AstraZeneca (NYSE: AZN).
Our purpose and values help explain why we exist, what we hope to accomplish, the behaviours we value, how we will achieve our goals, and the promise of our brand to our stakeholders. We operate in more than 100 countries and our innovative medicines are used by millions of patients worldwide. We want to be valued as a source of great medicines and trusted as a company that delivers business success responsibly. We are committed to operating with integrity and high ethical standards across all our activities.
April 26, 2019
Results in the first quarter were supported by Product Sales growth of 10% (14% at CER1 ) to $5,465m, a reflection of the sustained performance of new medicines2 (+77%, +83% at CER). Global Oncology sales increased by 54% (59% at CER), New CVRM3 by 15% (19% at CER) and, driven by the strength of Fasenra, Respiratory sales increased by 9% (14% at CER). Emerging Markets sales increased by 14% (22% at CER); China sales increased by 21% (28% at CER), with ex-China Emerging Markets also delivering strong growth at CER. US sales increased by 20%, while Europe sales declined by 12% (6% at CER). Japan sales increased by 26% (27% at CER) to $501m.
The Reported Operating Margin increased by seven percentage points to 20% and the Core Operating Margin increased by 13 percentage points to 30%. These financial results were accompanied by further positive pipeline developments, with 2019 set to be another busy year for news flow.
Pascal Soriot, Chief Executive Officer, commenting on the results said:
"Our 14% Product Sales growth in the quarter reflected the success of our new medicines and Emerging Markets. In Oncology, Tagrisso, Imfinzi and Lynparza continued to do well and, in BioPharma, Farxiga, Brilinta and Fasenra also grew strongly. Emerging Markets, our largest sales region, delivered an outstanding performance with a 22% growth rate; all of its sub-regions grew strongly, including China at 28%.
Our Core Operating Profit almost doubled, demonstrating strong operating-margin improvement. Together with this encouraging financial start to the year, our highly-productive and sustainable pipeline continued to deliver, notably with a regulatory approval for Lynparza in the EU for the treatment of metastatic breast cancer and approvals of Farxiga in type-1 diabetes. The recently-announced collaboration with Daiichi Sankyo also broadened an exciting Oncology portfolio with a potentially-transformative cancer treatment that could benefit patients around the world. We appreciate the support from our shareholders in realising this exceptional opportunity."
Product Sales increased by 10% in the quarter (14% at CER) to $5,465m
The Reported Gross Margin increased by two percentage points (three at CER) to 79%, partly reflecting the mix of Product Sales; the Core Gross Margin also increased by two percentage points to 80%
Reported Operating Expenses increased by 1% (5% at CER) to $3,858m and represented 70% of Total Revenue (Q1 2018: 74%). Core Operating Expenses increased by 1% (5% at CER) to $3,369m and represented 61% of Total Revenue (01 2018:65%)
Reported R&D Expenses declined by 1% (an increase of 3% at CER) to $1,266m. Core R&D Expenses declined by 1 % (an increase of 3% at CER) to $1,225m
Reported SG&A Expenses increased by 2% (7% at CER) to $2,514m; Core SG&A Expenses increased by 2% (6% at CER) to $2,066m, reflecting ongoing additional support for new medicines and growth in China
Reported Other Operating Income and Expense increased by 26% (27% at CER) to $593m, primarily reflecting the impact of the divestment of US rights to Synagis; Core Other Operating Income and Expense increased by 379% (383% at CER) to $594m
The Reported Operating Margin increased by seven percentage points to 20%; the Core Operating Margin increased by 13 percentage points to 30%
Reported EPS of $0.47, based on a weighted-average number of shares of 1,267m, represented an increase of 75% (90% at CER); the Reported Tax Rate was 26% (Q1 2018: 16%). Core EPS increased by 85% (100% at CER) to $0.89; the Core Tax Rate was 23% (Q1 2018: 18%). The tax rates reflected the geographical mix of profits and the impact of divestment transactions
On 29 March 2019, the Company initiated an equity placing of $3.5bn in conjunction with the recent strategic collaboration with Daiichi Sankyo Company, Limited (Daiichi Sankyo). The purpose of the placing was to fund the initial upfront and near-term milestone commitments arising from the collaboration, as well to strengthen AstraZeneca's balance sheet. One of the Company's capital-allocation priorities is to maintain a strong, investment-grade credit rating; the share issuance struck an appropriate balance between the Company's equity investors and creditors
Commercial summary Oncology Sales growth of 54% in the quarter (59% at CER) to $1,892m, including:
* Tagrisso sales of $630m, representing growth of 86% (92% at CER) that was driven by the 2018 regulatory approvals as a standard of care (SoC) in the 1st-line EGFR7 -mutated (EGFRm) NSCLC8 setting. There was a sequential decline in US sales of Tagrisso reflecting inventory and gross-to-net movements; underlying demand growth, however, remained strong. Globally, Tagrisso became AstraZeneca's biggest-selling medicine in the quarter
* Imfinzi sales of $295m, representing growth of 376% (381% at CER). The performance was a result of ongoing launches for the treatment of patients with unresectable, Stage III NSCLC. The majority of sales of Imfinzi were in the US, where it is the only approved medicine following SoC chemoradiation therapy (CRT) for the curative-intent treatment of patients with Stage III, unresectable NSCLC
* Lynparza sales of $237m, representing growth of 99% (105% at CER), driven by expanded use in the treatment of ovarian and breast cancer, including a particularly strong launch in the US as a 1st-line ovarian cancer treatment
* Oncology sales growth in Emerging Markets of 35% (46% at CER) to $490m
New CVRM Sales growth of 15% in the quarter (19% at CER) to $1,033m, including:
* Farxiga sales of $349m, with growth of 17% (23% at CER), ahead of an anticipated label update in major markets to reflect results from the DECLARE trial
* Brilinta sales of $348m, representing growth of 19% (24% at CER), due to continued market penetration in the treatment of acute coronary syndrome and high-risk post-myocardial infarction
* Bydureon sales of $142m, an increase of 2% (4% at CER), despite the impact of supply-chain constraints that are anticipated to ease later in the year
* New CVRM sales growth in Emerging Markets of 26% (40% at CER) to $239m
Respiratory Sales growth of 9% in the quarter (14% at CER) to $1,283m, including:
* A Symbicort sales decline of 8% (3% at CER) to $585m. US sales, at $176m, declined by 4%, reflecting continued pricing pressure and the impact of managed-market rebates, partially offset by positive volumes from government buying and a favourable gross-to-net adjustment. Emerging Markets sales increased by 4% (13% at CER) to $133m
* Pulmicort sales growth of 11% (16% at CER) to $383m
* Fasenra sales of $129m, representing growth of 514% (524% at CER). In the US, new-to-brand prescription data showed that Fasenra was the preferred novel-biologic medicine for the treatment of severe asthma during the period, despite being the third medicine to enter the market
* Respiratory sales growth in Emerging Markets of 18% (26% at CER) to $518m, driven by the aforementioned sales growth of Pulmicort
Emerging Markets The Company's largest region by Product Sales, with growth of 14% in the quarter (22% at CER) to $2,004m, including:
* A China sales increase of 21% (28% at CER) to $1,242m. Highlights included Oncology sales growth of 43% (51% at CER) to $284m and Respiratory growth of 25% (31% at CER) to $400m
* An ex-China sales increase of 3% (13% at CER) to $762m; every Emerging Market sub-region delivered strong growth at CER. Notable performances included sales of $281 m in (non-China) Asia-Pacific (+5%, +9% at CER) and $49m in Russia (+44%, +68% at CER)
FY 2019 guidance reiterated
The Company today reiterates its FY 2019 guidance. All measures in this section are at CER and Company guidance is on Product Sales and Core EPS only. All guidance and indications provided assume that the UK's anticipated exit from the European Union (EU), even in the event of a no-deal exit, proceeds in an orderly manner such that the impact is within the range expected, following the Company's extensive preparations for such an eventuality.
In addition to the aforementioned Product Sales growth, the Company anticipates productivity gains and operating leverage in FY 2019. Core Operating Profit is anticipated to grow at a faster rate than Product Sales, despite an anticipated decline in the sum of Collaboration Revenue and Core Other Operating Income and Expense vs. the prior year. More details are provided below.
Variations in performance between quarters can be expected to continue. 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 the fair-value adjustments arising on acquisition-related liabilities, intangibleasset impairment charges and legal-settlement provisions. Please refer to the section Cautionary Statements Regarding Forward-looking Statements at the end of this announcement.
FY 2019 indications
Outside of guidance, the Company provides its indications at CER for FY 2019 vs. the prior year:
* The Company anticipates strong and sustainable Product Sales growth to be accompanied by operating leverage, leading to an improvement in profitability. In FY 2019, the cash performance is expected to be adversely impacted by a number of one-off payments relating to prior business-development transactions; a significant proportion of these payments was made in Q1 2019
* As part of its long-term growth strategy, the Company remains committed to focusing on appropriate cashgenerating and value-accretive collaboration and divestment transactions that reflect the ongoing productivity of the pipeline and the Company's increasing focus on its main therapy areas. The sum of Collaboration Revenue and Core Other Operating Income and Expense, however, is anticipated to decline vs. the prior year
* Core Operating Expenses are expected to increase by a low single-digit percentage. Specific support for medicine launches and AstraZeneca in China historically has delivered compelling results and elements of that support will continue. The Company will retain flexibility in its investment approach
* Core Operating Profit is anticipated to increase, ahead of Product Sales, by a mid-teens percentage vs. FY 2018
* Capital expenditure is expected to be broadly stable and restructuring expenses are targeted to reduce vs. the prior year
* A Core Tax Rate of 18-22% (FY 2018: 11 %)
If foreign-exchange rates were to remain at the average of rates seen in the period January to March 2019, it is anticipated that there would be a low single-digit percentage adverse impact on Product Sales and Core EPS. In addition, the Company's foreign-exchange rate sensitivity analysis is contained within the operating and financial review.
AstraZeneca's sustainability ambition is founded on making science accessible and operating in a way that recognises the interconnection between the health of the business, people and the planet and that each of these impact one another. The Company's sustainability ambition is reinforced by its purpose and values, which are intrinsic to its business model and ensures that the delivery of its strategy broadens access to healthcare, minimises the environmental footprint of its activities and products of medicines and processes and ensures that all business activities are underpinned by the highest levels of ethics and transparency. A full update on the Company's sustainability progress is shown in the Sustainability section of this announcement.
Operating and financial review
All narrative on growth and results in this section is based on actual exchange rates, unless stated otherwise. Financial figures are in US$ millions ($m). The performance shown in this announcement covers the three-month period to 31 March 2019 (the quarter or Q1 2019) compared to the three-month period to 31 March 2018 (Q1 2018) respectively, unless stated otherwise. All commentary in the operating and financial review relates to the quarter, 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 Company 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 Company 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 76 of the Annual Report and Form 20-F Information 2018. Reference should be made to the reconciliation of Core to Reported financial information and 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 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 section of 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 percentages may not agree to totals.
Product Sales of $1,892m; an increase of 54% (59% at CER). Oncology Product Sales represented 35% of total Product Sales, up from 25% in Q1 2018.
Oncology: lung cancer
Tagrisso has been approved and launched in over 80 countries, including the US, in Europe, Japan and China for the 2nd-line treatment of patients with EGFR T790M21 -mutated NSCLC. By the end of the quarter, Tagrisso had been approved in over 65 countries including the US, in Europe and Japan for the 1st-line treatment of patients with EGFRm NSCLC; a number of additional regulatory reviews are also underway.
Product Sales of $630m represented growth of 86% (92% at CER), partly driven by regulatory approvals in the 1st-line setting. Continued growth was also delivered in the 2nd-line indication in other countries, including in Europe and Emerging Markets. Tagrisso became AstraZeneca's largest selling medicine in the quarter.
Sales in the US increased by 76% to $259m. Tagrisso was established last year as the SoC in the 1st-line setting with a very high penetration rate, following the April 2018 regulatory approval. Underlying demand growth remained strong in the quarter, despite adverse inventory and gross-to-net movements. Within Emerging Markets, Tagrisso sales increased by 94% (108% at CER) to $138m, with notable growth in China, where the medicine was added to the National Reimbursement Drug List (NRDL) with effect from January 2019. The AsiaPacific region has a relatively high prevalence of lung-cancer patients with an EGFR mutation; ate.30-40% of the total, this contrasts with c.10-15% in the Western Hemisphere.
In Europe, sales of $100m represented an increase of 45% (55% at CER), driven by further growth in testing rates, positive reimbursement decisions and strong levels of demand in the 2nd-line setting; additional decisions are expected in 2019. Sales of Tagrisso in Japan increased by 151% (153% at CER) to $123m, reflecting increasing use as a 1st-line treatment, following the 2018 regulatory approval in this setting where Tagrisso reached a very high penetration rate. Focused activities to maximise testing and utilisation rates in the 2nd-line setting also supported the performance.
Imfinzi is approved in c.45 countries, including the US, in Europe and Japan for the treatment of patients with unresectable, Stage III NSCLC whose disease has not progressed following platinum-based CRT. It is also approved for the 2nd-line treatment of patients with locally-advanced or metastatic urothelial carcinoma (bladder cancer) in eight countries, including the US.
Global Product Sales of Imfinzi increased by 376% (381% at CER) to $295m, of which $231 m were in the US, almost entirely for the treatment of unresectable, Stage III NSCLC. Sales of $34m in Japan reflected strong demand, supported by higher CRT and treatment rates. Sales in Europe of $23m followed recent regulatory approvals and launches; additional approvals are expected in due course.
Product Sales of $134m; a growth of 2% (7% at CER).
Emerging Markets sales increased by 21% (28% at CER) to $86m; Iressa entered the NRDL in China in 2017 and was included in the China '4+7' pilot tender scheme in 2018. Given the growing use of Tagrisso, sales of Iressa declined by 50% to $4m in the US and by 13% (7% at CER) to $26m in Europe. Japan sales amounted to $16m, reflecting a decline of 20%.
By the end of the quarter, Lynparza was approved in over 60 countries for the treatment of ovarian cancer. Launches in the treatment of breast cancer took place in the US and Japan in 2018 and regulatory approval was received in the EU in April 2019. Lynparza has now been approved in nearly 40 countries for the treatment of breast cancer.
Product Sales of Lynparza amounted to $237m, an increase of 99% (105% at CER). The strong performance was geographically spread, with launches continuing in Emerging Markets and the Established Rest of World region (RoW). Ongoing MSD22 co-promotion efforts also contributed to sales.
US sales increased by 80% to $119m, driven by the launch in the 1st-line BRCAm ovarian cancer indication at the end of 2018 and increased demand that reflected continued growth in the treatment with Lynparza of patients suffering from ovarian or breast cancer. Lynparza remained the leading US medicine in the poly ADP ribose polymerase (PARP)-inhibitor class, as measured by total prescription volumes and in both ovarian and breast cancer.
Sales in Europe increased by 55% (62% at CER) to $65m, driven by increasing levels of reimbursement and BRCA-testing rates; sales also benefitted from clinical-trial supply. The Company recently rolled out a number of launches in a broad, 2nd-line, maintenance ovarian-cancer indication, regardless of BRCA status. In 2018, the Company announced that the European Medicines Agency (EMA) had approved the use of Lynparza tablets (300mg twice daily) as a treatment for the same patient population.
Following the initial launch in April 2018, Japan sales of Lynparza, as a treatment for 2nd-line maintenance ovarian cancer and BRCAm breast cancer, amounted to $22m. Emerging Markets sales of $26m 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), resulting in the subsequent launch of Lynparza in China, the first PARR inhibitor to be approved in the country.
Oncology: haematology and other Oncology medicines
Product Sales of $29m; an increase of 263%.
Calquence was approved and launched in the US in October 2017. The medicine delivered a promising performance in the quarter, with c.40% of new patients now treated in the 2nd-line setting with Calquence in the approved indication of mantle cell lymphoma (MCL). At the end of 2018, the first regulatory approvals outside the US for the treatment of patients with MCL were granted in Brazil and the UAE.
Product Sales of $254m; a stable performance (4% growth at CER).
Emerging Markets sales of Faslodex increased by 15% (28% at CER) to $45m. US sales declined by 6% to $126m; a generic Faslodex medicine did not launch in the quarter. Europe sales declined by 8% (2% at CER) to $54m, reflecting the continued impact of generic entrants in certain countries. In Japan, sales increased by 33% to $28m.
Product Sales of $194m; an increase of 5% (13% at CER).
Emerging Markets sales of Zoladex increased by 13% (23% at CER) to $114m. Sales in Europe increased by 3% (9% at CER) to $35m. In the Established RoW region, sales declined by 10% (8% at CER) to $43m, driven by the effects of increased competition.
BioPharma - CVRM
Total CVRM sales, which include Crestor and other legacy medicines, increased by 4% (9% at CER) to $1,714m. Total CVRM sales represented 31% of total Product Sales. New CVRM sales increased by 15% (19% at CER) to $1,033m, reflecting strong performances from Farxiga and Brilinta.
Product Sales of $349m; an increase of 17% (23% at CER).
Emerging Markets sales of Forxiga increased by 38% (51% at CER) to $95m, reflecting ongoing launches, improved levels of patient access and strong performances in key markets, such as Brazil. US sales increased by 3% to $131m, impacted by changes in formulary access for competitor medicines. Sales in Europe increased by 20% (30% at CER) to $89m. In Japan, sales to the collaborator, Ono Pharmaceutical Co., Ltd, which records in-market sales in Japan, increased by 55% to $17m.
Product Sales of $153m, an increase of 19% (23% at CER) was partly driven by favourable prior year gross-tonet adjustments in the US, where sales increased by 59% to $78m.
Sales in Emerging Markets increased by 8% (23% at CER) to $43m, driven by the performance in China. Sales in Europe declined by 17% to $19m, highlighting the broader trend of a shift away from the dipeptidyl peptidase4 inhibitor class. Given the significant future potential of Farxiga, the Company continues to prioritise commercial support over Onglyza.
Product Sales of $142m; an increase of 2% (4% at CER). Sales were adversely impacted by ongoing supply constraints related to Bydureon BCise; these are anticipated to ease later in the year.
Sales in the US increased by 5% to $117m. Favourable sales volumes were driven by continued growth in the glucagon-like peptide-1 class, at the expense of insulin, for more-advanced T2D patients. Bydureon sales in Europe declined by 22% (17% at CER) to $18m.
Other CVRM medicines
Product Sales of $348m; an increase of 19% (24% at CER).
Emerging Markets sales of Brilinta increased by 28% (38% at CER) to $97m, bolstered by the entry onto the NRDL in China in 2017. US sales of Brilinta, at $153m, represented an increase of 33%. The performance was 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 declined by 3% in the quarter (growth of 3% at CER) to $83m; volume demand grew in the quarter.
Lokelma was approved in the US and EU in 2018 for the treatment of hyperkalemia, a serious condition characterised by elevated potassium levels in the blood associated with CV, renal and metabolic diseases. Lokelma's launch programme began in the Nordics in 2018 and further launches are anticipated to commence in major markets in due course, including the US in H2 2019.
Product Sales of $335m; a decline of 14% (9% at CER).
Sales in China declined by 6% (stable at CER) to $137m, partly a result of Crestor being unsuccessful in the '4+7' pilot tender scheme. US sales declined by 43% to $26m, underlining the ongoing impact of generic Crestor medicines. In Europe, sales declined by 40% (37% at CER) to $39m, reflecting a similar impact that began in 2017. In Japan, where AstraZeneca collaborates with Shionogi Co. Ltd, sales increased by 23% to $32m. This followed a period of decline resulting from the entry of multiple generic Crestor medicines in the market at the end of 2017.
BioPharma - Respiratory
Product Sales of $1,283m; an increase of 9% (14% at CER). Respiratory Product Sales represented 23% of total Product Sales.
Product Sales of $585m; a decline of 8% (3% at CER).
Symbicort continued to lead the global market by volume within the inhaled corticosteroid (ICS) / long-acting beta agonist (LABA) class. Emerging Markets sales of Symbicort increased by 4% (13% at CER) to $133m. In contrast, US sales declined by 4% to $176m, reflecting continued pricing pressure and the impact of managedmarket rebates. This was partially offset by positive volumes from government buying and a favourable grossto-net adjustment.
In Europe, sales declined by 14% (8% at CER) to $182m; the performance partly reflected the level of price competition from other branded and Symbicort-analogue medicines, plus government pricing interventions. Symbicort, however, continued to retain its class-leadership position and stabilised its volume market share in the class, with volume growth achieved in a number of markets.
In Japan, sales declined by 20% (18% at CER) to $40m following destocking by Astellas Pharma Co. Ltd (Astellas). In January 2019, AstraZeneca and Astellas announced that the sale and distribution of Symbicort, conducted by Astellas in Japan, was to be transferred back to AstraZeneca and that the co-promotion conducted by Astellas and AstraZeneca will be terminated on 30 July 2019. The Company will solely distribute and promote the medicine in Japan from 31 July 2019. In addition, during the period, the first generic Symbicort medicine received regulatory approval and multiple generic Symbicort medicines are anticipated to enter the Japanese market in due course.
Product Sales of $383m; an increase of 11% (16% at CER).
Emerging Markets, where sales increased by 16% (23% at CER) to $314m, represented 82% of global sales of Pulmicort. China, making up the overwhelming majority of Pulmicort sales in Emerging Markets, delivered a particularly strong double-digit performance, supported by higher demand and strong underlying volume growth, underpinned by the impact of AstraZeneca's investment in over 17,000 nebulisation centres.
Sales in the US and Europe declined by 17% to $24m and by 7% (4% at CER) to $25m, respectively, a consequence of the medicine's legacy status.
Product Sales of $129m, an increase of 514% (524% at CER).
In November 2017, the Company was granted regulatory approval for Fasenra in the US as a treatment of patients with severe, eosinophilic asthma; the approval was followed immediately by the launch of the medicine and US sales amounted to $93m in the quarter. New-to-brand prescription data showed that Fasenra was the preferred novel-biologic medicine for the treatment of severe asthma during the period, despite being the third medicine to enter the market.
In Europe and Japan, AstraZeneca was granted regulatory approval in January 2018 on a similar basis to that in the US. In Europe, sales totalled $18m in the quarter, predominantly reflecting strong sales in Germany. Sales in Japan amounted to $16m, following its launch in the second quarter of 2018. In addition, Fasenra led the novel asthma biologic-medicine class by new patient share in Germany and Japan during the period.
Product Sales of $48m; an increase of 26% (29% at CER).
US sales, representing 85% of the global total, increased by 41% to $41m, driven by favourable affordabilityprogramme changes and inventory movements. It is the only oral, selective, long-acting inhibitor of phosphodiesterase-4, an inflammatory enzyme associated with COPD.
Product Sales of $20m; a decline of 29% (25% at CER).
Duaklir, the Company's first inhaled dual bronchodilator medicine, is now available for patients in over 25 countries, with almost all sales emanating from Europe. The global LAMA/LABA class continued to grow in the period, albeit below expectations.
Product Sales increased by 100% to $10m.
Bevespi saw prescriptions in the period track in line with other LAMA/LABA launches; the class in the US, however, continued to grow more slowly than anticipated previously. Bevespi was the first medicine launched using the Company's proprietary Aerosphere Delivery Technology.
Other medicines (outside the main therapy areas)
Product Sales of $576m in the quarter; a decline of 38% (36% at CER), partly reflecting the aforementioned divestment of US rights to Synagis, as well as rights to Seroquel in a number of markets. Other Product Sales represented 11 % of total Product Sales, down from 19% in Q1 2018.
Product Sales of $363m; a decline of 19% (16% at CER).
Emerging Markets sales increased by 4% (12% at CER) to $190m. In Europe, sales declined by 74% to $16m. In October 2018, AstraZeneca announced that it had agreed to divest the prescription medicine rights to Nexium in Europe to GriJnenthal GmbH. Sales in the US declined by 34% to $66m and in Japan, where AstraZeneca collaborates with Daiichi Sankyo, sales declined by 16% (15% at CER) to $75m.
Profit and loss commentary
Reported Gross Profit increased by 8% in the quarter (13% at CER) to $4,362m; Core Gross Profit increased by 7% (13% at CER) to $4,425m, reflecting the growth in Product 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. The Reported Gross Margin increased by two percentage points (three at CER) to 79.3%; the Core Gross Margin increased by two percentage points to 80.5%. The increases primarily reflected the phasing of the mix of sales.
Reported R&D Expenses declined by 1% (an increase of 3% at CER) to $1,266m. Core R&D Expenses declined by 1% (an increase of 3% at CER) to $1,225m and represented 22% of Total Revenue (01 2018: 24%). Reported SG&A Expenses increased by 2% (7% at CER) to $2,514m, primarily reflecting ongoing investment focused on commercial and medical-affairs support for launches and extensions of the Company's new medicines. These included Lynparza, Tagrisso, Imfinzi, Calquence and Fasenra; additional investment was also added to support sales growth in China. Core SG&A Expenses increased by 2% (6% at CER) to $2,066m, reflecting the aforementioned investments and represented 38% of Total Revenue. (01 2018: 39%).
Other Operating Income and Expense
Where AstraZeneca does not retain a significant ongoing interest in medicines or potential new medicines, income from divestments is reported within Other Operating Income and Expense in the Company's financial statements. Reported Other Operating Income and Expense increased by 26% (27% at CER) to $593m and included $515m that reflected an agreement to sell US rights to Synagis to Swedish Orphan Biovitrum AB (publ). As part of the total consideration received, $150m related to the rights to participate in the future cashflows from the US profits or losses for MEDI8897. This was recognised as a financial liability and is presented in Other Payables within Non-current Liabilities. The associated cash flow is presented within Investing Activities. Core Other Operating Income and Expense increased by 379% (383% at CER) to $594m.
Reported Operating Profit increased by 58% in the year (68% at CER) to $1,097m, partly driven by the increases in Product Sales, the Reported Gross Margin and Other Operating Income and Expense. The Reported Operating Margin increased by seven percentage points to 20.0%. Core Operating Profit increased by 84% (96% at CER) to $1,650m; the Core Operating Margin increased by 13 percentage points to 30.0%.
Net Finance Expense
Reported Net Finance Expense increased by 1% (4% at CER) to $312m, partly a result of higher Net Debt. Excluding the discount-unwind on acquisition-related liabilities, Core Net Finance Expense increased by 12% (10% at CER) to $190m.
Profit Before Tax
Reported Profit Before Tax increased by 103% (122% at CER) to $758m, reflecting the growth in Product Sales and the Reported Gross Margin. Core Profit Before Tax increased by 102% (116% at CER) to $1,433m, also a result of the increase in Core Other Operating Income and Expense.
The Reported Tax Rate was 26% for the quarter, while the Core Tax Rate was 23%. These tax rates were higher than the UK Corporation Tax Rate of 19% due to the impacts of the geographical mix of profit, as well as divestment transactions. The net cash tax paid for the quarter was $334m (Q1 2018: $117m), representing 44% of Reported Profit Before Tax. Increased net cash tax primarily reflected the phasing of payments.
The Reported and Core Tax Rates in 01 2018 were 16% and 18%, respectively; the net cash tax paid represented 31% of Reported Profit Before Tax.
Reported EPS of $0.47 represented an increase of 75% (90% at CER). Core EPS increased by 85% (100% at CER) to $0.89.
A net cash outflow from operating activities of $387m compared to an outflow of $140m in Q1 2018, partly a result of increased net tax payments. The Gains on Disposal of Intangible Assets increased to $512m (Q1 2018: $65m), reflecting the impact of the aforementioned divestment of US rights to Synagis.
Net cash outflows before financing activities of $59m compared with an inflow of $133m in Q1 2018. The difference partly reflected the impact of historic business-development transactions and subsequent payments reported within Payment of Contingent Consideration on Business Combinations, as well as within the Purchase of Intangible Assets. The latter included the impact of a final true-up net payment of $413m to MSD, based on actual sales of Nexium and Prilosec from 2014 to 2018; this was accrued over the same period. A payment from Pfizer, Inc. of $175m was received in the quarter, recorded within Disposal of Intangible Assets, as part of a prior agreement to sell the commercialisation and development rights to AstraZeneca's late-stage small molecule antibiotics business in most markets globally outside the US. Reflecting strong sales growth and a pre-defined increase in royalty rates, the cash payment of contingent consideration in respect of the Bristol-Myers Squibb share of the global Diabetes alliance, amounted to $110m in the quarter (Q1 2018: $62m).
Capital expenditure amounted to $174m in the quarter, compared to $213m in Q1 2018. This included the investment in the new global headquarters in Cambridge, UK. In November 2018, the Company successfully completed the transition to Mace Group as construction manager. Following a detailed review of the construction programme, in order to optimise operational performance on site and produce a predictable schedule to completion, overall full completion of the building is now expected in late 2021. AstraZeneca continues to target an initial occupation in 2020. The Company maintains its anticipation of a broadly stable level of capital expenditure in FY 2019.
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.
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. In addition, the Company's external dividend payments, paid principally in pounds sterling and Swedish krona, are fully hedged from announcement to payment date. Foreign-exchange gains and losses on forward contracts for transactional hedging are taken to profit or loss.
Corporate and business development
AstraZeneca and Daiichi Sankyo enter collaboration for novel HER2-targeting antibody-drug conjugate In March 2019, AstraZeneca announced that it had entered into a global development and commercialisation collaboration agreement with Daiichi Sankyo for trastuzumab deruxtecan (DS-8201), a proprietary antibody-drug conjugate (ADC) and potential new targeted medicine for cancer treatment.
The companies will develop and commercialise trastuzumab deruxtecan jointly worldwide, except in Japan where Daiichi Sankyo will maintain exclusive rights. Daiichi Sankyo will be solely responsible for manufacturing and supply. Under the terms of the agreement, AstraZeneca will pay Daiichi Sankyo an upfront payment of $1.35bn, half of which was due upon execution (and settled in Q2 2019), with the remainder payable 12 months later. Contingent payments of up to $5.55bn comprise $3.8bn for potential successful achievement of future regulatory and other milestones, as well as $1.75bn for sales-related milestones. Overall, the transaction will be accounted for as an acquisition of an intangible asset, recognised initially at the present value of non-contingent consideration, with future milestones capitalised into the intangible asset as they are recognised. AstraZeneca and Daiichi Sankyo will share equally development and commercialisation costs as well as profits from trastuzumab deruxtecan worldwide, except for Japan, where Daiichi Sankyo will incur all costs and AstraZeneca will receive a royalty on sales.
Daiichi Sankyo will record sales in the US, certain countries in Europe and certain other markets where Daiichi Sankyo has affiliates. Gross profits and royalties shared with AstraZeneca will be accounted for as Collaboration Revenue by the Company. AstraZeneca is expected to record Product Sales in all other markets worldwide for which profits shared with Daiichi Sankyo will be accounted for within Cost of Sales.
There were no closing conditions to the agreement and the transaction completed in March 2019. The transaction and funding arrangements (see Note 6) did not impact the Company's financial guidance for 2019. The upfront payment and near-term milestones were and will be funded from the proceeds of an equity placement (see Note 6) of approximately $3.5bnbefore expenses, of which more than half was and will be used to fund this transaction and the ongoing collaboration.
AstraZeneca enters new development and commercialisation agreement for Fasenra In March 2019, AstraZeneca and Kyowa Hakko Kirin Co., Ltd. (KHK) announced a new development and commercialisation agreement for Fasenra in all indications beyond asthma and COPD in Asia. The Company previously had rights to Fasenra in countries and regions for COPD and asthma indications.
Under the new agreement, AstraZeneca will now have global rights to Fasenra for all current and future indications. Under the terms of the agreement, AstraZeneca made an upfront payment and, in addition, KHK will receive subsequent payments for regulatory and commercial milestones. Other financial terms are the same as prior agreements between the companies. AstraZeneca is now responsible for the development, sales and marketing of Fasenra for all indications globally.
Termination of lanabecestat collaboration with Lilly In March 2019, alongside collaboration partner Eli Lilly and Company (Lilly), AstraZeneca presented the results at the Alzheimer's and Parkinson's Disease Congress of the AMARANTH and DAYBREAK-ALZ trials for lanabecestat, an oral beta secretase-cleaving enzyme inhibitor. The results showed no significant diseaseslowing for those patients treated with lanabecestat and supported the decision to discontinue the AMARANTH, AMARANTH Extension and DAYBREAK-ALZ trials. The lanabecestat collaboration with Lilly will be terminated.
AstraZeneca's sustainability ambition has three priority areas33, aligned with the Company's purpose and business strategy:
* Access to healthcare
* Environmental protection
* Ethics and transparency
Recent developments and progress against the priorities are reported below:
Access to healthcare
During the period, the Company continued its investment in healthcare systems by expanding its Healthy Heart Africa programme into Ghana. In March 2019, AstraZeneca signed a Memorandum of Understanding with Ghana Health Services to bring the programme to the country, following a key stakeholder meeting to expedite the development and rollout of Ghana Hypertension Guidelines.
In March 2019, The Economist Intelligence Unit (ElU) published new research, supported by AstraZeneca as part of the Young Health Programme (VHP), that highlighted the need for an increased focus on adolescents as a way to address the growing global burden of non-communicable disease. The ElU research, Addressing NonCommunicable Diseases in Adolescence, assessed how ten representative countries of different income levels are addressing the challenges associated with non-communicable diseases (NCDs) among adolescents. It was based on an NCD scorecard evaluating national efforts in policy, awareness and implementation, with a focus on four risk factors / health areas: healthy diets, nutrition and physical exercise; alcohol and tobacco; sexual and reproductive health; and mental health. The aim of the research was to support policy discussion around the topic of NCD prevention, particularly as it relates to young people.
In March 2019, the Company launched its YHP in Mexico in partnership with Project HOPE, civil-society organisation Yo Quiero Yo Puedo and the National Cancer Institute. The aim is to transform the lives of young people in four districts of Mexico City by helping young people to change their behaviours, especially the use of tobacco, excessive consumption of alcohol, unhealthy diet and lack of physical activity. The programme will also address other barriers to healthy living, such as pollution and will promote education on sexual and reproductive health, gender equality and mental-health issues.
During the period, six research papers co-authored by AstraZeneca were published on Pharmaceuticals in the Environment, a notable example being an article published on environmental exposure and risk predictions resulting from patient use of medicines in China.
In the first quarter of 2019, AstraZeneca in Gothenburg, Sweden launched two new environmental initiatives. The Tork PaperCircle programme, in partnership with Sodexo and the city of Molndal, recycles all paper hand towels used in toilets on site, giving all employees a visible and tactile way to participate in sustainability efforts, as well as helping protect the environment and reduce the business's carbon footprint. The site cafeteria also launched a new initiative measuring food carbon footprint, with all dishes labelled based on their climate impact. By choosing dishes with low impact, colleagues can contribute to reducing the carbon footprint. The initiative is led by Sodexo, in cooperation with Klimato. The results of the food's climate impact will be reported monthly on TV screens across the site.
In the US, the Gaithersburg, MD and Wilmington, DE sites installed campus-wide composting facilities and the donation of unused cafeteria food to a local food bank respectively, to support efforts in waste management and the reduction of the Company's environmental footprint.
Ethics and transparency
During the period, the Company was recognised in a new report by the Workforce Disclosure Initiative (WDI), which aims to drive transparency from businesses on how they manage their workforce. 90 global companies disclosed to the 2018 WDI survey. AstraZeneca received a score of 71% vs. a sector average of 57% and a UK average of 58% for transparency around workforce practices including pay, conditions and wellbeing.
In the UK Gender Pay Report 2018, the Company provided gender-pay information for AstraZeneca in the UK and outlined plans for supporting women, as well as continuing to improve the diversity of its employee base. AstraZeneca's 2018 gender-pay gap data compared favourably with the national average in the UK -15% vs. 18% national average. Globally, at the close of 2018, 45% of roles in the Company were held by women and the Board of Directors comprised 42% women.
In respect of transparency on bioethical topics such as animals in science, human biological samples and clinical trials, a new Bioethics Global Standard was published on the company's website. The updated standard reflected the latest issues in the field as determined by the AstraZeneca Bioethics Advisory Group, a group of subjectmatter experts and corporate representatives, sponsored by the Company's Chief Medical Officer.
During the period, new anti-bullying and anti sexual-harassment standards were also published and communicated to global colleagues. The new standards set out the Company's expectations for behaviour to ensure all colleagues feel respected, supported and safe at work from any form of bullying and harassment, be it mental, physical or sexual.
During the period, the Company published its fourth annual Sustainability Report, describing progress and challenges in 2018. The content of the report was based on those sustainability issues deemed material through comprehensive stakeholder engagement and analysis; it included three years of data, where available.
AstraZeneca has a deep-rooted heritage in Oncology and offers a new generation of medicines that have the potential to transform patients' lives and the Company's future. At least six Oncology medicines are expected to be launched between 2014 and 2020, of which Tagrisso, Imfinzi, Lynparza, Calquence and Lumoxiti are already benefitting patients. An extensive pipeline of small-molecule and biologic medicines is in development and the Company is committed to advancing Oncology medicines, primarily focused on the treatment of patients with lung, ovarian, breast and blood cancers.
At the 2019 American Association for Cancer Research (AACR) Annual Meeting in Atlanta, several abstracts were presented from the TATTON Phase lb trial, testing the combination of Tagrisso with potential new medicines savolitinib or selumetinib in NSCLC patients who have progressed on prior EGFR tyrosine kinase inhibitor treatment. In addition, exploratory analyses of blood and tissue tumour mutational burden (TMB) from the Phase III MYSTIC trial were presented at the AACR meeting. These assessed TMB, specifically blood-based, as a potential biomarker of survival in 1st-line use of Imfinzi with or without tremelimumab vs. chemotherapy in metastatic NSCLC.
Oncology: lung cancer
Tagrisso Tagrisso 40mg and 80mg once-daily oral tablets have now received approval in more over 65 countries, including in the US, Japan and in the EU, for the 1st-line treatment of patients with Stage IV EGFRm NSCLC. Multiple other similar reviews are underway, including in China, where a decision is anticipated during the second quarter of 2019, based on a priority review granted in December 2018. Regulatory approvals have been achieved in over 80 countries, including the US, in the EU, Japan and in China for the 2nd-line treatment of patients with EGFR T790M-mutated NSCLC.
Imfinzi as a potential new medicine in other tumour types
The Company continues to advance multiple monotherapy trials of Imfinzi and combination trials of Imfinzi with tremelimumab and other potential new medicines in tumour types other than lung cancer.
Imfinzi has received regulatory approval for the 2nd-line treatment of patients with locally-advanced or metastatic urothelial carcinoma (bladder cancer) inthe US, Canada, Brazil, Israel, India, Australia, Hong Kong and the UAE.
Oncology: Lynparza (multiple cancers)
During the period, AstraZeneca and MSD announced positive results from the Phase III POLO trial in pancreatic cancer. The results demonstrated a statistically-significant and clinically-meaningful improvement in PFS with Lynparza vs. placebo; the safety and tolerability profile of Lynparza was consistent with previous trials. POLO was a randomised, double-blinded, placebo-controlled trial exploring the efficacy of Lynparza tablets as 1st-line maintenance monotherapy for patients with germline BRCAm (gBRCAm) metastatic adenocarcinoma of the pancreas (pancreatic cancer) whose disease has not progressed on platinum-based chemotherapy.
The Company also recently announced that the EMA had approved Lynparza as a monotherapy for the treatment of gBRCAm adult patients who have HER2-negative, locally-advanced or metastatic breast cancer. Under the aforementioned collaboration with MSD and following this new approval, AstraZeneca received $30m as Collaboration Revenue in Q2 2019. Also during the period, the Company acknowledged the regulatory submission acceptance in China of the supplemental New Drug Application (sNDA) by the NMPA, seeking approval for Lynparza monotherapy for gBRCAm, HER2-negative, locally-advanced or metastatic breast cancer.
During the period, AstraZeneca received regulatory approval for Calquence in relapsed MCL in Oatar; approval was achieved in prior periods in the US, Brazil and the UAE.
Other Oncology medicines
Selumetinib (NF1) During the period, the Company announced that the US FDA had granted Breakthrough Therapy Designation status for the MEK 1/2 inhibitor and potential new medicine, selumetinib. The designation was for the treatment of paediatric patients aged three years and older with NF1 symptomatic and/or progressive, inoperable plexiform neurofibromas, a rare, incurable genetic condition.
CVRM forms one of AstraZeneca's main therapy areas and a key growth driver for the Company. By following the science to understand more clearly the underlying links between the heart, kidneys and pancreas, AstraZeneca is investing in a portfolio of medicines to protect organs and improve outcomes by slowing disease progression, reducing risks and tackling co-morbidities. The Company's ambition is to modify or halt the natural course of CVRM diseases and potentially regenerate organs and restore function, by continuing to deliver transformative science that improves treatment practices and CV health for millions of patients.
Farxiga (diabetes) At the American College of Cardiology's (ACC) 68th Annual Scientific Session in New Orleans, the Company presented positive results from a pre-specified sub-analysis of the Phase III DECLARE-TIMI 58 trial showing that Farxiga reduced the relative risk of major adverse cardiovascular events (MACE) by 16%, compared to placebo in patients with T2D who had a prior heart attack (myocardial infarction). In another pre-specified subanalysis, Farxiga, compared to placebo reduced the relative risk of hospitalisation for heart failure (hHF) in patients with T2D regardless of their ejection fraction (EF) status, a measurement of the percentage of blood leaving the heart with each contraction.
These pre-specified sub-analyses of DECLARE-TIMI 58 added to the positive primary results of the trial presented in November 2018, which showed that Farxiga significantly reduced the risk of the composite of hHF or CV death compared to placebo, consistently across the trial's entire patient population. Additionally, there were fewer major adverse cardiovascular events observed with Farxiga in the broad patient population; this did not, however, reach statistical significance. During the period, the Company received regulatory acceptances for the DECLARE submissions in both the US and EU.
In March 2019, the Company announced that the EMA had approved Forxiga for use in T1D as an adjunct to insulin in patients with a body-mass index > 27 kg/m2, when insulin alone does not provide adequate glycaemic control, despite optimal insulin therapy. In March 2019, the Company announced that the Japanese Ministry of Health, Labour and Welfare had approved Forxiga as an oral adjunct treatment to insulin for adults with T1D. Forxiga is currently under regulatory review in the US for use as an adjunct treatment to insulin in adults with T1D, with a decision anticipated in the second half of 2019.
Bydureon (diabetes) During the period, the US FDA approved label updates for Bydureon and Bydureon BCise to reflect safety data from the EXSCEL (EXenatide Study of Cardiovascular Event Lowering) trial, which demonstrated that Bydureon did not increase the risk of MACE in patients with T2D and a broad range of CV risk.
Brilinta (myocardial infarction) During the period, the Company announced that the Phase III THEMIS trial had met its primary endpoint and demonstrated that Brilinta, taken in conjunction with aspirin, showed a statistically-significant reduction in a composite of MACE, compared to aspirin alone. THEMIS was conducted in over 19,000 patients with CAD and T2D with no history of prior heart attack (myocardial infarction) or stroke. Preliminary safety results were consistent with the known profile of Brilinta. The Company intends to present a full evaluation of the THEMIS data at a forthcoming medical meeting.
At the aforementioned ACC meeting, the Company presented data from a secondary analysis of the Phase III TREAT trial, demonstrating that that STEMI patients, aged 75 years or less, who received Brilinta following fibrinolysis, had a similar ischemic risk compared to those receiving clopidogrel, as measured by the secondary efficacy endpoint which was a composite of CV death. Ml or stroke after 12 months of treatment. Brilinta showed a similar efficacy in preventing CV events compared to clopidogrel, with a numerical reduction in events in the Brilinta arm; this was, however, not statistically significant. The trial was designed primarily to test for noninferiority, compared to clopidogrel, for safety at 30 days and was not powered statistically to detect significance of any treatment effects. A secondary safety analysis of TREAT was consistent with the known safety profile of Brilinta.
Lokelma (hyperkalemia) During the period, DIALIZE, a multi-centre, randomised, placebo-controlled, double-blinded Phase lllb trial investigating the efficacy of Lokelma as a treatment for patients with CKD on haemodialysis with hyperkalaemia, met its primary endpoint. DIALIZE was the first ever randomised, placebo-controlled trial to evaluate a potassium binder in patients on haemodialysis and will potentially inform regulatory updates in major markets. Before DIALIZE, limited scientific research had been conducted on this patient population. The Company intends to present results from the trial at a forthcoming medical meeting.
During the period, patient enrolment in the Phase II PRIORITZE HF trial was temporarily suspended. The trial was designed to evaluate the benefits and risks of using Lokelma to initiate and intensify renin angiotensin aldosterone system inhibitor (RAASi) therapy in HF patients. The suspension followed the identification of larger than anticipated measurement discrepancies between potassium-concentration levels at point of care vs. those in central laboratories. The differences identified resulted in some patients receiving inappropriate management of RAASi medication. The trial is anticipated to resume, following approval of an amendment to the trial protocol to measure potassium-concentration levels in central laboratories. The safety-monitoring committee recommended the continuation of the trial as planned. AstraZeneca anticipates an update to clinicaltrials.gov in due course.
Crestor (CV disease) During the period, the Company announced that the Phase III METEOR China trial met its primary endpoint, demonstrating that Crestor slowed progression of carotid intima-media thickness (CIMT) in adult Chinese patients with subclinical atherosclerosis. The preliminary safety results were consistent with the known safety profile of Crestor, which add long-term (two years) safety evidence of Crestor in the adult Chinese population. METEOR China was a randomised, double-blinded, placebo-controlled, multi-centre, parallel group trial assessing the effects of Crestor 20mg daily treatment for 104 weeks on the change in CIMT in adult Chinese patients with subclinical atherosclerosis. In total, 543 patients were randomised from 25 sites in China.
Respiratory AstraZeneca's Respiratory focus is aimed at transforming the treatment of patients with asthma and COPD through combined inhaled therapies and biologic medicines for the unmet medical needs of specific populations and an early pipeline focused on disease modification. The growing range of medicines includes a number of anticipated launches between 2017 and 2020; of these, Bevespi and Fasenra are already benefitting patients, with regulatory reviews for Symbicort as an anti-inflammatory reliever in mild asthma and PT010 in COPD underway. The capability in inhalation technology spans both pressurised metered-dose inhalers and dry-powder inhalers to serve patient needs, including the innovative Aerosphere Delivery Technology, a focus of AstraZeneca's future-platform development for respiratory-disease combination therapies.
Symbicort (asthma) In February 2019, the Brazilian Health Regulatory Agency (ANVISA) granted an expanded indication for Symbicort as a reliever of mild asthma symptoms. In April, a similar approval was also granted by the Ministry of Health of the Russian Federation. These approvals were based on data from the SYGMA 1 and SYGMA 2 trials. SYGMA 1 showed that using Symbicort as an anti-inflammatory reliever, in place of a short-acting beta-agonist alone, has the potential to reduce the risk of severe asthma attacks in this patient population by 64%. In April 2019, the Global Initiative for Asthma (GINA) announced updated global recommendations for clinical practice and the treatment of patients with differing asthma severities. The 2019 GINA Pocket Guide for Asthma Management and Prevention recommends the use of low dose ICS-formoterol combination therapy, as needed, as the preferred reliever therapy across all asthma severities. Short-acting beta-2 agonist monotherapy, asneeded, is no longer recommended as a preferred reliever therapy.
Fasenra (asthma) During the period, a Phase II trial demonstrated that Fasenra can achieve near-complete depletion of eosinophils and improve clinical outcomes in hypereosinophilic syndrome (HES); the results were published in the New England Journal of Medicine. The US FDA granted Orphan Drug Designation for Fasenra for the treatment of HES in February 2019. Fasenra is currently approved as an add-on maintenance treatment for patients with severe, eosinophilic asthma in the US, EU, Japan and other markets.
Tudorza (COPD) In March 2019, the US FDA granted regulatory approval for Tudorza based on the results from the ASCENT trial, which fulfilled a post-approval commitment to conduct a randomised, controlled trial to evaluate the risk of MACE with Tudorza as a treatment for patients with COPD. The trial achieved its co-primary endpoints for safety (MACE) and efficacy (exacerbation reduction); the data from the ASCENT trial has now been added to the US label. Tudorza is a LAMA, administered twice-daily via the breath-actuated inhaler, Pressair. Tudorza was approved first in the US in 2012 for the maintenance treatment of COPD.
Duaklir (COPD) In March 2019, the US FDA approved Duaklir as a maintenance treatment for patients with COPD. The approval was based on data from three Phase III trials, namely ACLIFORM, AUGMENT and AMPLIFY. The label also included clinical data from the ASCENT trial, which showed that Duaklir was effective at reducing COPD exacerbations. Duaklir is a fixed-dose LAMA/LABA combination, administered twice-daily via Pressair. It is the only twice-daily LAMA/LABA treatment in the US with COPD-exacerbation data included in its prescribing information.
As part of the collaboration agreement announced in March 2017, Circassia Pharmaceuticals pic will be responsible for Duaklir in the US with AstraZeneca continuing to manufacture and supply the medicine.
PT010 (COPD) During the period, the Company received regulatory submission acceptance for PT010 from the US FDA and the EMA, respectively. The acceptance was based on results from the KRONOS Phase III trial, which was published in The Lancet Respiratory Medicine in October 2018. Results of the Phase III ETHOS exacerbations trial are anticipated in H2 2019, potentially further characterising the overall profile of PT010 as a new medicine for patients with COPD.
Tezepelumab (severe, uncontrolled asthma) During the period, the first patient was recruited into the Phase III DESTINATION trial, evaluating the safety and tolerability of tezepelumab in adults and adolescents with severe, uncontrolled asthma.
Saracatinib (IPF) In March 2019, the US FDA granted Orphan Drug Designation for saracatinib, a potential new medicine for the treatment of IPF, a type of lung disease that results in scarring (fibrosis) of the lungs. IPF is a chronic, progressive, irreversible and ultimately fatal interstitial lung disease which affects c. 100,000 patients per year in the US. Saracatinib is an inhibitor of Src kinase, which regulates broad cell functions including cell growth and cell differentiation. Pre-clinical trials of saracatinib showed that it inhibits fibroblast activity and collagen deposition, which are key features of lung fibrosis. More recently, saracatinib completed its Phase I development.
There were no research & development updates for medicines outside of the three main therapy areas in the period.
Notes to the interim financial statements
1. Basis of preparation and accounting policies
These unaudited condensed consolidated interim financial statements (Interim Financial Statements) for the three months ended 31 March 2019 have been prepared in accordance with IAS 34 'Interim Financial Reporting' as adopted by the EU and as issued by the International Accounting Standards Board (lASB).
The annual financial statements of the Group are prepared in accordance with IFRSs as adopted by the EU and as issued by the lASB. Except as noted below, the interim financial statements have been prepared applying the accounting policies and presentation that were applied in the preparation of the Group's published consolidated financial statements for the year ended 31 December 2018. In addition, from 1 January 2019, AstraZeneca elected to early adopt the October 2018 update to IFRS 3, which changed the definition of a business. The EU has not yet endorsed this update to IFRS 3, but it is considered highly probable that the amendment will be endorsed during 2019 in time for the effective date of 1 January 2020. The change in definition of a business within IFRS 3 allowed the Group to apply the optional concentration test to perform a simplified assessment of whether an acquired set of activities and assets is or is not a business on a transaction by transaction basis. It is considered that adopting this amendment will provide more reliable and comparable information about certain transactions as it provides more consistency in accounting for substantially similar transactions that under the previous definition may have been accounted for in different ways despite limited differences in substance. The Group accounting policies will be updated to reflect the change.
IFRS 16 'Leases' is effective for accounting periods beginning on or after 1 January 2019 and replaces IAS 17 'Leases'. It eliminates the classification of leases as either operating leases or finance leases and, instead, introduces a single lessee accounting model. The adoption of IFRS 16 resulted in the Group recognising lease liabilities, and corresponding 'right-ofuse' assets for arrangements that were previously classified as operating leases.
The Group's principal lease arrangements are for property, most notably a portfolio of office premises, and for a global car fleet, utilised primarily by our sales and marketing teams. The Group has adopted IFRS 16 using a modified retrospective approach with the cumulative effect of initially applying the standard as an adjustment to the opening balance of retained earnings at 1 January 2019. The standard permits a choice on initial adoption, on a lease-by-lease basis, to measure the rightof-use asset at either its carrying amount as if IFRS 16 had been applied since the commencement of the lease, or an amount equal to the lease liability, adjusted for accruals or prepayments. The Group has elected to measure the right-of-use asset equal to the lease liability, with the result of no net impact on opening retained earnings and no restatement of prior period comparatives.
Initial adoption resulted in the recognition of right-of-use assets of $722m and lease liabilities of $720m. The weighted average incremental borrowing rate applied to the lease liabilities on 1 January 2019 was 3%.
The Group is using one or more practical expedients on transition, on a lease-by-lease basis, to leases previously classified as operating leases, including electing to not apply the retrospective treatment to leases for which the term ends within 12 months of initial application, electing to apply a single discount rate to portfolios of leases with similar characteristics, reliance on previous assessments on whether leases are onerous, excluding initial direct costs from the initial measurement of the right-of-use asset, and using hindsight in determining the lease term where the contract contains options to extend or terminate the lease.
Key judgements made in calculating the initial impact of adoption include assessing whether arrangements contain a lease and determining the lease term. Extension and termination options have been considered when determining the lease term, along with all facts and circumstances that may create an economic incentive to exercise an extension option, or not exercise a termination option. Extension periods (or periods after termination options) are only included in the lease term if the lease is reasonably certain to be extended (or not terminated). Estimates include calculating the discount rate which is based on the incremental borrowing rate.
The Group is applying IFRS 16's low-value and short-term exemptions. While the IFRS 16 opening lease liability is calculated differently from the previous operating lease commitment calculated under the previous standard, there are no material differences between the positions. The adoption of IFRS 16 has had no impact on the Group's net cash flows, although a presentation change has been reflected whereby cash outflows of $42m are now presented as financing, instead of operating. There is an immaterial benefit to Operating profit and a corresponding increase in Finance expense from the presentation of a portion of lease costs as interest costs. Profit before tax, taxation and Earnings per share have not been significantly impacted.
IFRIC 23 'Uncertainty Over Income Tax Treatments' is effective for accounting periods beginning on or after 1 January 2019 and provides further clarification on how to apply the recognition and measurement requirements in IAS 12 'Income Taxes'. It is applicable where there is uncertainty over income tax treatments. The EU endorsed IFRIC 23 on 24 October 2018. The adoption of IFRIC 23 has principally resulted in the Group measuring the effect of uncertainty on income tax positions using either the most likely amount or the expected value amount depending on which method is expected to better reflect the resolution of the uncertainty.
The Group has retrospectively applied IFRIC 23 from 1 January 2019 recognising the cumulative effect of initially applying the interpretation as decreases to income tax payable of $51m and to trade and other payables of $3m, and a corresponding adjustment to the opening balance of retained earnings of $54m. There is no restatement of the comparative information as permitted in the interpretation.
Effective from 1 January 2019, the Group is updating the presentation of an element of Total Revenue within the Statement of Comprehensive Income and changing the classification of some income to reflect the increasing importance of collaborations to AstraZeneca. Historically, Externalisation Revenue formed part of Total Revenue and only included income arising from collaborative transactions involving AstraZeneca's medicines, whether internally developed or previously acquired. Such income included upfront consideration, milestones receipts, profit share income and royalties, as well as other income from collaborations. The updated category of Collaboration Revenue includes all income previously included within Externalisation Revenue, as well as income of a similar nature arising from transactions where AstraZeneca has acquired an interest in a medicine and as part of the acquisition entered into an active collaboration with the seller. This change is a result of the growing importance of collaborations to AstraZeneca and is expected to result in future periods in income arising from all collaborations, other than product sales, being recognised within the Collaboration Revenue element of Total Revenue. No prior year restatement of financial results is therefore required as a result of this change.
Income from royalties and disposals of assets and businesses, where the Group does not retain a significant element of continued interest, continue to be recorded in other operating income.
The information contained in Note 5 updates the disclosures concerning legal proceedings and contingent liabilities in the Group's Annual Report and Form 20-F Information 2018.
The Group has considerable financial resources available. As at 31 March 2019 the Group has $8.2bn in financial resources (cash balances of $4.1bn and undrawn committed bank facilities of $4.1bn, of which $3.4bn is available until April 2022, $0.5bn is available until December 2020 (extendable to December 2021) and $0.2bn is available until December 2019 (extendable to December 2020), with only $3.7bn of debt due within one year). The Group's revenues are largely derived from sales of products which are covered by patents which provide a relatively high level of resilience and predictability to cash inflows, although the revenue is expected to continue to be significantly impacted by the expiry of patents over the medium term. In addition, government price interventions in response to budgetary constraints are expected to continue to adversely affect revenues in many of the mature markets. The Group, however, anticipates new revenue streams from both recently launched medicines and products in development, and the Group has a wide diversity of customers and suppliers across different geographic areas. Subsequent to the quarter end AstraZeneca PLC issued a total of 44,386,214 new ordinary shares of $0.25 each at a price of [pounds sterling]60.50 per share. The share issue completed on 2 April 2019 and generated proceeds of [pounds sterling]2.69bn ($3.5bn); further increasing the Group's financial resources. Consequently, the Directors believe that, overall, the Group is well placed to manage its business risks successfully.
On the basis of the above paragraph, the going concern basis has been adopted in these interim financial statements.
As detailed in the Group's most recent annual financial statements, the principal financial instruments consist of derivative financial instruments, other investments, trade and other receivables, cash and cash equivalents, trade and other payables, leases and interest-bearing loans and borrowings.
There have been no changes of significance to the categorisation or fair value hierarchy classification of our financial instruments from those detailed in the Notes to the Group Financial Statements in the Group's Annual Report and Form 20-F Information 2018.
The Group holds certain equity investments that are categorised as Level 3 in the fair-value hierarchy and for which fair value gains of nil have been recognised in Q1 2019. These are presented in Net gains on equity investments measured at fair value through other comprehensive income in the Condensed Consolidated Statement of Comprehensive Income.
Legal proceedings and contingent liabilities
AstraZeneca is involved in various legal proceedings considered typical to its business, including litigation and investigations relating to product liability, commercial disputes, infringement of intellectual property rights, the validity of certain patents, antitrust law and sales and marketing practices. The matters discussed below constitute the more significant developments since publication of the disclosures concerning legal proceedings in the Company's Annual Report and Form 20-F Information 2018 (the Disclosures). Unless noted otherwise below or in the Disclosures, no provisions have been established in respect of the claims discussed below.
As discussed in the Disclosures, for the majority of claims in which AstraZeneca is involved it is not possible to make a reasonable estimate of the expected financial effect, if any, that will result from ultimate resolution of the proceedings. In these cases, AstraZeneca discloses information with respect only to the nature and facts of the cases but no provision is made.
In cases that have been settled or adjudicated, or where quantifiable fines and penalties have been assessed and which are not subject to appeal, or where a loss is probable and we are able to make a reasonable estimate of the loss, AstraZeneca records the loss absorbed or make a provision for our best estimate of the expected loss.
The position could change over time and the estimates that we have made and upon which we have relied in calculating these provisions are inherently imprecise. There can, therefore, be no assurance that any losses that result from the outcome of any legal proceedings will not exceed the amount of the provisions that have been booked in the accounts. The major factors causing this uncertainty are described more fully in the Disclosures and herein.
AstraZeneca has full confidence in, and will vigorously defend and enforce, its intellectual property.
Matters disclosed in respect of the first quarter of 2019 and to 26 April 2019
US patent proceedings As previously disclosed, in July 2017, Bristol-Myers Squibb, E.R. Squibb & Sons LLC, Ono Pharmaceutical Co and Tasuku Honjo filed a patent infringement action in the US District Court for the District of Delaware (the District Court) relating to AstraZeneca's commercialisation of Imfinzi. A trial has been scheduled for October 2020. Discovery is ongoing.
US patent proceedings As previously disclosed, in November 2017, Pharmacyclics LLC (Pharmacyclics, a company in the AbbVie group) filed a patent infringement lawsuit in the US District Court for the District of Delaware (the District Court) against Acerta Pharma and AstraZeneca relating to Calquence. A trial has been scheduled for June 2020.
In April 2018, AstraZeneca and Acerta Pharma filed a complaint in the District Court against Pharmacyclics and AbbVie, Inc. alleging that their medicine, Imbruvica, infringes a US patent owned by Acerta Pharma. In November 2018, Janssen Biotech, Inc. intervened as a defendant. A trial has been scheduled for January 2021.
Patent proceedings outside the US As previously disclosed, in Germany, in January 2017, the German Federal Patent Court declared the German part of European Patent No. EP 1,250,138 (the '138 patent) invalid. In April 2019, the German Federal Court of Justice upheld the January 2017 decision and determined the '138 patent to be invalid.
US patent proceedings As previously disclosed, in May 2018, AstraZeneca initiated ANDA litigation against Zydus Pharmaceuticals (USA) Inc. (Zydus) in the US District Court for the District of Delaware (the District Court). In January 2019, following a stipulation filed by the parties, the District Court dismissed claims related to US Patent Nos. 7,851,502, 7,919,598, 8,221,786, 8,361,972, 8,501,698, and 8,716,251. AstraZeneca continues to allege that Zydus' generic version of Farxiga, if approved and marketed, would infringe AstraZeneca's US Patents Nos. 6,414,126, 6,515,117, and 8,685,934. A trial is scheduled for February 2021.
Patent proceedings outside the US As previously disclosed, in Canada, in September 2017, Apotex Inc. (Apotex) challenged the patents listed on the Canadian Patent Register with reference to Brilinta. AstraZeneca discontinued the proceeding against Apotex in February 2019 after Apotex withdrew its challenge.
US patent proceedings
As previously disclosed, in October 2018 AstraZeneca initiated ANDA litigation against Mylan Pharmaceuticals Inc., Mylan Laboratories Limited, Mylan Inc., and Mylan N.V. in the US District Court for the District of Delaware and in the US District Court for the Northern District of West Virginia. In March 2019, following stipulations filed by the parties, the Delaware and West Virginia Courts dismissed without prejudice Mylan Laboratories Limited, Mylan Inc., and Mylan N.V. from those actions.
Product liability litigation
Nexium and Losec/Prilosec
As previously disclosed, in the US, AstraZeneca is defending various lawsuits brought in federal and state courts involving multiple plaintiffs claiming that they have been diagnosed with various injuries following treatment with proton-pump inhibitors, including Nexium and Prilosec. In May 2017, counsel for a group of such plaintiffs claiming that they have been diagnosed with kidney injuries filed a motion with the Judicial Panel on Multidistrict Litigation (JPML) seeking the transfer of any currently pending federal court cases as well as any similar, subsequently filed cases to a co-ordinated and consolidated pre-trial multidistrict litigation (MDL) proceeding. In August 2017, the JPML granted the motion and consolidated the pending federal court cases in an MDL proceeding in federal court in New Jersey for pretrial purposes.
As previously disclosed, in Canada, in July and August 2017, AstraZeneca was served with three putative class action lawsuits. Two of the lawsuits seek authorisation to represent individual residents in Canada who allegedly suffered kidney injuries from the use of proton pump inhibitors, including Nexium and Losec, and the third, pending in Quebec, seeks authorisation to represent such individual residents in Quebec.
Farxiga and Xigduo XR
As previously disclosed, in several jurisdictions in the US, AstraZeneca has been named as a defendant in lawsuits involving plaintiffs claiming physical injury, including diabetic ketoacidosis and kidney failure, from treatment with Farxiga and/or Xigduo XR. In April 2017, the Judicial Panel on Multidistrict Litigation ordered transfer of any currently pending cases as well as of any similar, subsequently filed cases to a co-ordinated and consolidated pre-trial multidistrict litigation proceeding in the US District Court for the Southern District of New York. A majority of these claims have been resolved or dismissed.
As previously disclosed, in October 2016, AstraZeneca completed its sale of certain assets related to the US rights to ToprolXL and AstraZeneca's authorised generic metoprolol succinate product to Aralez Pharmaceuticals Trading DAC (Aralez). In August 2018, Aralez commenced voluntary insolvency proceedings and AstraZeneca filed a proof of claim in those proceedings asserting its unsecured claims. In October 2018, Aralez filed a motion in the Bankruptcy Court seeking to sell the US rights to Toprol-XL and its authorised generic and AstraZeneca filed an objection to the proposed sale. In March 2019, AstraZeneca entered into an agreement with the senior secured creditor and the settlement has now been approved by the Bankruptcy Court, bringing this matter to a close.
Synagis Litigation in New York
As previously disclosed, in the US, in June 2011, Medlmmune received a demand from the US Attorney's Office for the Southern District of New York requesting certain documents related to the sales and marketing activities of Synagis. In July 2011, Medlmmune received a similar court order to produce documents from the Office of the Attorney General for the State of New York Medicaid and Fraud Control Unit pursuant to what the government attorneys advised was a joint investigation. Medlmmune has cooperated with these inquiries. In March 2017, Medlmmune was served with a lawsuit filed in US Federal Court in New York by the Attorney General for the State of New York alleging that Medlmmune inappropriately provided assistance to a single specialty care pharmacy. In September 2018, the US Federal Court in New York denied Medlmmune's motion to dismiss the lawsuit brought by the Attorney General for the State of New York.
In June 2017, Medlmmune was served with a lawsuit in US Federal Court in New York by a relator under the qui tam (whistleblower) provisions of the federal and certain state False Claims Acts. The lawsuit was originally filed under seal in April 2009 and alleges that Medlmmune made false claims about Synagis. In November 2017, Medlmmune was served with an amended complaint in which relator set forth additional false claims allegations relating to Synagis. In September 2018, the US Federal Court in New York dismissed the relator's lawsuit. In January 2019, relator appealed the decision of the US Federal Court in New York.
Louisiana Attorney General Litigation
As previously disclosed, in the US, in March 2015, AstraZeneca was served with a state court civil complaint filed by the Attorney General for the State of Louisiana (the State) alleging that, in connection with enforcement of its patents for Toprol-XL, it had engaged in unlawful monopolisation and unfair trade practices, causing the State government to pay increased prices for ToprolXL. In April 2019, a Louisiana state court heard oral argument on and granted AstraZeneca's motion for summary judgment, ordering the dismissal of the State's complaint and judgment to be entered in AstraZeneca's favour.
On 2 April 2019 AstraZeneca PLC issued a total of 44,386,214 new ordinary shares of $0.25 each at a price of [pounds sterling]60.50 per share, raising proceeds of [pounds sterling]2.69bn ($3.5bn) before expenses. The new ordinary shares rank pari passu in all respects with the existing ordinary shares of $0.25 in the capital of AstraZeneca PLC, including the right to receive all dividends and other distributions declared, made or paid on or in respect of such shares after the date of issue. As at 2 April the issued share capital of AstraZeneca PLC with voting rights was 1,311,755,099 ordinary shares of $0.25.
On 18 April 2019, AstraZeneca repaid early a floating-rate $500m bank term loan which was included within current interestbearing loans and borrowings as at 31 March 2019.
On 25 April 2019, the European Commission (the Commission) issued its decision on the State aid review of UK Controlled Foreign Company Group Financing Exemption. The Commission has concluded that part of the UK measures were unlawful and incompatible State aid and have instructed Her Majesty's Revenue and Customs to recover the State aid. AstraZeneca is reviewing the details of the ruling and assessing any impact upon the Company's historic tax positions. Given the complexities of the ruling, tax legislation and the possibility of appeal, the Company has been unable to estimate reliably any additional liability at this time; this is not, however, expected to be material.
|Printer friendly Cite/link Email Feedback|
|Title Annotation:||Leading Companies|
|Publication:||United Kingdom Pharmaceuticals|
|Date:||Aug 14, 2019|
|Previous Article:||Amgen UK (NYSE: AMGN).|
|Next Article:||Bristol Myers Squibb UK.|