Astrazeneca Regulatory News (AZN)

AstraZeneca PLC

29 April 2020 07:00 BST

First-quarter 2020 results

Robust results in unprecedented times; leveraging scientific expertise in the fight against COVID-19

AstraZeneca delivered a quarter of strong revenue and profit growth, reflecting the immense efforts of supply-chain, commercial and other colleagues around the world to get vital medicines to patients. As part of the fight, the Company has rapidly responded to the pandemic, firstly in China and then globally.

Pascal Soriot, Chief Executive Officer, commented:

"Our focus ensured another quarter of strong growth across every therapy area and region. The new medicines performed extremely well, and our pipeline continued to deliver. Standouts included landmark news for Tagrisso, Farxiga and Koselugo, our latest oncology medicine. The progress made on all fronts provides confidence that we will, once again, meet our full-year commitments.

I could not be prouder of how the AstraZeneca team has responded to the challenges of COVID-19. We moved quickly to maintain continuity of care, contribute to society, and use our scientific expertise to fight the pandemic. We hope our efforts to protect organs from damage, mitigate the cytokine storm and the associated hyperinflammatory state, and target the virus prove to be successful."

COVID-19

The Company donated nine million face masks to support healthcare workers around the world, delivered in collaboration with the World Economic Forum's COVID Action Platform. AstraZeneca also contributed to the UK Government's testing effort with a dedicated site in Cambridge operated in collaboration with the University of Cambridge and GlaxoSmithKline plc (GSK), with a goal to deliver 30,000 tests a day in May 2020.

The Company has mobilised research efforts to find new ways to help target the virus, reduce the cytokine storm, arising from an overactive immune response, and potentially protect organs. As part of the effort to target the virus, the Company is identifying novel SARS-CoV-2-neutralising monoclonal antibodies that can be used for treatment, as well as a prophylaxis against viral infection.

AstraZeneca is evaluating the use of Calquence, approved in a number of countries for the treatment of chronic lymphocytic leukaemia, in the Phase II CALAVI trial, which is assessing the suppression of the cytokine storm that inflames the lungs and other organs of some COVID-19 patients. The Company is also looking at protecting organs in the Phase III DARE-19 trial, assessing whether Farxiga, an oral medicine that has demonstrated benefits in heart failure and kidney disease, can potentially reduce organ failure. The Company has also joined the UK Government's ACCORD-2 proof-of-concept clinical-trial platform, to speed the development of medicines for patients with COVID-19.

Q1 2020 financial performance

Table 1: Financial summary

Of the growth at CER in Total Revenue, AstraZeneca estimates a low-to-mid single-digit percentage benefit of short-term inventory increases in the distribution channel, longer prescriptions and improved treatment-regimen adherence by patients, as indirect effects of the ongoing COVID-19 pandemic. This benefit is anticipated to reverse in the coming months.

The new medicines5 continued to perform especially well and there was excellent progress from the pipeline, with several regulatory approvals and particularly significant news regarding the potential use of Tagrisso in the adjuvant treatment of EGFRm6 lung cancer, as well as Farxiga in chronic kidney disease.

Total Revenue growth of 16% (17% at CER) to $6,354m; this included Product Sales of $6,311m (+15%, +17% at CER). Total Revenue increased in the quarter across all three therapy areas7 and in every region. Highlights included:

- The performance of the new medicines, improving by 47% (49% at CER) to $2,986m, included new-medicine growth in Emerging Markets of 82% (87% at CER) to $658m. These medicines represented 47% of Total Revenue (Q1 2019: 37%)

- Total Revenue growth across all therapy areas: Oncology +33% (+34% at CER) to $2,518m, New CVRM8 +7% (+8% at CER) to $1,102m and Respiratory & Immunology +21% (+22% at CER) to $1,555m

- Total Revenue growth in every region: an increase in Emerging Markets of 13% (16% at CER) to $2,273m, with China Total Revenue growth of 14% (17% at CER) to $1,416m. Total Revenue in the US increased by 16% in the quarter to $2,091m and in Europe by 22% (25% at CER) to $1,204m; Japan Total Revenue increased by 10% (8% at CER) to $553m

Broad Company response to COVID-19

AstraZeneca's priority during the COVID-19 global pandemic is to continue to safely supply all of the Company's medicines to millions of patients. A description of the specific impact on and the actions by the Company regarding the pandemic is shown below; for the latest AstraZeneca communications regarding COVID-19, please click here.

a) Colleagues

Office-based colleagues are typically working from home; in a growing number of countries that are potentially past the pandemic's peak, however, colleagues have returned to the office, in line with government guidelines. For supply-chain and research and development (R&D) roles that cannot be performed from home, AstraZeneca has put clear processes in place relating to social distancing. In April 2020, the Company implemented voluntary assessments of critical supply-chain and manufacturing colleagues at three sites, using the Company's own laboratories, to rapidly identify and isolate COVID-19 cases.

b) Supply chain

The Company did not see any material disruptions to its supply chain in the period. AstraZeneca's manufacturing sites in China returned to full capacity within weeks of the declared outbreak, with little intervening impact on supply. The Company's supply chain includes an effective inventory management policy for each medicine, as well as robust business continuity plans (BCPs). These plans seek to ensure that there are appropriate inventory levels of active pharmaceutical ingredients and critical materials to ensure manufacturing and supply continuity. AstraZeneca's approach to BCP utilises various strategic measures, for example, inventory, dual-supply processes, and operational agility.

Some medicines experienced particular growth in global demand in the quarter, partly reflecting short-term inventory increases in the distribution channel, as well as prescription-lengthening and improved treatment-regimen adherence by patients. This growth in the quarter was within the Company's fulfilment capability; AstraZeneca is, however, closely monitoring fulfilment risks, particularly within Respiratory & Immunology.

c) Sales and marketing

Interactions with healthcare professionals and organisations have been significantly impacted and virtual meetings today, especially in the US, Europe and Japan, remain predominant. As part of the early response to the pandemic, AstraZeneca quickly expanded its levels of digital activities, including:

- remote detailing to healthcare professionals

- collaborating with telemedicine providers and e-pharmacies

- investing in new platforms designed for communication with healthcare professionals

In a growing number of countries that are potentially past the pandemic's peak, face-to-face meetings with healthcare professionals have been increasingly reinitiated.

d) Clinical trials

AstraZeneca has focused on ensuring the continued safety of patients in all of its ongoing clinical trials, while activating continuity plans in order to minimise trial disruption from the pandemic. Mitigation strategies included home-based treatment and monitoring options, moving patient recruitment to less-affected regions, and planning for accelerated recruitment once the pandemic has receded. Having assessed the COVID-19 impact across the pipeline, the Company does not expect material delays to anticipated dates of late-stage and lifecycle-management news flow in 2020 and 2021.

Impact on operations, performance and the Condensed Consolidated Interim Financial Statements

The impact of COVID-19 on the Company's operations is highly uncertain and cannot be predicted with confidence and the extent of any adverse impact on AstraZeneca's operations will depend on the global duration, extent and severity of the pandemic. To the extent the pandemic adversely affects AstraZeneca operations and/or performance, the Company expects it to have the effect of heightening many of the risks described beginning on page 246 in the Risk section of the Annual Report and Form 20-F Information 2019, such as those relating to the delivery of the pipeline or launch of new medicines, the execution of the Company's commercial strategy, the manufacturing and supply of medicines and reliance on third-party goods and services.

In the current environment, the Directors have considered the impact of a range of possible future COVID-19 related scenarios and believe the Group retains sufficient liquidity to continue to operate. As detailed in Note 1 of the Notes to the Interim Financial Statements, the going-concern basis has been adopted in these Condensed Consolidated Interim Financial Statements (Interim Financial Statements). For an impact assessment on the Interim Financial Statements, also see Note 1.

Guidance

The Company provides guidance for FY 2020 at CER on:

- Total Revenue, comprising Product Sales and Collaboration Revenue

- Core EPS

Guidance on Total Revenue and Core EPS reflects the changing nature and growing strategic impact of Collaboration Revenue which, over time, will primarily comprise potential income from existing collaborations as follows:

- A share of gross profits derived from sales of Enhertu in several markets, where those sales are recorded by Daiichi Sankyo Company, Limited (Daiichi Sankyo)

- A share of gross profits derived from sales of roxadustat in China, recorded by FibroGen Inc. (FibroGen)9

- Milestone revenue from the MSD10 collaboration on Lynparza

- Smaller amounts of milestone and royalty revenue from other marketed and pipeline medicines

The guidance below is subject to the assumption that the global impact of the COVID-19 pandemic lasts for several more months and is based on recent trends in the business. The Company will monitor closely the development of the pandemic and anticipates providing an update at the H1 2020 results. Variations in performance between quarters can be expected to continue.

Financial guidance for FY 2020 is unchanged. Total Revenue is expected to increase by a high single-digit to a low double-digit percentage and Core EPS is expected to increase by a mid- to high-teens percentage. AstraZeneca recognises the heightened risks and uncertainties from the impact of COVID-19 referred to above.

The Company is unable to provide guidance and indications on a Reported basis because the Company 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 section cautionary statements regarding forward-looking statements at the end of this announcement.

Indications

The Company provides indications for FY 2020 at CER:

- The Company is focused on improving operating leverage

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

- Capital Expenditure is expected to be broadly stable versus the prior year

Currency impact

If foreign-exchange rates for April to December 2020 were to remain at the average of rates seen in the quarter, it is anticipated that there would be a low single-digit adverse impact on Total Revenue and Core EPS. In addition, 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 16% in the quarter (17% at CER) to $6,354m. Product Sales increased by 15% (17% at CER) to $6,311m, primarily driven by the performance of the new medicines, as well as Symbicort's double-digit growth at CER in every region

- The Reported and Core Gross Profit Margin11 declined by two percentage points in the quarter to 77% and 78% respectively. The falls reflected the impact of one-off adjustments related to Group inventory, the growth in profit share from the collaboration with MSD in respect of Lynparza and an element of foreign-exchange impact

- Reported Total Operating Expense increased by 9% in the quarter (10% at CER) to $4,194m and represented 66% of Total Revenue (Q1 2019: 70%); part of the rise, also reflected in Core R&D Expense, was driven by the investment related to Enhertu. Core Total Operating Expense increased by 7% (8% at CER) to $3,600m and represented 57% of Total Revenue (Q1 2019: 61%); the increase was also driven by SG&A Expense related to investment in Oncology-medicine launches and AstraZeneca's further expansion in China. In addition, Reported SG&A Expense was adversely impacted by intangible asset impairments, including a $102m charge relating to Bydureon

- The Reported Operating Profit Margin declined in the quarter by one percentage point (stable at CER) to 19%; the Core Operating Profit Margin also declined by one percentage point (stable at CER) to 29%

- Reported EPS of $0.59 in the quarter, represented an increase of 27% (33% at CER); this was despite an increase in the weighted-average number of shares to 1,312m (Q1 2019: 1,267m). Core EPS increased by 17% (21% at CER) to $1.05

Commercial summary

Oncology

Total Revenue increased by 33% in the quarter (34% at CER) to $2,518m.

Table 2: Select Oncology medicine performances

Oncology Total Revenue increased in Emerging Markets by 45% (49% at CER) to $711m.

New CVRM

Total Revenue increased by 7% in the quarter (8% at CER) to $1,102m.

Table 3: Select New CVRM medicine performances

New CVRM Total Revenue increased in Emerging Markets by 39% in the quarter (43% at CER) to $332m.

Respiratory & Immunology

Total Revenue increased by 21% in the quarter (22% at CER) to $1,555m.

Table 4: Select Respiratory & Immunology medicine performances

Respiratory & Immunology Total Revenue increased in Emerging Markets by 4% (6% at CER) to $540m.

Following the launch of an authorised-generic version of Symbicort in the US in collaboration with Prasco, LLC (Prasco), US sales of Symbicort grew by 76% in the quarter to $310m. The performance partly reflected an element of inventory build by Prasco.

Emerging Markets

As the Company's largest region, at 36% of Total Revenue, Emerging Markets' Total Revenue increased by 13% in the quarter (16% at CER) to $2,273m, including:

- A China Total Revenue increase of 14% (17% at CER) to $1,416m

- An ex-China Total Revenue increase of 12% (15% at CER) to $857m

Sustainability summary

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

- Access to healthcare: during the period, AstraZeneca announced a donation of nine million face masks to support healthcare workers around the world as they respond to the COVID-19 global pandemic; more than eight million masks have already been delivered. In addition, AstraZeneca, GSK and the University of Cambridge announced a collaboration to support the UK Government's five-pillar plan to boost testing

- Environmental protection: to coincide with Earth Day on 22 April 2020, the Company announced a new one-year collaboration focusing on water stewardship with World Wide Fund for Nature Sweden, to identify opportunities to improve the Company's approach and strategy towards water stewardship. AstraZeneca's longer-term ambition is to implement Science-Based Targets for Water, once a global methodology is available, to lead the way on water stewardship for the pharmaceutical industry; including the development of industry-specific tools to assess water risk in the context of Pharmaceuticals in the Environment

- Ethics and transparency: since committing to providing greater transparency around payments to healthcare professionals and healthcare organisations at the 2018 Annual General Meeting, the Company has further progressed this work during the period across Canada, the Philippines and New Zealand, while continuing to monitor the regulatory landscape in Argentina, Chile, India and Morocco

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

Notes

The following notes refer to pages one to six.

1. 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.

2. Reported financial measures are the financial results presented in accordance with International Financial Reporting Standards (IFRS), as issued by the International Accounting Standards Board and adopted by the EU. The UK is yet to announce its IFRS endorsement authority and is anticipated to continue to follow the EU endorsement process for the foreseeable future.

3. Earnings per share.

4. 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 Interim Financial Statements. See the operating and financial review for a definition of Core financial measures and a reconciliation of Core to Reported financial measures.

5. Tagrisso, Imfinzi, Lynparza, Calquence, Enhertu, Farxiga, Brilinta, Lokelma, roxadustat, Fasenra, Bevespi and Breztri. The new medicines are pillars in the three therapy areas and are important platforms for future growth. The Total Revenue of Enhertu and roxadustat in the quarter entirely reflected Ongoing Collaboration Revenue.

6. Epidermal growth factor receptor mutation.

7. Defined here as Oncology, New CVRM and Respiratory & Immunology.

8. New Cardiovascular (CV), Renal & Metabolism comprises Brilinta and Renal & Diabetes medicines.

9. FibroGen and AstraZeneca are collaborating on the development and commercialisation of roxadustat in the US, China, and other global markets. FibroGen and Astellas Pharma Inc. (Astellas) are collaborating on the development and commercialisation of roxadustat in territories including Japan, Europe, the Commonwealth of Independent States, the Middle East and South Africa.

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

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

12. Not meaningful.

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

Innovation is critical to addressing unmet patient needs and is at the heart of the Company's growth strategy. The focus on research and development is designed to yield strong and sustainable results from the pipeline.

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.

Report calendar

The Company intends to publish its first-half and second-quarter financial results on 30 July 2020.

AstraZeneca

AstraZeneca (LSE/STO/NYSE: 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.

All narrative on growth and results in this section is based on actual exchange rates, and financial figures are in US$ millions ($m), unless stated otherwise. The performance shown in this announcement covers the three-month period to 31 March 2020 (the quarter or Q1 2020) compared to the three-month period to 31 March 2019 (Q1 2019) respectively, unless stated otherwise.

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 Interim 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 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 of 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 of this announcement.

Net Debt is defined as interest-bearing loans and borrowings and lease liabilities, net of cash and cash equivalents, other investments, and net derivative financial instruments. Reference should be made to Note 3 'Net Debt' included in the Notes to the Interim Financial Statements in this announcement.

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 49% of Total Revenue (Q1 2019: 43%), specialty-care medicine Total Revenue increased by 32% in the quarter (34% at CER) to $3,139m.

Table 8: Top-ten medicines by Total Revenue

Table 9: Collaboration Revenue

Other Ongoing Collaboration Revenue included Zoladex, Farxiga, Nexium OTC and other royalties. No Initial Collaboration Revenue was recorded in the quarter.

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

Oncology

Total Revenue of $2,518m in the quarter; an increase of 33% (34% at CER). No Lynparza Collaboration Revenue was recorded in this quarter. The performance of Enhertu was reflected in Collaboration Revenue; no Product Sales of Enhertu were recorded in the quarter.

Oncology Total Revenue represented 40% of overall Total Revenue (Q1 2019: 35%).

Tagrisso

Tagrisso has received regulatory approval in 81 countries, including the US, China, in the EU and Japan for the 1st-line treatment of patients with EGFRm NSCLC. To date, reimbursement has been granted in 20 countries, with further reimbursement decisions anticipated throughout 2020, as well as additional regulatory decisions in many countries. This followed Tagrisso's approval and launch in 88 countries, including the US, China, in the EU and Japan for the treatment of patients with EGFR T790M[33]-mutated NSCLC.

Total Revenue, entirely comprising Product Sales, amounted to $982m in the quarter and represented growth of 56% (58% at CER). This was partly driven by the aforementioned regulatory approvals and reimbursements in the 1st-line setting. Continued growth was also delivered in the 2nd-line setting, for example, within Europe and Emerging Markets. Sequentially, Total Revenue increased by $98m from Q4 2019 to Q1 2020, including sequential growth in the US. Total Revenue in the US increased by 43% year-on-year in the quarter to $371m. Demand growth continued, with Tagrisso established as the standard of care (SoC) in the 1st-line setting, following regulatory approval in 2018.

In Emerging Markets, Tagrisso Total Revenue increased by 103% in the quarter (109% at CER) to $280m, with notable growth in China, following the admission in 2019 to the China National Drug Reimbursement List (NRDL) in the 2nd-line setting. Tagrisso Total Revenue in Japan increased by 25% (23% at CER) to $153m. In Europe, Total Revenue of $162m in the quarter represented an increase of 62% (66% at CER), driven by its emerging use in the 1st-line setting, as more reimbursements were granted, as well as continued strong levels of demand in the 2nd-line setting.

Imfinzi

Imfinzi has received regulatory approval in 62 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 reimbursement agreements increased to 27 in the quarter. During the period, Imfinzi was also approved for the treatment of ES-SCLC patients in the US and Singapore. It is also approved for the 2nd-line treatment of patients with locally advanced or metastatic urothelial carcinoma (bladder cancer) in 16 countries, including in the US.

Total Revenue, entirely comprising Product Sales, amounted to $462m in the quarter and represented growth of 57%, almost exclusively for the treatment of unresectable, Stage III NSCLC. Total Revenue in the US increased by 24% to $286m. In Japan, growth of 66% (64% at CER) represented sales of $56m. Sales in Europe of $75m followed recent regulatory approvals and launches. Imfinzi was also launched in the quarter in China for the treatment of unresectable, Stage III NSCLC.

Lynparza

Lynparza has received regulatory approval in 73 countries for the treatment of ovarian cancer. Launches for the treatment of metastatic breast cancer took place in the US and Japan in 2018 in the EU in April 2019. Lynparza has now been approved in 64 countries for the treatment of metastatic breast cancer and, in four countries, including the US, for the treatment of pancreatic cancer.

Total Revenue amounted to $397m in the quarter and represented growth of 67% (69% at CER); no Lynparza Collaboration Revenue was recorded in the period. The strong performance was geographically spread, with launches continuing in Emerging Markets and the Established Rest of World region (RoW).

US sales amounted to $197m and increased by 66%, driven by the launch in the 1st-line BRCAm ovarian cancer setting at the end of 2018. Lynparza continued to be the leading medicine in the poly ADP ribose polymerase-inhibitor class, as measured by total prescription volumes in both ovarian and breast cancer. Sales in Europe increased by 57% (61% at CER) to $102m, driven by increasing levels of reimbursement and BRCAm-testing rates, as well as successful recent 1st-line ovarian cancer launches, including in the UK and Germany.

Japan sales of Lynparza amounted to $34m, representing growth of 55% (53% at CER). Emerging Markets sales of $56m, up by 113% (120% at CER), reflected the regulatory approval of Lynparza as a 2nd-line maintenance treatment of patients with ovarian cancer by the China National Medical Products Administration (NMPA). Lynparza was admitted to the China NRDL for the same indication, with effect from January 2020.

Calquence

Total Revenue, entirely comprising Product Sales, amounted to $88m in the quarter and represented growth of 202%, with the overwhelming majority of sales in the US. Calquence was approved by the US Food and Drug Administration (FDA) for the treatment of CLL and small lymphocytic lymphoma (SLL) in November 2019. Calquence has received 13 regulatory approvals for the treatment of patients with mantle-cell lymphoma, and six in CLL.

Enhertu

Product Sales, recorded by Daiichi Sankyo, amounted to $30m. This reflected sales in the US, where Enhertu has been launched and where Daiichi Sankyo is the principal. Total Revenue, entirely comprising resulting Collaboration Revenue recorded by AstraZeneca, amounted to $14m in the quarter, following the recent launch in the US at the beginning of the year. Enhertu was approved by the US FDA for the treatment of 3rd-line HER2+ breast cancer in December 2019.

Legacy: Iressa

Total Revenue, entirely comprising Product Sales, amounted to $77m in the quarter and represented a decline of 42% (41% at CER). Sales in Emerging Markets declined by 28% (26% at CER) to $62m, reflecting Iressa's inclusion on the China volume-based procurement programme.

Legacy: Faslodex

Total Revenue, entirely comprising Product Sales, amounted to $166m in the quarter and represented a decline of 35% (34% at CER).

Emerging Markets sales of Faslodex increased by 7% (10% at CER) to $48m. US sales declined by 83% to $23m, reflecting the launch of multiple generic Faslodex medicines. In Europe, where generic competitor medicines are established, sales increased by 19% (22% at CER) to $64m, while in Japan, sales increased by 4% (3% at CER) to $29m.

Legacy: Zoladex

Total Revenue, predominantly comprising Product Sales, amounted to $228m in the quarter and represented growth of 16% (19% at CER).

Emerging Markets sales of Zoladex increased by 30% (35% at CER) to $149m. Sales in Europe increased by 1% (3% at CER) to $35m. In the Established RoW region, sales declined by 10% (9% at CER) to $39m, driven by the effects of increased competition.

BioPharmaceuticals: CVRM

Total Revenue, which included roxadustat Ongoing Collaboration Revenue of $3m and sales of Crestor and other legacy medicines, were stable in the quarter (increase of 1% at CER) to $1,707m and represented 27% of Total Revenue (Q1 2019: 31%).

New CVRM Total Revenue, which excluded sales of Crestor and other legacy medicines, increased by 7% in the quarter (8% at CER) to $1,102m, reflecting strong performances from Farxiga and Brilinta. New CVRM Total Revenue represented 17% of overall Total Revenue in the quarter (Q1 2019: 19%); this change partly reflected the particular growth of Oncology.

Farxiga

Total Revenue, predominantly comprising Product Sales, amounted to $407m in the quarter and represented growth of 16% (19% at CER).

Emerging Markets sales increased by 49% (55% at CER) to $141m. In China, Farxiga was admitted to the NRDL with effect from the start of 2020; as expected, this adversely impacted the price of the medicine. This impact, however, was offset by the volume benefit derived from the launch within the NRDL listing. The performance also reflected growth in the sodium-glucose layer transport protein 2 (SGLT2) inhibitor class at the expense of the dipeptidyl-peptidase 4 (DPP-4) inhibitor class.

US sales declined by 14% to $113m. Growth in the quarter was adversely affected by the impact on price from increased levels of competition, the mix of sales and managed markets. There were, however, favourable movements in the share of new-to-brand prescriptions, a result of a label update in Q3 2019 to reflect results from the DECLARE CVOT.

Sales in Europe increased by 30% (34% at CER) to $116m, partly reflecting growth in the SGLT2 inhibitor class and an acceleration of new-to-brand prescriptions following a similar DECLARE label update. In Japan, sales to the collaborator, Ono Pharmaceutical Co., Ltd, which records in-market sales, declined by 24% (25% at CER) to $13m.

Brilinta

Total Revenue, entirely comprising Product Sales, amounted to $408m in the quarter and represented growth of 17% (19% at CER). Patient uptake continued in the treatment of acute coronary syndrome and high-risk post-myocardial infarction (MI); the performance also reflected aforementioned short-term inventory increases, given the hospital-dispensation setting.

Emerging Markets sales of Brilinta increased by 38% (42% at CER) to $134m. US sales of Brilinta, at $165m, represented an increase of 8%, driven primarily by increasing levels of demand in both hospital and retail settings, as well as a lengthening in the average-weighted duration of treatment, reflecting the growing impact of 90-day prescriptions. Sales of Brilique in Europe increased by 12% in the quarter (15% at CER) to $93m, reflecting performances in Spain, Germany and the UK.

Onglyza

Total Revenue, entirely comprising Product Sales, amounted to $141m in the quarter and represented a decline of 8% (6% at CER).

Sales in Emerging Markets increased by 10% (13% at CER) to $47m, driven by the performance in China. US sales of Onglyza declined by 14% in the quarter to $67m; given the significant future potential of Farxiga, the Company continues to prioritise commercial support over Onglyza. Europe sales declined by 19% (17% at CER) to $15m, also highlighting the broader trend of a shift away from the DPP-4 inhibitor class.

Bydureon

Total Revenue, entirely comprising Product Sales, amounted to $100m in the quarter and represented a decline of 30% (29% at CER).

US sales of $84m reflected a decline of 28% in the quarter, resulting from competitive pressures and the impact of managed markets. Patients continue to transition from the dual-chamber pen to the BCise device. Bydureon sales in Europe fell by 34% (32% at CER) to $12m. Reflecting the recent and potential performance of Bydureon, a $102m intangible asset impairment charge was recorded in the quarter.

Lokelma

Total Revenue, entirely comprising Product Sales, amounted to $11m in the quarter and reflected sequential growth of 42% over Q4 2019.

The US represented the overwhelming majority of sales, following the recent launch of the medicine. Lokelma led new-to-brand prescription market share during the quarter. The medicine has received regulatory approval in the EU, China and Japan and for the treatment of hyperkalaemia, with further launches in several markets anticipated soon.

Roxadustat

Total Revenue, entirely comprising Ongoing Collaboration Revenue, amounted to $3m in the quarter. The period saw a focus on achieving hospital listings across the country. Roxadustat was approved by the China NMPA for the treatment of anaemia in CKD in dialysis-dependent and non-dialysis dependent patients in December 2018 and August 2019, respectively. Roxadustat was admitted to the China NRDL with effect from January 2020.

Legacy: Crestor

Total Revenue, predominantly comprising Product Sales, amounted to $302m in the quarter and represented a decline of 10% (8% at CER).

Sales in Emerging Markets declined by 15% (13% at CER) to $192m. The performance was adversely impacted by the effect of volume-based procurement in China. US sales increased by 9% to $28m. In Europe, sales declined by 12% (10% at CER) to $34m. In Japan, where AstraZeneca collaborates with Shionogi Co. Ltd, sales increased by 5% (3% at CER) to $34m.

BioPharmaceuticals: Respiratory & Immunology

Total Revenue, which included Ongoing Collaboration Revenue of $3m from Duaklir and Eklira, increased by 21% in the quarter (22% at CER) to $1,555m and represented 24% of Total Revenue (Q1 2019: 23%).

Symbicort

Total Revenue, entirely comprising Product Sales, amounted to $790m in the quarter and represented growth of 35% (36% at CER).

An authorised-generic version of Symbicort was launched in the US by the Company's collaborator, Prasco. US sales grew by 76% to $310m; this partly reflected an element of inventory build by Prasco. Symbicort also continued its global market-volume and value leadership within the inhaled corticosteroid / long-acting beta agonist (LABA) class. Emerging Markets sales increased by 17% in the quarter (20% at CER) to $156m, reflecting particularly strong performances in China and the Middle East & Africa.

In Europe, sales increased by 7% in the quarter (10% at CER) to $195m. In Japan, sales grew by 40% (38% at CER) to $56m, supported by the continued effect of AstraZeneca regaining full rights, following termination in 2019 of the Astellas co-promotion agreement. In Japan, Symbicort pricing was, however, adversely impacted by the recent market entry of a generic medicine.

Pulmicort

Total Revenue, entirely comprising Product Sales, amounted to $380m in the quarter and represented a decline of 1% (stable at CER).

Emerging Markets, where sales were stable in the quarter (+1% at CER) at $313m, represented 82% of global Total Revenue of Pulmicort. The performance in China was impacted by local COVID-19 pandemic restrictions, resulting in a disruption of hospital dispensation and significantly reduced access and attendance to outpatient nebulisation rooms. It also reflected a particularly benign influenza season in China, resulting in a significantly reduced number of asthma exacerbations. Sales in the US declined by 3% to $23m and sales in Europe increased by 3% (6% at CER) to $26m.

Fasenra

Fasenra has received regulatory approval in 56 countries, including in the US, 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 39 countries. Total Revenue, entirely comprising Product Sales, amounted to $199m in the quarter and represented growth of 54% (55% at CER).

Sales in the US increased by 29% in the quarter to $120m. For the aforementioned treatment of patients, Fasenra ended the quarter as the leading novel biologic medicine in the US, as measured by new-to-brand prescriptions. In Europe, sales of $46m in the quarter represented an increase of 154% (161% at CER), reflecting a number of successful launches. Sales in Japan increased by 32% (30% at CER) to $21m. In its approved indication and among new patients, Fasenra obtained the leading market share of all biologic medicines in the 'top-five' European countries and in Japan. In Emerging Markets, sales amounted to $6m in the quarter (Q1 2019: $nil).

Daliresp/Daxas

Total Revenue, entirely comprising Product Sales, amounted to $53m in the quarter and represented growth of 11% (12% at CER).

US sales, representing 85% of the global total, increased by 10% to $45m, driven by higher demand, partially offset by adverse inventory movements.

Bevespi

Total Revenue, entirely comprising Product Sales, amounted to $12m in the quarter and represented growth of 22%.

Bevespi has been launched in the US, in a number of European countries and in Japan. The global LABA / long acting muscarinic antagonist class continued to grow more slowly than expected.

Breztri

Total Revenue, entirely comprising Product Sales, amounted to $4m in the quarter (Q1 2019: $nil).

Following regulatory approvals for the treatment of COPD, Breztri was launched in Japan and China.

Other medicines (outside the three main therapy areas)

Total Revenue, primarily comprising Product Sales, amounted to $557m in the quarter; a decline of 4% (3% at CER). Other Total Revenue represented 9% of overall Total Revenue (Q1 2019: 10%).

Nexium

Total Revenue, predominantly comprising Product Sales, amounted to $348m in the quarter; a decline of 6% (5% at CER). Emerging Markets sales of Nexium declined by 2% (an increase of 1% at CER) to $187m. In Japan, where AstraZeneca collaborates with Daiichi Sankyo, sales were stable at $79m.

Table 11: Regional Total Revenue

Table 12: Emerging Markets therapy-area performance

Table 13: Notable new-medicine performances in Emerging Markets - Total Revenue

The new medicines represented 29% of Emerging Markets Total Revenue (Q1 2019: 18%). Total Revenue from specialty-care medicines increased by 45% (50% at CER) to $854m and comprised 38% of Emerging Markets sales in the quarter (Q1 2019: 29%).

China Total Revenue, which included $3m of roxadustat Ongoing Collaboration Revenue, comprised 62% of Emerging Markets Total Revenue in the quarter and increased by 14% (17% at CER) to $1,416m.

New-medicine Total Revenue in China, primarily driven by Tagrisso and Lynparza in Oncology and Brilinta and Farxiga in New CVRM, delivered particularly encouraging growth and represented 27% of China Total Revenue (Q1 2019: 13%). This performance was augmented by strong sales of Zoladex, Symbicort and a resilient performance from Pulmicort.

Ex-China Emerging Markets, comprising entirely of Product Sales, increased by 12% in the quarter (15% at CER) to $857m. The new medicines represented 32% of ex-China Emerging Markets Total Revenue in the quarter (Q1 2019: 26%), increasing by 41% (45% at CER) to $277m. The performance was underpinned by strong levels of growth across the following:

Table 14: Ex-China Emerging Markets: Total Revenue

Table 15: Reported Profit and Loss

Table 16: Reconciliation of Reported Profit Before Tax to EBITDA

Table 17: Reconciliation of Reported to Core financial measures

a) Gross Profit

The increases in Reported and Core Gross Profit in the quarter reflected the growth in Product Sales. The declines in the Reported and Core Gross Margin partly reflected the impact of one-off adjustments related to Group inventory, the growth in profit share from the collaboration with MSD in respect of Lynparza and an element of foreign-exchange impact.

b) Total Operating Expense

Reported Total Operating Expense in the quarter represented 66% of Total Revenue (Q1 2019: 70%), Core Total Operating Expense represented 57% of Total Revenue (Q1 2019: 61%).

Reported and Core R&D Expense increased partly as a result of investment in the development of Enhertu. Reported and Core SG&A Expense grew primarily due to additional select investment in Oncology-medicine launches and AstraZeneca's further expansion in China. In addition, Reported SG&A Expense was adversely impacted by an increased level of intangible asset impairments, including a $102m charge relating to Bydureon.

c) Other Operating Income and Expense[34]

Reported and Core Other Operating Income and Expense in the quarter included $350m of income that reflected an agreement to divest commercial rights to a number of legacy hypertension medicines.

d) Net Finance Expense

The declines in Reported and Core Net Finance Expense partly reflected a favourable movement in loan interest following the repayment of a $1bn bond in 2019.

e) Taxation

The Reported and Core Tax Rates for the quarter were both 20% (Q1 2019: 26% and 23% respectively). Taxation Paid for the quarter was $477m, representing 51% of Reported Profit Before Tax (Q1 2019: $334m, 44%).

f) EPS

Reported EPS of $0.59 in the quarter, represented an increase of 27% (33% at CER). This was despite an increase in the weighted-average number of shares to 1,312m (Q1 2019: 1,267m). Core EPS increased by 17% (21% at CER) to $1.05.

Table 18: Cash Flow

The increase in Net Cash Inflows from Operating Activities in the quarter primarily reflected an underlying improvement in business performance, combined with favourable working-capital movements. The positive cash performance was partly offset by the aforementioned increase in Taxation Paid.

The increase in Net Cash Inflows before Financing Activities primarily reflected the aforementioned improvement in Net Cash Inflows from Operating Activities, as well as a reduction in the Purchase of Intangible Assets, partially offset by a reduction in cash flows from the Disposal of Intangible Assets. The cash payment of contingent consideration, in respect of the former Bristol-Myers Squibb Company (BMS) share of the global diabetes alliance, amounted to $124m in the quarter.

Capital Expenditure

Capital expenditure amounted to $186m in the quarter, compared to $174m in Q1 2019. This included investment in the new AstraZeneca R&D centre on the Biomedical Campus in Cambridge, UK.

The Company anticipates a broadly stable level of total capital expenditure in FY 2020 (FY 2019: $979m).

Table 19: Net Debt summary

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. After providing for investment in the business, supporting the progressive dividend policy and maintaining a strong, investment-grade credit rating, the Board will keep under review potential investment in immediately earnings-accretive, value-enhancing opportunities.

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 20: Currency sensitivities

The Company provides the following currency-sensitivity information:

AstraZeneca's sustainability approach has three priority areas[39], aligned with the Company's purpose and business strategy:

- Access to healthcare

- Environmental protection

- Ethics and transparency

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

a) Access to healthcare

During the period, AstraZeneca announced a donation of nine million face masks to support healthcare workers around the world as they respond to the COVID-19 global pandemic. The Company has also collaborated with the World Economic Forum's COVID Action Platform, created with the support of the World Health Organization, to identify countries in greatest need; more than eight million masks have already been delivered.

During the period, AstraZeneca proactively communicated with its healthcare and community partners, who are working to support healthcare systems, patients and caregivers around the world, to reinforce the Company's support of their efforts during the COVID-19 pandemic. AstraZeneca will continue to meet funding commitments and support community partner decisions to postpone or cancel programmes or reallocate funding towards relief and response efforts. For example, Healthy Heart Africa (HHA) collaborators who support the delivery of the Company's programme in local communities in Kenya, Ethiopia, Tanzania and Ghana, have repurposed local facilities and diverted resources towards providing protective clothing to healthcare workers. AstraZeneca's Young Health Programme partners have stopped all community-based outreach and are delivering disease prevention messaging over virtual networks. In addition, the Company is ensuring that its collaborators are safe and supported and is encouraging them to follow the appropriate governmental guidance.

In March 2020, the manuscript 'Burden of prehypertension among adults in Kenya: a retrospective analysis of findings from the HHA programme' was published in the BMC Public Health journal; this was the third HHA manuscript published in the last twelve months. The publication outlined the high prevalence of hypertension (HTN) and pre-HTN in Kenya, with more than 50% of the six million screening records analysed found to have pre-HTN, in addition to 20% with HTN, among an average screening age of 45 years.

b) Environmental protection

To coincide with Earth Day on 22 April 2020, AstraZeneca announced a new one-year collaboration focusing on water stewardship with World Wide Fund for Nature Sweden, to identify opportunities to improve the Company's approach and strategy towards water stewardship. Responsible management of water, particularly where sites are situated in water-stressed areas, is critical to the development and manufacture of the Company's medicines. AstraZeneca's longer-term ambition is to implement Science-Based Targets for Water, once a global methodology is available, to lead the way on water stewardship for the pharmaceutical industry; including the development of industry-specific tools to assess water risk in the context of Pharmaceuticals in the Environment.

This approach will ensure that AstraZeneca is more meaningfully contributing to the sustainable management of water resources within river basins. The Company's water target is to maintain absolute water use at the 2015 level through 2025. Since 2015, the Company has developed a standard methodology to assess water risk and stress at its global sites, which has enabled the Company to broaden its understanding of water-related risks and opportunities for priority investment. AstraZeneca has prioritised implementing water-efficiency projects, identified through water audits at 11 sites, including Yelahanka, Bangalore, India; Shanghai, China; and Canóvanas, Puerto Rico; and implemented rainwater harvesting at five sites: Wuxi, China; Cambridge, UK; Macclesfield, UK; Canóvanas, Puerto Rico and Frederick, US.

During the period, the AstraZeneca Green Labs initiative received two 'My Green Lab' certifications, reflecting the Company's commitment to laboratory sustainability. AstraZeneca's R&D site in Boston, US achieved Gold Level Certification for implementing over 60% of recommended sustainable lab practices; and the Company's R&D site in South San Francisco, US achieved Green Level Certification, awarded for implementing over 80% of recommended-sustainability practices. This is the highest level of certification provided by My Green Lab, placing the Company's South San Francisco site as one of only 10 laboratories certified at this level, out of more than 400 worldwide. The programme is the first of its scope in the industry, bringing together scientists, facilities management, engineering and safety health and environment to improve the environmental sustainability of research laboratories. AstraZeneca's major sites in the UK and Sweden are in scope and aim to become My Green Lab certified in the coming months.

c) Ethics and transparency

Since committing to providing greater transparency around payments to healthcare professionals and healthcare organisations at the 2018 Annual General Meeting, AstraZeneca successfully progressed in 2019 the disclosure programme into an additional five markets covering Brazil, Colombia, Korea, Mexico and Saudi Arabia. In 2020, the Company is intending to further progress this work across Canada, the Philippines (where enhanced legislation has been recently passed, superseding the existing Administrative Order) and New Zealand, while continuing to monitor the regulatory landscape in Argentina, Chile, India and Morocco.

d) Other developments

In March 2020, the Company released its sixth annual Sustainability Report via its website and social media. The report was released in conjunction with the Annual Report and Form 20-F Information 2019. The report outlined progress and challenges and aims for the future. Many of the new sustainability initiatives and programmes launched in 2019 were a result of engagement and activism from AstraZeneca colleagues around the world, demonstrating how sustainability is being embedded across the organisation.

For more details on AstraZeneca's sustainability ambition, approach and targets, please refer to the latest Sustainability Report 2019 and Sustainability Data Summary 2019. Additional information is available at astrazeneca.com/sustainability.

As the COVID-19 pandemic develops, the Company will evaluate the impact on the initiation of clinical trials, ongoing recruitment and follow-ups. It is prudent to assume that some delays will arise as a consequence of the pandemic. AstraZeneca does not expect significant delays to anticipated late-stage and lifecycle-management 2020 and 2021 news-flow dates.

A comprehensive data pack comprising AstraZeneca's pipeline of medicines in human trials can be found in the latest clinical-trials appendix, available on astrazeneca.com. Highlights of developments in the Company's late-stage pipeline since the prior results announcement are shown below:

Table 21: Update from the late-stage pipeline

Oncology

Oncology: lung cancer

a) Tagrisso

In April 2020, the Company announced that the ADAURA Phase III trial for Tagrisso in the adjuvant treatment of patients with Stage IB, II and IIIA EGFRm NSCLC with complete tumour resection was to be unblinded early following a recommendation from an Independent Data Monitoring Committee (IDMC), based on its determination of overwhelming efficacy. The primary endpoint of the trial is disease-free survival. Tagrisso was assessed against placebo for a treatment duration of up to three years. The trial will continue to assess the secondary endpoint of OS. In its communication to AstraZeneca, the IDMC did not raise any new safety concerns. The data will be presented at a forthcoming medical meeting.

Table 22: Key Tagrisso trials in lung cancer

b) Imfinzi

In March 2020, the Company announced that Imfinzi had been approved in the US as a 1st-line treatment for adult patients with ES-SCLC in combination with SoC chemotherapies, etoposide plus either carboplatin or cisplatin (platinum-etoposide) utilising the fixed dose of Imfinzi 1,500mg every three weeks, for four cycles with chemotherapy, then every four weeks until progression. This followed the regulatory approval in Singapore earlier in the period.

Prior to this, AstraZeneca announced high-level results from the final analysis of the Phase III CASPIAN trial, which showed that Imfinzi, in combination with a choice of SoC chemotherapies, confirmed a sustained, clinically meaningful OS benefit for patients with ES-SCLC treated in the 1st-line setting. The second experimental arm, testing tremelimumab, an anti-CTLA4 monoclonal antibody, added to Imfinzi and SoC, did not meet its primary endpoint of demonstrating a statistically significant improvement in OS. In June 2019, it was announced that the CASPIAN trial met one primary endpoint for Imfinzi plus SoC by demonstrating a statistically significant and clinically meaningful improvement in OS versus SoC alone at a planned interim analysis.

During the period, AstraZeneca announced that the Phase III DANUBE trial for Imfinzi and Imfinzi plus tremelimumab in unresectable, Stage IV (metastatic) bladder cancer did not meet the primary endpoints of improving OS versus SoC chemotherapy for Imfinzi monotherapy in patients whose tumour cells and/or tumour-infiltrating immune cells express high levels (≥25%) of PD-L1[44], or for Imfinzi plus tremelimumab in patients regardless of their PD-L1 expression. The safety and tolerability profiles for Imfinzi and the combination with tremelimumab were consistent with previous trials. The data will be presented at a forthcoming medical meeting.

Table 23: Key Imfinzi trials in lung cancer

During the period, the AEGEAN trial in neo-adjuvant NSCLC was expanded to include 800 patients and the primary endpoints optimised to include event-free survival, as well as major pathological response. The first data are now anticipated beyond 2021.

As previously announced, the POSEIDON trial of Imfinzi and chemotherapy trial with and without tremelimumab in 1st-line NSCLC will continue to assess the additional primary endpoint of OS, following the positive PFS readout in 2019, with data anticipated in 2021. The Company anticipates presenting the trial outcomes at a forthcoming medical meeting when the overall trial outcomes are obtained.

Table 24: Key Imfinzi trials in tumour types other than lung cancer

The Phase III KESTREL trial's final analysis plan for Imfinzi with and without tremelimumab in 1st-line HNSCC is being optimised following learnings from the EAGLE trial in the 2nd-line HNSCC setting and learned regulatory insights; as such the data readout is now expected in 2021.

c) Lynparza (multiple cancers)

During the period, Lynparza was added to the US National Comprehensive Cancer Network's guidelines, in combination with bevacizumab in ovarian cancer patients who had previously been treated with bevacizumab.

In March 2020, the Company announced that Lynparza had been granted orphan designation in Japan for the maintenance treatment of germline BRCAm curatively unresectable pancreatic cancer. The Japan Ministry of Health, Labour and Welfare (MHLW) grants the designation to medicines intended for the treatment of diseases that affect fewer than 50,000 patients in Japan and for which there is a high unmet medical need. During the period, the Company made a regulatory submission in Japan for Lynparza in prostate cancer, based on data from the Phase III PROfound trial.

In April 2020, AstraZeneca announced further positive results from the Phase III PROfound trial of Lynparza in men with metastatic castration-resistant prostate cancer who have a homologous recombination repair gene mutation (HRRm) and have progressed on prior treatment with new hormonal-agent treatments, such as enzalutamide and abiraterone.

Table 25: Key Lynparza trials

Enhertu (breast and other cancers)

During the period, Daiichi Sankyo announced that Enhertu had been approved by Japan's MHLW for the treatment of patients with HER2+ unresectable or metastatic breast cancer, following chemotherapy. Approval of Enhertu was based on the results of the pivotal Phase II DESTINY-Breast01 trial of Enhertu monotherapy in HER2+ metastatic breast cancer patients.

Table 26: Key Enhertu trials

Koselugo (NF1)

During the period, the Company announced that the US FDA has approved the MEK 1/2 inhibitor, Koselugo (formerly selumetinib) for the treatment of paediatric patients aged two years and older who suffer from NF1 and symptomatic, inoperable plexiform neurofibromas (PNs). The approval was based on positive results from the National Cancer Institute (NCI) Cancer Therapy Evaluation Program-sponsored Phase II SPRINT Stratum 1 trial, coordinated by the NCI's Center for Cancer Research, Pediatric Oncology Branch. This was the first regulatory approval anywhere in the world of a medicine for the treatment of NF1 PNs.

During the period, Koselugo received a regulatory submission acceptance in the EU for the treatment of NF1.

Cediranib

In March 2020, the Company announced high-level results from the Phase III GY004 trial, led by NRG Oncology and sponsored by the US NCI, that examined the efficacy and safety of the potential new medicine cediranib when added to Lynparza versus platinum-based chemotherapy in patients with platinum-sensitive relapsed ovarian cancer. The trial did not meet the primary endpoint, in the intention-to-treat population, of a statistically significant improvement in PFS. Cediranib is an oral vascular endothelial growth factor receptor inhibitor, which blocks the growth of blood vessels supporting tumour growth.

CVRM

a) Farxiga (heart failure)

In March 2020, the Company announced that the DAPA-CKD Phase III trial for Farxiga in patients with CKD would be stopped early, following a recommendation from an IDMC, based on its determination of overwhelming efficacy. The decision followed a routine assessment of efficacy and safety. The Company anticipates presentation of the data at a forthcoming medical meeting.

During the period, the Company decided not to pursue the application for Farxiga in type-1 diabetes in the US. This followed a complete response letter received in 2019. Forxiga is currently approved for the treatment of type-1 diabetes in the EU and Japan.

Table 27: Key large CVRM outcomes trials

b) Lokelma (hyperkalaemia)

In April 2020, the US FDA approved a label update for Lokelma to include a dosing regimen specifically to treat hyperkalaemia (elevated levels of potassium in the blood) in patients with end-stage renal disease on chronic haemodialysis. The approval by the agency was based on positive results from the Phase IIIb DIALIZE trial.

Similarly, during the period, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion on a dosing and administration label update for Lokelma to include patients with hyperkalaemia on stable haemodialysis. The recommendation was also based on data from the Phase IIIb DIALIZE trial, which showed that 41% of patients receiving Lokelma maintained pre-dialysis potassium levels on at least three out of four dialysis treatments after the long interdialytic interval and did not require urgent rescue therapy. This compared with 1.0% of patients receiving placebo, making it a statistically significant and clinically meaningful improvement. The safety profile of Lokelma observed in DIALIZE was consistent with previous trials.

In March 2020, Lokelma was approved in Japan for the treatment of patients with hyperkalaemia. The approval by the MHLW was based on positive results from stand-alone trials in Japan and the global clinical-trial programme. Lokelma is approved for the treatment of hyperkalaemia in the US, EU, Canada, Hong Kong, China, Russia and most recently, Japan.

c) Roxadustat (anaemia)

During the period, AstraZeneca accomplished a number of regulatory submissions for roxadustat in rest-of-world countries, including Brazil, Chile, India, Mexico, Philippines, South Korea and Taiwan. In addition, a regulatory submission was made to the ACSS consortium for Australia, Canada and Singapore. FibroGen and Astellas are responsible for European regulatory submissions, including Switzerland.

Respiratory & Immunology

AstraZeneca has taken the opportunity to rename its Respiratory therapy area Respiratory & Immunology. With common pathways and underlying disease drivers across respiratory and immunology, AstraZeneca is following the science from chronic lung diseases to immunology-driven disease areas.

Fasenra (eosinophil-driven diseases)

During the period, the Company announced three new trials for Fasenra in skin diseases, adding to the five trials already underway for the medicine in eosinophil-driven diseases (EDDs) beyond severe asthma. In EDD, immune-system dysfunction causes eosinophil recruitment and activation of eosinophils (a type of white blood cell), leading to chronic local and/or systemic inflammation. The three new trials for Fasenra in skin diseases include two Phase II trials to assess the potential of the medicine as a treatment for atopic dermatitis and chronic spontaneous urticaria, as well as a Phase III trial in bullous pemphigoid (BP).

Table 28: Key Fasenra lifecycle management trials

For more details on the development pipeline, including anticipated timelines for regulatory submission/acceptances, please refer to the latest Clinical Trials Appendix available on astrazeneca.com.

Table 29: Condensed consolidated statement of comprehensive income - Q1 2020

Table 30: Condensed consolidated statement of financial position

Table 31: Condensed consolidated statement of changes in equity