FORM 6-K

 

 

SECURITIES AND EXCHANGE COMMISSION


Washington D.C. 20549

 

 

Report of Foreign Issuer

 

 

Pursuant to Rule 13a-16 or 15d-16 of

the Securities Exchange Act of 1934

 

 

 

For period ending 06 February 2019

 

GlaxoSmithKline plc

(Name of registrant)

 

 

 

980 Great West Road, Brentford, Middlesex, TW8 9GS

(Address of principal executive offices)

 

 

 

Indicate by check mark whether the registrant files or

will file annual reports under cover Form 20-F or Form 40-F

 

 

 

Form 20-F x     Form 40-F

 

--

 

Indicate by check mark whether the registrant by furnishing the

information contained in this Form is also thereby furnishing the

information to the Commission pursuant to Rule 12g3-2(b) under the

Securities Exchange Act of 1934.

 

 

 

Yes      No x

 

 

 

 

 

Issued: Wednesday, 6 February 2019, London U.K.

 

GSK delivers sales, earnings and cash flow growth in 2018 Total EPS 73.7p, +>100% AER, +>100% CER; Adjusted EPS 119.4p +7% AER, +12% CER

 

2018 financial, product and strategy highlights
●	Group sales £30.8 billion, +2% AER, +5% CER
●	Pharmaceuticals sales £17.3 billion, flat AER, +2% CER; Vaccines sales £5.9 billion, +14% AER, +16% CER; Consumer Healthcare sales £7.7 billion, -1% AER, +2% CER
●	Total new Respiratory product sales £2.6 billion, +35% AER, +38% CER
●	Total HIV sales £4.7 billion, +9% AER, +11% CER.  Dolutegravir-based regimens £4.4 billion, +14% AER, +16% CER
●	Shingrix sales £784 million, +>100% AER, +>100% CER
●	Total Group operating margin 17.8%, +4.3 percentage points AER, +5.0 percentage points CER
●	Adjusted Group operating margin 28.4%, flat AER, +0.5 percentage points CER.  (Pharmaceuticals: 33.3%; Vaccines 33.0%; Consumer Healthcare 19.8%)
●	Total EPS 73.7p, +>100% AER, +>100% CER, reflecting stronger operating performance, lower restructuring and impairment charges as well as a favourable comparison with impact of US tax reform in 2017
●	Adjusted EPS 119.4p, +7% AER, +12% CER, driven by improved operating margin and continued financial efficiencies
●	Net cash flow from operations £8.4 billion.  Free cash flow £5.7 billion, improvement reflecting greater focus on cash conversion, particularly working capital
●	23p dividend declared for the quarter; 80p for full year 2018
●	4 major transactions, including new Consumer Healthcare JV, announced in 2018 to support strategy and reshape of the Group's portfolio
2019 guidance
●	Expect Adjusted EPS to decline -5% to -9% CER reflecting recent approval of a generic competitor to Advair in the US.  Guidance also reflects expected impact of Tesaro acquisition and assumes Consumer Healthcare nutrition disposal and Consumer JV with Pfizer close as previously indicated
●	Expect 80p dividend for 2019
Pipeline update and newsflow
●	Rebuild of Pharmaceuticals pipeline continues with 33* of the 46* new medicines now in development targeting modulation of the immune system
●	Major progress made in immuno-oncology pipeline with 16* assets now in clinical development, reflecting organic progression, the Tesaro acquisition and the alliance with Merck KGaA, Darmstadt, Germany*
●	Major data readouts and other significant newsflow expected on multiple new medicines in HIV, Oncology, Immuno-inflammation and Respiratory in 2019:
	-		FDA approval decision expected for dolutegravir + lamivudine in H1
	-		FDA filings planned for long-acting injectable cabotegravir + rilpivirine in H1 and fostemsavir for highly treatment-experienced patients in H2
	-		Pivotal stage data readouts expected for BCMA for 4L multiple myeloma, Zejula for 1L maintenance ovarian cancer and PD1 dostarlimab for endometrial cancer
	-		Updated phase I PFS data from DREAMM-1 study for BCMA to be published in leading journal in H1
	-		Phase III start planned for anti-GMCSF for treatment of rheumatoid arthritis in H2
	-		Results of pivotal CAPTAIN study to support filing of Trelegy for use in asthma expected in H1

 

2018 results
	2018		Growth				Q4 2018		Growth
	£m		£%		CER%		£m		£%		CER%
Turnover	30,821		2		5		8,197		7		5
Total operating profit	5,483		34		43		1,554		>100		>100
Total earnings per share	73.7p		>100		>100		24.7p		>100		>100
Adjusted operating profit	8,745		2		6		2,196		8		4
Adjusted earnings per share	119.4p		7		12		31.2p		14		10
Net cash from operating activities	8,421		22				4,119		44
Free cash flow	5,692		63				3,317		83

 

The Total results are presented under 'Financial performance' on pages 6 and 22 and Adjusted results reconciliations are presented on pages 14, 15, 30 and 31.  Adjusted results are a non-IFRS measure that may be considered in addition to, but not as a substitute for, or superior to, information presented in accordance with IFRS.  Adjusted results are defined on page 4 and £% or AER% growth, CER% growth, free cash flow and other non-IFRS measures are defined on page 44.  GSK provides guidance on an Adjusted results basis only for the reasons set out on page 5.  All expectations, guidance and targets regarding future performance and dividend payments should be read together with "Outlook, assumptions and cautionary statements" on page 45.

*

Includes M7824, the subject of the alliance with Merck KGaA, Darmstadt, Germany, expected to close in Q1 2019.

 

 

Emma Walmsley, Chief Executive Officer, GSK said:   "GSK delivered improved operating performance in 2018 with Group sales growth, strong commercial execution of new product launches, especially Shingrix, continued cost discipline and better cash generation.   "It was also a significant year for the Group strategically, with the launch of a new R&D strategy focused on immunology, genetics and new technologies, together with a series of transactions that support our strategy and reshape of the Group's portfolio.   "We are making good progress against our priority to rebuild our Pharmaceuticals pipeline, particularly in oncology.  Since July, we have doubled the number of oncology assets in clinical development to 16 through the advancement of our internal programmes and with targeted business development including the recently completed acquisition of Tesaro and our new alliance with Merck KGaA that is expected to close in Q1 2019.  During 2019, we expect to receive pivotal data on three new cancer medicines, all of which have the potential to be launched in the next two years.   "We are also focused on completing the transactions to divest our Consumer Healthcare nutrition business to Unilever; and the formation of our new joint venture with Pfizer that will create a new, world leading Consumer Healthcare company and which provides a unique opportunity to deliver substantial value for shareholders.   "Finally, I would like to thank all our customers, suppliers and employees for their support and hard work in 2018 and look forward to working with them in 2019, which will be an important year of execution for GSK."

 

 

2019 guidance

 

In 2019, we now expect Adjusted EPS to decline in the range of -5% to -9% at CER.  This guidance reflects the recent approval of a substitutable generic competitor to Advair in the US and the expected impact of the Tesaro acquisition and assumes that the proposed Consumer Healthcare nutrition disposal closes by the end of 2019 and the proposed Consumer Healthcare Joint Venture with Pfizer closes during H2 2019.   GSK expects to maintain the dividend for 2019 at the current level of 80p per share.   All expectations, guidance and targets regarding future performance and dividend payments should be read together with "Outlook, assumptions and cautionary statements" on page 45.   If exchange rates were to hold at the closing rates on 31 January 2019 ($1.31/£1, €1.14/£1 and Yen 143/£1) for the rest of 2019, the estimated positive impact on 2019 Sterling turnover growth would be less than 1% and if exchange gains or losses were recognised at the same level as in 2018, the estimated positive impact on 2019 Sterling Adjusted EPS growth would be around 1%.

 

 

Contents	Page
Total and Adjusted results	4
Financial performance - year ended 31 December 2018	6
Financial performance - three months ended 31 December 2018	22
Cash generation and conversion	37
Returns to shareholders	39
Research and development	40
Reporting definitions	44
Outlook, assumptions and cautionary statements	45
Contacts	46
Income statements	47
Statement of comprehensive income - year ended 31 December 2018	48
Statement of comprehensive income - three months ended 31 December 2018	49
Pharmaceuticals turnover - year ended 31 December 2018	50
Pharmaceuticals turnover - three months ended 31 December 2018	51
Vaccines turnover - year ended 31 December 2018	52
Vaccines turnover - three months ended 31 December 2018	52
Balance sheet	53
Statement of changes in equity	54
Cash flow statement - year ended 31 December 2018	55
Segment information	56
Legal matters	58
Taxation	58
Additional information	59
Reconciliation of cash flow to movements in net debt	63
Net debt analysis	63
Free cash flow reconciliation	63
Non-controlling interests in ViiV Healthcare	64

 

 

 

Brand names and partner acknowledgements Brand names appearing in italics throughout this document are trademarks of GSK or associated companies or used under licence by the Group. Cialis is a trademark of Eli Lilly and Company and Gardasil is a trademark of Merck Sharp & Dohme Corp.

 

 

Total and Adjusted results

 

Total reported results represent the Group's overall performance.   GSK also uses a number of adjusted, non-IFRS, measures to report the performance of its business.  Adjusted results and other non-IFRS measures may be considered in addition to, but not as a substitute for or superior to, information presented in accordance with IFRS.  Adjusted results are defined below and other non-IFRS measures are defined on page 44.   GSK believes that Adjusted results, when considered together with Total results, provide investors, analysts and other stakeholders with helpful complementary information to understand better the financial performance and position of the Group from period to period, and allow the Group's performance to be more easily compared against the majority of its peer companies.  These measures are also used by management for planning and reporting purposes.  They may not be directly comparable with similarly described measures used by other companies.   GSK encourages investors and analysts not to rely on any single financial measure but to review GSK's quarterly results announcements, including the financial statements and notes, in their entirety.   GSK is committed to continuously improving its financial reporting, in line with evolving regulatory requirements and best practice and has made a number of changes in recent years.  In line with this practice, GSK expects in 2019 to continue to review its reporting framework (including, where relevant, the use of alternative performance measures).   Adjusted results exclude the following items from Total results, together with the tax effects of all of these items:

 

●	amortisation of intangible assets (excluding computer software) and goodwill
●	impairment of intangible assets (excluding computer software) and goodwill
●	major restructuring costs, which include impairments of tangible assets and computer software, (under specific Board approved programmes that are structural, of a significant scale and where the costs of individual or related projects exceed £25 million), including integration costs following material acquisitions
●	transaction-related accounting or other adjustments related to significant acquisitions
●	proceeds and costs of disposals of associates, products and businesses; significant legal charges (net of insurance recoveries) and expenses on the settlement of litigation and government investigations; other operating income other than royalty income, and other items
●	the impact of the enactment of the US Tax Cuts and Jobs Act in 2017

 

Costs for all other ordinary course smaller scale restructuring and legal charges and expenses are retained within both Total and Adjusted results.   As Adjusted results include the benefits of Major restructuring programmes but exclude significant costs (such as significant legal, major restructuring and transaction items) they should not be regarded as a complete picture of the Group's financial performance, which is presented in its Total results.  The exclusion of other Adjusting items may result in Adjusted earnings being materially higher or lower than Total earnings.  In particular, when significant impairments, restructuring charges and legal costs are excluded, Adjusted earnings will be higher than Total earnings.   GSK has undertaken a number of Major restructuring programmes in recent years in response to significant changes in the Group's trading environment or overall strategy, or following material acquisitions, including the Novartis transaction in 2015.  Costs, both cash and non-cash, of these programmes are provided for as individual elements are approved and meet the accounting recognition criteria.  As a result, charges may be incurred over a number of years following the initiation of a Major restructuring programme.   Significant legal charges and expenses are those arising from the settlement of litigation or government investigations that are not in the normal course and materially larger than more regularly occurring individual matters.  They also include certain major legacy matters.   Reconciliations between Total and Adjusted results, providing further information on the key Adjusting items, are set out on pages 14, 15, 30 and 31.   GSK provides earnings guidance to the investor community on the basis of Adjusted results.  This is in line with peer companies and expectations of the investor community, supporting easier comparison of the Group's performance with its peers.  GSK is not able to give guidance for Total results as it cannot reliably forecast certain material elements of the Total results, particularly the future fair value movements on contingent consideration and put options that can and have given rise to significant adjustments driven by external factors such as currency and other movements in capital markets.

 

ViiV Healthcare ViiV Healthcare is a subsidiary of the Group and 100% of its operating results (turnover, operating profit, profit after tax) are included within the Group income statement.     Earnings are allocated to the three shareholders of ViiV Healthcare on the basis of their respective equity shareholdings (GSK 78.3%, Pfizer 11.7% and Shionogi 10%) and their entitlement to preferential dividends, which are determined by the performance of certain products that each shareholder contributed.  As the relative performance of these products changes over time, the proportion of the overall earnings allocated to each shareholder also changes.  In particular, the increasing sales of dolutegravir-containing products have a favourable impact on the proportion of the preferential dividends that is allocated to GSK.  Adjusting items are allocated to shareholders based on their equity interests.  GSK was entitled to approximately 85% of the Total earnings and 82% of the Adjusted earnings of ViiV Healthcare for 2018.    As consideration for the acquisition of Shionogi's interest in the former Shionogi-ViiV Healthcare joint venture in 2012, Shionogi received the 10% equity stake in ViiV Healthcare and ViiV Healthcare also agreed to pay additional future cash consideration to Shionogi, contingent on the future sales performance of the products being developed by that joint venture, principally dolutegravir.  Under IFRS 3 'Business combinations', GSK was required to provide for the estimated fair value of this contingent consideration at the time of acquisition and is required to update the liability to the latest estimate of fair value at each subsequent period end.  The liability for the contingent consideration recognised in the balance sheet at the date of acquisition was £659 million.  Subsequent re-measurements are reflected within other operating income/expense and within Adjusting items in the income statement in each period.  At 31 December 2018, the liability, which is discounted at 8.5%, stood at £5,937 million, on a post-tax basis.   Cash payments to settle the contingent consideration are made to Shionogi by ViiV Healthcare each quarter, based on the actual sales performance of the relevant products in the previous quarter.  These payments reduce the balance sheet liability and hence are not recorded in the income statement.  The cash payments made to Shionogi by ViiV Healthcare in 2018 were £793 million.   Because the liability is required to be recorded at the fair value of estimated future payments, there is a significant timing difference between the charges that are recorded in the Total income statement to reflect movements in the fair value of the liability and the actual cash payments made to settle the liability.    Further explanation of the acquisition-related arrangements with ViiV Healthcare are set out on page 64.

 

 

Financial performance - 2018

 

Total results

 

	2018 £m		2017 £m		Growth £%		Growth CER%
Turnover	30,821		30,186		2		5
Cost of sales	(10,241)		(10,342)		(1)		-
Gross profit	20,580		19,844		4		7
Selling, general and administration	(9,915)		(9,672)		3		5
Research and development	(3,893)		(4,476)		(13)		(12)
Royalty income	299		356		(16)		(17)
Other operating income/(expense)	(1,588)		(1,965)
Operating profit	5,483		4,087		34		43
Finance income	81		65
Finance expense	(798)		(734)
Profit on disposal of associates	3		94
Share of after tax profits of associates   and joint ventures	31		13
Profit before taxation	4,800		3,525		36		46
Taxation	(754)		(1,356)
Tax rate %	15.7%		38.5%
Profit after taxation	4,046		2,169		87		100
Profit attributable to non-controlling   interests	423		637
Profit attributable to shareholders	3,623		1,532
	4,046		2,169		87		100
Earnings per share	73.7p		31.4p		>100		>100

 

 

Sales performance - 2018

 

Group turnover by business	2018
	£m		Growth £%		Growth CER%
Pharmaceuticals	17,269		-		2
Vaccines	5,894		14		16
Consumer Healthcare	7,658		(1)		2
Group turnover	30,821		2		5

 

Group turnover was up 2% AER, 5% CER to £30,821 million.   Pharmaceuticals sales were flat at AER but up 2% CER, driven primarily by the growth in HIV sales and the new Respiratory products, Nucala and the Ellipta portfolio.  This was partly offset by lower sales of Seretide/Advair and Established Pharmaceuticals.  Overall Respiratory sales declined 1% AER but grew 1% CER.   Vaccines sales were up 14% AER, 16% CER, primarily driven by sales of Shingrix in the US and growth in influenza and Hepatitis vaccines, which also benefited from a competitor supply shortage, partly offset by declines in some Established Vaccines.   Consumer Healthcare sales declined 1% AER but grew 2% CER with broad-based growth in Oral health and Wellness partly offset by increased competitive pressures in Europe, the divestments of some smaller brands, including Horlicks and MaxiNutrition in the UK, as well as the impact of the implementation of the Goods & Services Tax (GST) in India.

 

Group turnover by geographic region	2018
	£m		Growth £%		Growth CER%
US	11,982		6		9
Europe	7,973		-		(1)
International	10,866		(1)		4
Group turnover	30,821		2		5

 

US sales grew 6% AER, 9% CER, driven by the growth of Shingrix and Hepatitis vaccines as well as strong performances from HIV and Benlysta, offset by declines in Established Pharmaceuticals and Respiratory.   Europe sales were flat at AER, but declined 1% CER, as declines in Established Pharmaceuticals, older HIV products, Meningitis vaccines and Consumer Healthcare more than offset growth from Tivicay and Triumeqand the new Respiratory products.   In International, sales declined 1% AER, but grew 4% CER, reflecting strong growth in Tivicay, Triumeq and the Respiratory portfolio.  Sales in Emerging Markets declined 2% AER, but grew 4% CER.

 

 

Pharmaceuticals

 

	2018
	£m		Growth £%		Growth CER%
Respiratory	6,928		(1)		1
HIV	4,722		9		11
Immuno-inflammation	472		25		28
Established Pharmaceuticals	5,147		(7)		(4)
	17,269		-		2
US	7,453		(2)		1
Europe	4,072		2		1
International	5,744		-		5
	17,269		-		2

 

Pharmaceuticals turnover in the year was £17,269 million, flat at AER, but up 2% CER, driven primarily by the growth in HIV sales, which were up 9% AER, 11% CER, to £4,722 million, reflecting share growth over the year in the dolutegravir portfolio; Triumeq, Tivicay and Juluca.  Respiratory sales declined 1% AER, but grew 1% CER, to £6,928 million, with growth from the Ellipta portfolio and Nucala partly offset by lower sales of Seretide/Advair.  Sales of Established Pharmaceuticals were down 7% AER, 4% CER.   In the US, sales declined 2% AER but grew 1% at CER, with growth in the HIV portfolio and Benlysta offsetting declines in Established Pharmaceuticals and Respiratory.  In Europe, sales grew 2% AER, 1% CER, with growth in the Respiratory portfolio offsetting the continued impact of generic competition to Epzicom and Avodart.  International was flat at AER but grew 5% CER, with growth driven by HIV and the new Respiratory portfolio.   Respiratory Total Respiratory sales declined 1% AER, but grew 1% CER, with the US down 5% AER, 3% CER.  In Europe, sales grew 5% AER, 4% CER and International grew 3% AER, 7% CER.  Growth from the Ellipta portfolio and Nucala was partly offset by lower sales of Seretide/Advair.   Sales of Nucala were £563 million in the year, up 64% AER, 66% CER, continuing to benefit from the global rollout of the product.  US sales of Nucala grew 44% AER, 48% CER to £341 million, despite increased competition, benefiting from continued market expansion.   Sales of Ellipta products were up 29% AER, 32% CER, driven by continued growth in all regions.  In the US, sales grew 24% AER, 27% CER, reflecting further market share gains, partly offset by the impact of continued competitive pricing pressures, particularly for ICS/LABAs.  In Europe, sales grew 42% AER, 41% CER.  Sales of Trelegy Ellipta, our new once-daily closed triple product, contributed £156 million to total Ellipta sales, benefiting from an expanded label in the US.   Relvar/Breo Ellipta sales grew 8% AER, 10% CER, to £1,089 million, primarily driven by growth in Europe, which was up 25% AER, 24% CER to £253 million, and in International, which was up 26% AER, 31% CER to £255 million.  In the US, Breo Ellipta sales declined 3% AER, 1% CER, with volume growth of 27%, reflecting continued market share growth, offset by the combined impact of prior period payer rebate adjustments and increased competitive pricing pressure.  Anoro Ellipta sales grew 39% AER, 42% CER to £476 million, driven primarily by share gains in the US.  All Ellipta products, Breo, Anoro, Incruse, Arnuity and Trelegy, continued to grow market share in the US during the year.   Sales of New Respiratory products, comprising Ellipta products and Nucala, grew 35% AER, 38% CER to £2,612 million.   Seretide/Advair sales declined 23% AER, 21% CER to £2,422 million.  Sales of Advair in the US declined 32% AER, 30% CER (9% volume decline and 21% negative impact of price) primarily reflecting increased competitive pricing pressures.  In Europe, Seretide sales were down 19% AER, 20% CER to £599 million (13% volume decline and a 7% price decline).  This reflected continued competition from generic products and the transition of the Respiratory portfolio to newer products.  In International, sales of Seretide were down 7% AER, 4% CER, to £726 million (5% volume decline and 1% positive impact of price), with declines in markets with generic competition partly offset by growth from other developing markets.   HIV HIV sales increased 9% AER, 11% CER to £4,722 million in the year, with the US up 8% AER, 10% CER, Europe up 7% AER, 6% CER and International up 14% AER, 20% CER.   The growth was driven by the increase in market share over the year in the dolutegravir products which grew 14% AER, 16% CER.  This was partly offset by the decline in the established portfolio, particularly the impact of generic competition to Epzicom/Kivexa in Europe.  Triumeq, Tivicay and Juluca (which was approved in the US in November 2017), recorded sales of £2,648 million, £1,639 million and £133 million, respectively, in the year.  Epzicom/Kivexa sales declined 50% AER, 48% CER to £117 million.   Immuno-inflammation Sales in the year were up 25% AER, 28% CER, primarily driven by Benlysta, which grew 26% AER, 29% CER to £473 million.  In the US, Benlysta grew 24% AER, 27% CER to £420 million, benefiting from the launch of the sub-cutaneous formulation in the third quarter.   Established Pharmaceuticals Sales of Established Pharmaceuticals were £5,147 million, down 7% AER, 4% CER, reflecting efforts to maximise the value from this portfolio but also the benefit of certain post-divestment contract manufacturing sales and the first instalment of a 12-month Relenza supply contract in Europe.   The Avodart franchise was down 7% AER, 5% CER to £572 million, primarily due to the loss of exclusivity in Europe, with the US impact now broadly annualised.  Coreg franchise sales declined 63% AER, 63% CER following a generic Coreg CR entrant to the US market in Q4 2017.  Lamictal sales declined 5% AER, 3% CER to £617 million.

 

 

Vaccines

 

	2018
	£m		Growth £%		Growth CER%
Meningitis	881		(1)		2
Influenza	523		7		10
Shingles	784		>100		>100
Established Vaccines	3,706		(1)		-
	5,894		14		16
US	2,701		45		48
Europe	1,561		(2)		(4)
International	1,632		(3)		-
	5,894		14		16

 

Vaccines turnover grew 14% AER, 16% CER to £5,894 million, primarily driven by growth in sales of Shingrix, Hepatitis vaccines, which also benefited from a competitor supply shortage and higher sales of influenza products.  This was partly offset by lower sales of DTPa-containing vaccines (Infanrix, Pediarix and Boostrix) due to increased competitive pressures, particularly in Europe, and unfavourable year-on-year CDC stockpile movements in the US, together with lower Synflorix sales, reflecting lower pricing and demand in Emerging Markets.   Meningitis Meningitis sales were down 1% AER but up 2% CER to £881 million.  Bexsero sales grew 5% AER, 9% CER driven by demand and share gains in the US, together with continued growth in private market sales in International, partly offset by the completion of vaccination of catch-up cohorts in certain markets in Europe.  Menveo sales declined 15% AER, 12% CER, primarily reflecting supply constraints in Europe and International as well as a strong comparator in 2017 and unfavourable year-on-year CDC stockpile movements in the US, partly offset by demand and share gains in the US.   Influenza Fluarix/FluLaval sales grew 7% AER, 10% CER to £523 million, driven by strong sales execution in the US and improved sales in Europe, partly offset by increased price competition in the US.   Shingles Shingrix recorded sales of £784 million, primarily in the US and Canada, driven by demand and share gains. US sales benefited from market growth in new patient populations now covered by immunisation recommendations and Shingrix has now achieved a 98% market share.     Established Vaccines Sales of DTPa-containing vaccines (Infanrix, Pediarix and Boostrix) were down 8% AER, 7% CER. Infanrix, Pediarix sales were down 8% AER, 7% CER to £680 million, reflecting increased competitive pressures in Europe as well as unfavourable year-on-year CDC stockpile movements in the US, partly offset by stronger demand in International.  Boostrix sales declined 8% AER, 7% CER to £517 million, primarily driven by the return to the market of a competitor in Europe and lower demand in International.   Hepatitis vaccines grew 17% AER, 19% CER to £808 million, benefiting from stronger demand in the US and Europe as well as a competitor supply shortage in the US.   Rotarix sales were down 1% AER but up 1% CER to £521 million, reflecting higher demand in Europe, partly offset by lower demand in International.   Synflorix sales declined 17% AER, 17% CER to £424 million, primarily impacted by lower pricing and demand in Emerging Markets.

 

 

Consumer Healthcare

 

	2018
	£m		Growth £%		Growth CER%
Wellness	3,940		(2)		1
Oral health	2,496		1		4
Nutrition	643		(5)		1
Skin health	579		(4)		(1)
	7,658		(1)		2
US	1,828		-		2
Europe	2,340		(1)		(2)
International	3,490		(2)		4
	7,658		(1)		2

 

Consumer Healthcare sales in the year declined 1% AER but grew 2% CER to £7,658 million, with broad-based growth in Oral health and Wellness partly offset by a decline in Panadol and lower sales of smaller brands.  International markets performed strongly, particularly India and Brazil, whilst Europe was impacted by intensifying competitive pressure in the second half of 2018.   The aggregate impact from generic competition on Transderm Scop in the US, the divestment of Horlicks and MaxiNutrition in the UK and other small non-strategic brands and implementation of the Goods & Service Tax (GST) in India was to reduce overall sales growth by approximately one percentage point.   Wellness Wellness sales declined 2% AER but grew 1% CER to £3,940 million.  Respiratory sales grew in low single digits, led by Theraflu supported by a strong cold and flu season earlier in the year as well as the TherafluPowerPods launch in the US in the second half of the year.  Otrivin grew in mid single digits, benefiting from new variants, and Flonase returned to growth following a weaker allergy season earlier this year.   Pain relief sales were flat as low single-digit growth in Voltaren and double-digit growth in Fenbid were offset by a decline in Panadol sales due to a change in the route-to-market model in South-East Asia and the discontinuation of slow-release Panadol products in the Nordic countries.   Oral health Oral health sales grew 1% AER, 4% CER to £2,496 million, as increased competitive pressures in Europe were offset by double digit growth from Sensodyne in a number of International markets, including India and Turkey, and strong single-digit growth in the US driven by Sensodyne Rapid.  Denture care grew in high single digits through the launch of Corega Max in Russia and Brazil and Gum health delivered double-digit growth with continued strong Parodontax performance in the US.  Growth was also partly impacted by de-stocking in International.   Nutrition Nutrition sales declined 5% AER but grew 1% CER to £643 million.  The Nutrition business in India performed strongly across the product portfolio including new innovations such as Horlicks Protein+ which was launched earlier in the year.  The impact of divestments and India GST implementation on growth was approximately eight percentage points.   Skin health Skin health sales were down 4% AER, 1% CER to £579 million, largely driven by a decline in Physiogel and the divestment of several small non-strategic brands in the US, which had a negative impact on growth of one percentage point.

 

 

Total results - 2018

 

Cost of sales Cost of sales as a percentage of turnover was 33.2%, down 1.0 percentage points at AER and 1.4 percentage points in CER terms compared with 2017.  This primarily reflected a favourable comparison with £363 million of non-cash restructuring costs from the write-downs of assets in 2017 related to the decision to withdraw Tanzeum progressively.  The year also benefited from a more favourable product mix in Vaccines and Consumer Healthcare, particularly the launch of Shingrix, together with a further contribution from integration and restructuring savings.  This was partly offset by continued adverse pricing pressure in Pharmaceuticals, particularly in Respiratory, and in Established Vaccines, together with increased input costs and an adverse comparison with the benefit of a settlement for lost third party supply volume in 2017 in Vaccines.   Selling, general and administration SG&A costs as a percentage of turnover were 32.2%, 0.1 percentage points higher than in 2017 at both AER and CER, reflecting growth of 3% AER, 5% CER.  The increase in SG&A costs primarily reflected higher restructuring costs, and investment in promotional product support, particularly for new launches in Respiratory, HIV and Vaccines, partly offset by tight control of ongoing costs, particularly in non-promotional and back office spending, across all three businesses.   Research and development R&D expenditure was £3,893 million (12.6% of turnover), 13% AER, 12% CER lower than in 2017.  This reflected reduced restructuring costs primarily due to the comparison with the provision for obligations as a result of the decision to withdraw Tanzeum in 2017 and lower intangible impairments, a favourable comparison with the impact of the Priority Review Voucher purchased and utilised in H1 2017 and the benefit of the R&D prioritisation initiatives started in the second half of last year.  This was partly offset by increased investment in the progression of a number of mid and late-stage programmes, particularly in Oncology, as well as provisions for the costs payable to a third party relating to the use of a Priority Review Voucher awarded in 2018.   Royalty income Royalty income was £299 million (2017: £356 million), down 16% AER and 17% CER, the reduction primarily reflecting the patent expiry of Cialis, partly offset by an increase in the Gardasil royalty.   Other operating income/(expense) Other operating expense of £1,588 million (2017: £1,965 million) primarily reflected £1,846 million (2017: £1,517 million) of accounting charges arising from the re-measurement of the contingent consideration liabilities related to the acquisitions of the former Shionogi-ViiV Healthcare joint venture and the former Novartis Vaccines business, the value attributable to the Consumer Healthcare Joint Venture put option previously held by Novartis and the liabilities for the Pfizer put option and Pfizer and Shionogi preferential dividends in ViiV Healthcare.  The 2017 charges included the impact of US tax reform, which increased the fair value of these liabilities by £666 million.  This was partly offset by the profit on a number of asset disposals, including tapinarof, as well as a gain arising from the increase in value of the shares in Hindustan Unilever Limited to be received on the disposal of Horlicks and other Consumer Healthcare brands, net of disposal costs.   The accounting charges were driven primarily by a £758 million re-measurement of the contingent consideration liability due to Shionogi, largely related to the regular updates of exchange rate assumptions to period end rates and sales forecasts following a number of studies including the GEMINI study completed in Q2 2018, together with a £430 million unwind of the discount.  In addition, a net charge of £658 million reflected the re-measurement of the valuation of the Consumer Healthcare put option to reflect the price agreed with Novartis to acquire its shareholding, together with movements in exchange rates largely offset by gains on hedging contracts.   Operating profit Total operating profit was £5,483 million in 2018 compared with £4,087 million in 2017.  The increase in operating profit primarily reflected a favourable comparison with charges of £666 million in 2017 arising from the impact of US tax reform on the valuation of the Consumer Healthcare and HIV businesses and reduced restructuring costs and asset impairments.  In addition, there was a contribution from sales growth, a more favourable mix, primarily in Vaccines and Consumer Healthcare, benefits from the prioritisation of R&D expenditure and comparison with the impact of the Priority Review Voucher utilised and expensed in 2017, alongside continued tight control of ongoing costs.  This was partly offset by the increased impact of accounting charges related to the re-measurement of the liabilities for contingent consideration, put options and preferential dividends, continuing pricing pressure, particularly in Respiratory, increased input costs, the comparison with the benefit in Q2 2017 of a settlement for lost third party supply volume in Vaccines, investments in new product support, particularly for launches in Respiratory, HIV and Vaccines and a reduction in royalty income.   Contingent consideration cash payments which are made to Shionogi and other companies reduce the balance sheet liability and hence are not recorded in the income statement.  Total contingent consideration cash payments in 2018 amounted to £1,137 million (2017: £685 million).  This included a cash milestone paid to Novartis of $450 million (£317 million) as well as cash payments made to Shionogi of £793 million (2017: £671 million).   Net finance costs Net finance costs were £717 million compared with £669 million in 2017.  This reflected higher debt levels following the acquisition from Novartis of its stake in the Consumer Healthcare Joint Venture in June 2018 as well as additional interest on tax arising from a historic tax settlement, recorded in Q3 2018, and an adverse comparison with a provision release of £24 million in Q4 2017, partly offset by the benefit of a one-off accounting adjustment to the amortisation of long term bond interest charges of £20 million in Q1 2018, the benefit from older bonds being refinanced at lower interest rates and the translation impact of exchange rate movements on the reported Sterling costs of foreign currency denominated interest-bearing instruments.   Taxation The charge of £754 million represented an effective tax rate on Total results of 15.7% (2017: 38.5%) and reflected the different tax effects of the various Adjusting items.  This includes the effect of a reduced estimate of the 2017 impact of US tax reform of £125 million, following additional guidance being released by the IRS and a re-assessment of estimates of uncertain tax positions following the settlement of a number of open issues with tax authorities.  The reduction from the prior year effective tax rate on Total profits was driven primarily by a favourable comparison with the impact of US tax reform, which resulted in a number of charges in Q4 2017.   Non-controlling interests The allocation of earnings to non-controlling interests amounted to £423 million (2017: £637 million).  The reduction was primarily due to the lower allocation of Consumer Healthcare profits of £117 million (2017: £415 million) following the buyout of Novartis' interest.  This was partly offset by an increased allocation of ViiV Healthcare profits and higher net profits in some of the Group's other entities with non-controlling interests.   Earnings per share Total earnings per share was 73.7p, compared with 31.4p in 2017.  The increase in earnings per share primarily reflected a favourable comparison with charges in 2017 arising from the impact of US tax reform, reduced restructuring costs and asset impairments, increased operating profits, a lower tax rate and a reduced non-controlling interest allocation of Consumer Healthcare profits, partly offset by higher transaction-related charges arising from increases in the valuation of the liabilities for contingent consideration, put options and preferential dividends.

 

Currency impact on 2018 results The results for 2018 are based on average exchange rates, principally £1/$1.33, £1/€1.13 and £1/Yen 147.  Comparative exchange rates are given on page 59.  The period-end exchange rates were £1/$1.27, £1/€1.11 and £1/Yen 140.   In 2018, turnover increased 2% in AER terms and 5% CER.  Total EPS was 73.7p compared with 31.4p in 2017.  The negative currency impact primarily reflected the strength of Sterling, particularly against the US Dollar, Yen and Emerging Market currencies, relative to 2017.

 

 

Adjusting items The reconciliations between Total results and Adjusted results for 2018 and 2017 are set out below.

 

Year ended 31 December 2018

 

	Total results £m	Intangible amort- isation £m	Intangible impair- ment £m	Major restruct- uring £m	Transaction- related £m	Divestments, significant legal and other items £m	Adjusted results £m
	------------	------------	------------	------------	------------	------------	------------
Turnover	30,821						30,821
Cost of sales	(10,241)	536	69	443	15	-	(9,178)
	------------	------------	------------	------------	------------	------------	------------
Gross profit	20,580	536	69	443	15	-	21,643
Selling, general and administration	(9,915)		2	315	98	38	(9,462)
Research and development	(3,893)	44	45	49		20	(3,735)
Royalty income	299						299
Other operating income/(expense)	(1,588)			2	1,864	(278)	-
	------------	------------	------------	------------	------------	------------	------------
Operating profit	5,483	580	116	809	1,977	(220)	8,745
Net finance costs	(717)			4	(3)	18	(698)
Profit on disposal of associates	3					(3)	-
Share of after tax profits of   associates and joint ventures	31						31
	------------	------------	------------	------------	------------	------------	------------
Profit before taxation	4,800	580	116	813	1,974	(205)	8,078
Taxation	(754)	(109)	(19)	(170)	(239)	(244)	(1,535)
Tax rate %	15.7%						19.0%
	------------	------------	------------	------------	------------	------------	------------
Profit after taxation	4,046	471	97	643	1,735	(449)	6,543
	------------	------------	------------	------------	------------	------------	------------
Profit attributable to   non-controlling interests	423				251		674
Profit attributable to   shareholders	3,623	471	97	643	1,484	(449)	5,869
	------------	------------	------------	------------	------------	------------	------------
Earnings per share	73.7p	9.6p	2.0p	13.1p	30.2p	(9.2)p	119.4p
	------------	------------	------------	------------	------------	------------	------------
Weighted average number of   shares (millions)	4,914						4,914
	------------						------------

 

 

Year ended 31 December 2017

 

	Total results £m	Intangible amort- isation £m	Intangible impair- ment £m	Major restruct- uring £m	Transaction- related £m	Divestments, significant legal and other items £m	US tax reform £m	Adjusted results £m
	------------	------------	------------	------------	------------	------------	------------	------------
Turnover	30,186							30,186
Cost of sales	(10,342)	546	400	545	80	-		(8,771)
	------------	------------	------------	------------	------------	------------	------------	------------
Gross profit	19,844	546	400	545	80	-		21,415
Selling, general and   administration	(9,672)			248		83		(9,341)
Research and   development	(4,476)	45	288	263		18		(3,862)
Royalty income	356							356
Other operating income/   (expense)	(1,965)				1,519	(220)	666	-
	------------	------------	------------	------------	------------	------------	------------	------------
Operating profit	4,087	591	688	1,056	1,599	(119)	666	8,568
Net finance costs	(669)			4		8		(657)
Profit on disposal of   associates	94					(94)		-
Share of after tax profits   of associates and joint   ventures	13							13
	------------	------------	------------	------------	------------	------------	------------	------------
Profit before taxation	3,525	591	688	1,060	1,599	(205)	666	7,924
Taxation	(1,356)	(134)	(176)	(209)	(619)	(251)	1,078	(1,667)
Tax rate %	38.5%							21.0%
	------------	------------	------------	------------	------------	------------	------------	------------
Profit after taxation	2,169	457	512	851	980	(456)	1,744	6,257
	------------	------------	------------	------------	------------	------------	------------	------------
Profit attributable to   non-controlling interests	637				42		114	793
Profit attributable to   shareholders	1,532	457	512	851	938	(456)	1,630	5,464
	------------	------------	------------	------------	------------	------------	------------	------------
Earnings per share	31.4p	9.4p	10.5p	17.4p	19.2p	(9.4)p	33.3p	111.8p
	------------	------------	------------	------------	------------	------------	------------	------------
Weighted average   number of shares   (millions)	4,886							4,886
	------------							------------

 

Intangible asset amortisation and impairment Intangible asset amortisation was £580 million compared with £591 million in 2017.  Intangible asset impairments related to commercial and Pharmaceuticals R&D development assets were £116 million (2017: £688 million).  The 2017 charge included impairments related to the withdrawal of Tanzeum and a number of other commercial and Pharmaceuticals R&D development assets.  These charges were non-cash items.

 

Major restructuring and integration Within the Pharmaceuticals sector, the highly regulated manufacturing operations and supply chains and long lifecycle of the business mean that restructuring programmes, particularly those that involve the rationalisation or closure of manufacturing or R&D sites, are likely to take several years to complete.   Major restructuring costs are those related to specific Board approved Major restructuring programmes.  Major restructuring programmes, including integration costs following material acquisitions, are those that are structural and are of a significant scale where the costs of individual or related projects exceed £25 million.  Other ordinary course smaller scale restructuring costs are retained within Total and Adjusted results.   The Board approved a new Major restructuring programme in July 2018, which is designed to significantly improve the competitiveness and efficiency of the Group's cost base with savings delivered primarily through supply chain optimisation and reductions in administrative costs.

 

Total Major restructuring charges incurred in 2018 were £809 million (2017: £1,056 million), analysed as follows:

 

	2018						2017
	Cash £m		Non-cash £m		Total £m		Cash £m		Non-cash £m		Total £m
Combined restructuring and   integration programme	330		110		440		531		525		1,056
2018 major restructuring   programme	279		90		369		-		-		-
	609		200		809		531		525		1,056

 

Non-cash charges arising under the existing Combined restructuring and integration programme primarily related to the write-down of assets as part of the announced plans to reduce the manufacturing network.  Cash charges arose from restructuring in the Europe and International Pharmaceuticals commercial operations and some manufacturing sites.  Non-cash charges under the 2018 major restructuring programme primarily related to announced plans to restructure the manufacturing network and cash charges to date under the 2018 major restructuring programme primarily related to restructuring in the US Pharmaceuticals commercial operation, as well as some manufacturing sites and central functions.    Total cash payments for the two programmes made in the year were £537 million (2017: £555 million).   The analysis of major restructuring charges by business was as follows:

 

	2018 £m		2017 £m
Pharmaceuticals	563		682
Vaccines	104		177
Consumer Healthcare	72		137
	739		996
Corporate & central functions	70		60
Total Major restructuring costs	809		1,056

 

The analysis of Major restructuring charges by Income statement line was as follows:

 

	2018 £m		2017 £m
Cost of sales	443		545
Selling, general and administration	315		248
Research and development	49		263
Other operating income/(expense)	2		-
Total Major restructuring costs	809		1,056

 

The Combined restructuring and integration programme delivered incremental annual cost savings in the year of £0.3 billion.  Given its relatively recent launch, the benefit delivery this year from the 2018 major restructuring programme was not material.

 

The analysis of incremental annual cost savings in the year by Income statement line was as follows:

 

	2018 £bn		2017 £bn
Cost of sales	0.2		0.2
Selling, general and administration	0.1		0.4
Research and development	-		0.1
Total Major restructuring savings	0.3		0.7

 

Total cash charges for the Combined restructuring and integration programme are now expected to be approximately £4.1 billion with non-cash charges up to £1.6 billion.  The programme has now delivered approximately £3.9 billion of annual savings, including an estimated currency benefit of £0.3 billion.  The programme is now expected to deliver by 2020 total annual savings of £4.4 billion on a constant currency basis, including an estimated benefit of £0.4 billion from currency on the basis of 2018 average exchange rates.   The 2018 major restructuring programme is expected to cost £1.7 billion over the period to 2021, with cash costs of £0.8 billion and non-cash costs of £0.9 billion, and is expected to deliver annual savings of around £400 million by 2021 (at 2018 rates).  These savings will be fully re-invested to help fund targeted increases in R&D and commercial support of new products.

 

Transaction-related adjustments Transaction-related adjustments resulted in a net charge of £1,977 million (2017: £1,599 million).  This primarily reflected £1,846 million of accounting charges for the re-measurement of the contingent consideration liabilities related to the acquisitions of the former Shionogi-ViiV Healthcare joint venture and the former Novartis Vaccines business, the value attributable to the Consumer Healthcare Joint Venture put option held by Novartis and the liabilities for the Pfizer put option and Pfizer and Shionogi preferential dividends in ViiV Healthcare.

 

Charge/(credit)	2018 £m		2017 £m
Consumer Healthcare Joint Venture put option	658		986
Contingent consideration on former Shionogi-ViiV Healthcare   Joint Venture (including Shionogi preferential dividends)	1,188		556
ViiV Healthcare put options and Pfizer preferential dividends	(58)		(126)
Contingent consideration on former Novartis Vaccines business	58		101
Other adjustments	131		82
Total transaction-related charges	1,977		1,599

 

A net charge of £658 million relating to the Consumer Healthcare Joint Venture represented the re-measurement of the valuation of the Consumer Healthcare put option to the agreed valuation of $13 billion (£9.2 billion on signing), together with an increase due to movements in exchange rates, which was largely offset by gains on hedging contracts.   The £1,188 million charge relating to the contingent consideration for the former Shionogi-ViiV Healthcare Joint Venture represented a £758 million increase in the valuation of the contingent consideration due to Shionogi, primarily as a result of updated exchange rate assumptions and sales forecasts following the GEMINI study completed in Q2 2018, together with a £430 million unwind of the discount.   Other adjustments included a £51 million charge reflecting the release of an indemnity asset relating to the tax treatment of inventory acquired as part of the Novartis Vaccines acquisition, with a corresponding offset in tax, as well as acquisition costs relating to the acquisition of Tesaro completed in January 2019 and the announced agreement with Pfizer to combine our consumer healthcare businesses.   Contingent consideration cash payments which are made to Shionogi and other companies reduce the balance sheet liability and hence are not recorded in the income statement.  Total contingent consideration cash payments in the year amounted to £1,137 million (2017: £685 million).  This included a cash milestone paid to Novartis of $450 million (£317 million) as well as cash payments made by ViiV Healthcare to Shionogi in relation to its contingent consideration liability (including preferential dividends) which amounted to £793 million (2017: £671 million).   An explanation of the accounting for the non-controlling interests in ViiV Healthcare is set out on page 64.   Divestments, significant legal charges and other items Divestments and other items included the profit on a number of asset disposals, including tapinarof, a gain arising from the increase in value of the shares in Hindustan Unilever Limited to be received on the disposal of Horlicks and other Consumer Healthcare brands, which is expected to complete by the end of 2019, net of disposal costs, as well as equity investment impairments and certain other adjusting items.  A charge of £33 million (2017: £68 million) for significant legal matters included the benefit of the settlement of existing matters as well as provisions for ongoing litigation.  Significant legal cash payments were £39 million (2017: £192 million).

 

 

Adjusted results The reconciliations between Total results and Adjusted results for 2018 and 2017 are set out on pages 14 and 15.

 

	2018
	£m		% of turnover		Growth £%		Growth CER%
Turnover	30,821		100		2		5
Cost of sales	(9,178)		(29.8)		5		6
Selling, general and administration	(9,462)		(30.7)		1		4
Research and development	(3,735)		(12.1)		(3)		(2)
Royalty income	299		1.0		(16)		(17)
Adjusted operating profit	8,745		28.4		2		6
Adjusted profit before tax	8,078				2		6
Adjusted profit after tax	6,543				5		9
Adjusted profit attributable to shareholders	5,869				7		12
Adjusted earnings per share	119.4p				7		12

 

Operating profit by business	2018
	£m		% of turnover		Growth £%		Growth CER%
Pharmaceuticals	8,420		48.8		(3)		-
Pharmaceuticals R&D*	(2,676)				(2)		(1)
Total Pharmaceuticals	5,744		33.3		(3)		-
Vaccines	1,943		33.0		18		25
Consumer Healthcare	1,517		19.8		10		15
	9,204		29.9		3		7
Corporate & other unallocated costs	(459)				22		15
Adjusted operating profit	8,745		28.4		2		6