Legal proceedings brought against AZ considered to be contingent liabilities
340B Qui Tam
US Proceedings
In July 2023, AstraZeneca was served with an unsealed civil lawsuit brought by a qui tam relator on behalf of the United States, several states, and the District of Columbia in the United States District Court for Central District of California. The complaint alleges that AstraZeneca violated the False Claims Act and State-Law Counterparts. In September 2023, AstraZeneca filed a motion to dismiss the relator's claims.
Subsequent events
In November, AstraZeneca announced a collaboration and investment agreement with Cellectis, a clinical-stage biotechnology company, to accelerate the development of next generation therapeutics in areas of high unmet need, including oncology, immunology and rare diseases. In Q4 2023, under the terms of the collaboration agreement, Cellectis will receive an initial payment of $105m from AstraZeneca, which comprises a $25m upfront cash payment and an $80m equity investment. AstraZeneca expects to treat its investment in Cellectis as an associate.
In November, AstraZeneca and Eccogene entered into an exclusive licence agreement for ECC5004, an investigational oral once-daily GLP-1RA for the treatment of obesity, type-2 diabetes and other cardiometabolic conditions. Under the terms of the agreement, AstraZeneca obtained exclusive global rights for development and commercialisation in all territories except China where Eccogene has the right to co-develop and co-commercialise alongside AstraZeneca. Eccogene will receive an initial upfront payment of $185m and up to an additional $1.825bn in future clinical, regulatory, and commercial milestones and tiered royalties.
Note 7
Table 27: 9M 2023 - Product Sales year-on-year analysis[86]
| World | US | Emerging Markets | Europe | Established RoW |
$m | Act % chg | CER % chg | $m | % chg | $m | Act % chg | CER % chg | $m | Act % chg | CER % chg | $m | Act % chg | CER % chg | |
Oncology | 12,692 | 17 | 20 | 5,652 | 20 | 2,925 | 7 | 15 | 2,428 | 19 | 19 | 1,687 | 18 | 28 |
Tagrisso | 4,380 | 7 | 10 | 1,679 | 14 | 1,261 | 4 | 11 | 821 | 6 | 6 | 619 | (4) | 5 |
Imfinzi | 3,102 | 53 | 56 | 1,708 | 55 | 270 | 20 | 31 | 547 | 36 | 35 | 577 | 90 | n/m |
Lynparza | 2,070 | 6 | 9 | 902 | 1 | 409 | 14 | 24 | 543 | 10 | 10 | 216 | 7 | 16 |
Calquence | 1,839 | 25 | 26 | 1,337 | 12 | 69 | n/m | n/m | 353 | 76 | 77 | 80 | 64 | 74 |
Enhertu | 178 | n/m | n/m | - | - | 121 | n/m | n/m | 40 | n/m | n/m | 17 | n/m | n/m |
Orpathys | 33 | (3) | 4 | - | - | 33 | (3) | 4 | - | - | - | - | - | - |
Zoladex | 699 | (3) | 5 | 12 | 9 | 521 | 3 | 11 | 98 | (2) | (1) | 68 | (31) | (24) |
Faslodex | 217 | (16) | (10) | 9 | (38) | 113 | (6) | - | 22 | (50) | (50) | 73 | (8) | - |
Others | 174 | (36) | (32) | 5 | (36) | 128 | (38) | (34) | 4 | (41) | (40) | 37 | (29) | (22) |
BioPharmaceuticals: CVRM | 7,887 | 14 | 18 | 1,972 | 11 | 3,507 | 10 | 18 | 1,825 | 29 | 29 | 583 | 10 | 19 |
Farxiga | 4,358 | 36 | 40 | 1,000 | 34 | 1,653 | 35 | 43 | 1,356 | 42 | 41 | 349 | 26 | 36 |
Brilinta | 996 | (2) | - | 551 | 2 | 224 | 1 | 10 | 203 | (5) | (5) | 18 | (54) | (51) |
Lokelma | 300 | 44 | 49 | 156 | 28 | 37 | n/m | n/m | 41 | 98 | 99 | 66 | 32 | 44 |
roxadustat | 208 | 41 | 51 | - | - | 208 | 41 | 51 | - | - | - | - | - | - |
Andexxa | 129 | 16 | 19 | 57 | (8) | - | - | - | 44 | 51 | 51 | 28 | 40 | 54 |
Crestor | 860 | 4 | 11 | 40 | (19) | 678 | 8 | 15 | 41 | 38 | 38 | 101 | (11) | (4) |
Seloken/Toprol-XL | 496 | (30) | (23) | - | - | 482 | (30) | (24) | 8 | (19) | (19) | 6 | (18) | (13) |
Onglyza | 180 | (12) | (8) | 44 | (26) | 99 | 1 | 9 | 25 | (17) | (17) | 12 | (30) | (27) |
Bydureon | 123 | (40) | (40) | 101 | (43) | 2 | 15 | 14 | 20 | (30) | (30) | - | - | - |
Others | 237 | (16) | (13) | 23 | (13) | 124 | (19) | (13) | 87 | (10) | (10) | 3 | (52) | (49) |
BioPharmaceuticals: R&I | 4,517 | 5 | 8 | 1,900 | (3) | 1,315 | 19 | 29 | 847 | 7 | 7 | 455 | (1) | 6 |
Symbicort | 1,842 | (4) | (1) | 589 | (18) | 600 | 26 | 36 | 408 | (8) | (8) | 245 | (12) | (7) |
Fasenra | 1,134 | 12 | 13 | 718 | 11 | 48 | 62 | 69 | 262 | 14 | 14 | 106 | (1) | 6 |
Breztri | 478 | 69 | 73 | 263 | 60 | 123 | 73 | 86 | 55 | n/m | n/m | 37 | 48 | 58 |
Saphnelo | 191 | n/m | n/m | 178 | n/m | 1 | n/m | n/m | 5 | n/m | n/m | 7 | n/m | n/m |
Tezspire | 51 | n/m | n/m | - | - | - | - | - | 28 | n/m | n/m | 23 | n/m | n/m |
Pulmicort | 493 | 3 | 10 | 22 | (58) | 392 | 16 | 24 | 49 | (1) | - | 30 | (18) | (13) |
Bevespi | 42 | (2) | (2) | 24 | (23) | 5 | 21 | 32 | 12 | 70 | 70 | 1 | 59 | 10 |
Daliresp/Daxas | 41 | (74) | (74) | 32 | (79) | 2 | (23) | (10) | 6 | (9) | (9) | 1 | 3 | (25) |
Others | 245 | (30) | (27) | 74 | (44) | 144 | (20) | (14) | 22 | (35) | (34) | 5 | (4) | 2 |
BioPharmaceuticals: V&I | 667 | (82) | (81) | 15 | (98) | 181 | (82) | (81) | 236 | (66) | (66) | 235 | (76) | (73) |
COVID-19 mAbs | 126 | (91) | (90) | - | n/m | 5 | (97) | (97) | 7 | (97) | (96) | 114 | (51) | (45) |
Vaxzevria | 28 | (98) | (98) | - | n/m | 18 | (97) | (97) | 10 | (97) | (97) | - | n/m | n/m |
Beyfortus | 52 | n/m | n/m | - | - | - | - | - | 52 | - | - | - | - | - |
Synagis | 383 | - | 6 | (1) | n/m | 158 | 9 | 15 | 109 | (12) | (9) | 117 | 2 | 11 |
FluMist | 78 | 32 | 28 | 16 | 44 | - | n/m | n/m | 58 | 28 | 22 | 4 | 79 | 71 |
Rare Disease | 5,793 | 11 | 12 | 3,469 | 9 | 487 | 54 | 68 | 1,165 | 8 | 8 | 672 | 1 | 9 |
Soliris | 2,429 | (17) | (15) | 1,313 | (22) | 338 | 55 | 74 | 530 | (15) | (15) | 248 | (36) | (31) |
Ultomiris | 2,141 | 56 | 58 | 1,260 | 63 | 47 | 38 | 39 | 495 | 43 | 42 | 339 | 54 | 68 |
Strensiq | 847 | 23 | 24 | 690 | 26 | 29 | 14 | 16 | 64 | 9 | 8 | 64 | 12 | 22 |
Koselugo | 246 | 65 | 65 | 144 | 26 | 49 | n/m | n/m | 38 | n/m | n/m | 15 | n/m | n/m |
Kanuma | 130 | 17 | 18 | 62 | 11 | 24 | 53 | 55 | 38 | 13 | 12 | 6 | 4 | 12 |
Other medicines | 910 | (27) | (22) | 104 | (7) | 580 | (5) | 3 | 67 | (29) | (29) | 159 | (63) | (60) |
Nexium | 735 | (25) | (20) | 88 | (6) | 458 | 5 | 14 | 36 | (1) | (2) | 153 | (63) | (60) |
Others | 175 | (33) | (31) | 16 | (13) | 122 | (29) | (25) | 31 | (47) | (47) | 6 | (54) | (50) |
Total Product Sales | 32,466 | 1 | 4 | 13,112 | 3 | 8,995 | 1 | 8 | 6,568 | 7 | 7 | 3,791 | (16) | (9) |
Table 28: Q3 2023 - Product Sales year-on-year analysis[87]
| World | US | Emerging Markets | Europe | Established RoW |
$m | Act % chg | CER % chg | $m | % chg | $m | Act % chg | CER % chg | $m | Act % chg | CER % chg | $m | Act % chg | CER % chg | |
Oncology | 4,389 | 16 | 17 | 1,986 | 16 | 971 | 4 | 13 | 849 | 22 | 15 | 583 | 28 | 35 |
Tagrisso | 1,465 | 5 | 6 | 577 | 11 | 409 | 1 | 8 | 281 | 5 | (1) | 198 | (3) | 2 |
Imfinzi | 1,126 | 53 | 54 | 610 | 48 | 87 | (4) | 7 | 208 | 54 | 45 | 221 | n/m | n/m |
Lynparza | 702 | 7 | 8 | 322 | 3 | 131 | 12 | 26 | 178 | 8 | 2 | 71 | 11 | 16 |
Calquence | 654 | 16 | 15 | 468 | 2 | 28 | n/m | n/m | 128 | 63 | 54 | 30 | 65 | 72 |
Enhertu | 73 | n/m | n/m | - | - | 48 | n/m | n/m | 16 | n/m | n/m | 9 | n/m | n/m |
Orpathys | 12 | 6 | 13 | - | - | 12 | 6 | 13 | - | - | - | - | - | - |
Zoladex | 239 | - | 5 | 5 | 29 | 182 | 4 | 11 | 31 | (1) | (6) | 21 | (29) | (25) |
Faslodex | 64 | (21) | (16) | 3 | (41) | 32 | (19) | (13) | 6 | (53) | (55) | 23 | (5) | - |
Others | 54 | (33) | (30) | 1 | (59) | 42 | (34) | (32) | 1 | 11 | 11 | 10 | (30) | (22) |
BioPharmaceuticals: CVRM | 2,683 | 14 | 16 | 690 | 9 | 1,161 | 7 | 15 | 657 | 40 | 32 | 175 | 6 | 10 |
Farxiga | 1,554 | 41 | 41 | 366 | 31 | 579 | 41 | 48 | 506 | 54 | 45 | 103 | 24 | 29 |
Brilinta | 331 | (2) | (1) | 193 | 4 | 64 | (16) | (4) | 68 | 4 | (2) | 6 | (45) | (46) |
Lokelma | 102 | 30 | 31 | 51 | 15 | 13 | 39 | 48 | 16 | 97 | 87 | 22 | 31 | 38 |
roxadustat | 74 | 31 | 39 | - | - | 74 | 30 | 39 | - | - | - | - | - | - |
Andexxa | 40 | (3) | (5) | 20 | - | - | - | - | 15 | 32 | 20 | 5 | (50) | (47) |
Crestor | 275 | (1) | 6 | 14 | (10) | 219 | 2 | 9 | 9 | 6 | 3 | 33 | (11) | (7) |
Seloken/Toprol-XL | 153 | (36) | (29) | - | - | 149 | (36) | (29) | 2 | (45) | (45) | 2 | (4) | (18) |
Onglyza | 53 | (20) | (17) | 9 | (57) | 33 | - | 9 | 8 | (9) | (16) | 3 | (27) | (25) |
Bydureon | 35 | (48) | (49) | 28 | (52) | 1 | 97 | 90 | 6 | (25) | (30) | - | - | - |
Others | 66 | (23) | (21) | 9 | 15 | 29 | (40) | (37) | 27 | (1) | (2) | 1 | (42) | (39) |
BioPharmaceuticals: R&I | 1,451 | 2 | 3 | 609 | (8) | 422 | 14 | 23 | 266 | 9 | 2 | 154 | 3 | 7 |
Symbicort | 555 | (12) | (10) | 156 | (34) | 195 | 15 | 24 | 123 | (7) | (13) | 81 | (11) | (8) |
Fasenra | 389 | 10 | 10 | 249 | 9 | 19 | 56 | 67 | 86 | 12 | 5 | 35 | 1 | 4 |
Breztri | 171 | 66 | 69 | 98 | 69 | 42 | 51 | 62 | 19 | n/m | n/m | 12 | 37 | 46 |
Saphnelo | 76 | n/m | n/m | 71 | n/m | - | - | - | 2 | n/m | n/m | 3 | n/m | n/m |
Tezspire | 21 | n/m | n/m | - | - | - | - | - | 11 | n/m | n/m | 10 | n/m | n/m |
Pulmicort | 148 | 2 | 7 | 5 | (69) | 119 | 16 | 24 | 13 | (11) | (16) | 11 | (8) | (5) |
Bevespi | 13 | (5) | (4) | 8 | (23) | 2 | (2) | 7 | 3 | 77 | 72 | - | - | - |
Daliresp/Daxas | 11 | (79) | (79) | 8 | (83) | - | (36) | (2) | 2 | (2) | (18) | 1 | n/m | - |
Others | 67 | (31) | (28) | 14 | (55) | 45 | (20) | (14) | 7 | (14) | (19) | 1 | (7) | 7 |
BioPharmaceuticals: V&I | 224 | (74) | (74) | 15 | (95) | 32 | (76) | (75) | 122 | (33) | (35) | 55 | (78) | (77) |
COVID-19 mAbs | - | n/m | n/m | - | n/m | - | n/m | n/m | - | n/m | n/m | - | n/m | n/m |
Vaxzevria | - | n/m | n/m | - | - | - | n/m | n/m | - | n/m | n/m | - | n/m | n/m |
Beyfortus | 50 | n/m | n/m | - | - | - | - | - | 50 | - | - | - | - | - |
Synagis | 99 | (5) | (1) | - | - | 32 | (13) | (7) | 16 | (4) | (10) | 51 | 1 | 6 |
FluMist | 75 | 28 | 23 | 15 | 41 | - | - | - | 56 | 22 | 16 | 4 | 81 | 76 |
Rare Disease | 1,974 | 13 | 14 | 1,179 | 9 | 163 | 49 | 70 | 397 | 15 | 8 | 235 | 16 | 22 |
Soliris | 781 | (13) | (12) | 420 | (20) | 124 | 47 | 71 | 163 | (14) | (19) | 74 | (28) | (26) |
Ultomiris | 777 | 50 | 49 | 445 | 41 | 17 | n/m | n/m | 184 | 51 | 41 | 131 | 70 | 78 |
Strensiq | 285 | 20 | 21 | 237 | 23 | 5 | (32) | (10) | 22 | 17 | 8 | 21 | 13 | 19 |
Koselugo | 87 | 81 | 81 | 54 | 51 | 11 | 51 | 69 | 15 | n/m | n/m | 7 | n/m | n/m |
Kanuma | 44 | 21 | 19 | 23 | 27 | 6 | (4) | (2) | 13 | 31 | 23 | 2 | (10) | (5) |
Other medicines | 297 | (27) | (22) | 36 | (3) | 190 | (11) | (4) | 19 | (32) | (34) | 52 | (59) | (56) |
Nexium | 244 | (22) | (17) | 29 | (6) | 153 | 3 | 13 | 11 | 5 | (2) | 51 | (59) | (56) |
Others | 53 | (43) | (41) | 7 | 10 | 37 | (44) | (41) | 8 | (54) | (53) | 1 | (66) | (57) |
Total Product Sales | 11,018 | 4 | 5 | 4,515 | 2 | 2,939 | 3 | 12 | 2,310 | 18 | 11 | 1,254 | (7) | (3) |
Table 29: Alliance Revenue
9M 2023 | 9M 2022 | ||
$m | $m | ||
Enhertu | 741 | 335 | |
Tezspire | 179 | 42 | |
Vaxzevria: royalties | - | 67 | |
Other royalty income | 59 | 51 | |
Other Alliance Revenue | 25 | 9 | |
Total | 1,004 | 504 |
Table 30: Collaboration Revenue
9M 2023 | 9M 2022 | ||
$m | $m | ||
Lynparza: regulatory milestones | - | 250 | |
COVID-19 mAbs: licence fees | 180 | - | |
Farxiga: sales milestones | 28 | - | |
tralokinumab: sales milestones | 20 | 110 | |
Beyfortus: regulatory milestones | 71 | - | |
Other Collaboration Revenue | 18 | 80 | |
Total | 317 | 440 |
Table 31: Other operating income and expense
9M 2023 | 9M 2022 | ||
$m | $m | ||
brazikumab licence termination funding | 75 | 104 | |
Divestment of rights to Plendil | - | 61 | |
Divestment of US rights to Pulmicort Flexhaler | 241 | - | |
Update to the contractual relationships for Beyfortus (nirsevimab) | 712 | - | |
Other | 205 | 160 | |
Total | 1,233 | 325 |
Other shareholder information
Financial calendar
Announcement of full year and fourth quarter 2023 results: 8 February 2024
Dividends are normally paid as follows:
First interim: Announced with the half year results and paid in September
Second interim: Announced with full year results and paid in March
Contacts
For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here.
Addresses for correspondence
|
|
| |
Registered office | Registrar and transfer office | Swedish Central Securities Depository | US depositary Deutsche Bank Trust Company Americas |
1 Francis Crick Avenue Cambridge Biomedical Campus Cambridge CB2 0AA | Equiniti Limited Aspect House Spencer Road Lancing West Sussex BN99 6DA | Euroclear Sweden AB PO Box 191 SE-101 23 Stockholm | American Stock Transfer 6201 15th Avenue Brooklyn NY 11219
|
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
|
Trademarks
Trademarks of the AstraZeneca group of companies appear throughout this document in italics. Medical publications also appear throughout the document in italics. AstraZeneca, the AstraZeneca logotype and the AstraZeneca symbol are all trademarks of the AstraZeneca group of companies. Trademarks of companies other than AstraZeneca that appear in this document include Arimidex and Casodex, owned by AstraZeneca or Juvisé (depending on geography); Beyfortus, a trademark of Sanofi Pasteur Inc.; Enhertu, a trademark of Daiichi Sankyo; Losec, owned by AstraZeneca or Cheplapharm (depending upon geography); Seloken, owned by AstraZeneca or Taiyo Pharma Co., Ltd (depending on geography); Synagis, owned by AstraZeneca or Sobi aka Swedish Orphan Biovitrum AB (publ). (depending on geography); and Tezspire, a trademark of Amgen, Inc.
Information on or accessible through AstraZeneca's websites, including astrazeneca.com, does not form part of and is not incorporated into this announcement.
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Disease, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.
Cautionary statements regarding forward-looking statements
In order, among other things, to utilise the 'safe harbour' provisions of the US Private Securities Litigation Reform Act of 1995, AstraZeneca (hereafter 'the Group') provides the following cautionary statement:
This document contains certain forward-looking statements with respect to the operations, performance and financial condition of the Group, including, among other things, statements about expected revenues, margins, earnings per share or other financial or other measures. Although the Group believes its expectations are based on reasonable assumptions, any forward-looking statements, by their very nature, involve risks and uncertainties and may be influenced by factors that could cause actual outcomes and results to be materially different from those predicted. The forward-looking statements reflect knowledge and information available at the date of preparation of this document and the Group undertakes no obligation to update these forward-looking statements. The Group identifies the forward-looking statements by using the words 'anticipates', 'believes', 'expects', 'intends' and similar expressions in such statements. Important factors that could cause actual results to differ materially from those contained in forward-looking statements, certain of which are beyond the Group's control, include, among other things:
? the risk of failure or delay in delivery of pipeline or launch of new medicines
? the risk of failure to meet regulatory or ethical requirements for medicine development or approval
? the risk of failures or delays in the quality or execution of the Group's commercial strategies
? the risk of pricing, affordability, access and competitive pressures
? the risk of failure to maintain supply of compliant, quality medicines
? the risk of illegal trade in the Group's medicines
? the impact of reliance on third-party goods and services
? the risk of failure in information technology or cybersecurity
? the risk of failure of critical processes
? the risk of failure to collect and manage data in line with legal and regulatory requirements and strategic objectives
? the risk of failure to attract, develop, engage and retain a diverse, talented and capable workforce
? the risk of failure to meet regulatory or ethical expectations on environmental impact, including climate change
? the risk of the safety and efficacy of marketed medicines being questioned
? the risk of adverse outcome of litigation and/or governmental investigations
? intellectual property-related risks to our products
? the risk of failure to achieve strategic plans or meet targets or expectations
? the impact that global and/or geopolitical events may have or continue to have on these risks, on the Group's ability to continue to mitigate these risks, and on the Group's operations, financial results or financial condition
? the risk of failure in financial control or the occurrence of fraud
? the risk of unexpected deterioration in the Group's financial position
Nothing in this document, or any related presentation/webcast, should be construed as a profit forecast.
- End of document -
[1] Constant exchange rates. The differences between Actual Change and CER Change are due to foreign exchange movements between periods in 2023 vs. 2022. CER financial measures are not accounted for according to generally accepted accounting principles (GAAP) because they remove the effects of currency movements from Reported results.
[2] Effective 1 January 2023, the Group has updated the presentation of Total Revenue. For further details of the presentation of Alliance Revenue and Collaboration Revenue, see the Basis of preparation and accounting policies section of the Notes to the Interim financial statements section.
[3] Reported financial measures are the financial results presented in accordance with UK-adopted International Accounting Standards and International Financial Reporting Standards (IFRSs) as issued by the International Accounting Standards Board (IASB) and International Accounting Standards as adopted by the European Union.
[4] Earnings per share.
[5] Core financial measures are adjusted to exclude certain items. The differences between Reported and Core measures are primarily due to costs relating to the acquisition of Alexion, amortisation of intangibles, impairments, legal settlements and restructuring charges. A full reconciliation between Reported EPS and Core EPS is provided in Table 13 and Table 14 in the Financial performance section of this document.
[6] The COVID-19 medicines are Vaxzevria, Evusheld, and AZD3152 - the COVID-19 antibody currently in development.
[7] Cardiovascular, Renal and Metabolism.
[8] Respiratory & Immunology.
[9] The calculation of Reported and Core Product Sales Gross Margin (formerly termed as Gross Margin) excludes the impact of Alliance Revenue and Collaboration Revenue.
[10] Programmed cell death protein 1/cytotoxic T-lymphocyte-associated protein 4.
[11] Glucagon-like peptide 1 receptor agonist.
[12] Hormone receptor.
[13] Eosinophilic granulomatosis with polyangiitis.
[14] Human epidermal growth factor receptor 2.
[15] Relapsed or refractory chronic lymphocytic leukaemia.
[16] Neuromyelitis optica spectrum disorder.
[17] Epidermal growth factor receptor mutation.
[18] Non-small cell lung cancer.
[19] Vaccines & Immune Therapies.
[20] In Table 2, the plus and minus symbols denote the directional impact of the item being discussed, e.g. a '+' symbol next to an R&D expense comment indicates that the item increased the R&D expense relative to the prior year.
[21] Cost of goods sold.
[22] Income from disposals of assets and businesses, where the Group does not retain a significant ongoing economic interest, continue to be recorded in Other operating income and expense in the Company's financial statements.
[23] Metastatic castration-resistant prostate cancer.
[24] Human epidermal growth factor receptor mutant.
[25] Chronic lymphocytic leukaemia.
[26] Heart failure with preserved ejection fraction.
[27] Atypical haemolytic uraemic syndrome.
[28] Paroxysmal nocturnal haemoglobinuria.
[29] Programmed death-ligand 1.
[30] Chronic kidney disease.
[31] Chronic obstructive pulmonary disease.
[32] Pressure metered dose inhaler.
[33] Product Sales shown in the Imfinzi line include Product Sales from Imjudo.
[34] COVID-19 monoclonal antibodies.
[35] National reimbursement drug list.
[36] Biliary tract cancer.
[37] Hepatocellular carcinoma.
[38] Small cell lung cancer.
[39] Poly ADP ribose polymerase.
[40] Platinum sensitive relapse.
[41] Breast cancer gene mutation.
[42] Germline (hereditary) breast cancer gene mutation.
[43] Bruton tyrosine kinase inhibitor.
[44] Sodium-glucose cotransporter 2.
[45] Type-2 diabetes.
[46] Heart failure with reserved ejection fraction.
[47] European Society of Cardiology.
[48] Fixed dose combination.
[49] 'New-to-brand' share represents a medicine's share in the dynamic market.
[50] Inhaled corticosteroid.
[51] Long-acting beta-agonist.
[52] Respiratory syncytial virus.
[53] Complement component 5.
[54] Generalised myasthenia gravis.
[55] Other Operating Income.
[56] Other adjustments include fair-value adjustments relating to contingent consideration on business combinations and other acquisition-related liabilities, discount unwind on acquisition-related liabilities (see Note 4) and provision movements related to certain legal matters, including a $510m charge to provisions relating to a legal settlement with BMS and Ono and a $425m charge to provisions relating to a multidistrict litigation proceeding legal settlement in 9M 2023 (see Note 6).
[57] Other adjustments include fair-value adjustments relating to contingent consideration on business combinations and other acquisition-related liabilities, discount unwind on acquisition-related liabilities (see Note 4) and provision movements related to certain legal matters, including a $425m charge to provisions relating to a multidistrict litigation proceeding legal settlement in Q3 2023 (see Note 6).
[58] Securities Exchange Commission.
[59] Based on best prevailing assumptions around currency profiles.
[60] Based on average daily spot rates 1 Jan 2022 to 31 Dec 2022.
[61] Based on average daily spot rates 1 Jan 2023 to 30 Sep 2023.
[62] Based on average daily spot rates 1 Sep 2023 to 30 Sep 2023.
[63] Change vs. the average spot rate for the previous year
[64] Other currencies include AUD, BRL, CAD, KRW and RUB.
[65] Progression free survival.
[66] Central nervous system.
[67] Fluorouracil, oxaliplatin and docetaxel .
[68] Pathologic complete response.
[69] Gastro oesophageal junction.
[70] Transarterial chemoembolisation.
[71] Overall survival.
[72] Immunohistochemistry.
[73] v-erb-b2 avian erythroblastic leukemia viral oncogene homolog 2.
[74] Overall response rate.
[75] Small lymphocytic lymphoma.
[76] Antibody drug conjugate.
[77] Heart failure.
[78] Transthyretin-mediated amyloid cardiomyopathy and transthyretin-mediated amyloid polyneuropathy
[79] Severe eosinophilic asthma.
[80] Immunoglobulin A neuropathy.
[81] Compete Response Letter.
[82] Supplemental biologics license application.
[83] Lactic dehydrogenase.
[84] Transthyretin-mediated amyloid cardiomyopathy.
[85] Effective 1 January 2023, the Group has updated the presentation of Total Revenue. See Note 1 for further details of the presentation of Alliance Revenue.
[86] The table provides an analysis of year-on-year Product Sales, with Actual and CER growth rates reflecting year-on-year growth. Due to rounding, the sum of a number of dollar values and percentages may not agree to totals.
[87] The table provides an analysis of year-on-year Product Sales, with Actual and CER growth rates reflecting year-on-year growth. Due to rounding, the sum of a number of dollar values and percentages may not agree to totals.