AZN: full-year 2020 results

AstraZeneca PLC

11 February 2021 07:00 GMT

Full-year 2020 results

Accelerating the scientific and commercial evolution; 2021 guidance shows continuing progress

AstraZeneca delivered strong results in the year, in line with guidance that was reconfirmed during the year. With over half of Total Revenue coming from the fast-growing new medicines¹, the Company leveraged its revenue growth to make further progress in profitability, while the strategy of sustainable growth through innovation brought numerous further benefits for patients. AstraZeneca's patient-centric strategy, focus on innovation and capital-allocation priorities remain unchanged, with sustainable long-term growth in revenue, profit and cash generation set to continue.

Pascal Soriot, Chief Executive Officer, commented:

"The performance last year marked a significant step forward for AstraZeneca. Despite the significant impact from the pandemic, we delivered double-digit revenue growth to leverage improved profitability and cash generation. The consistent achievements in the pipeline, the accelerating performance of our business and the progress of the COVID-19 vaccine demonstrated what we can achieve, while the proposed acquisition of Alexion is intended to accelerate our scientific and commercial evolution even further.

Additional investment in new medicines continued to fuel our rapidly growing oncology and biopharmaceuticals therapy areas. Tagrisso's future was enhanced with its first regulatory approval in early, potentially-curable lung cancer and further national reimbursement in China in advanced disease. Farxiga again expanded its potential beyond diabetes, while tezepelumab promised real hope for patients suffering from severe asthma. Thanks to the focus on an industry-leading pipeline and consistent execution, I am confident that we will continue to deliver more progress for patients and sustained, compelling results."

Table 1: Financial summary

Highlights of Total Revenue in the year included:

An increase in Product Sales of 10% (11% at CER) to $25,890m. The quarter was the first for many years with Product Sales in excess of $7,000m. New-medicine Total Revenue improved by 33% in the year to $13,950m, including growth in Emerging Markets of 53% (59% at CER) to $2,845m. Globally, the new medicines represented 52% of Total Revenue (FY 2019: 43%)

Oncology growth of 23% (24% at CER) to $11,455m, while New CVRM⁷ increased by 7% (9% at CER) to $4,702m. Respiratory & Immunology declined by 1% (stable at CER) to $5,375m, a reflection of the impact in China of COVID-19

An increase in Emerging Markets of 7% (10% at CER) to $8,711m, with China growth of 10% (11% at CER) to $5,375m. In the US, Total Revenue increased by 13% to $8,833m and in Europe by 10% (9% at CER) to $5,540m. Both regions delivered stronger growth rates in the final quarter compared to the full year - see the Regional Total Revenue section for details

Guidance

The Company provides guidance for FY 2021 at CER.

Total Revenue is expected to increase by a low-teens percentage,
accompanied by faster growth in Core EPS to $4.75 to $5.00.

The guidance does not incorporate any revenue or profit impact from sales of COVID-19 Vaccine AstraZeneca (C19VAZ). The Company intends to report these sales separately from the next quarter. Similarly, the guidance excludes the proposed acquisition by the Company of Alexion Pharmaceuticals, Inc. (Alexion), anticipated to close in Q3 2021. AstraZeneca recognises the heightened risks and uncertainties from the impact of COVID-19. Variations in performance between quarters can be expected to continue.

The Company is unable to provide guidance and indications on a Reported basis because AstraZeneca cannot reliably forecast material elements of the Reported result, including any fair-value adjustments arising on acquisition-related liabilities, intangible-asset impairment charges and legal-settlement provisions. Please refer to the cautionary-statements section regarding forward-looking statements at the end of this announcement.

Indications

The Company provides indications for FY 2021 at CER:

-     AstraZeneca continues its focus on improving operating leverage, while addressing its most important capital-allocation priority of re-investment in the business, namely continued investment in R&D and the support of medicines and patient access in key markets

-     A Core Tax Rate of 18-22%. Variations in the Core Tax Rate between quarters are anticipated to continue

Currency impact

If foreign-exchange rates for January 2021 were seen over the full year, it is anticipated that there would be a low single-digit favourable impact on Total Revenue and Core EPS. The Company's foreign-exchange rate sensitivity analysis is contained within the operating and financial review.

Financial summary

-     Total Revenue, comprising Product Sales and Collaboration Revenue, increased by 9% in the year (10% at CER) to $26,617m. Product Sales grew by 10% (11% at CER) to $25,890m, driven primarily by the performances of the new medicines across Oncology and BioPharmaceuticals, including Tagrisso and Farxiga. Total Revenue included $2m of C19VAZ Product Sales within Other medicines; from the next quarter, AstraZeneca intends to report the C19VAZ sales performance separately

-     The Reported Gross Profit⁸ Margin was stable (up by one percentage point at CER) at 80%, while the Core Gross Profit Margin was stable, also at 80%, in line with the Company's expectations

-     Reported Total Operating Expense declined by 2% in the year to $17,684m and represented 66% of Total Revenue (FY 2019: 74%). Core Total Operating Expense increased by 6% to $15,633m and comprised 59% of Total Revenue (FY 2019: 60%)

-     Reported R&D Expense declined by 1% in the year to $5,991m, primarily reflecting the comparative effect of the $533m impairment of Epanova in FY 2019. Core R&D Expense increased by 10% to $5,872m, representing 22% of Total Revenue (FY 2019: 22%). The increases partly reflected investment in the Oncology pipeline, including the development of datopotamab deruxtecan (DS-1062), and the ending in FY 2019 of the release of the upfront funding of Lynparza development, as part of the collaboration with MSD⁹

-     Reported SG&A Expense declined by 3% in the year to $11,294m; Core SG&A Expense increased by 3% (4% at CER) to $9,362m, representing 35% of Total Revenue (FY 2019: 37%). The difference in the movements partly reflected fair-value adjustments arising on acquisition-related liabilities, as well as an increase in legal provisions recognised in 2019

-     Reported Other Income and Expense declined by 1% in the year to $1,528m. Core Other Income and Expense fell by 2% to $1,531m

-     The Reported Operating Profit Margin increased by seven percentage points in the year (eight at CER) to 19%. The Core Operating Profit Margin increased by one percentage point (two at CER) to 28% and AstraZeneca anticipates further sustainable expansion in the Core Operating Profit Margin over time

-     Reported EPS of $2.44 in the year represented an increase of 137% (142% at CER). Core EPS grew by 15% (18% at CER) to $4.02

-     The Board has reaffirmed its commitment to the progressive dividend policy. A stable second interim dividend of $1.90 per share has been declared, keeping the unchanged full-year dividend per share at $2.80

-     Net Cash Inflow from Operating Activities of $4,799m in the year, a year-on-year increase of $1,830m, primarily reflected an underlying improvement in business performance and declines in Working Capital and Short-Term Provisions. EBITDA progression continued, with growth of 24% (27% at CER) in the year to $8,311m, while Net Debt of $12,110m represented an increase of $206m

Commercial summary

Oncology

Total Revenue increased by 23% in the year (24% at CER) to $11,455m.

Table 2: Select Oncology medicine performances

New CVRM

Total Revenue increased by 7% in the year (9% at CER) to $4,702m.

Table 3: Select New CVRM medicine performances

Respiratory & Immunology

Total Revenue declined by 1% in the year (stable at CER) to $5,375m. The adverse impact of the decline in Pulmicort sales reduced Respiratory & Immunology Total Revenue growth by 12 percentage points.

Table 4: Select Respiratory & Immunology medicine performances

Emerging Markets

Total Revenue increased by 7% in the year (10% at CER) to $8,711m, including:

-     A China increase of 10% (11% at CER) to $5,375m. The strong performance was limited by the adverse impacts of COVID-19 on sales of Pulmicort and the pricing effect of the China volume-based procurement (VBP) programme on Brilinta, Losec and Arimidex. The Company continued to prioritise patient access to its medicines and geographical expansion in the Chinese market; this included additional successful inclusion of a number of medicines on the National Reimbursement Drug List (NRDL). Admission to the list has an immediate adverse impact on pricing; typically, however, this is more than offset by a subsequent favourable effect on volumes

-     An ex-China increase of 1% (9% at CER) to $3,336m, with particularly strong performances in Russia and Latin America

COVID-19

The ongoing pandemic has had a significant impact on every aspect of life in 2020, and the Company recognises the outstanding contribution of colleagues at AstraZeneca and their unrelenting focus on improving the lives of patients. The largest direct impacts of COVID-19 on the Company's portfolio of medicines included reduced sales of Pulmicort in China on fewer nebulisation-centre visits and reduced elective surgery, and less use globally of infused and injectable medicines, such as Imfinzi and Fasenra. There was also a decline in the number of hospital admissions around the world for the treatment of heart attacks and lower levels of elective percutaneous coronary intervention¹⁰, adversely impacting sales of Brilinta. Some medicines, however, may have benefited from shifts in patient care and behaviours, including oral medicines such as Calquence, which saw an element of benefit from the substitution from infused-chemotherapy regimens.

AstraZeneca has collaborated to mobilise research efforts to target the SARS-CoV-2 virus, in order to provide protection to societies and people against COVID-19 and to treat patients with severe disease. C19VAZ, developed in collaboration with the University of Oxford, received authorisation in December 2020 for emergency supply from the UK Medicines and Healthcare Products Regulatory Agency (MHRA). Additional regulatory decisions have also been granted by regulatory authorities in a number of individual countries, including India, Argentina, Mexico and Morocco, and by the European Medicines Agency (EMA). In February 2021, the World Health Organization's (WHO) Strategic Advisory Group of Experts on Immunization (SAGE)  also recommended C19VAZ for use in individuals 18 years and over, with a preferred dosing interval of eight to 12 weeks.

In addition to C19VAZ, the Company has initiated five Phase III clinical trials of AZD7442, a long-acting antibody (LAAB) combination therapy for the prevention and treatment of COVID-19, to evaluate safety and efficacy in preventing infection and treating patients in outpatient and inpatient settings. Further details of the Company's broad COVID-19 research and development programme are shown in the research and development section of this announcement. Details of AstraZeneca's work with governments and other organisations, including agreements on the supply of C19VAZ, can be found in the comprehensive sustainability section of this announcement.

Sustainability summary

During the period, the Company received recognition of its broad sustainability efforts, featuring in the top five for the sector in the Dow Jones Sustainability Index (DJSI) and inclusion in the Corporate Knights Global 100 Index, which identifies globally sustainable companies.

Recent developments and progress against the Company's sustainability priorities are reported below:
 

a)   Access to healthcare

In December 2020, AstraZeneca, through an advanced-purchase agreement with Gavi, the Vaccines Alliance, committed to enabling access to 170m doses of C19VAZ in up to 190 countries worldwide, through the COVAX Facility (COVAX). COVAX is a coalition co-led by CEPI, the Coalition for Epidemic Preparedness Innovations, Gavi, and the WHO. It is the only global initiative bringing governments and manufacturers together to ensure that safe and effective COVID-19 vaccines are available worldwide to both higher-income and lower-income countries.
 

b)   Environmental protection

During the period, AstraZeneca was recognised for its leadership in sustainability by global environmental non-profit CDP, a charity that runs a global disclosure system for investors, companies, cities, states and regions to manage their environmental impacts. The Company received a place on the 'A List' for both climate action and water security. AstraZeneca was one of only three organisations worldwide to achieve this double A List recognition for five consecutive years. The Company also featured among the top 7% on CDP's 2020 Supplier Engagement Leaderboard, recognising progress in working with suppliers to address their emissions.
 

c)   Ethics and transparency

In January 2021, the Company was recognised for its efforts in promoting inclusion and diversity by the Bloomberg Gender Equality Index (BGEI), which tracks the performance of public companies committed to disclosing their efforts to support gender equality through policy development, representation and transparency. The Company was also listed as a participant in ShareAction's Workforce Disclosure Initiative (WDI), an annual survey that aims to improve corporate transparency and accountability on workforce issues and provide companies and investors with comprehensive and comparable data to help increase the provision of good jobs worldwide.

A more extensive sustainability update is provided later in this announcement.

Notes

The following notes refer to pages one to five.

1.   Tagrisso, Imfinzi, Lynparza, Calquence, Enhertu, Koselugo, Farxiga, Brilinta, Lokelma, roxadustat, Fasenra, Bevespi and Breztri. The new medicines are pillars in the three therapy areas of Oncology, Cardiovascular (CV), Renal & Metabolism (CVRM), and Respiratory & Immunology and are important platforms for future growth. The Total Revenue of Enhertu and roxadustat in the year entirely reflected Collaboration Revenue.

2.   Constant exchange rates. These are financial measures that are not accounted for according to generally accepted accounting principles (GAAP) because they remove the effects of currency movements from Reported results.

3.   Reported financial measures are the financial results presented in accordance with International Financial Reporting Standards (IFRS), adopted pursuant to Regulation (EC) No 1606/2002 as it applies in the EU and as issued by the International Accounting Standards Board.

4.   Earnings per share.

5.   Not meaningful.

6.   Core financial measures. These are non-GAAP financial measures because, unlike Reported performance, they cannot be derived directly from the information in the Group's Financial Statements. See the operating and financial review for a definition of Core financial measures and a reconciliation of Core to Reported financial measures.

7.   New CVRM comprises Brilinta, Renal and Diabetes medicines.

8.   Gross Profit is defined as Total Revenue minus Cost of Sales. The calculation of Reported and Core Gross Profit Margin excludes the impact of Collaboration Revenue and any associated costs, thereby reflecting the underlying performance of Product Sales.

9.   Merck & Co., Inc., Kenilworth, NJ, US, known as MSD outside the US and Canada.

10.  Percutaneous coronary intervention is a nonsurgical procedure intended to improve blood flow to the heart.

Table 5: Pipeline highlights

The following table highlights significant developments in the late-stage pipeline since the prior results announcement:

Table 6: Pipeline - anticipated major news flow

Conference call

A conference call and webcast for investors and analysts will begin at 11:45am UK time today. Details can be accessed via astrazeneca.com.

Reporting calendar

The Company intends to publish its first-quarter results on Friday, 30 April 2021.

AstraZeneca

AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, CVRM, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.

Contacts

For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here.

Operating and financial review

All narrative on growth and results in this section is based on actual exchange rates, and financial figures are in US$ millions ($m), unless stated otherwise. The performance shown in this announcement covers the twelve-month period to 31 December 2020 (the year or FY 2020) and the three-month period to 31 December 2020 (the quarter, the fourth quarter or Q4 2020), compared to the twelve-month period to 31 December 2019 (FY 2019) and the three-month period to 31 December 2019 (Q4 2019) respectively, unless stated otherwise.

Forward-looking statements in this announcement do not reflect the impact of the performance of C19VAZ or the proposed acquisition by the Company of Alexion, which is expected to close in Q3 2021.

Core financial measures, EBITDA, Net Debt, Initial Collaboration Revenue and Ongoing Collaboration Revenue are non-GAAP financial measures because they cannot be derived directly from the Group's Condensed Consolidated Financial Statements. Management believes that these non-GAAP financial measures, when provided in combination with Reported results, will 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

-     Other specified items, principally comprising the Diabetes alliance^[39], acquisition-related costs, which include fair-value adjustments and the imputed finance charge relating to contingent consideration on business combinations and legal settlements

Details on the nature of Core financial measures are provided on page 80 of the Annual Report and Form 20-F Information 2019. Reference should be made to the Reconciliation of Reported to Core financial measures table included in the financial performance section in this announcement.

EBITDA is defined as Reported Profit Before Tax after adding back Net Finance Expense, results from Joint Ventures and Associates and charges for Depreciation, Amortisation and Impairment. Reference should be made to the Reconciliation of Reported Profit Before Tax to EBITDA included in the financial performance section in this announcement.

Net Debt is defined as Interest-bearing loans and borrowings and Lease liabilities, net of Cash and cash equivalents, Other investments, and net Derivative financial instruments. Reference should be made to Note 3 'Net Debt' included in the Notes to the Condensed Financial Statements in this announcement.

Ongoing Collaboration Revenue is defined as Collaboration Revenue excluding Initial Collaboration Revenue (which is defined as Collaboration Revenue that is recognised at the date of completion of an agreement or transaction, in respect of upfront consideration). Ongoing Collaboration Revenue comprises, among other items, royalties, milestone revenue and profit-sharing income. Reference should be made to the Collaboration Revenue table in this operating and financial review.

The Company strongly encourages investors and analysts not to rely on any single financial measure, but to review AstraZeneca's financial statements, including the Notes thereto and other available Company reports, carefully and in their entirety.

Due to rounding, the sum of a number of dollar values and percentages may not agree to totals.

Table 7: Total Revenue by therapy area

Specialty-care medicines comprise all Oncology medicines, Brilinta, Lokelma, roxadustat and Fasenra. At 53% of Total Revenue (FY 2019: 48%), specialty-care medicines increased by 21% in the year (22% at CER) to $14,103m.

Table 8: Top-ten medicines by Total Revenue

Table 9: Collaboration Revenue

Other Collaboration Revenue included Zoladex, Farxiga, Eklira, Nexium OTC^[40] and other royalties. No Initial Collaboration Revenue was recorded in the year.

Total Revenue

The performance of the Company's medicines is shown below, with a geographical split of Product Sales shown in Note 7.

Table 10: Therapy area and medicine performance - FY 2020

Table 11: Therapy area and medicine performance - Q4 2020

Total Revenue summary

Oncology

Total Revenue of $11,455m in the year; an increase of 23% (24% at CER). The performance of Enhertu was reflected entirely in Collaboration Revenue.

Oncology represented 43% of overall Total Revenue (FY 2019: 38%).

Tagrisso

Tagrisso has received regulatory approval in five countries, including the US, for use as an adjuvant treatment of EGFRm NSCLC patients, with three reimbursements granted so far. This expands upon the patient benefit from use in the 1st-line treatment of patients with EGFRm NSCLC with regulatory approval in 87 countries, including the US, China, in the EU and Japan. To date, reimbursement has been granted in 40 countries in this setting, with further decisions anticipated. These developments followed Tagrisso's regulatory approval in 89 countries, including the US, China, in the EU and Japan for the treatment of patients with EGFR T790M^[42] NSCLC, an indication in which 66 reimbursements have been obtained.

Total Revenue, entirely comprising Product Sales, amounted to $4,328m in the year and represented growth of 36%. Sales in the US increased by 24% to $1,566m. Approval was granted by the US Food and Drug Administration (FDA) in December 2020 for the adjuvant treatment of Stage Ib to IIIa EGFRm NSCLC patients.

In Emerging Markets, Tagrisso sales increased by 59% in the year (63% at CER) to $1,208m, with notable growth in China; admission to the 2021 China NRDL was obtained for the 1st-line and renewed for the 2nd-line setting, commencing in March 2021. Japan increased by 16% (14% at CER) to $731m, despite a Q4 2019 price reduction of 15%. In Europe, sales of $748m in the year represented an increase of 58% (56% at CER), driven by use in the 1st-line setting, as more reimbursements were granted.

Imfinzi

Imfinzi has received regulatory approval in 67 countries, including the US, China, in the EU and Japan for the treatment of patients with unresectable, Stage III NSCLC whose disease has not progressed following platinum-based chemoradiation therapy (CRT). The number of reimbursements increased to 28 in the year. Imfinzi has also been approved for the treatment of ES-SCLC patients in 51 countries, with five reimbursements obtained.

Total Revenue, entirely comprising Product Sales, amounted to $2,042m in the year and represented growth of 39%, predominantly for the treatment of unresectable, Stage III NSCLC patients. The US increased by 14% to $1,185m; in Japan, growth of 28% (26% at CER) represented sales of $270m. Europe increased by 106% (104% at CER) to $370m, reflecting a growing number of reimbursements, while Emerging Markets increased to $158m (FY 2019: $30m), following recent regulatory approvals and launches, including in China.

Lynparza

Lynparza has received regulatory approval in 78 countries for the treatment of ovarian cancer; it has also been approved in 76 countries for the treatment of metastatic breast cancer, and in 55 countries for the treatment of pancreatic cancer. Lynparza has received regulatory approval in 49 countries for the 2nd-line treatment of certain prostate-cancer patients.

Lynparza Total Revenue amounted to $2,236m in the year and represented growth of 24%; this included Collaboration Revenue of $460m.

Product Sales in the year amounted to $1,776m, reflecting growth of 48% (49% at CER). The strong performance was geographically spread, with further indication launches continuing globally. US Product Sales increased by 40% to $876m, as the launches in prostate cancer and 1st-line HRD+ ovarian cancer started to take effect. Lynparza continued to be the leading medicine in the poly ADP ribose polymerase-inhibitor (PARPi) class, as measured by total prescription volumes. Product Sales in Europe increased by 52% (51% at CER) to $435m, reflecting additional reimbursements and increasing BRCAm-testing rates, as well as successful recent 1st-line BRCAm ovarian cancer launches, including in the UK and Germany.

Japan Product Sales of Lynparza amounted to $167m, representing growth of 29% (27% at CER). Emerging Markets Product Sales were $264m, up by 98% (108% at CER). In China, Lynparza was admitted to the NRDL as a 1st-line treatment for BRCAm ovarian cancer patients with effect from March 2021.

Enhertu

US sales, recorded by Daiichi Sankyo Company Limited (Daiichi Sankyo), amounted to $200m in the year, including $64m in the quarter. Enhertu was approved at the end of 2019 by the US FDA for the treatment of 3rd-line HER2+ breast cancer. Total Revenue, entirely comprising Collaboration Revenue recorded by AstraZeneca, amounted to $96m in the year, with $33m recorded in the quarter.

Calquence

Total Revenue, entirely comprising Product Sales, amounted to $522m in the year and represented growth of 219%, with the overwhelming majority of sales in the US. Calquence was approved by the US FDA for the treatment of CLL in November 2019. In total, Calquence has received regulatory approvals for this indication in 51 countries and in 23 countries for the treatment of patients with R/R mantle cell lymphoma (MCL).

Koselugo

Total Revenue, entirely comprising Product Sales in the US, amounted to $38m in the year, following its launch during the second quarter for the treatment of the rare disease NF1 in paediatric patients aged two years and older who have symptomatic, inoperable plexiform neurofibromas.

Zoladex

Total Revenue, predominantly comprising Product Sales, amounted to $938m in the year and represented growth of 13% (17% at CER).

Emerging Markets Product Sales of Zoladex increased by 14% (20% at CER) to $561m, reflecting increased use and access in prostate cancer. Product Sales in Europe increased by 4% to $140m while, in the Established Rest of World (RoW) region, Product Sales increased by 1% to $182m.

Faslodex

Total Revenue, entirely comprising Product Sales, amounted to $580m in the year and represented a decline of 35% (34% at CER).

Emerging Markets fell by 9% (4% at CER) to $180m, while US sales declined by 83% to $55m, reflecting the launch in 2019 of multiple generic Faslodex medicines; in Europe, sales fell by 3% to $221m. In Japan, they declined by 11% (13% at CER) to $116m, driven by a mandated price reduction in the second quarter.

Iressa

Total Revenue, entirely comprising Product Sales, amounted to $268m in the year and represented a decline of 37% (36% at CER). Emerging Markets fell by 23% (22% at CER) to $221m, driven by the impact of Iressa's inclusion in China's VBP programme and subsequent price reduction.

BioPharmaceuticals: CVRM

Total Revenue increased by 3% in the year (4% at CER) to $7,139m and represented 27% of Total Revenue (FY 2019: 29%). This included roxadustat Collaboration Revenue of $30m, as well as the Product Sales of Crestor and other legacy medicines.

New CVRM Total Revenue, which excludes sales of Crestor and other legacy medicines, increased by 7% in the year (9% at CER) to $4,702m, mainly reflecting the strong performance of Farxiga. New CVRM represented 66% of overall CVRM Total Revenue in the year (FY 2019: 63%).

Farxiga

Total Revenue, predominantly comprising Product Sales, amounted to $1,964m in the year and represented growth of 27% (30% at CER). Q4 2020 Total Revenue increased by 40% to $587m, reflecting volume growth across the regions.

Emerging Markets Product Sales increased by 46% in the year (55% at CER) to $686m. In China, Forxiga was admitted to the NRDL with effect from the start of 2020; as expected, this adversely impacted pricing. This was, however, more than offset by the derived volume uplift.

US Product Sales increased by 6% in the year to $569m, partly driven by regulatory approval in May 2020 for the treatment of patients with heart failure with reduced ejection fraction (HFrEF) in both patients with and without T2D, based on the compelling patient benefit seen in the results from the DAPA-HF trial. Sales in the fourth quarter increased by 31% to $184m, reflecting by the comparative effect of an adverse prior-year gross-to-net adjustment.

Product Sales in Europe increased by 36% in the year (35% at CER) to $507m, partly reflecting growth in the SGLT2^[43] class, the beneficial addition of CVOT data to the label and HFrEF regulatory approval in November 2020. In Japan, sales to collaborator Ono Pharmaceutical Co., Ltd, which records in-market sales, increased by 29% (27% at CER) to $117m.

Brilinta

Total Revenue, entirely comprising Product Sales, amounted to $1,593m in the year and represented growth of 1% (2% at CER).

Global demand over the year was adversely impacted by the effects of COVID-19, reflected in fewer acute coronary syndrome hospital admissions. Sales in Q4 2020 declined by 15% to $363m, also driven by a VBP-related mandatory price reduction in China in Q3 2020.

Emerging Markets sales were stable in the year (up by 4% at CER) at $461m. Sales in the fourth quarter, however, declined by 39% (36% at CER) to $69m, following the aforementioned price reduction in China. US sales, at $732m, represented growth of 3%, with an increase in the average-weighted duration of treatment partly offset by the adverse COVID-19 impact, also reflected in fewer elective procedures. Sales of Brilique in Europe declined by 3% in the year to $342m, with the performance similarly impacted by COVID-19.

Onglyza

Total Revenue, entirely comprising Product Sales, amounted to $470m in the year and represented a decline of 11% (10% at CER).

Sales in Emerging Markets increased by 14% (18% at CER) to $201m, driven by the performance in China and the growing DPP-4^[44] class. US sales of Onglyza fell by 28% in the year to $166m, while Europe sales declined by 16% (17% at CER) to $58m, highlighting the shift away from the class.

Bydureon

Total Revenue, entirely comprising Product Sales, amounted to $448m in the year and represented a decline of 18%.

US sales of $382m reflected a fall of 17% in the year, resulting from competitive pressures and the impact of managed markets. Sales in Europe declined by 20% to $53m.

Lokelma

Total Revenue, entirely comprising Product Sales, amounted to $76m in the year (FY 2019: $14m), an increase of 461% (463% at CER), despite the impact from COVID-19 on the overall market. The US represented the overwhelming majority of sales; Lokelma continued to lead new-to-brand prescription market share in the US. The medicine has received regulatory approval in several markets for the treatment of hyperkalaemia, including in the EU, China and Japan, with further launches anticipated in a number of markets soon. In December 2020, the medicine was excluded from the latest round of the China NRDL process.

Roxadustat

Total Revenue, entirely comprising Collaboration Revenue, amounted to $30m in the year in China. Q4 2020 revenue of $11m reflected a sequential quarterly increase of 46%. The Company continued to focus in the year on achieving hospital listings and patient access across China.

In July 2020, FibroGen Inc. (FibroGen) and AstraZeneca entered into an amendment to revise the existing licence agreement for roxadustat in China. From January 2021, the Company recognised the overwhelming majority of its future revenue in China as Product Sales.

Crestor

Total Revenue, predominantly comprising Product Sales, amounted to $1,182m in the year and represented a decline of 10% (9% at CER).

Product Sales in Emerging Markets fell by 7% (5% at CER) to $748m. The performance continued to be adversely impacted by the ongoing effects of the aforementioned VBP programme in China. US Product Sales declined by 11% to $92m. In Europe, Total Revenue fell by 31% (32% at CER) to $131m while, in Japan, where AstraZeneca collaborates with Shionogi Co., Ltd, Product Sales declined by 4% (5% at CER) to $164m.

In December 2020, it was announced that the Company had agreed to sell the commercial rights to Crestor in over 30 countries in Europe to Grünenthal GmbH. The divestment closed earlier in the first quarter of 2021.

BioPharmaceuticals: Respiratory & Immunology

Total Revenue declined by 1% in the year (stable at CER) to $5,375m and represented 20% of Total Revenue (FY 2019: 22%). This included Ongoing Collaboration Revenue of $18m from Duaklir, Eklira and other medicines.

Symbicort

Total Revenue, entirely comprising Product Sales, amounted to $2,721m in the year and represented an increase of 9% (10% at CER), a result of growth in the US. Q4 2020 Total Revenue declined by 5% to $680m, driven by the impact of generic competition in Europe and Japan. Symbicort remains the global market-volume and value leader within the inhaled corticosteroid (ICS) / long-acting beta agonist (LABA) class.

US sales grew by 23% in the year to $1,022m; an authorised-generic version of Symbicort was launched in the US by the Company's collaborator, Prasco LLC (Prasco), in January 2020. The performance in Emerging Markets in the year slowed down versus FY 2019, reflecting a reduction in hospital visits in China due to COVID-19, leading to fewer initiations. Despite this, Emerging Markets sales increased by 4% (9% at CER) to $567m.

In Europe, sales increased by 2% in the year to $694m, with positive volume growth seen in the major countries. In Japan, sales declined by 16% (18% at CER) to $189m, driven by the impact of generic competition and an unfavourable price comparison versus 2019, partly reflecting the termination of the Astellas Pharma Inc. co-promotion agreement. This impact in Japan was particularly acute in the fourth quarter, when sales declined by 53% (54% at CER) to $45m.

Pulmicort

Total Revenue, entirely comprising Product Sales, amounted to $996m in the year and represented a decline of 32%, as the continued effects of COVID-19 impacted the hospital treatment of respiratory patients. Q4 2020 Total Revenue declined by 11% (14% at CER) to $368m.

Emerging Markets, where Pulmicort sales fell by 33% in the year to $798m, represented 80% of the global total. Alongside the effects of COVID-19, the performance in China was impacted by a reduction in the number of paediatric patients attending outpatient nebulisation rooms. In the fourth quarter, however, the volume of adult elective procedures, a smaller use, largely recovered. Pulmicort can be used in this setting when oral corticosteroids (OCS) are unsuitable.

Sales in the US declined by 35% in the year to $71m, due to the fall in the use of Pulmicort Respules. In Japan, sales declined by 51% (52% at CER) to $30m as a result of generic competition and fell in Europe by 10% to $73m.

Fasenra

Fasenra has received regulatory approval in 59 countries, including the US, in the EU and Japan for the treatment of patients with severe, uncontrolled eosinophilic asthma. With further regulatory reviews ongoing, Fasenra has already achieved reimbursement in 47 countries.

Total Revenue, entirely comprising Product Sales, amounted to $949m in the year and represented growth of 35% (34% at CER), a result of increased demand, despite the impact of COVID-19 on the level of new-patient starts in several countries. Fasenra remained the leading novel biologic in the majority of markets in the new-to-brand prescription share for patients with severe, uncontrolled asthma.

Sales in the US grew by 25% in the year to $603m, due to increased volume demand as a result of the impact of COVID-19 earlier in the year. The adverse effect of COVID-19 on the dynamic market was partially offset by the growth in market share and increased persistency. In Europe, sales of $203m represented an increase of 72% (70% at CER), reflecting ongoing successful launches and additional reimbursement. Sales in Japan increased by 16% (14% at CER) to $100m. In Emerging Markets, sales amounted to $12m (FY 2019: $5m).

Daliresp/Daxas

Total Revenue, entirely comprising Product Sales, amounted to $217m in the year and represented an increase of 1%. US sales, comprising 88% of the global total, increased by 3% to $190m.

Bevespi

Total Revenue, entirely comprising Product Sales, amounted to $48m in the year and represented an increase of 16% (15% at CER). Bevespi has been launched in the US, in a number of European countries and in Japan. Sales in the US increased by 7% in the year to $44m while, in Europe, sales amounted to $3m (FY 2019: $nil). Bevespi was recently included in the China NRDL, with effect from March 2021.

Breztri

Breztri has received regulatory approval in 34 countries, including the US, in the EU, China and Japan for the treatment of patients with COPD. With further regulatory reviews ongoing, Breztri has already achieved reimbursement in four countries.

Total Revenue, entirely comprising Product Sales, amounted to $28m in the year (FY 2019: $2m). Sales in the US amounted to $5m (FY 2019: $nil), largely as a result of stocking. Sales in Japan amounted to $9m (FY 2019: $2m) where prescriptions were limited by Ryotanki, a regulation which limits prescriptions to two weeks' supply in the first year of launch. In October 2020, Ryotanki was lifted for Breztri and the restriction no longer applied. Emerging Markets amounted to $14m (FY 2019: $nil). Breztri was recently included in the China NRDL, with effect from March 2021.

Other medicines (outside the three main therapy areas)

Total Revenue, primarily comprising Product Sales, amounted to $2,649m in the year, representing a decline of 2%. The performance partly reflected the divestment of global rights to Movantik, excluding Europe, Canada and Israel, to RedHill Biopharma in April 2020. Other medicines Total Revenue represented 10% of overall Total Revenue (FY 2019: 11%).

Nexium

Total Revenue, predominantly comprising Product Sales, amounted to $1,524m in the year, representing an increase of 1% (2% at CER). Emerging Markets Product Sales of Nexium increased by 1% (4% at CER) to $757m in the year, with particular strength in Q4 2020 when sales of $193m represented an increase of 11%, reflecting later phasing of demand in the year.

In Japan, where AstraZeneca collaborates with Daiichi Sankyo, Product Sales increased by 6% (4% at CER) to $423m, while Product Sales in the US declined by 22% to $169m. In Europe, Product Sales increased by 12% (10% at CER) to $71m.

Further to the previous VBP-programme round in Q4 2020, China concluded another round in February 2021, including Nexium (oral). The Company, however, chose not to compete on price and consequently accepted a mandatory price reduction of 30%.

Losec/Prilosec

Total Revenue, entirely comprising Product Sales, amounted to $183m in the year, representing a decline of 30%. This partly reflected the divestment of global commercial rights, excluding China, Japan, the US and Mexico, to Cheplapharm Arzneimittel GmbH (Cheplapharm) in October 2019. Emerging Markets fell by 15% (14% at CER) to $152m as Losec was subject to a mandatory price reduction as part of the impact of aforementioned VBP programme in China; sales in Europe fell by 59% to $20m.

FluMist

Total Revenue, entirely comprising Product Sales, increased by 161% in the year (153% at CER) to $295m, reflecting the greater use of influenza vaccines as health authorities in northern-hemisphere countries expanded seasonal-vaccination programmes beyond typical levels during the ongoing COVID-19 pandemic. In the US, sales increased by 254% in the year to $70m and, in Europe, by 135% (126% at CER) to $219m.

Synagis

The commercial rights to the sale and distribution of Synagis outside the US, held by AbbVie Inc (AbbVie) since 1997, will revert to AstraZeneca upon the expiry of the current agreement on 30 June 2021. In general, the Company will solely distribute and promote the medicine outside the US from 1 July 2021. The agreement with Swedish Orphan Biovitrum AB (publ), for the rights to Synagis in the US, was unaffected by this decision.

Total Revenue, entirely comprising Product Sales, amounted to $372m in the year, representing an increase of 4%. In Q4 2020, global sales increased by 24% to $78m, reflecting the phasing of orders from AbbVie and preparations for the aforementioned reversion of commercial rights. Sales in Europe, wholly reflecting sales to AbbVie made under the current supply agreement for markets outside the US, amounted to $325m in the year, representing an increase of 4%.

Regional Total Revenue

Table 12: Regional Total Revenue