GlaxoSmithKline plc Final Results for FY 2021

GSK delivers FY 2021 reported sales of £34 billion, stable at AER, +5% CER;

Total EPS 87.6p -24% AER, -13% CER and Adjusted EPS of 113.2p -2% AER, +9% CER

 

 

Highlights

 

Strong commercial execution drives growth across Pharmaceuticals, Vaccines and Consumer Healthcare (excluding brands divested/under review)

·

Pharmaceuticals £17.7 billion +4% AER, +10% CER; New and Specialty medicines £10 billion +20% AER, +26% CER; Respiratory +21% AER, +28% CER; Immuno-inflammation +22% AER, +29% CER; Oncology +31% AER, +37% CER; total HIV -2% AER, +3% CER

·

Vaccines £6.8 billion -3% AER, +2% CER; Shingrix £1.7 billion -13% AER, -9% CER

·

COVID-19 solutions sales £1.4 billion; Xevudy £958 million; pandemic adjuvant £447 million

·

Consumer Healthcare £9.6 billion -4% AER, stable CER (+4% excluding brands divested/under review)

 

 

Continued momentum in R&D delivery and strengthening of pipeline

·

3 major product approvals during 2021; Apretude HIV long-acting medicine for prevention (Dec); Xevudy for COVID-19 (Dec); and Jemperli for endometrial cancer (April)

·

Strong pipeline of 21 vaccines and 43 medicines, many offering potential best or first-in-class opportunities for patients, and of which 22 are in pivotal trials

·

Positive Phase III data on daprodustat in anaemia due to chronic kidney disease presented at American Society of Nephrology. On track to file in EU and US in H1 2022

·

20+ deals executed securing access to 5 novel clinical assets, including with iTeos in immuno-oncology, Alector in immuno-neurology and Vir Biotechnology in flu, plus technologies that expand our capabilities in human genetics and AI

·

Expect to report milestones in 2022 on up to 7 of the 11 potential new vaccines and medicines identified as key future growth drivers including Older Adults RSV vaccine (H1 2022)

 

 

Cost discipline supports delivery of Adjusted EPS of 113.2p

·

Total Group operating margin 18.2%. Total EPS 87.6p -24% AER, -13% CER

·

Adjusted Group operating margin 25.8%. Adjusted EPS 113.2p -2% AER, +9% CER. This included a contribution to growth from COVID-19 solutions of approximately +8% AER, +9% CER (+17% AER, +20% CER for Q4 2021)

·

Full year 2021 net cash flow from operations £8.0 billion. Full year free cash flow £4.4 billion

 

 

On track to demerge a new world-leading Consumer Healthcare business mid-2022

·

Progress to create new Board with appointment of Chair Designate

·

Capital Markets Day on 28 February to highlight overall strategy, capabilities and operations, including detailed financial information and superior growth ambitions

 

 

2022 guidance for new GSK

·

New GSK, the biopharma business, expected to deliver growth in 2022 sales of between 5% to 7% at CER and growth in 2022 Adjusted operating profit of between 12% to 14% at CER including the anticipated benefit in royalty income from Gilead settlement

·

This 2022 guidance excludes any contribution from COVID-19 solutions

·

Dividend of 23p declared for Q4 2021; 80p FY 2021

 

 

Emma Walmsley, Chief Executive Officer, GSK: “We have ended the year strongly, with another quarter of excellent performance driven by first-class commercial execution, and we enter 2022 with good momentum. This is going to be a landmark year for GSK, with a step-change in growth expected and multiple R&D catalysts, including milestones on up to 7 key late-stage pipeline assets. 2022 is also the year when we demerge our world-leading Consumer Healthcare business. At our capital markets event later this month, we will set out the future growth ambitions and highly attractive financial profile of this business, and the outstanding opportunity it provides for shareholders.”

 

 

The Total results are presented in summary on page 2 and under 'Financial performance' on pages 13 and 28 and Adjusted results reconciliations are presented on pages 23 , 24 , 38 and 39 . 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 10 and £% or AER% growth, CER% growth, free cash flow and other non-IFRS measures are defined on page 61 . GSK provides guidance on an Adjusted results basis only, for the reasons set out on page 10 . All expectations, guidance and targets regarding future performance and dividend payments should be read together with 'Guidance, assumptions and cautionary statements' on pages 62 and 63 .

 

 

2021 results

 

 

 

 

 

 

 

 

2021

 

Growth

 

Q4 2021

 

Growth

 

£m

 

£%

 

CER%

 

£m

 

£%

 

CER%

 

 

 

 

 

 

 

 

 

 

 

 

Turnover

34,114  

 

– 

 

 

9,527  

 

 

13

 

 

 

 

 

 

 

 

 

 

 

 

Total operating profit

6,201  

 

(20)

 

(9)

 

895  

 

(16)

 

1

Total earnings per share

87.6p

 

(24)

 

(13)

 

15.0p

 

10 

 

31

 

 

 

 

 

 

 

 

 

 

 

 

Adjusted operating profit

8,806  

 

(1)

 

 

1,893  

 

 

15

Adjusted earnings per share

113.2p

 

(2)

 

 

25.6p

 

 

22

 

 

 

 

 

 

 

 

 

 

 

 

Net cash from operating activities

7,952  

 

(6)

 

 

 

3,767  

 

(2)

 

 

Free cash flow

4,437  

 

(18)

 

 

 

2,901  

 

(7)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2022 guidance

We set out below our guidance for new GSK in 2022. This guidance is provided at CER and excludes the commercial impact of COVID-19 solutions.

 

In 2022 we expect to continue to deliver on our strategic priorities. We plan to increase targeted investment in R&D, to build on and invest behind our top line momentum for key growth drivers and to deliver the demerger of our Consumer Healthcare business in mid-year. Assuming global economies and healthcare systems approach normality as the year progresses, we expect sales of Specialty Medicines to grow approximately 10% at CER and sales of General Medicines to show a slight decrease, primarily reflecting increased genericisation of established Respiratory products. Vaccines sales are expected to grow at a low teens percentage at CER for the year as a whole. However, governments' prioritisation of COVID-19 vaccination programmes and ongoing measures to contain the pandemic are expected to result in some continued disruption to adult immunisations, with the impact weighted to the first half. For Shingrix, despite the potential for short-term pandemic disruption, we continue to expect strong double-digit growth and record annual sales based on strong demand in existing markets and geographical expansion.

 

Reflecting these factors, in 2022 for new GSK we expect sales to grow between 5% to 7% at CER and Adjusted operating profit to grow between 12% to 14% at CER as compared with 2021. This includes the future benefit in royalty income from the settlement and license agreement with Gilead Sciences, Inc. (Gilead) announced on 1 February 2022.

 

Medium term outlooks will be provided for Consumer Healthcare at a Capital Markets Day scheduled for 28 February 2022. Until such time as the formal criteria for treating Consumer Healthcare as a 'Discontinued operation' have been satisfied (currently expected in Q2 2022), GSK will continue to present the Consumer Healthcare business within 'Continuing operations' and will consolidate the business for reporting purposes until the demerger has completed.

 

Dividend policies and expected pay-out ratios are unchanged for new GSK and new Consumer Healthcare (subject to new Consumer Healthcare board approval). The expected distribution per share for the new Consumer Healthcare Company for the second half of 2022 has been adjusted from that highlighted at the GSK Investor Update in June 2021 to reflect the total number of shares in the new Consumer Healthcare company that are expected to be in issue upon demerger. The future dividend policies and guidance in relation to the expected dividend pay-out in 2022 across both new GSK and new Consumer Healthcare are provided on page 43.

 

2022 COVID-19 solutions expectations

In 2022, based on known binding agreements from governments we expect that COVID-19 solutions will contribute a similar sales level to 2021, but a substantially reduced profit contribution due to the increased proportion of lower margin Xevudy sales. We expect this to reduce new GSK Adjusted Operating profit growth (including COVID-19 solutions in both years) by between 5% to 7%. We continue to discuss further opportunities with governments.

 

All expectations, guidance and targets regarding future performance and dividend payments should be read together with 'Guidance, assumptions and cautionary statements' on pages 62 and 63. If exchange rates were to hold at the closing rates on 31 January 2022 ($1.34/£1, €1.20/£1 and Yen 155/£1) for the rest of 2022, the estimated impact on 2022 Sterling turnover growth for new GSK would be stable and if exchange gains or losses were recognised at the same level as in 2021, the estimated impact on 2021 Sterling Adjusted Operating Profit growth for new GSK would also be stable.

 

Results presentation

 

A webcast of the quarterly results presentation hosted by Emma Walmsley, GSK CEO, will be held at 2pm GMT on 9 February 2022. Presentation materials will be published on www.gsk.com prior to the webcast and a transcript of the webcast will be published subsequently.

 

Information available on GSK's website does not form part of, and is not incorporated by reference into, this Results Announcement.

 

 

Operating performance – 2021

 

Turnover

 

 

£m

 

Growth

£%

 

Growth

CER%

 

 

 

 

 

 

Pharmaceuticals

17,729

 

 

10

Vaccines

6,778

 

(3)

 

2

Consumer Healthcare

9,607

 

(4)

 

 

 

 

 

 

 

Group turnover

34,114

 

– 

 

5

 

 

 

 

 

 

 

Group turnover was £34,114 million in the year, stable at AER but up 5% CER. Sales of COVID-19 solutions contributed approximately 4 percentage points to growth in the year.

 

Pharmaceutical turnover in the year was £17,729 million, up 4% AER and 10% CER. Sales of Xevudy, the monoclonal antibody treatment for COVID-19 of £958 million contributed approximately 6 percentage points to total Pharmaceuticals growth.

 

Vaccines turnover was £6,778 million in the year, down 3% AER but up 2% CER, primarily driven by pandemic adjuvant sales, partially offset by lower demand for routine adult vaccination due to COVID-19 vaccination programme deployment and disease circulation across regions. Vaccines turnover excluding pandemic vaccines decreased 9% AER, 5% CER to £6,331 million.

 

Consumer Healthcare turnover was £9,607 million, down 4% AER but remained stable at CER reflecting dilution from divestments given the completion of the portfolio rationalisation at the end of Q1 2021. Sales excluding brands divested/under review decreased 1% AER but increased 4% CER reflecting the underlying strength of brands across the portfolio and categories and continuing growth in e-commerce.

 

Operating profit

Total operating profit was £6,201 million compared with £7,783 million in 2020. This primarily reflected an unfavourable comparison to the net profit on disposal in Q2 2020 of Horlicks and other Consumer brands and resultant sale of shares in Hindustan Unilever. This was partly offset by lower major restructuring costs, lower re-measurement charges on the contingent consideration liabilities and the unwind in 2020 of the fair market value uplift on inventory arising on completion of the Consumer Healthcare Joint Venture with Pfizer.

 

Adjusted operating profit was £8,806 million, 1% lower than 2020 at AER, but 9% higher at CER on a turnover increase of 5% CER. The Adjusted operating margin of 25.8% was 0.3 percentage points lower at AER, 0.9 percentage points higher on a CER basis than in 2020. The increase in Adjusted operating profit primarily reflected the benefit from incremental pandemic sales, sales growth in Pharmaceuticals and tight control of ongoing costs, favourable legal settlements and benefits from continued restructuring across the business. This was offset by lower sales in Vaccines, higher supply chain costs in Vaccines and Consumer Healthcare, divestments in Consumer Healthcare and increased investment in R&D across Vaccines and Pharmaceuticals.

 

Earnings per share

Total EPS was 87.6p, compared with 115.5p in 2020. This primarily reflected an unfavourable comparison as 2020 benefited from the net profit on disposal of Horlicks and related transactions, partly offset by a credit of £397 million to Taxation in 2021 resulting from the revaluation of deferred tax assets, lower major restructuring costs and lower re-measurement charges on the contingent consideration liabilities. Adjusted EPS was 113.2p compared with 115.9p in 2020, down 2% AER but up 9% CER, on a 9% CER increase in Adjusted operating profit primarily reflecting incremental pandemic sales, sales increases in Pharmaceuticals, tight cost control and favourable legal settlements and lower interest costs, partly offset by lower sales in Vaccines, higher supply chain costs in Vaccines, increased R&D investment and a higher effective tax rate.

 

Cash flow

The net cash inflow from operating activities for the year was £7,952 million (2020: £8,441 million). The decrease primarily reflected adverse exchange impacts, increased trade receivables, adverse timing of returns and rebates (RAR) and increased separation costs, partly offset by improved adjusted operating profit at CER and reduced tax payments including tax on disposals.

 

 

Operating performance – Q4 2021

 

Turnover

Q4 2021

 

 

 

 

 

 

 

£m

 

Growth

£%

 

Growth

CER%

 

 

 

 

 

 

Pharmaceuticals

5,221

 

20 

 

25 

Vaccines

1,809

 

(10)

 

(7)

Consumer Healthcare

2,497

 

 

10 

 

 

 

 

 

 

Group turnover

9,527

 

 

13 

 

 

 

 

 

 

 

Group turnover was £9,527 million in the quarter, up 9% AER, 13% CER. Sales of COVID-19 solutions contributed approximately 11 percentage points to total growth in the quarter.

 

Pharmaceutical turnover in the quarter was £5,221 million, up 20% AER, 25% CER. The increase was driven by strong growth in New and Specialty products, partly offset by a decrease in the Established Products portfolio. Sales of Xevudy of £828 million contributed approximately 20 percentage points to Pharmaceuticals growth in the quarter.

 

Vaccines turnover decreased 10% AER, 7% CER to £1,809 million. This was primarily driven by lower Meningitis vaccines sales associated with the return to a normal US back-to-school season, lower DTPa-containing vaccines sales due to unfavourable CDC purchasing patterns in the US and lower Shingrix sales resulting from the negative impact of COVID-19 vaccination programme deployment and disease circulation, partly offset by pandemic adjuvant sales.

 

Consumer Healthcare turnover in the quarter was £2,497 million, up 6% AER, 10% CER. Sales excluding brands divested/under review increased 7% AER, 11% CER with strong growth across the whole portfolio but particularly Respiratory health which rebounded from the historically low cold and flu season in both Q4 2020 and Q1 2021.

 

Operating profit

Total operating profit was £895 million in Q4 2021 compared with £1,061 million in Q4 2020. This reflected higher re-measurement charges on the contingent consideration liabilities including the impact of the Gilead settlement partly offset by lower restructuring and higher profit on disposal of assets.

 

Adjusted operating profit was £1,893 million, 4% higher than Q4 2020 at AER, 15% higher at CER on a turnover increase of 13% CER. The Adjusted operating margin of 19.9% was 0.9 percentage points lower at AER, and 0.2 percentage points higher on a CER basis than in Q4 2020. The increase in Adjusted operating profit primarily reflected leverage from £920 million of pandemic sales as well as strong growth in New and Specialty Products and a favourable prior period RAR adjustment in Pharmaceuticals, continued tight control of ongoing costs and benefits from continued restructuring across the business. This was partly offset by increased investment in R&D, increased investment behind launches and higher supply chain costs resulting from lower demand and higher inventory adjustments in Vaccines.

 

Earnings per share

Total EPS was 15.0p, compared with 13.6p in Q4 2020. This primarily reflected lower restructuring and higher disposal income partly offset by higher re-measurement charges. Adjusted EPS was 25.6p compared with 23.3p in Q4 2020, up 9% AER and 22% CER, on a 15% CER increase in Adjusted operating profit reflecting positive leverage from Xevudy sales in the quarter and lower interest costs partly offset by a higher non-controlling interest allocation of Consumer Healthcare profits.

 

Cash flow

The net cash inflow from operating activities for the quarter was £3,767 million (Q4 2020: £3,855 million). The reduction primarily reflected adverse exchange impacts and a lower seasonal reduction in trade receivables in the quarter and phasing of tax payments partly offset by improved adjusted operating profit at CER and favourable timing of RAR.

 

 

R&D pipeline

 

We focus on the science of the immune system, human genetics and advanced technologies to develop Vaccines and Specialty Medicines in four core therapeutic areas – Infectious Diseases, HIV, Oncology and Immunology/Respiratory. We also remain open to opportunities outside these core therapy areas where there are scale opportunities consistent with the science of the immune system and human genetic validation.

 

As disclosed at the Investor Update on 23 June 2021, the company has a robust late-stage R&D pipeline with many assets having the potential to be first-in-class or best-in-class, as well as offering significant strategic lifecycle opportunities. The late-stage pipeline will help deliver the sales ambition set by the company for 2021-2026 and beyond.

 

Our R&D pipeline currently comprises 64 Vaccines and Specialty Medicines.

 

Pipeline news flow highlights since Q3 2021 are listed below in chronological order.

 

Infectious diseases

 

Rotarix

·

Submitted a supplemental Biologics License Application for Rotarix Liquid (PCV free) in the US

 

Shingrix

·

Received approval in Canada for the prevention of shingles in adults aged 18 years and older who are or who will be at increased risk of shingles due to immunodeficiency or immunosuppression caused by known disease or therapy

 

Varicella new strain candidate vaccine

·

Started a Phase II trial of a varicella candidate vaccine for use in the US for children aged 12 to 15 months

 

Cervarix

·

Withdrew an application to the EMA for the prevention of head and neck cancers related to human papillomavirus (HPV)

 

HIV

 

Apretude (cabotegravir extended-release injectable suspension)

·

Received approval from the FDA for Apretude, the first and only long-acting injectable pre-exposure prophylaxis (PrEP) option to reduce the risk of sexually acquired HIV-1

 

Cabenuva/Vocabria (cabotegravir) and Rekambys (rilpivirine)

·

Received approval from the FDA for every-two-month dosing for virologically suppressed adults living with HIV without prior treatment failure or resistance to cabotegravir or rilpivirine

·

Announced a decision from the European Commission to update the Summary of Product Characteristics for Vocabria and Janssen's Rekambys injections to be initiated with or without an oral lead-in period for the long-acting treatment of HIV

·

Presented positive interim data from the CARISEL Phase IIIb trial showing Vocabria and Janssen's Rekambys can be implemented successfully in a variety of European healthcare settings at the 2021 European AIDS Conference

 

VH4004280 (capsid protein inhibitor)

·

Dosed the first patient in a Phase I trial investigating our capsid protein inhibitor for HIV

 

Oncology

 

Blenrep (belantamab mafodotin)

·

Presented new data from the DREAMM-9 Phase I trial and two collaborative studies at the 2021 American Society of Haematology annual meeting. Collectively, these data suggest that with an optimised dose, schedule and combination treatment, corneal events associated with Blenrep may be reduced in patients receiving earlier lines of therapy

·

Expanded our collaboration with SpringWorks Therapeutics to include two new sub-studies evaluating the combination of Blenrep plus nirogacestat with standard-of-care multiple myeloma therapies in the DREAMM-5 trial

 

Jemperli (dostarlimab)

·

Received approval in Canada for the treatment of adult patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer, that has progressed on or following prior treatment with a platinum containing regimen

 

Immuno-oncology combinations

·

Dosed the first patient in a Phase I trial of GSK4428859 (EOS-448; TIGIT antagonist) in combination with Jemperli (dostarlimab)

 

GSK3326595 and GSK3368715 (PRMT5 inhibitor and Type I PRMT inhibitor)

·

Removed from the Phase I pipeline due to prioritisation within the synthetic lethal portfolio (termination of in-license agreement with Epizyme will be effective on 16 March 2022)

 

Next-generation cell therapy

·

Lyell announced FDA clearance of an Investigational New Drug application to initiate a Phase I trial, in collaboration with GSK, for LYL132 – an investigational T-cell receptor therapy that incorporates next-generation enhancements for patients with solid tumours expressing NY-ESO-1

 

Immunology/Respiratory

 

Nucala (mepolizumab)

·

Received approval from the FDA for a 40 mg prefilled syringe for appropriate patients aged 6 to 11 years old who have severe eosinophilic asthma, administered at home or by a child's health care provider

·

Received approval from the European Commission for Nucala in three additional eosinophil-driven diseases; hypereosinophilic syndrome, eosinophilic granulomatosis with polyangiitis, and chronic rhinosinusitis with nasal polyps, making it the only treatment in Europe approved for use in four eosinophil-driven diseases

·

Received approval in Canada as an add-on maintenance treatment with intranasal corticosteroids in adult patients with severe chronic rhinosinusitis with nasal polyps inadequately controlled by intranasal corticosteroids alone

 

GSK4527223 (AL001; progranulin-elevating monoclonal antibody)

·

Alector presented positive data from the INFRONT-2 Phase II open-label trial of AL001 for the treatment of symptomatic frontotemporal dementia patients with a progranulin mutation at the 2021 Clinical Trials on Alzheimer's Disease conference

 

GSK4532990 (ARO-HSD; RNA interference)

·

Announced a worldwide license agreement with Arrowhead Pharmaceuticals for GSK4532990 (ARO-HSD), a genetically validated investigational RNA interference therapeutic currently in Phase I/II trials for patients with non-alcoholic steatohepatitis (NASH). The agreement covers the medicine's development and commercialisation outside of greater China. The deal closed on 24 January 2022

 

Benlysta (belimumab)

·

Received coverage in China's 2021 National Reimbursement Drug List for paediatric systemic lupus erythematosus in children aged five years and older

·

Recommended by the UK National Institute for Health and Care Excellence (NICE) as an add-on treatment option for active autoantibody-positive systemic lupus erythematosus in eligible people with high disease activity despite standard treatment

 

GSK3888130 (IL-7 monoclonal antibody)

·

Dosed the first patient in a Phase I trial investigating our monoclonal antibody against IL-7, a genetically validated target for multiple sclerosis

 

Opportunity driven

 

Daprodustat (oral hypoxia-inducible factor prolyl hydroxylase inhibitor)

·

Presented new data from five trials in the ASCEND Phase III programme at the American Society of Nephrology's Kidney Week 2021. Presentations from the pivotal ASCEND-ND and ASCEND-D trials confirm the potential for a new oral treatment for patients with anaemia due to chronic kidney disease in both non-dialysis and dialysis settings. These data were simultaneously published in the New England Journal of Medicine

 

Linerixibat (IBAT inhibitor)

·

Dosed the first patient in the GLISTEN Phase III trial for cholestatic pruritus in primary biliary cholangitis

·

Received Orphan Drug Designation from the European Commission

 

GSK3884464

·

Dosed the first patient in a Phase I trial investigating GSK3884464 for heart failure

 

COVID-19

 

Xevudy (sotrovimab, VIR-7831/GSK4182136)

·

Submitted an application to the FDA requesting an amendment to the Emergency Use Authorisation to include intramuscular administration

·

Received binding agreements for the sale of approximately 1.7 million doses worldwide, including a portion of those procured by the US Government

·

Oxford University included sotrovimab in the RECOVERY trial, the world's largest COVID-19 study, as a possible treatment for hospitalised patients

·

Granted marketing authorisation from the European Commission for the early treatment of COVID-19 in adults and adolescents (aged 12 years and over and weighing at least 40 kg) who do not require supplemental oxygen and who are at increased risk of progressing to severe infection

·

Announced that preclinical studies demonstrated sotrovimab retains activity against the full combination of mutations in the spike protein of the Omicron variant

·

Granted conditional marketing authorisation from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) and a supply agreement with the UK Government for the treatment of symptomatic adults and adolescents (aged 12 years and over and weighing at least 40 kg) with acute COVID-19 infection who do not require oxygen supplementation and who are at increased risk of progressing to severe infection

·

Announced data from the COMET-TAIL Phase III trial demonstrating that intramuscular administration of sotrovimab was non-inferior and offered similar efficacy to intravenous administration for high-risk populations

 

Vaccine collaborations

·

Medicago submitted Emergency Use Authorisation for a jointly developed plant-based COVID-19 vaccine candidate in Canada

·

Announced with Medicago data from the Phase III trial of their plant-based COVID-19 vaccine candidate, in combination with GSK's pandemic adjuvant, that demonstrated 71% efficacy against the main variants of SARS-COV-2 circulating at the time of the trial

·

Announced with Sanofi that a single booster dose of the recombinant adjuvanted COVID-19 vaccine candidate was well tolerated and delivered consistently strong immune responses regardless of the primary vaccine received

 

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